Patient information

The StrokeLink network is the French clinical research network for stroke. The purpose of this page is to provide information for those seeking to learn more about the conduct of a clinical trial involving stroke patients.

Clinical research is a means of improving knowledge of diseases such as stroke, developing new methods, technologies, treatments (drugs, medical devices, etc.), in order to improve the quality of care.

For patients who have experienced a stroke, clinical research enables the development of better care both during the acute phase and afterwards during rehabilitation, particularly when the patient is affected by physical and/or cognitive after-effects.

Through such research, the effectiveness of new methods can be demonstrated. Every year, thousands of people take part in clinical trials, thereby helping to continuously improve the quality of care.

Clinical research is strictly regulated by law. In France, two main legal frameworks apply :

> European Regulations, which cover research involving drugs, medical devices and in vitro diagnostic medical devices. These regulations apply throughout Europe.

> The Loi Jardé, a French law that classifies all studies not falling under the scope of European regulations. It is divided into three categories, each corresponding to a specific type of research.

Before a clinical trial can be initiated in a hospital, several authorisations are required from the competent clinical research bodies. The Agence Nationale de Santé et de Sécurité du Médicament (ANSM), the Comité de Protection des Personnes (CPP) and the Commission Nationale Informatique et Liberté (CNIL) work to guarantee both patient safety and the protection of personal data. These three organisations must give their approval for any study involving human beings.

Before starting participation in a study, patients must be informed about the purpose of the study, the expected risks and benefits, and the existing alternatives. They must then express their consent, i.e. give their agreement, in writing and/or orally, depending on the type of study.

The process of obtaining consent in stroke research is a special case. Indeed, in clinical research, there are emergency situations, such as stroke, for which the law provides specific procedures.

Several scenarios are possible :

• If the patient is able to express consent, understand and interact with the doctor, he/she can give consent to participate in the proposed clinical study.

• If the patient is unable to express consent, understand and interact with the doctor, but is accompanied by a trusted person (a close friend, family member, etc.), the latter may consent on behalf of the patient. However, once the patient has recovered, his/her consent will be required for the study continuation.

  In the event that the patient still has deficits preventing him/her to express consent, understand and interact with the doctor, the consent of the trusted person will again be required for the study continuation.

• If the patient is unable to express consent, understand and interact with the doctor, and is unaccompanied, then the doctor will be able to include the patient in the clinical research trial using "emergency consent". This means that the doctor enrolls the patient in the study, in his or her place and name. This is an exception to the principle of prior consent. However, the doctor will seek the consent of the patient or a trusted person as soon as possible.

   

Key point : if the patient can not give consent, a legal representative or a trusted person may be asked to do so. Nevertheless, the consent of the patient will always be sought as soon as his/her condition allows.

You can:

• Withdraw from the clinical trial at any time without having to provide a reason. This withdrawal will not have consequences on your medical care
• Access information related to your health
• Be informed in the event of a serious event occurring during the trial, affecting you or other participants
• Receive information on the final results of the trial
• Check and rectify your personal data
• Refuse the transmission of your personal data

To find out about clinical trials taking place in Europe or worldwide, you can consult :

• European studies: Clinical Trials Register

• Worldwide studies: ClinicalTrials.gov

If you would like more information about clinical research, you can consult the following websites:

• ANSM

• Code de la santé publique

• CNIL