A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another.
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Since 2021, patients have grown considerably more amenable to taking part in clinical trials, a new survey by the Center for Information & Study on Clinical Research Participation (CISCRP) has found.
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In 2024, the clinical trials industry will continue to build on prior initiatives and find new ways to solve old problems that relate to clinical research site sustainability, which directly translates to study success. The SCRS 2023 Site Landscape Survey data shed light on issues currently impacting sites most and how sponsors and CROs can support site success.
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A new draft guidance from the FDA addresses significant developments in the use of DMCs, including their growing use outside of therapeutic areas that involve high morbidity or death.
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The FDA’s Good Clinical Practice Program (GCPP) regularly fields questions from clinical research professionals on various GCP-related topics. GCPP’s responses interpret the FDA’s position, offer advice on how to proceed and point out key documents and resources that provide more in-depth guidance. The following is an excerpt from the 2023 edition of GCP Questions, FDA Answers, published by CenterWatch, a WCG company.
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