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Journal for Clinical Studies
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Category Archives: Volume 9 Issue 1

Demand-led Supply: Increasing Efficiency in Clinical Studies Logistics

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development…

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How Integration of Consumer and Medical Devices is Reshaping Clinical Trials

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new…

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Why would Cardiovascular Outcomes Trials and Rare Disease Studies have Anything in Common?

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

Cardiovascular outcomes trials (CVOTs) are some of the largest interventional trials being conducted, enrolling several thousand subjects, sometimes with follow-up…

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Bridging the Clinical Data Structure Gap to Empower Holistic Risk Management

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM)…

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Why and How a Research Lab Should Embrace Research Quality

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the…

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Latest FDA Guidance on Non-Inferiority Designs

Volume 9 Issue 1By flabio513th February 2017

To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence”…

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Integrative Approach to the Conduct of Rare Disease Clinical Trials

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

The planning and execution of rare disease clinical trials involves unique considerations. Examples include the role of patient advocacy groups,…

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Human Challenge Studies: An Effective Tool for Drug Development

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed…

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Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

The last few months have seen a battle build between the pharma industry and the EMA, following the issue of…

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Five Reasons to Embrace the ICH E6 (R2) Addendum Now: Improve Study Efficiencies by Centralising Risk-based Quality Oversight and Trial Management

Editorial Archive, Volume 9 Issue 1By flabio513th February 2017

In November 2016, the ICH E6 (R2) Addendum to Good Clinical Practice was implemented, delivering a breath of fresh air…

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