Information for patients

The CRISALIS network, among its missions, includes the information of the actors of clinical research in asthma. At the heart of care, the severe asthma patient is an integral part of clinical research!

This page aims to provide information to patients who wish to find out more before participating in a research project or clinical trial (what it implies, how it works, rights and protection as a volunteer, etc.) and to give information about French patient organizations. 
 

Anyone can, under certain conditions, participate in a research or clinical trial. It is not individual interest that should drive this commitment, but the desire to contribute to progress in health.

Without a clinical trial, there can be no new therapeutic methods, no new medication: it is impossible to distribute treatments without having demonstrated their effectiveness and safety. That's why, every year, thousands of citizens get involved in clinical trials to test new drugs or new approaches to healthcare.

Because volunteers need to be informed in order to get involved, we offer you some answers about:

• clinical research and the legal framework that governs it,
• clinical trials on health products (drugs, devices or cell and gene therapy),
• participation in a clinical trial: practical aspects (eligibility, procedure, rights of volunteers taking part in research),
• directories of clinical trials.

 

What is clinical research?

Clinical research (as defined by the Jardé law which governs it in France) corresponds to scientific studies carried out on human beings, with a view to developing biological or medical knowledge. It is prospective research, involving the follow-up of patients or healthy volunteers. This research is essential to better understand and/or treat diseases, as well as to identify potential risk factors. In the long run, it enables un improvement of our health.

When we talk about clinical research, we often think first of clinical trials aimed at evaluating a new drug, a medical device or a biotherapy. But this area of health research is much broader. Clinical research also allows :

• the identification of molecular or cellular mechanisms involved in diseases (which may itself lead to the identification of new therapeutic targets),
• the identification of genetic or environmental risk factors (which can lead to prevention strategies)
• the comparison of several available diagnostic or therapeutic approaches or the realization of a survey on the quality of life of patients and the care pathway (which can be used to formulate recommendations on the management of patients)...

 

What is the legal framework?

Research involving the human person ("RIPH" in French) is governed by legislative texts that distinguish three categories. These categories are differentiated mainly by the nature of the intervention intended for the research protocol (whether or not it modifies the usual care of the participants) and the level of risk and constraints for the persons who agree to participate in it

A distinction is also made between research on health data and research on biological samples. Retrospective research, which involves biological samples that have already been collected or data that already exists, is subject to a different regulatory framework, which requires, in particular, that the protection of individuals who have provided their samples or data be ensured.

In all cases, this research must :

• be carried out by a sponsor who manages the study, ensures compliance with good practices guaranteeing the integrity of the study and verifies that funding has been obtained,
• have obtained the favorable opinion of a committee for the protection of individuals ("CPP" in French),
• receive authorization from the French Data Protection Authority ("Commission Nationale Informatique et Liberté, CNIL") concerning the processing of personal data of the persons involved (or respect a reference methodology).

Category 1 research (interventional research on drugs) must also be authorized by the National Agency for Drug Safety ("Agence Nationale de Sécurité du Médicament et des produits de santé, ANSM"). For category 2 studies (interventional with minimal risks and constraints) and category 3 studies (non-interventional), the ANSM is simply informed of the opinion given by the CPP, without any authorization being required.

 

What is a clinical trial?

A clinical trial is a biomedical research which is organized and conducted on humans in order to develop biological or medical knowledge. A 'clinical trial' often refers to a category 1 interventional trial involving a health product (drug, device or cell and gene therapy).

The purpose of a clinical trial on a health product (drug, device or cell and gene therapy) is to evaluate its safety and efficacy in healthy or sick volunteers. The drug may be granted a marketing authorization (MA) by the French National Agency for Drug Safety ("ANSM") if it is proven to be effective, safe for the patient and can be used safely.

The purpose of drug clinical trials is to establish or verify some pharmacokinetic (how the drug is absorbed, distributed, metabolized and excreted), pharmacodynamic (how the drug works) and therapeutic (efficacy and safety) data for a new drug or a new way of using a known treatment.

The clinical evaluation of the safety and efficacy of a new drug takes place in four distinct and successive phases, each of which gives rise to a different trial.

The trial can be conducted on sick or healthy volunteers.

A clinical trial cannot be conducted without prior information of the person on whom the trial is conducted and without his or her informed consent.

The objective, the conditions for carrying out the trial, the methods of inclusion, information, treatment and monitoring of the persons participating in the trial by the investigating physicians and the procedures for collecting information on the efficacy and tolerance of the drugs are defined in a pre-established protocol.

