The first day of the CDDF Annual Conference on Challenges, Advances, and Open Questions in Global Cancer Drug Development and Clinical Trial brought together a diverse group of stakeholders into open, constructive discussions in order to improve cancer drug development. Here are the key takeaways from Day 1’s program:
SESSION 1: CDDF/AAADV JOINT SESSION ON DIVERSITY IN GLOBAL DRUG DEVELOPMENT
[Key Takeaways]
🔶Audience is highly involved in the topic (~70%).
🔶More research and a better definition of diversity data points are necessary.
🔶Diversity research needs to focus first on large patient groups, such as sex and age.
🔶Diversity in clinical research is based on ICH regulations as well as FDA & EMA guidance.
🔶Use a large toolset to increase appropriate representation in clinical trials.
[Next Steps]
🔶Answer open questions regarding diversity through discussion and research.
🔶Participate in initiatives that formulate recommendations for diversity in clinical research.
SESSION 2: ENDPOINT IN DRUG DEVELOPMENT: PROGRESS AND CONTROVERSIES
[Key Takeaways]
🔶“Regulatory” considerations on endpoints involve complex trade-offs:
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- The value of different endpoints is in the “eye of the beholder”.
- Patient preference studies.
- Focus on communication (more than choice).
🔶Regardless of choice, there is a need to communicate effectively between all parties involved.
🔶Estimands frameworks will be necessary to be able to communicate systematically.
🔶There will always be a need for case by case assessments for further validation (including clinical relevance) of novel endpoints.
[Next Steps]
🔶Is OS truly relevant still? Do we have to take it disease by disease?