Aboutus

As with all global operations, operating under different regulatory guidelines, under-standing different cultural and ethical values, negotiating regional operational procedures and finding the right partner in Emerging Markets has remained a challenge for the research and development based, pharma-ceutical, bio-pharmaceutical and medical devices companies.

JCS with its uniquely selected editorial advisory board will provide you with regional and country by country information on the emerging markets. Information that will enable you to prepare for, and avoid any last minute glitches on Pre Clinical and Clinical Management, Trial Design, Regulatory, Validatory and Submission Issues, Subject Recruitment and Retention, Site management, Data capture and Data collection, Logistics and Patient Information and Compliance. JCS uniquely brings you experiences in trials for Vaccine Development and emerging market diseases.

Nermeen Varawala Vice President, Scientific & Medical Affairs, PRA International.

Wholehearted thanks to our readers, contributors and advertisers for the enthusiastic welcome given to the launch issue of Journal for Clinical Studies. Your response has validated our belief that there is a real place for a journal that addresses the operational, regulatory, clinical and scientific issues related to the conduct of clinical trials in emerging countries. The utilisation of emerging countries for new drug development has been proven to deliver cost and time savings.

In addition it holds the promise to assist with the development of products able to meet huge unmet medical need within both developed and emerging countries. It will be the endeavor of the editorial team at JfrCS to enable our readers to achieve their emerging country clinical trial objectives by providing a forum for the sharing of experiences, highlighting of best practices, updating of regulatory information and discussion of the unresolved scientific questions.

In keeping with our objectives this second issue of JfrCS covers a wide and relevant range of topics. Given the attention that India and China continue to receive, this issue includes numerous points of view on them. Dr. Zeng, of Incrom China explains how the Clinical Trial Approval and Clinical Site Certification process in China so markedly differs from other countries and Stefan Astrom of Astrom Clinical Research presents a survey of domestic CROs in China, arguing that they will increasingly participate in the provision of global pharmaceutical services. Whilst Kamal Sahani, Cliniminds echoes the call of India’s recent but fast growing clinical research sector for education and training initiatives and Ajita Kondalkar of iGATE Clinical Research International explains why the world’s leading pharmaceutical companies are conducting their diabetes mellitus clinical trials in India. Examining the uncharted territories of international clinical research; Maha Al-Farhan of ClinArt International asks whether there is any point in considering the inclusion of Saudi Arabia while Simon Adriensen of Medilingua discusses how to overcome language related hurdles in Africa.

To address the global regulatory matters; Jane Ricciuti, Thomson Reuters reports on the FDA ruling about the acceptance of foreign data from trials not conducted under an IND; whilst Oscar Podesta, Chiltern International and Ezequiel Klimovsky remind us that the regulatory environment in Latin America is steadily evolving and that access, relationships and collaboration with regulatory agencies in the region remains key. Dario Tanziani, Adams & Adams provides an overview of the South African regulatory and intellectual property environment and Francis Crawley brings us up-to-date with regulatory changes in Africa.

On the technology front, Mark Wren, Maria Sumner and Rob Nichols of PhaseForward describe the successful adoption of EDC -electronic data capture- in emerging countries and the ensuing benefits. This is complemented by Darah Ryan of CMED, experiences of setting up Really Remote EDC in Sub Saharan Africa. Ian Davidson of HMD Clinical makes the case for internationalization of clinical trial IT systems from the ground up to overcome the need for redeveloping systems for each country or language on a case by case basis. In addition, Stanley Tam of CRL Medinet describes how Asia has built “fit for purpose” Central Laboratory capabilities – an important facilitator of clinical research in the region and Gbolahan Fatuga of Caligeo Clinical OneVision articulates the unusual idea that public education and encouragement to participate in international clinical trials within emerging countries could assist with combating the huge problem of counterfeit drugs in these countries. We hope that this array of information and ideas will prompt you to send us your feedback and perhaps even write an article sharing your own experiences with our community of professionals engaged in emerging country clinical trials.

Hermann Schulz, MD, CEO, INTERLAB central lab services worldwide GmbH

Welcome to the first issue of JfrCS

Yes, on behalf of the editorial board I want to give a promise to our readers: you will enjoy reading the Journal for Clinical Studies due to it offering a completely different view of clinical research.

Having looked into other journals which are already available both to the pharmaceutical, biotechnology and medical devices industry and to CROs, JfrCS will provide country by country objectives on the various diseases and “hands-on” assistance. You will receive a practical insight for planning multisite clinical studies in developed and emerging countries especially if remote locations or naïve patients are involved. Selected articles will address issues of vehement importance to investigators and patients.

This very first issue of JfrCS gives you a colourful picture of clinical research in Russia (Igor Stefanov, SynRG), Ukraine and Moldova (N.M. Tsvitbaum, INNOPHAR), China (Kelli Bravo, ADOBE) and Africa (Alan Eggleston, CMED), defining the culture shock when dealing with different mentalities and operational procedures. Diseases covered this time include mental disorders (Lars Schmiedeberg, Cognitive Drug Research), cholera (Catherine Lund, OnQ) and infections (Janet Jones, Kendle). Patient safety is specifically taken care by Devrim Dogam, Encorium, in early phase studies and by Mike Blume and Susan Boyle, Spacelabs (ambulatory BP monitoring). Five articles focus on central labs (Hermann Schulz, INTERLAB), cross-border logistics in emerging countries (Alain Eudaric, Parexel), IMP supplies (Claudio Lorck, Temmler Werke), medical devices (Art Gertel, Breadsworth, and Nancy Stark,

Clinical Device Group) and, last but not least, on women participation in clinical trials (Rajam Jaishankar, Quest Life Sciences).

