In this whitepaper, Susan Daniels and Suzette Matthijsse share insights on why Joint Clinical Assessment (JCA) strategy, patient representativeness, and community engagement need to be planned together.
Key takeaways:
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- The JCA changes when you need to plan. JCAs are mandatory for oncology products and Advanced Therapy Medicinal Products (ATMPs). They extend to orphan medicines in 2028 and all new medicines by 2030. Once the final scope is issued, you have 100 days (60 if accelerated) to submit the dossier.
- Diversity gaps are now an evidence risk. Only 6% of pivotal Phase III trials supporting US Food & Drug Administration (FDA) approvals between 2017 and 2023 matched the US racial and ethnic distribution.
- Patients are grading the process. The European Organisation for Rare Diseases (EURORDIS) gave the first JCA report, on tovorafenib, an overall “C”.
- This isn’t just a European issue. US sponsors designing mainly for the FDA may face different populations, comparators, and outcomes in the JCA.
- Five actions compound in value the earlier you take them. They include starting the Patient/Population, Intervention, Comparison, and Outcome (PICO) simulation before Phase III enrolls, auditing your trial population against real-world EU patients, and treating real-world evidence as a first-order planning question.
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