The Evidence REVEAL Study: Exploring the Use of Real-World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry
- The European Medicines Agency (EMA) should develop an RWE framework for premarketing authorization in Europe.
- EMA and the European Medicines Regulatory Network (EMRN) could lead the development of RWE standards in the EU and beyond.
- Joint demonstration projects by the European Commission and industry could establish when RWE is acceptable for regulatory decision making.
- Clarity is needed on how the new EU Clinical Trial Regulation will support complex trials.
- EMA and the Clinical Trials Facilitation Group (CTFG) could facilitate better alignment for the acceptance of complex clinical trials across Europe.
- Joint demonstration projects by the European Commission and industry could establish the applicability of CCT design.
- Collaboration among academia, industry, and health authorities is essential for the regulatory acceptance of novel evidence generation methods.
The rapid evolution of science and technology allows innovative approaches to generate new types of evidence about the effectiveness of medical product development so as to speed up patients’ access to better diagnostics and treatment. Our study explored how two emerging approaches, the use of real-world evidence (RWE) and complex clinical trial (CCT) design, are currently being used by the pharmaceutical industry to support premarketing authorization of medical product development and reviewed the international landscape for regulatory acceptance of such novel approaches.
Combining evidence from a literature review, company survey, and interviews with international regulators and experts, we found that 80% of Europe-based pharmaceutical companies have used RWE and 50% have used CCTs, in some capacity. Further, we present case examples of how companies are using these approaches and how international regulators are preparing for such developments. To conclude, we provide a set of recommendations for European industry and regulators to consider so that these novel approaches achieve their full potential within the EU regulatory system...
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