Our promise given above is strongly underlined by the high quality of all these papers and the support of their authors. You as the reader of this new journal can help the JfrCS team by giving your feedback on our content, quality, design and vision. We look forward to your feedback.

Dr. Stefan Astrom, Founder and CEO, Astrom Research International

A good 2009 to all of our readers, contributors and advertisers! The January issue of JfrCS covers a variety of topics and aspects of clinical trials in emerging countries. In line with the mission of the journal, a number of articles contain countryspecific information from emerging markets as to challenges and obstacles, while others cover areas of current interest.

The country-specific articles include procedures for import of drugs in connection with clinical trial applications in China (Xunting Zeng, InCrom China). Two interesting articles describe some challenges of clinical trials in India. Kamal Sahani of CLINIMINDS describes the initiatives of Indian regulatory authorities to restructure regulatory procedures, while Dr. Janet Jones of Kendle examines efforts to maximise the potential for clinical trials in India.

Francis Crawley (GCP Alliance Reviews) describes a joint initiative by the Good Clinical Practice Alliance – Europe (GCPA) in collaboration with the UN Economic Commission for Africa (UNECA) and the African Union (AU), to jointly develop Guidelines for Health Research in Africa (Afroguide). Nigeria is a country that may contribute to the access of patients in international clinical trials. Globahan Fatuga of Calegio Clinical One Vision and Ifeoma Okoye from AGCPN highlight the importance of GCP training in Nigeria and explain the experience gained working with the Train the Trainer Programme.

The clinical trials arena in the United Arab Emirates is developing rapidly. Maha Al-Farhan of Clinart International analyses demographics

and other factors of importance in this process. Two articles pinpoint initiatives by the FDA to engage in clinical research in foreign countries outside the US. Joseph M. Pickett of EXPERTBRIEFINGS depicts the FDA Watch compilation of international laws and regulations while Jerry Boxall of ACM Pivotal describes the impact of FDA opening offices in China and India.

Best practices in the clinical supply chain are focused on in two articles. Claudio Lorck of Temmler AG explains why depots of intermediate storage are often necessary in emerging countries’ settings, and Sean Smith & Ian Hunter of Fisher Scientific discuss the best practices for the clinical supply chain in China and India. Insurance as an overlooked area in trial planning is described by Chris

Tait of CHUBB INSURANCE.

Does the current economic slowdown affect clinical trials in emerging countries? This is discussed by Dr. Nermeen Varawalla of ECCRO, while another aspect is brought forward in an interview with Hermann Schulz, CEO of INTERLAB, as to why central labs are the best choice in complex trials including specialised tests.

Clinical Trials in Rapidly Developing Economies such as the BRIC area (Brazil, Russia, India, and China) is depicted in clear context by Georg Mathis (Appletree GMBH). Elisabeth Moench (Medici Global) stresses the fundamentals of effective pre-study planning when one wants to avoid study delays and poor patient enrolment.

This January issue covers two important therapeutic areas. Karl M. Eckl, of INNOPHAR GmbH, stresses the significance of QTc intervals being recorded under highly controlled settings, while Edward Mukwaya and Catherine Lund of ONQ Consulting contribute with an essential review on malaria: statistics, control and treatment. Adaptive trial design is a new tool for implementing efficient trials.

How and why is explained by Richard Young of CMED. Finally, Jean-Pierre Tassignon (Crossover CRI AG) looks into an area of significant importance to the entire R&D community, namely fraud and misconduct in scientific research.

We welcome all suggestions as to areas of interest to be covered in future issues of the Journal, and hope you will benefit and enjoy the January volume of the JfrCS.

Patricia Lobo, Managing Director & Senior Consultant, Life Science Business Consulting

I’m delighted and honoured to be invited to join the Editorial Advisory Board of JCS. We have some interesting articles in this issue covering drug development and clinical research in China, India, Israel, Russia, Australia and New Zealand, as well as other articles such as cold chain logistics, IT, distribution and logistics of medicines to remote parts of the world, and outsourcing pre-clinical discovery.

In this Spring issue there is an article by James Vornor of Parexel, who reviews the current state of global efforts to improve stroke treatment (page 52 - 55). Every year an estimated 150,000 people in the UK have a stroke. Of all people who suffer from a stroke, about a third are likely to die within the first 10 days, about a third are likely to make a recovery within one month and about a third are likely to be left disabled and needing rehabilitation. Stroke has a greater disability impact than any other medical condition. A quarter of a million people are living with long-term disability as a result of stroke in the UK.

Stroke in low-to middle income countries has doubled in 40 years according to a recent article published in The Lancet Neurology (Feb 2009). New figures show that stroke mortality rates and burden vary greatly by country and between regions, with low-income countries being the most affected. However, known risk factors for stroke, including diabetes and alcohol consumption, are poor predictors of national stroke mortality and burden and do not explain the greater burden in low-income countries.

These are the conclusions of an article to be published online first and in the April edition of The Lancet Neurology, and presented at the International Stroke Conference in San Diego, by S Claiborne Johnston from the University of California, San Francisco, which coordinated the study with the World Health Organization (WHO).

