Latest FDA Guidance on Non-Inferiority Designs

Feb 13, 2017

To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence” of effectiveness from “adequate and well‐controlled studies.” In November 2016, the FDA issued a final guidance for industry, Non-Inferiority Clinical ...

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Integrative Approach to the Conduct of Rare Disease Clinical Trials

Feb 13, 2017

The planning and execution of rare disease clinical trials involves unique considerations. Examples include the role of patient advocacy groups, the value of outcomes registries and complete natural histories, the challenge in recruiting and retaining study participants, the special qualifications ...

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Human Challenge Studies: An Effective Tool for Drug Development

Feb 13, 2017

Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed in regional clinics and hospitals. In an HCS, subjects may either be inoculated with a candidate vaccine before being exposed ...

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