The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

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:

    • 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?


 

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