A second study shows that, over the past forty years, the incidence of stroke in low-to-middle income countries has increased by more than 100%, and people living in these countries face a 20% greater risk of stroke than those living in high-income countries, where the incidence of stroke has declined by 42%. These are some of the main findings of a Review by Valery Feigin from the National Research Centre for Stroke in New Zealand and international colleagues, published Online First and in the April edition of The Lancet Neurology. Currently stroke is the number two killer in the world and if the number of incidents in developing countries continues to rise at the same rate, it will be number one within 20 years.

In the UK, ACT F.A.S.T. (recognizing signs in Face, Arms, Speech and Time to call the emergency services) is a new national Government campaign aimed at helping people to recognize the signs of stroke, and to act to save the lives and reduce the damage caused.

Meanwhile, Scientists have developed a tiny scaffold of stem cells to fill holes in the brain caused by stroke damage. So far tested in rats, the biodegradable balls loaded with stem cells were able to replace brain tissue in damaged areas within a week. The team, who report the results in Biomaterials, are now planning to add in a protein to encourage new blood vessel growth in the treated areas. But there is still a long way to go in stem cell therapy for stroke survivors. Previous research in injecting stem cells into rats with stroke damage has had some success but, because they lack structural support, the cells end up migrating into surrounding healthy tissue, the researchers said.

Enjoy our March issue of JCS and I look forward to meeting you at the DIA Spring 2009 in Berlin.

Mark A. Goldberg, M.D., Chief Operating Officer, PAREXEL International

The theme for the 45th Annual DIA Meeting to be held in San Diego, California is “Better Medicines: Improving Safety with Every Step.” This seems an apt theme, particularly against the backdrop of the Obama administration’s likely focus on safety and comparative effectiveness in drug development. Safety will remain paramount in the global search for effective new therapies.

With the knowledge that many potential adverse events will not emerge until much larger populations of patients are exposed, proactive pharmacovigilance planning is a growing focus for the biopharmaceutical industry. Voluntary reporting of adverse events is being replaced by registries and newer forms of non-interventional studies that will better characterise the profiles of marketed treatments. Technology has a key role to play in this area. An example is the potential that electronic medical records hold to mine data for safety signals, with the requisite protection of personal information, without having to use either specially designed studies or to rely on physician reporting. The approach to safety concerns is also evolving as companies implement new Risk Evaluation and Mitigation Strategies (REMS).

In early phase studies, a goal will be to generate more comprehensive safety profiles of compounds. This will be facilitated by innovative trial designs, including the use of adaptive studies. In addition, the role of biomarkers will continue to evolve as a tool to better predict potential safety issues as well as efficacy.

It is anticipated that medications that more specifically target the underlying mechanisms of disease will also have more attractive safety profiles. While the emergence of personalised medicine and the pairing of treatments and diagnostics may be progressing more slowly than some had expected, this area remains an inevitable evolution for the biopharmaceutical industry.

This year’s Annual Meeting will bring representatives of the biopharmaceutical industry together at a time of heightened uncertainty. The industry faces pressures due to global economic challenges, patent expirations, and decreased R&D productivity among other factors. In the U.S., the direction of the new administration, beyond the safety considerations mentioned earlier, is still emerging and includes such considerations as drug importation, pricing, and reimbursement. With large mergers and acquisitions changing the landscape, the industry will likely experience additional shifts in drug development priorities.

Combined with these market dynamics are a few key trends that continue to shape the biopharmaceutical industry, including increased globalisation of drug development, continued adoption of eClinical technologies, and the growing importance of strategic partnerships between CROs and pharmaceutical companies.

• Increased globalisation of drug development is being driven by several factors, including the ability to access diverse patient populations and the lower cost of conducting quality clinical research in emerging geographies. Another major driver is the increasing importance of new end markets for biopharmaceutical products in a number of geographies, including India and China.

• The use of technology has progressed from the adoption of a disparate set of tools from various vendors to the increasing availability of integrated technology suites. These suites offer the potential to meaningfully decrease cost and ease system interoperability. Combining these technology platforms with clinical expertise will help to bring greater productivity to development programs.

• Evolving strategic relationships among service providers and sponsors will lead to new operating models and the emergence of best practices in partnering. These enhanced partnerships, which will create new expectations of CROs in the areas of expertise and relationship management, promise to bring greater innovation and efficiencies to the drug development process.

Since change creates opportunities, it is likely that many of these emerging and ongoing trends will be favourable for the biopharmaceutical services industry, despite the current economic environment. The hope is that industry challenges will further drive innovation and enhance the performance of R&D investments. Service providers have an important role to play, in partnership with sponsors, to fulfil that promise. Given the many significant and evolving dynamics, this year’s meeting promises to foster an interesting dialogue among industry participants.

Mr. Jerry Boxall Managing Director, ACM Global Central Laboratory, Europe

I would like to extend all of our readers, contributors and advertisers a warm welcome to the latest edition of JCS.

As always, we have a wide variety of interesting and thought-provoking articles, this time with a clear focus on the emerging markets.

FDA Watch, compiled by Joseph Pickett of Expertbriefings. com, highlights the toughening stance on enforcement now being adopted by the FDA, backed by the Obama administration, as well as the growth trend now being seen in post-market studies. Continuing on the FDA theme, Alexandra Muntanola of Thomson Reuters highlights new guidance from the FDA that is intended to ensure that complete data sets are retained for FDA-regulated clinical trials.

