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What is a clinical trial ? A clinical study or trial allows to collect, under strict medical supervision, within the bounds of the law and according to a particular protocol, various information about the investigational product, either a new drug, or a drug that already exists. Which parties are involved in a clinical trial ? - the sponsor is the pharmaceutical company which has developed a drug to treat a given disease, with intent to market it - the investigator is the qualified physician in charge of conducting a clinical trial - the healthy volunteer is a male/female without any diagnosed disorder, willing to participate in a clinical study - the patient volunteer is a male/female who accepts to help therapeutical progress of the disease he/she is suffering from. What are the regulatory requirements ? - Since August 27th 2006, France has been implementing the EU Clinical Trials Directive 2001/EC into national legislation (application decree n°2006-477 dated 26 april 2006) detailing new rules on good clinical practice for investigation of medicinal products. - An advisory committee - the CPP (Comité pour la Protection des Personnes), an independent body constituted of medical, scientific and non-scientific members - warrants the protection of the rights, safety and well-being of human subjects involved in a trial - The AFSSAPS (French health security agency for health care), a dependency of the French Ministry of Health, grants permission to perform a study. - The subject voluntarily confirms his/her willingness to participate in a trial, after having been informed of all aspects that are relevant to the subject’s decision in participating. With the investigator, he/she documents his/her informed consent by means of a written, signed and dated informed consent form. - The Good Clinical Practice (GCP) is "an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects". - A request for authorization by the CNIL (a national committee for data protection) aims at ensuring the subject’s anonymity and the confidentiality of collected data. , |