How to determine the value of new methodologies and tools in clinical research? Traditional clinical methodologies usually demonstrate the efficacy and safety of new medicines. Alternatives to conventional methodologies in clinical research have been sought for years. However, the use of new clinical methodologies and tools in Market Access is rare. As a matter of fact, new approaches in data, methods and tools can be especially useful for trials with small sample size or with specific characteristics. There is a need to accelerate the availability of innovations for patients. Therefore, the French Health Innovation Agency launched a call for expression of interest within the France 2030 investment plan.
Dr. Meriem Bouslouk-Marx, Adviser at MBM Future Health, evaluated within a distinguished international jury the potential value of new clinical methodologies. She brought to the evaluation her comprehensive experience in evidence-based decision-making at Germany’s top health policy body, the G-BA.
The French National Research Agency (ANR) operates the Evaluation of new methodologies in clinical research initiative. Pre-defined eligibility and evaluation criteria served as the basis for the assessment of the proposals. The procedure for the submission was in two-stages. The jury examined the letters of intent in Phase 1 and after that, the completed applications in Phase 2. The thorough analysis of the individual facts of each proposal garanteed an informed decision-making. The selected projects in April 2026 are use cases including artificial intelligence, synthetic control arms, real-world data mining and in silico trials. The pilot cases have a period not exceeding 24 months to demonstrate the value of using these approaches. Most projects target cancer subtypes, rare cancers and rare diseases as a whole. In conclusion, the impact on patients will definitely prove the value of these new clinical methodologies.
