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

The second 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 2’s program:


SESSION 3: OPTIMIZE EVIDENCE GENERATION AND PATIENT ACCESS WITH INNOVATIVE CANCER TRIALS (METHODOLOGY)

[Key Takeaways]

🔶ACT EU aims to establish EU as attractive for clinical research, clinical trial methodology is a priority action area for ACT EU.

🔶RCTs remain the gold standard, preferred by decision-makers, even for small populations.

🔶External control data / borrowed data can be used when carefully planned and where RCTs cannot be performed for ethical reasons or where in rare conditions there are very few patients.

🔶Include the patient voice early in drug development/trial design.

🔶HTAs need to see data on diverse patient populations like those treated in clinical practice.  The absence of these data will give rise to many questions.

[Next Steps]

🔶Sponsors, and the wider research community, need to plan prospectively to ensure the availability of suitable patient data of good quality to enable construction of external (concurrent) control arms.

🔶More work is needed to enable high quality use of external data, for instance in the context of the European Health Data Space (EHDS), there is a need for all patient data to be carefully recorded and curated (EHDS).

🔶Include patient perspective more systematically in JSC/HTA process.

🔶Advance understanding of “pragmatic trials” and how to do better trials that represent the actual patient populations, and preferences.


SESSION 4: NAVIGATING PRECISION ONCOLOGY DEVELOPMENT IN VIEW OF NEW REGULATIONS

[Key Takeaways]

🔶The IVDR and the FDA LDT regulations are welcomed by all stakeholders and will ensure quality diagnostics are available for patients.

🔶Alignment of IVDR requirements and streamlining of approval process within Europe is crucial for clinical research , especially at early stage of development, to ensure EU remains attractive.

🔶Combined studies drug/IVD face extended approval timelines and complex regulatory hurdles, which are impactful also for academic research, potentially leading inequities in access to clinical trials across Europe.

🔶COMBINE was a swift reaction from regulators, which brings all stakeholders together, with the promise of addressing the current issues in a timely manner.

[Next Steps]

🔶Ensure education of all stakeholders to ensure a productive and collaborative discussions moving forward.

🔶Implementation of the solutions identified by COMBINE.

🔶Continued monitoring effectiveness of the implemented solutions and dialogue with all stakeholders.


 

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