FDA FY2023 Inspection-Based Warning Letter Trends, TransCelerate's Digital Data Flow Initiative, and More
Clinical Leader
A resource and forum to investigate and resolve the common struggles related to running effective clinical trials.
Welcome to the Clinical Trial Insights newsletter, featuring strategic insights and expert opinions on designing and running clinical trials. Each edition covers the latest trending articles on ClinicalLeader.com.
In this week's issue, we'll review the trends in FDA FY2023 inspection-based warning letters, TransCelerate's Digital Data Flow initiative for digitizing the clinical protocol, the benefits and challenges of adaptive designs, predictions on the future of clinical data science, and other popular insights.
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Last Year’s DCT Is Today’s Clinical Trial
Join us March 6th for a discussion on the current landscape of decentralized clinical trials (DCTs) and how they've become an indispensable practice in the era of evidence generation and modern clinical trials.
TOP 5 READS OF THE PAST WEEK
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 and 94 of them were based on an on-site inspection of the company. Elizabeth Oestreich , Kalah Auchincloss , and Madeleine Giaquinto provide an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
Medidata Solutions provides a brief introduction to adaptive designs, including their major benefits and challenges and best practices for operationalizing them. This foundation will help maximize the likelihood of success when implementing an adaptive trial design.
领英推荐
A proliferation of clinical trial platform systems has meant increased friction for data exchange. Kelsey Jakee and Rob DiCicco share how TransCelerate BioPharma Inc. is tackling this problem with the Digital Data Flow Initiative, a program of work aimed at automating the exchange of protocol information across the study life cycle.
Ross Jackson , a consultant and author of two books on patient recruitment, talks about patient retention, why it continues to be a problem, and some of the possible ways to improve how long patients stay in studies.
In 2021, Patrick Nadolny, global head of clinical data management at Sanofi, made several predictions about clinical trial technology. Our editorial staff recently caught up with Nadolny to revisit his predictions, examine current trends in clinical trial technology, and imagine what innovations will shape the industry in the next few years.
MORE TO EXPLORE
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Literally The Man Who Wrote the Book(s) on Patient Recruitment
1 年Some good stuff being discussed here, as usual. Always worth getting different perspectives from industry insiders, thanks.