In Australasia Watch, Russell Neal of CNS Pty. Ltd explores the development of genetically modified organisms (GMOs) in the region, and in China Watch, Dr Xunting Zeng of INCROM China explains the basic requirements for clinical trials in China and takes a look at Drug Administration Law.

Looking at new emerging markets in our ever-changing global landscape, Ebru Oncu of Encorium provides an update on the emergence of Turkey as a market for conducting clinical trials, and the drivers encouraging growth in clinical trials there. Kyung Won Jang of the Korea Health Industry Development Institute provides a report from the Asia-Pacific region on the launch of the APEC Harmonisation Center (AHC) in June, with an inaugural workshop on multi-regional clinical trials, while Dr Claudio Lorck of Temmler AG looks at the temperature-controlled shipment of investigational products to clinical centres.

Continuing the emerging markets theme, our regulatory section takes a look at regulation of data generated in emerging countries, with Prof. Anthony Woodman of ICRI Global Research exploring the potential concerns over such data. Tom Konopka of Medmarc Insurance and Frederic Nouaille of Biomedic Insurance look at insurance considerations for global clinical trials and highlight some of the risks that need to be covered, as well as the need for an understanding of the insurance requirements for all of the countries involved in a trial. David Maughan of MESM contributes an article on the issue of equipment maintenance in evolving markets, and the challenges this can present.

In our market analysis section, Dr Anthony Ikeme of Clintriad Pharma Services looks at clinical trials in Africa, and encourages collaboration with specialist CROs on the ground to identify and monitor the best trained GCP-compliant sites in the region.

Looking at therapeutic studies, John D’Souza of ACM Global Central Laboratory submits a report highlighting the role of the pathologist in the diagnosis and management of breast and prostate cancers, while Denis Miller of Parexel International looks at the particular challenges in cancer diagnosis and management in the emerging markets. Focusing on technology, Trudy Madden of Phase forward encourages the use of web-integrated interactive response technology (IRT) to automate the key processes involved in drug accountability, while Steve Heath of Medidata solutions takes a look at the importance of continued eClinical investments for small and mid-sized pharma and biotech companies.

I am sure you will agree that we have again compiled an impressive range of articles covering many topical areas of discussion, and looking closely at the developing growth within new regions and markets around the world. I hope that there is something here of interest to everyone, and that you enjoy reading this edition of the JCS.

Mr. Mark Barker Publisher Journal For Clinical Studies.

We have reached the end of 2009, and what a year it has been. I think we are all going to look back at 2009 and notice that the world has changed. We are all looking at the broader picture. From US, India & China pledging to reduce Carbon Emissions to the Pharmaceutical Industries endeavouring to find cure for many forgotten diseases, and diseases still prevalent in many developing countries, I think we will make this into a better world. When we launched Journal For Clinical Studies in 2008, we wanted to encourage Sponsors & CROs alike to venture out and utilise the vast pool of treatment naive population in the world, to find cure for diseases, and make health care available to all.

We wish to thank all our readers, contributors and advertisers for the enthusiasm with which the Journal for Clinical Studies has been welcomed and adopted as a must read journal. We would especially like to thank our editorial advisory board for the dedication and commitment they have given to this unique journal, and sourcing out information that are crucial to the modern drug discovery and development world.

In this latest issue we bring you another selection of valuable information. Trends in Clinical Trials and CT Supply Management – what happened in 2009, what may be expected in 2010 is an area covered by Dr Claudio Lorck of Temmler AG. While Walter Chalkley of Thomson Reuters writes on The FDA-EMEA Good Clinical Practice Initiative and the need to harmonise and eliminate duplicate activities. Russell Neal focuses on how Australia and New Zealand offer proven solutions for helping SMEs with exciting novel products, While Francine Hakim of Caribbean Clinical Research Associate writes on the need for a good solid community education campaign to educate local communities, where clinical trials are being introduced for the first time into a region. Eastern Europe and the Baltic regions are relative new comers in the Clinical Trials field. Dr Janis Skards of Documeds provides a quick guide on what is happening in these newer European economies. Dr. Xunting Zeng of INCROM CHINA looks in to the important developments in China, the compilation of the Pharmacopoeia of China (2010 Edition) and the issue of the Regulation for National Essential Drugs List. The Korea Food and Drug Administration released a report on approval status of clinical trials in Korea last July, and Do Hyun Cho of KHIDI looks into this issue. Our India Watch, is on “The glorious metamorphosis: Compelling reasons for doing clinical research in India” is a joint initiative by FICCI and Ernst & Young, and is an outstanding initiative to portray the clinical research landscape in India. Dr. Ranya Shahrouri of ClinArt analyses Jordan for the first time in JCS and Francis P. Crawley of GCP Alliance examines China. Stephen Gunnigle of Kinapse looks at ways in which clinical trials can be run more effectively. The hot topic of Pharmacovigilance is explained by Sanjay Motivaras of 4G Pharmacovigilance, especially with new medicinal products

Dr. Nermeen Varawalla, President & CEO of ECCRO gives you a detailed overview of DIA Clinical Forum, Nice 2009: Improving Clinical Development Together. Heinrich Klech, CEO of Vienna School of Clinical Research reflects on improving people’s skills in Emerging Countries while Kohei Wada of Daiichi Sankyo, Co Ltd & JPMA representative of ICH Steering Committee explains the Role of the ICH-GCG (Global Cooperation Group) in facilitating the roll-out of ICH in non-ICH regions and countries. We have a focus on South Africa where Dr Lynn Katsoulis, Chairperson of SACRA discusses the regulation of device studies and practical issues encountered when conducting clinical trials on devices in South Africa. Dr Patricia Lobo interviews Dr. Dave Clark of Aurum Institute for Health Research on THIBELA a preventive study into TB in the gold mining industry, and finally Dr Jessica Trusler of BARC explains how various partnerships will define a new reality for Africa’s disease burden and a legacy of good health for its people.