 

In practice 

Once the authorizations have been obtained, the research is carried out under the direction and supervision of an investigator (physician, health professionals or a person qualified in the field concerned by the research) who must: 1- inform the persons solicited to participate in a study and 2- collect their agreement to participate in the study and make sure that they have fully understood the information given. Depending on the category of the study, this agreement can be an informed consent (written, express) or a non-opposition, in accordance with the French law.

Throughout the duration of the trial, the ANSM is kept informed of any serious and unexpected adverse events that may be related to the experimental drug and of any new fact related to the research that may call into question the safety of the persons taking part in the research; it may take any decision concerning these trials (suspension, ban).

 

👉 Who can participate in a clinical trial? 

Sick or healthy, anyone can be asked to participate in health research. This proposal can be made during a consultation with a doctor, but also by means of a poster or media announcement. It is also possible to volunteer independently, by contacting structures dedicated to clinical and health research, such as Inserm's Clinical Investigation Centers ("CIC"), or the thematic clinical investigation networks of the F-CRIN infrastructure of which CRISALIS is a part.

Being a volunteer does not mean that you will automatically be included in a trial.

Each study has inclusion criteria based on age, gender, type and stage of disease, medical history, and associated diseases. These criteria guarantee homogeneous groups of patients, and therefore reliable, relevant and robust results.

 

👉 You are eligible for a clinical trial and your doctor suggests you participate (to "include" you, in clinical jargon), how does it work?

Clinical trials must be conducted under the direction and supervision of a physician investigator. The investigator must clearly inform the volunteer of:

• the purpose, methodology and duration of the research,
• the expected benefits, constraints and foreseeable risks, including in the event that the research is stopped before its completion,
• the possible medical alternatives,
• the arrangements for medical care planned at the end of the research, if such care is necessary, in the event of a premature termination of the research, and in the event of an exclusion from the research,
• the favorable opinion of the CPP and the authorization of the ANSM,
• his right to be informed, during or at the end of the research, of the information concerning his health that the he holds,
• if applicable, the prohibition to participate simultaneously in another research project or the period of exclusion provided by the protocol and his registration in the national file,
• his or her right to refuse to participate in research or to withdraw consent at any time without incurring any liability or prejudice as a result.

The communicated information is summarized in a written document given to the person.

Persons participating in clinical research have rights (see next paragraph), including the right to a reflection period to decide whether or not to participate.

Consent is given in writing, in accordance with the law. 

Once consent has been given, and before actually participating in the clinical research project, the participant is usually given a preliminary medical examination, adapted to the research, the results of which are communicated to him/her directly, or through a physician of his/her choice.

At the end of the "inclusion" visit or at the next visit, if the results are in agreement with the study criteria, the investigating physician can confirm the inclusion. If this is not the case, the volunteer will not be able to participate, but will of course continue to be treated in accordance with the standard of care required for the treatment of his/her disease.

During and throughout the study, the clinical research team (clinical research technician and/or nurse) accompanying the investigating physician will be available to answer any questions, accompany and guide the included volunteer at the rhythm of the planned visits and examinations.

 

👉 What are the rights of people participating in clinical research? 

The law makes it clear that the interests of the people involved in clinical research always take precedence over those of science and society. It also states that research must be designed to minimize pain, discomfort and fear.

The main rights of volunteers in a clinical trial are:

• to take time to think, with their loved ones and their general practitioner if they wish, before deciding to participate in the study,
• to leave the trial at any time, without giving a reason, simply by telling the study doctor
• to be informed about their health,
• to be kept informed if a serious event occurs in one or more participants during the trial,
• be informed of the overall results of the trial,
• to verify and correct their data,
• to refuse to have their data transmitted,
• obtain compensation in case of prejudice.

 

Directories of drug clinical trials

The ANSM authorizes clinical trials in France.

It is possible to consult the European Medicines Agency's Clinical Trials Register or the international database Clinicaltrials.gouv, which contains the main information about the trial. Additional information can be obtained from the sponsor of each trial.

Sources: ANSM, INSERM ("Institut National de la Santé et de la Recherche Médicale")

 

The "severe asthmatics" organization 

This French patient organization was created in 2018 on the initiative of 3 people suffering from severe asthma. 

Goals of the organization:

1. To make known the specificity of this rare and serious form of asthma,
2. To offer a space for exchange and listening to break the isolation and lack of understanding of severe asthmatics,
3. To help the daily life of these patients and to bring them information on the new existing therapies.
4. To improve the care pathway for people who have difficulties in being taken care of.

For more information:

Visit the website or download the organization's flyer (French).

 

The "Asthma & Allergies" organization

Created in 1991, it is a non-profit organization, governed by the 1901 French law, whose main objectives are to inform and support people with asthma or allergies, parents of asthmatic children, as well as doctors and health professionals.

 

For more information:

Visit the organization's website (French).