PARIS, Oct 22 (APM) - The French economic committee for health products (CEPS) presents in its 2013 annual report a brief summary of the first year of operation of the new committee set up to monitor real-world studies, which shut down its first 16 studies previously ordered.
The monitoring committee which was established following the amendment to the agreement with the French pharma industry body (LEEM) of December 2012, brings together members of CEPS and the French national authority for health (HAS), according to the CEPS report published on Tuesday.
Interviews can be held with pharma executives, and even with LEEM, but these parties do not attend the deliberations. Set up on April 9, 2013, the committee met four times during the year. It should now meet every two months.
Its task is to “contribute to the implementation and performance of studies in medical practice concentrating particularly on the obstacles in the way of their feasibility within the set lead times,” CEPS pointed out.
The exchanges between CEPS and HAS on the studies they ordered “aim to clarify and simplify the process and particularly the contents of the study itself through prioritisation of the objectives, their implementation in line with the assessment requirements; they also involve schedule compliance”.
Reasons for terminating studies
Among the first tasks, the monitoring committee “performed a reflection process on the post-registration studies to perform, maintain, postpone or interrupt. It also identified the studies that had not been started yet and/or those needing to be speeded up owing to an inclusion rate too slow for the scheduled lead times,” CEPS says.
It examined 18 studies requested between 2000 and 2012 and shut down 16:
:: two for which the marketing authorisations (AMM) of the drugs have been withdrawn,
:: two for drugs not registered despite favourable opinions since 2003 and 2008,
:: seven studies not started and not mentioned in the agreements between CEPS and the pharma companies or that the Transparency Commission (CT) had not itself requested,
:: and five studies that were difficult to perform owing to insufficient sales,
The last two studies were maintained but suspended owing to the provisional suspension of the marketing authorisation of one of the products and the lack of registration for reimbursement for the second.
The monitoring committee also worked on its core activity, namely, the performance of the studies.
“A procedure to solve study feasibility problems has been set up,” CEPS said. In 2013, this concerned vaccines to protect against human papillomavirus (HPV) Sanofi Pasteur-MSD’s Gardasil and GlaxoSmithKline’s Cervarix and drugs to treat pollen allergy ALK’s Grazax and Stallergenes’ Oralair.
CEPS does not say how many requests either made by itself or by the CT are currently in progress.
It said in 2013 it requested 11 post-marketing studies including four due to serve as the basis for a performance contract. It also reports that it integrated in agreements studies requested by the CT or the European Medicines Agency (EMA).
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