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Evolving Methodologies in Clinical Research: Insights from F-CRIN and AIS

Evolving Methodologies in Clinical Research: Insights from F-CRIN and AIS
The integration of new methodologies in clinical research holds great promise for accelerating innovation and improving patient outcomes. The French Agency for Health Innovation (AIS) and the French Clinical Research Infrastructure Network (F-CRIN) have initiated a working group to establish guidelines for these emerging methodologies. (Credit: F-CRIN)

The rapid evolution of clinical research methodologies is driven by the increasing availability of clinical data. The integration of new methodologies in clinical research holds great promise for accelerating innovation and improving patient outcomes. The French Agency for Health Innovation (AIS) and the French Clinical Research Infrastructure Network (F-CRIN) have initiated a working group to establish guidelines for these emerging methodologies. They released their initial findings and recommendations.

The Growing Role of New Methodologies

Traditional randomized controlled trials (RCTs) have long been the gold standard in clinical research. However, new methodologies are gaining traction, providing additional insights and complementing RCTs. These methods can accelerate the development of healthcare products while ensuring high standards of efficacy and safety. It is particularly interesting in areas where traditional proof of efficacy is challenging. This is the case of rare diseases, slow-progressing conditions, and antibiotic resistance. They also cater to the increasing personalization of healthcare products, especially those targeting genetic or molecular anomalies.

Our affiliated publication DirectIndustry e-magazine interviewed Christophe Bianchi, CTO at software company Ansys about the advantages of computer-based testing in the medical field. Experiments are increasingly done on computers using software like Ansys to complement and accelerate in vivo and in vitro approaches. The concept is to simulate the interaction of medical products with the body without the need for real-body testing. This new in-silico medicine approach has the potential to revolutionize science and medicine. 

Read the full article: In Vivo, In Vitro, In Silico: Clinical and Pharmaceutical Trials Through Digital Simulation

The French Agency for Health Innovation (AIS) and the French Clinical Research Infrastructure Network (F-CRIN) have released two documents based on their multidisciplinary working group’s efforts. It also includes input from the National Agency for Medicines and Health Products Safety (ANSM) and the High Authority for Health (HAS). These documents reflect the challenges and potential of integrating new clinical research methodologies.

For more details and to access the reports, visit F-CRIN’s website.

Findings and Recommendations

Clinical Trial Methodologies: a Slow Adoption

This retrospective study, conducted by a consulting company dedicated to epidemiology and biostatistics Horiana and PASS (patient access), compares evaluations from the FDA, EMA (European Medicines Agency), and HAS on dossiers incorporating new research methodologies. It reveals a slow adoption of these methodologies among clinical trial sponsors and regulatory authorities. Issues encountered include the evaluation of non-controlled trials, external control arms, and new trial formats like in silico trials and AI-driven research. 

The findings guide future efforts to accelerate innovation while enriching early-phase evidence through virtual data (simulations, AI).

Use of Real-World Data in Clinical Research

The report provides an overview of real-world health data utilization for research purposes. It also underscores the necessity of well-defined conditions for using healthcare data in clinical trials. It is indeed crucial for constructing virtual control groups using individual or aggregated care data.

Next Steps

These publications lay the groundwork for a more operational phase aimed at facilitating the deployment of new methodological approaches through a framework agreed upon by both health authorities and trial sponsors. A call for expressions of interest (AMI) will be launched by the end of the year, enabling pilot projects to demonstrate the efficacy, usage, and evaluation of these new tools.

Recognizing the global nature of these methodological advancements, AIS and F-CRIN are organizing an international colloquium on June 24 at CHU Lille, France. The event, “Next Generation of Clinical Research – AI, In Silico and External Arm: Time to Make Them Real,” aims to share findings and foster international collaboration on these emerging methodologies.

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