With more than 500 studies and 16,600 patients included in international trials, France is one of the leading countries in Europe in terms of clinical research.
France remains an attractive country for international clinical research. In 2016, 10% of global studies were carried out in France, i.e. more than 500 tests, indicates a investigation by the Federation of drug companies (Leem).
With more than 16,600 patients included in clinical trials in 2015 (compared to 14,600 in 2014), France continues to be one of the major players in research. French patients represent more than 8% of the total number of participants included in international trials, against less than 6% in 2014. It is thus ahead of Germany, Spain and Great Britain. “This increase is partly due to the greater number of phase III and IV clinical studies carried out in France, which by definition include more patients,” explains Leem.
Some progress to be made
The dynamics of French research seem mainly driven by cancer research. A little less than half of the 507 studies carried out in France are devoted to onco-hematology. This is followed by studies in the field of infectious diseases, cardiology and metabolic diseases, neurology and psychiatry and rare diseases. However, Leem notes a decline in early trials in 2015. Apart from onco-hematology which alone accounts for 90% of trials, all the other disciplines are on the decline.
The time taken to set up clinical studies has increased slightly in France. The median time between the submission of the clinical research file to the National Medicines Safety Agency and its authorization by this authority fell from 55 days in 2014 to 57 days in 2016. At the same time, the median time for submitting a notice by the Personal Protection Committees (CPP) remains 62 days as in 2014.
“France is still penalized by the length of the delays before the start of the test. Due to a lack of resources allocated to the ANSM as well as to the PPCs, the administrative deadlines are still likely to lengthen, especially since the ANSM is entrusted, under the terms of the Jardé law, with new methodological evaluation tasks, deplores the main pharmaceutical lobby.
Involve patients more
Leem therefore recommends reducing these delays by providing human and financial resources to the various bodies requested by those responsible for clinical trials. It also recommends strengthening clinical research training for healthcare professionals, and involving patients more by designing an information platform.
“France’s attractiveness in terms of clinical research must become a priority issue for the country,” assures Patrick Errard, president of Leem. For patients, because rapid access to innovation, including at early stages of development, is crucial. But also for the vitality of our economy, because countries with strong clinical research potential will have an undeniable advantage in constituting the major industrial centers of tomorrow ”. The latter hopes that the next government will make medical research one of its priorities.
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