What is clinical research ?

During a visit with your angiologist, or during hospitalisation, you may be offered participation in a clinical trial on thrombosis.

Clinical research is research conducted on human beings to improve scientific medical knowledge and patient therapeutic and medical care. Clinical trials may be conducted in sick or healthy participants.

A clinical trial can be defined as a method for assessing the efficacy of a new treatment by comparing it to the treatment currently used, or the absence of treatment if no treatment is currently indicated for the condition. They are a way to check or study the safety and efficacy of treating with a given drug, medical equipment or technique. Additionally, to comply with Good Clinical Practice, they must meet rigourous methodological criteria. Clinical research helps improve diagnosis, care, and treatment practices for patients.

Legislation governing clinical research :

Research on human beings is governed by a very strict legal framework and many ethical guidelines have written about it. The basic principles of international ethics concerning medical research on humans were drawn up in two texts: the 1947 Nuremberg Code, and the 1964 Declaration of Helsinki (revised in 1975).
In France, the first law establishing a legal framework for all trials on humans was adopted as late as august 10th, 1988: it was the Huriet-Sérusclat law of August 10th, 1988. This law protects individuals participating in biomedical research by making it mandatory to inform participants and to obtain their official consent.
This law was then adapted to the European Directive # 2001/20/CE (April 4th, 2001), which aimed to harmonise clinical trial regulations between all member states. The law of August 9th, 2004 replaced the Huriet-Sérusclat law on August 27th, 2006, the day that the new legal and regulatory system was implemented in France.

Actors in clinical Research :

Industrial companies are among the main actors in the research and development of new therapies. However, without institutions such as teaching hospitals, there could be no patient inclusions into international clinical trials, and there would be deficiencies in some fields of research which industrial companies do not conduct, such as clinical practice comparison trials or safety evaluations of one particular drug on a specific population (e.g., the elderly).
Therefore research is one of the missions of public hospitals, along with health care and teaching, and public hospitals can be an ideal place to conduct clinical research.

You can also download the document entitled: "Les Essais Cliniques: les réponses aux questions que vous vous posez »

In addition, this document has appendixes on:

• Experts of parliamentary reports and public studies on the current state of clinical trials in France.
• Regulations governing clinical trials
• Definitions and messages
• An introduction to the l’IFPMA (International Federation of Pharmaceutical Manufacturers & Associations)

The LEEM website also provides downloadable leaflets on the topic.

The following brochure has been available for download from their website since May 15th, 2009 : Participation d’un enfant, d’un adolescent ou d’un adulte à un essai clinique sur un médicament.
For a different source of information on clinical trials : Boehringer Ingelheim, section "en savoir plus sur les essais cliniques".

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