We wish you all happy holiday season and see you in January 2010. “Happy New Year!”

Patricia Lobo, Managing Director & Senior Consultant, Life Science Business Consulting

A happy New Year to you! As our first issue of JCS 2010 goes out to you readers, we hear that the UK economy has come out of recession, after figures showed it had grown. The UK’s had been the last major economy still in recession, as Germany, France, Japan and the US emerged from recession last year. According to official data from the Office of National Statistics (ONS), the UK economy grew by just 0.1% in the last three months of 2009, compared to the previous quarter. During the 18 months of recession, public borrowing increased to an estimated £178bn, while output slumped by 6%. Some commentators are less jubilant on the ONS figures as they recognise that there’s more than a good chance that the 0.1% growth in Q4 will end up being revised downwards. Would it be tempting to predict a positive outlook for the life science industry for 2010? Reductions in health spending and industry job cuts could have an impact on the market, but an ageing population and a health service under pressure will guarantee an increasing demand for pharmaceuticals. According to Epsicon (The Pharmaceutical Market – January 2010), the UK pharmaceutical market is set to experience moderate growth over the coming years, tempered slightly by the effects of the economic recession. Public spending cuts are likely, as public debt continues to increase, and health expenditure is set to suffer as a result. I was particularly impressed by the 8th Annual Partnerships in Clinical Trials Congress and Exhibition by Informa, held in early November 2009 in Rotterdam. The meeting is an annual review of the industry’s best practice clinical partnerships between sponsors, CROs and other service providers. The conference Chair, John Sergeant, investigated the topic of how much the recession has impacted on clinical partnerships. Anatole Kaletsky, Associate Editor and Principal Economic Commentator of The Times, presented with great clarity an examination of the economic downturn and its impact on the pharmaceutical industry. The case study presented by Eli Lilly and Covance about risk-sharing in a successful clinical partnership was very well received. Jeffrey P. McMullen, President and Chief Executive Officer, PharmaNet Development Group, Inc., gave a detailed analysis of CRO growth opportunities in a more challenging market environment.

One of the major challenges facing globalisation of clinical trials is the recruitment of patients into clinical trials. As the demand for larger patient pools grows, countries with less experience are quickly emerging as clinical trial sites. The most prominent emerging regions include CEE, Latin America, and Asia. This globalisation trend is introducing new challenges in conducting clinical research, including language and cultural barriers. These create significant barriers to patient recruitment, especially in obtaining informed consent. In addition, regulatory approval processes and timelines in each country vary considerably. Lynn Katsoulis discusses improvements in the regulatory standards, timelines and enrolment potential in South Africa, whilst Rajam Jaishankar reviews the latest from the DCGI (Drugs Controller General India) (see pages 12 and 14 respectively) and Ryan Simper looks at the demand for language services providers in the changing clinical development world (page 52). On the patient recruitment front, my colleague Keith Thrower assesses the benefits and problems in emerging markets (page 38), whilst Oscar Podesta and Matthew McLoughlin focus on clinical research in Latin America (pages 16 and 27 respectively), Anna Ravdel on Russia (page 24), Rabinder Buttar on Diabetes in India & the Gulf Region (page 42) and Rayna Shahrouri on Tunisia (page 18).

I am looking forward to meeting visitors to the forthcoming meetings listed on our events page, where you can pick up a copy of Journal for Clinical Studies hot off the press for hours of interesting reading. Thank you for your support, and keep the articles rolling in.

I would like to thank all of our readers, contributors and advertisers, and extend a warm welcome to our latest edition of JCS.

