The collection of real-life data[1] is a central issue for the evaluation of medicinal products and medical devices. On the one hand, the HAS increasingly considers that these data are essential for the re-evaluation of health products. On the other hand, the collection of real-life data has become systematic for certain modes of care (such as early access for medicinal products).
As a reminder, a methodological guide on real-life studies for the evaluation of health products was published by the HAS in June 2021. It recommended the reuse of pre-existing data.
To this end, the HAS wishes to list the real-life studies and databases that can be mobilized by manufacturers to respond to requests for additional data from health product evaluation commissions.
In May 2022, the HAS therefore launched a call for census to all promoters of studies or databases, regardless of their status, interested in contributing to requests for additional data via partnerships with medicinal product or medical device manufacturers. It should be noted that there is no obligation for sponsors to respond to this call.
Responses may be published in summary form by the HAS if the data source presented is considered usable to respond to requests for additional data.
What are the effects for the industry?
The HAS inventory of real-life studies and databases should allow :
- on the one hand, accelerate the availability of study results;
- on the other hand, to limit the duplication of data collection. In this respect, the HAS reminds us that, in the context of a post-registration study or an early or derogatory access, it favours the use of data collections that are already in place.
However, this census raises questions when it concerns studies that manufacturers finance without being sponsors. In this case, can the promoters’ responses to the HAS’s call for proposals be detrimental to the industry’s subsequent evaluation of their health products? If so, how can these risks be avoided?
[1] These data, called “observational data” or “real-life data”, concern the use, efficacy or tolerance of a health product in current practice. They are generated during routine patient care and therefore reflect current practice.
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