2024-07-09 09:12:02
The Association of Clinical Research Companies (AFCRO) issued a call in mid-June to alert public authorities to the numerous “administrative inconsistencies” that hinder health innovation. Simplification of procedures, transparency of information, promotion of research centers… Dr. Hubert Méchin, Chairman of AFCROs, introduced in detail the measures that can “restore the attractiveness of French clinical research”.
Comments collected by Renaud Degas and Géraldine Bouton
What is the context that drives your call today to save clinical research in France?
Hubert Machen: Although France has long maintained its leading position, it has lost one or even two places in the European clinical research rankings. Among other things, we have been calling for years to simplify administrative procedures. The latter is a serious impediment to innovation because of its heaviness and temporary nature. An increasing number of French clinical trials are being conducted abroad. our The final barometer* shows that the number of clinical studies promoted by industrialization has dropped by regarding 40%. Only academically promoted research is likely to sustain the volume of clinical research in France, and the same goes for research by medical device manufacturers. Overall, the trend is not optimistic.
Our voices echo research and reports has been published in National Advisory Committee on Ethics in the Life and Health Sciences, Academy of Medical Sciences, Pharmaceutical Companies, and many others ecosystem participants. By ignoring our calls, France is missing out on opportunities to innovate. This is highly detrimental to patients, who therefore do not benefit from rapid and durable access to new treatments, medical devices or treatment strategies.
Specifically, what are the implications for clinical research? Are other research areas affected?
HM: Both clinical and real-life studies are affected. For example, the country has the largest database in the world national health data system And its 67 million patients! This is an important asset, but we had to wait 12 to 18 months to sign an agreement with the health insurance company that would allow us to recover the data, even though we had all the necessary authorizations from the CNIL.
These deadlines are often incompatible with the needs and challenges of the research being conducted. This has also led some laboratories to switch to other countries. Research based on real-life data also encounters problemsInteroperability between information systems. Cities and hospitals have a lot of different software. All of this complicates the extraction and analysis of data generated during treatment.
What leverage should you use?
HM: The first is to simplify and modify legislative texts to facilitate research implementation. We call on health authorities, the National Medicines and Healthcare Products Safety Agency and the Personal Protection Council to adhere to regulatory deadlines for reviewing research projects, including a commitment to shorten deadlines for early case studies. Then, for SNDS, it is necessary to provide direct access to the SNDS and temporarily provide a copy of the SNDS to the project leader who has been working with the material for many years.
In addition to simplifying procedures, what other measures might be considered?
HM: We must work on survey centers to promote them and enhance their effectiveness. The time it takes to sign a contract with a hospital is three times longer than in many countries. Here, let’s simplify the funding grid for clinical research once more to increase efficiency and avoid using resources. For example, this might involve application packages.
There is also a need to financially promote these centers and survey doctors by earmarking funds Credit for teaching, research, reference and innovation tasks Go in the direction of the most investment. There is a need to raise awareness, train and inform medical researchers regarding the challenges of clinical research. Finally, clinical trials need greater transparency to bridge the gap between researchers and patients. Project development status eclair database The listing of clinical trials must be completed as soon as possible to provide an information platform for patients and patient associations at national level.
Focus on clinical research enterprises
AFCROs is the French CRO (Clinical Research Organization) association, founded in 2002. It now has approximately 100 member, service and consulting companies engaged in academic promotion and private clinical research in the field of biomedical research. www.afcros.com
1721283913
#heeding #call #France #opportunities #innovate