FDA Guidance in this issue is compiled by Regina Ballinger of Thomson Reuters and focuses on Investigator Responsibilities for Protecting Study Subjects in Clinical Trials and In Australasia Watch Russell Neal of Clinical Research Network, CNS Pty. Ltd explores the ongoing efforts across both Australia and New Zealand to harmonise non-regulatory aspects such as indemnity and Clinical Trial Agreements. China Watch by Barry Sears of Biocair International focuses on logistics and common belief that shipping samples to and from mainland China is a difficult process. Do Hyun Cho of KHIDI writes on the World’s Third Largest Clinical Trials City according to the US government database (clinicaltrials.gov, 2009). Seoul’s high ranking is recognised as demonstrating unusually rapid growth. Dr. Ranya Shahrouri of ClinArt Fz LLC writes the Clinical Research settings in Saudi Arabia and the currently major bioethics debates taking place through the National Bioethic Committee, such as stem cell research, genetic research and the Islamic opinion of different types of research. Clinical Research in Turkey by Sule Mene of Mene Research focuses on clinical trial regulations which became effective on 11th March 2010 brings significant competitive advantages to Turkey compared to other countries in the region. Outsourcing of processes of the clinical trial supply chain is covered by Dr. Claudio Lorck of Temmler AG. In our regulatory section, Hoss Dowlat, Vice President, Global Strategy, Parexel Consulting, outlines key considerations for biopharmaceutical companies in evaluating the impact of EU Variation Considerations for Biopharmaceutical Companies and new regulations and derived guidance related to the Variations. Market Evaluation, Exploratory Clinical Drug Development in Russia is explored by Maikel Raghoebar of FOCUS Clinical Drug Development Clinical Trial Application in Bulgaria is explored by Dr. Nelly Tzolova, MD of Ecopharm Clinical Research Ltd while an Interview with Rabinder Buttar of ClinTec International focuses on the opportunities for clinical trials presented in Lebanon, CIS States, Russia & Latin America. Regulatory Landscapes for Future Antidiabetic Drug Development - EMA Guidance on Assessment of Cardiovascular Risk, by Dr. Rick Turner and Erica Caveney of Quintiles focus on the cardiovascular safety assessment component of that general guidance, which is currently in a consultation period until 31st July 2010. The Complex Aspects of Women’s Health is covered by Dr. Rajam Jaishanker of Quest Life Sciences while Dr Ian smith of Synexus writes on the Importance of Effective Clinical Trials in Vaccine Development. Daragh Ryan of CMED highlights eClinical Systems Selection while the Challenge of Training Clinical Research Staff for Global Clinical Trials is covered by Diana Anderson, President & CEO of D. Anderson & Company who shares some of the most frequently discussed topics, offering helpful information regarding best practices.

JCS launches a new Book Review section. We welcome Dr. Rick Turner, as The Editor In Chief of the Book Review Section. I will like to invite all authors and publishers to send us your manuscripts for review. You can find the postal details on Page 60.

We hope that you enjoy this informative edition of JCS, and look forward to meeting you all at DIA Annual Meeting in Washington.

Dr. Maha Al-Farhan, President and CEO, ClinArt International.

It is evident that those who have their heart and soul in clinical trials had been writing in the JCS since its inception; as a matter of fact JCS never ceases to amaze me with the amount of in-depth and detailed information about doing clinical trials in faraway places. In this issue Donald F. Grabarz of International Regulatory Consultants LLC contemplates the conduct of clinical studies in sites other than the United States or EU member states, while Russell Neal of Clinical Research Network (CNS Pty. Ltd) describes the return of optimism in the industry and easing of money flow with developers planning ahead.

One can never undermine the value of local knowledge. The situation in Latin America with regards to the resourcing solutions model is a challenging one, as explained by Oscar Podestá of Chiltern International, while Malgorzata Szerszeniewska, the MD and CEO of EastHORN Clinical Services explores the high level of variation in the cost of conducting clinical trials in Central and Eastern Europe, Latin America and Asia. But can Russia, Ukraine and Eastern Europe help biopharmaceutical companies to bring the product to market in a cost-effective way? This question is analysed by David Passov of ClinStar. On the same lines Rani Abraham of ClinTec International FZ-LLC explains the under-discovered potential of running clinical trials in the Middle East and North Africa. As she put it; “this emerging market now holds a high potential for clinical trials”; and Dr. Guy Patrick of Centrical Global Limited discusses ways of tapping into the appealing prospect of conducting clinical trials in emerging markets in a calculated way. Chris Tait of the Chubb Group of Insurance Companies talks about the growing concern that Europe is seen as a complex and expensive place to run trials and therefore is possibly losing out on trial activity; but would a simple process help to reduce costs by reducing expensive overages of study medication? Just-In-Time packaging and labelling is explained by Dr. Claudio Alexander Lorck of Temmler Werke GmBH. Japan, a key ICH member, has often been regarded as one of the more challenging venues in which to conduct clinical trials and obtain licensing for new medicines. However, it is now declared “open for business” as explained by Alberto Grignolo, PhD & Yoshitaka Aida, DVM, PhD in the regulatory watch page.

The Cardiovascular Safety Watch section provides interesting information about automated reading of electrocardiogram (ECG) intervals by Dr. Rick Turner of Quintiles Cardiac Safety Services, while Alison Bond & Katherine Hutchinson of Quanticate explore why pharmacovigilance has a vital part to play in the avoidance of adverse effects of medicines.

In the therapeutic section, Anna La Noce of Pharmanet Development Corporation explains why an increase in the number of clinical trials dedicated to the evaluation of cognitive effects of antiepileptic treatment in children is expected in the future. It is also worth reading about naturally occurring substances that can enhance cognitive function; the rationale for such self-medication is discussed by Dr. Keith Wesnes of United Biosource Corporation.

We hope that you enjoy reading this issue, and we look forward to seeing you all at the DIA Annual Meeting in Washington DC.

Dr. Charles Horth, Lifescience Business Consultant, Cytops Limited

If necessity is the mother of invention then it shouldn’t come as a big surprise that China, the world’s largest and most populous country inhabited by over 1.3 billion people, possesses an enormous driver for healthcare. Inevitably, with its vast potential for clinical research and development this huge country attracts global pharma companies and CROs to do business.

