What changes for the CRA and SSC (Site study Coordinating) professions in France within 10 years?
The CRA and SSC professions are relatively recent. Appeared with the emergence of Clinical Research, they are exercised by industrial promoters, institutional, in CROs, and in hospitals.
What could be the CRA and the SSC future missions in 10 years? The most popular therapeutic areas? You will find the France CRA and SC future skills here.
1. Oncology, onco-heamatology, virology, vaccines, rare diseases, medical technologies: the present and future assets of France
Over a few years, industrial clinical research tends to decline in France, in favor of other European countries; we may wonder what the CRA and the SC will become in 10 years.
We do not know how various European and French laws will impact French CRA and Site study Coordinator jobs. However, France remains an attractive country for international clinical research. Indeed, our country has strengths in clinical research such as in oncology, virology, vaccines and rare diseases domains, but also in the medical technologies (genomics, proteomics, and bio-informatics). We can therefore expect that these therapeutic areas continue to be that of the future for CRAs and the SSCs.
Beside the relocation of clinical trials to Eastern Europe countries, factors induce to think that the CRA and the SSC ought to diversify, and also be more internationally oriented.
2. SSC New missions to patients
With the current context, hospitals are facing a shortage of doctors. Consequently, they have less and less time to devote to studies than before (obtaining the consent, patient information).
In the US, depending on the type of study (e.g. studies with a drug already on the market or have minimal risk) the Clinical research coordinators (CRC) who are in the equivalent of SSC in French are allowed to explain , secure, sign, and date the informed patients consent. To overcome the shortage of doctors, the American model could be applied in France.
3. Institutional promoters CRAs will take part in the protocols designing
Hospital doctors regularly develop clinical research projects particularly within the PHPO (Public Hospitals of Paris Organization) (in French:AP-HP (Assistance publique – Hôpitaux de Paris). To develop their projects, they need to get a CRHP (Clinical Research Hospital Program) (in French: Programme hospitalier de la recherche clinique).
The CRHP (in french: PHRC) is funding research projects by hospitals which objectives are:
- evaluating safety, tolerance, or feasibility of health technologies use in human beings (e.g. studies of phase I and I / II, studies of Phase IV)
- health technologies effectiveness measuring.
The results of the projects suggested by physicians must allow direct changes to the patients management.
These doctors have a strong desire to push forward the medicine through clinical research. Yet they are less and less available to design and draft new protocols. These missions will be relayed to the CRAs who will draft protocols and allows to the investigator the medical validation of the document. Naturally, the CRA trainings will be more comprehensive to consider this new aspect of the profession.
4. The CRA and his new legal powers
Patients are increasingly interested in participating in clinical research protocols, especially for chronic diseases. This intensification will be even more emphasized by the European Regulation (applied from May 2016) that wants a clinical trial transparency with patients.
One of the consequences concerns the legal aspect: patients are increasingly aware of their rights in clinical research, litigation risks increase, especially in case of error in obtaining the consent.
The CRA will be especially affected by this development as part of his monitoring and must develop skills in legal matters. Indeed, it will be necessary to strengthen the legal, risk management and traceability of the documents.
Again, the CRA training have to provide a suitable education.
5. New emerging countries and international dimension
More and more clinical studies will be international, new pharmaceutical laboratories from emerging countries in Latin America and Asia will require English and computer skills master (data entry and processing). Negotiation skills, relational skills, and knowledge of cultures will be needed to better manage relationships with these new customers.
6. Remote monitoring
Furthermore, we believe that the remote monitoring will increase with the expansion of electronic notebook. You can find more information about it in a previous blog post “remote monitoring, an evolution of the CRA profession” of Severine Lopez.
We believe that CRA and SSC will remain be essential within studies, for the quality of clinical trials insurance, both in scientific, technical and regulatory level.
The CRA and SSC play and will play a key role in clinical trials: they will always be essential to the researches success, but in the coming years they will have to be more versatile than they already are. Master the future therapeutic areas, new SSC missions, and legal skills, English language and knowledge of other cultures will be needed to maintain his own attractiveness within the French clinical research.
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