Your study : BMR or routine care?
You have to make a regulatory submission for a study but you’re not sure how to classify this study? Or you simply want to have a simple and comprehensive view of the current typology of clinical research studies? This article explains you the various studies of interventional research and how to differentiate them.
Thanks to Hélène Marquet, one of our collaborators, for writing this article.
Today, the typology of clinical research studies is based on the Code of Public Health. Despite its publication in the Official newspaper in March 2012, the Jardé law that planned, among other things, a new typology of research based on risk, is still not implemented and is suspended to the publication of decrees and orders for its entry in force.
Furthermore, the new European regulation on drug trials was published in the Official newspaper of the European Union on May 27, 2014. The French legislation will have to be adapted to make them compatible and consistent with the new European regulations which will be applicable at the earliest by the end of May 2016.
To start, here is a simple diagram of clinical research classification:
Interventional research involves any diagnostic or monitoring act carried on the person and not justified by the medical care of the person. Therapeutic strategies or additional diagnostic or monitoring procedures are then determined in advance by a research protocol.
It includes BioMedical Research (BMR) and Research on Routine Care (RC).
Biomedical Research means:
“The research organized and practiced on humans for the development of biological or medical knowledge” (L1121-1 CSP).
As for the Research on the Routine Care, it is defined as:
“… aiming to assess routine care, other than those on medication, when all the acts were performed and products used habitually but that special monitoring arrangements are provided by a protocol…” (L1121-1 CSP);
“of researches aimed to evaluate actions, combinations of medical acts or strategies for prevention, diagnosis or treatment which are common practice, that is to say subject to professional consensus, in accordance with their instructions.”(CSP R1121-3)
– and for which: “The specific terms of monitoring implemented in this researches involve only negligible risks and constraints for the person consenting to research.” (CSP R1121-3)
But does not include:
– Researches on innovative obsolete techniques or strategies;
– Researches evaluating innovative combinations;
– Researches comparing medical strategies;
… that are part of BMR.
In this type of trial, randomization is permitted (Decree 2006-477).
Practically, to qualify a research to start the test, you can refer to the following table:
Inspired by the ICC URC Necker Cochin
It is important to define the type of your study to initiate the right regulatory submission procedures and begin your research project quickly.
I hope this article has helped you to classify your study. If you still encounter difficulties, you can join the CPP that is assigned to your study in order to enlighten you more.
You can also contact the Legal and Regulatory Affairs ANSM by phone at + 33 (1) 55 87 36 58 or send an e-mail to email@example.com.
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For more information on clinical research, I recommend this book:
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