It’s not merely the unmet demand for Western medicines but also preventive treatments, including vaccines, where the greatest scope exists for a collaborative effort. China recently introduced a major new commercialisation policy that includes a budget to support research in the country’s vaccine industry. The policy, together with the earlier dissolution of the state monopoly on purchasing vaccines, will make the biotech sector in China more competitive and allow entry of foreign vaccine developers. This could put new vaccines onto the Chinese market if vaccine companies invest in research and introduce marketing strategies that raise awareness among the general population of the need for vaccines. Probably the biggest challenge for prevention and treatment is with HIV/AIDS. According to HIV Vaccine Trials Network, China’s first AIDS outbreak was not reported until 1989, in Yunnan province near China’s southwest border. Today, about 650,000 people in China are living with HIV/AIDS. Although a small fraction of China’s population, the sheer number of people at risk is daunting. Yunnan, with 44 million inhabitants, remains the most concentrated region, with about 80,000 people infected with HIV, a half of them involving intravenous drug users who spread the disease by sharing needles. Other areas of HIV/AIDS concentration are in Henan, central China, Xinjiang in northwest, Guangxi and Guangdong in the south. Among companies with an interest in HIV, Avexa Limited entered into a licensing agreement with the Shanghai Institute of Organic Chemistry (SIOC) to develop one of Avexa’s HIV integrase inhibitor series. SIOC takes responsibility for future development costs of the program in China and will pay Avexa 50% of any net commercialisation revenues. Avexa retains all development and marketing rights for the program outside of China.

Among major CROs, PPD opened its first office in China in 2003. Simon Britton, PPD’s vice president of clinical development for Asia Pacific sees the vaccines market as one of the fastest growing segments in the industry. In China the clinical trial market is growing at about 20% each year.

In April 2010, PPD opened a vaccine clinical research centre at the Taizhou China Medical City in order to provide clinical monitoring services to global and local biopharmaceutical companies seeking to develop vaccines in China. In China, vaccine studies are carried out by the Chinese Center for Disease Control and Prevention instead of them being done in Phase I clinics or by investigators at hospitals.

The studies require thousands of patients for enrollment, compared to hundreds for studies conducted in other countries. Even so, China has a short recruitment period for vaccine trials so they are completed a lot quicker.

In this issue of JCS, there’s a feature article about clinical trials in China (see pp 110) by Harriet King, Marketing Executive of Biocair International, giving an insight into the conduct of clinical trials in Asia. Looking ahead Terrapinn is organizing its World PharmaTrials Asia 2010 4-day event, from 13-16 September 2010 at Gran Melia, Shanghai, China. Day two of the conference will deal with flu vaccine trials responding to pandemic threats and the recruitment of patients for vaccine trials. Further details from Terrapinn: http://www.terrapinn.com/2010/ pharmatrialscn/index.stm or contact Fiona Ho, by email: world. events@terrapinn.com or phone: +65 6322 2320 / +65 9794 9527.

Welcome to the 12th Issue of JCS. It has been a pleasure and honour to work with so many respected members of the pharmaceutical and clinical research industry. We thank you all for the effort and support you have given to make JCS the most unique journal on its second anniversary. We bring you again a wide range of relevant topics, which will guide you and give you a thorough insight into the progress made in the field of clinical research globally. Highlighted countries featured in this issue are — Australia, Pakistan and Morocco. Each of these countries have taken progressive steps to improve the environment for clinical research. For example, Trade Development Authority of Pakistan in collaboration with the Ministry of Health and Jinnah Postgraduate Medical Centre (JPMC) aims to invite the companies that conduct clinical trials to Pakistan and establish their centres in the country. In Morocco, clinical trials are now extremely organised due to the fact that most research ethics committees follow the guidelines of the Ministry of Public Health, which is compliant with ICH-GCP. Our very popular Watch pages, where you get bite size, regular information on topics ranging from FDA & EMA guidelines, cardiovascular safety to clinical trial risk management and insurance, are a must read for professionals in this industry.

We hope you can keep the issues for future reference. Our therapeutic section covers chronic pain trials, therapies for the elderly and focus on the very important subject of paediatrics. I take this opportunity to inform you about the Middle East & North Africa – Pharmaceutical Compliance Conference we are organising. I hope you can pencil the dates of 22 – 23rd of February 2011 in your diaries. The conference will bring together heads of regulatory affairs from FDAs in Saudi Arabia, Jordan, Egypt and Tunisia with leaders of global pharmaceutical and biotech companies to analyse and discuss the vital issues and opportunities in this fast expanding sector. JCS has also launched its weekly newsletter. Clips of news concerning trials in emerging countries, up to date regulatory news, and relevant company information and links into various articles featured within JCS can be sent directly to you every week. Please visit www.jforcs.com and sign in. I hope you enjoy the latest issue. We look forward to seeing you all at the 9th Annual Partnership in Clinical Trials in Vienna. Mark A. Barker

Welcome to the latest edition of our Journal. Once again the issue is packed with a diverse range of interesting articles covering a broad spectrum of topics. Looking through the array of topics, some themes emerge that illustrate the nature of the sector we all work in. The first thing that struck me, as if I needed any reminding, is the truly global nature of our business. Clinical work is being carried out pretty much everywhere, and each location has something different to offer, as well as presenting its own blend of challenges. This month we have articles covering specific locations such as South Africa, Latin America and India, and we bring you a feature from Estonia by Riin Ehin on work being done on developing cancer vaccines from potato virus.

