Implementing Adaptive Trials: Operational Considerations

In this webinar the speakers will discuss operational challenges that are of key importance in adaptive trials:

The needs:

• to validate the design through simulations,
• to control the trial centrally,
• to collect and analyze key data rapidly,
• to preserve the trial blinding and integrity,
• and to document all important adaptive decisions taken.

These challenges will be illustrated using an actual phase I trial in oncology, and the speakers will argue that the issues can be addressed through:

• proper planning,
• choice of experienced vendors and independent groups (coordinating center and DSMB),
• statistical teams with adequate expertise and experience with the design chosen,
• recourse to efficient computer technology (IWRS, EDC, automated emailing),
• and oversight by a specialized team.

Finally, issues specific to the design of pivotal trials for registration will be addressed.

Speakers

Marc Buyse, Sc.D., Founder, IDDI

Marc Buyse holds a doctorate degree in biostatistics from the Harvard School of Public Health (USA). He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, and an Associate Professor of biostatistics at Hasselt University in Belgium. He has published extensively on cancer clinical trials.

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Linda Danielson, M.S., Chief Operating Officer, IDDI

Linda Danielson is Chief Operating Officer at the International Drug Development Institute (IDDI) in Louvain-la-Neuve, Belgium. She obtained her M.S. degree in 1990 from the University of Wisconsin, Madison. She has over 20 years of experience in the Pharmaceutical Industry and worked at UCB prior to IDDI. She has also been President of the Biostatistical Section of the Belgian Statistical Society and the Belgian representative to the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI).

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