The second theme that is prominent is the impact of regulation on the clinical workflow, especially with regard to research, the management of trials and the launch of product to market. From J Rick Turner’s piece about the impact of the FDA advisory notices on cardiovascular safety (this issue he explains how the FDA uses REMS as a tool to mitigate overall risk) through to Walter Chalkley’s piece on the FDA’s proposed rule governing the reporting of information regarding falsification of data, there is plenty of advice and guidance on how to cope with the rigours imposed by the increasingly complex regulatory environment. Complexity is a recurring theme too. Nothing seems simple these days. In the September 2010 issue, we brought you a detailed view of etiopathogenesis in relation to respiratory diseases in children, and explained the complexities presented when regulation and directives have slightly different purposes. In this case an EU paediatric regulation and a directive on clinical trials have produced inconsistencies between member states in the requirements for running some trials, making the decision-making process for conducting trials more complex, and therefore more difficult. In this November issue, we continue with the very important topic of paediatrics, where Rick Turner and Cynthia Jackson explain the factors affecting paediatric clinical trials and their regulations.

In another piece, Dr Alvin gives an insight into where we should focus in terms of reproductive therapeutic solutions in her look at testosterone replacement therapy in Adult Testosterone Deficiency Syndrome. She suggests future clinical trials should also examine treatment patterns among men with symptomatic androgen deficiency, and the profile of asymptomatic men with low testosterone levels, which might assist in understanding the mechanisms by which low testosterone levels increase risk of disease.

We have incorporated a new CNS Watch page starting from this issue. Henry J. Riordan starts with DSM-5’s impact on psychiatric clinical trials. In recent years, the DSM-5 Task Force and Work Group members have been labouring to revise DSM-IV-TR criteria to reflect recent advances in the science and conceptualisation of mental disorders. I hope you find this valuable.

This issue also has a wealth of advice aimed at speeding processes up, dealing effectively with necessary regulation and ultimately improving efficiency, and therefore the returns to be made on the considerable investment required in today’s clinical world. Benjamin Jackson concentrates on the importance of relationships to the success of the recruitment of patients for trials conducted in global trials; and Joseph Bedford explains the value of interactive voice and web response systems in global clinical trials.

It seems that many of us need some help to find clarity and understanding in the maelstrom that we know as modern business life, and indeed life in general. A few quiet minutes spent reading and considering this month’s content may well go a long way towards making this particular corner of our daily existence a little easier to deal with.

On a closing note to 2010, we would like to wish all of you a Very Merry Christmas and a Prosperous New Year.

Andrew King, Managing Director, Biocair International

Only twenty one new drugs were approved by the U.S. Food and Drug Administration in 2010, the fewest since 2007, a reflection of the FDA’s willingness to delay or reject medicines with potential safety risks or uncertain benefits as compared to available treatments. This compares with 25 approvals last year, 24 in 2008 and only 19 new drugs in 2007, the fewest in 24 years. Further in 2010 the FDA restricted the use of GlaxoSmithKline Plc’s diabetes medication Avandia and withdrew Abbott Laboratories weight-loss drug Meridia.

These events highlight the increased industry wide caution with respect to drug safety. In addition pharmaceutical and biotechnology sponsors are under pressure to demonstrate that their new product delivers additional value and benefits as compared to existing treatments. Demonstrating equally or marginally improved efficacy does not appear to be good enough anymore. The financial constraints remain, albeit to a lesser extent than in previous years. Given this back drop, 2011 promises to be a challenging year for us engaged in developing safer, more efficacious and innovative medicines.

The first 2011 issue of Journal for Clinical Studies covers a wide and relevant range of topics. Addressing pharmacovigilance and drug safety; we are informed of the revised FDA Safety Reporting Regulations for investigational new drug applications and the deliberations of the Cardiac Safety Research Consortium (CSRC). Dr Joy Chukwujindu of Crown Drug Safety and Crown Consultants advises that when developing risk assessment and minimization plans, sponsors should consider input from affected healthcare delivery partners.

Providing updates on the continually evolving global clinical trial landscape, the issue features articles on the clinical research opportunities in China and a report on FDA’s New Guidance on Biomarkers and Patient

Reported Outcome Qualification for neurological drugs, Also there is a report the new law in Russia “On circulation of medicines” which became effective on 1st September 2010, transferring the right to issue licenses for performing clinical research from The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) to the Ministry of Healthcare and Social Development. Africa is highlighted; with articles on the evolving South African clinical trial regulatory landscape and Professor Ifeoma J. Okoye, Chair of The Association for Good Clinical Practice in Nigeria is optimistic about Africa wide collaboration, harmonised clinical trial regulations across Africa and an evolving Nigerian clinical trial sector.

Sharing best industry practices there are articles on Phase I studies and where it can add value in Drug Development, Efficient and Cost-Effective Monitoring for Observational Studies, and central laboratory expertise for paediatric clinical trials, latest thinking in Phase I research and coordinated clinical supplies logistics.

I know you will find this rich selection of articles to be thought provoking and I hope this issue and the other 2011 issues will keep you abreast of developments in the sector and help you innovate and develop new practices which in due course you too will share with our readership.

Happy reading and all best wishes for a productive 2011!

Dr Nermeen Varawalla, MD, DPhil(Oxon), MBA

CEO and Founder, ECCRO