Participants-Volunteers
In order to carry out certain kinds of research, the Public Research Centre for Health needs volunteers either in good health or suffering from particular diseases, who are willing to take part in studies.
Your participation is the key to success in health research. It is an important contribution to the development of treatments for diseases. We need you.
What are the types of studies for which we need volunteers?
1. Epidemiological studies in the general population:
We carry out studies to learn about the state of health of the population living in Luxemburg, to identify risk factors to which it is subject and to follow developments over time. To do this, we need people willing to answer questionnaires about their health, their lifestyles, their circumstances, and who are willing to undergo a check-up, free of charge, sometimes including blood tests or radiological examinations. These studies concern both healthy and sick people equally. For these studies, each participant receives a research number so that the data collected are always anonymous.
How do you take part?
For this type of study, you will have been selected on the basis of the national register of the Sécurité Sociale (national health insurance). We send a letter addressed to you personally, inviting you to participate in the study, along with an information leaflet about the research and a consent form for you to sign. If you agree to participate, all you have to do is return the reply coupon and you will be contacted by the research team in charge of the study.
2. Clinical epidemiology studies
We carry out clinical studies on particular diseases (cancer, cardio- and cerebro-vascular diseases, Parkinson’s disease, Alzheimer’s disease, allergic diseases, mental illnesses, etc) to gain a better understanding of the origins of these illnesses and their development, to improve diagnosis and treatment. These studies are carried out in collaboration with specialists or family doctors. For these studies, each participant receives a research number so that the data collected are always anonymous.
How do you take part?
For this type of study, it is the doctor who is treating you for your illness who will suggest that you take part in the study, explain the study to you, give you the information leaflet and give you the consent form to sign should you agree to take part. Sometimes, once you have signed up, the research team will contact you to arrange for you to take part in the study.
For some very specific studies, we may find it necessary to look for volunteers through the press or television. In this case, if you fit the criteria, you can contact us on the numbers shown on the media and we will provide you with all the information on how to take part.
3. Therapeutic trials
We carry out studies testing the effectiveness of new therapies for particular diseases. These new therapies may be drugs, but they may also be behavioural therapies, new surgical techniques, etc. These studies are carried out in collaboration with specialists or family doctors. For these studies, each participant receives a research number so that the data collected are always anonymous.
How do you take part?
For this type of study, it is the doctor who is treating you for your illness who will suggest that you take part in the study, explain the study to you, give you the information leaflet and give you the consent form to sign should you agree to take part. Sometimes, once you have signed up, the research team will contact you to arrange for you to take part in the study.
The rights of volunteers taking part in research
No person may be included in a study without having given his or her consent. Luxemburgish law, based on European directives, is very strict on this subject and protects the rights of participants in research.
Before suggesting that you take part in a study, the Public Research Centre for Health must obtain the agreement of the National Ethics Committee (CNE) for Research, and must either notify, or request authorisation from the National Data protection Commission (CNPD) depending on the type of study.
Before giving your consent, you must have received an information leaflet explaining the aims of the research, as well as the various stages in the study, examinations or treatments you will have to undergo. The doctor suggesting that you take part in the study will also explain this information to you.
This leaflet must include the name of the investigating doctor and of the contact person you can go to for further information.
You can give your consent to take part in the study and decide to discontinue participation at any time during the study without prejudice. You just have to inform either the doctor or any other member of the research team. You are not obliged to give any reasons.
At any time during the study, you can make a complaint relating to your care in the study to the research team by filling out the form provided. We will process your complaint and keep you informed of any follow-up.
During the study, you have the right to access the data collected about you in the course of the study. To do so, you must request it from the investigating doctor or from the project leader responsible for the study within the Public Research Centre for Health.
Your voluntary participation in a study means that you agree to the data about you collected as part of the study being used, duly anonymised, and being kept at the Public Research Centre for Health for a specified length of time as agreed with the National Ethics Committee for Research.
Participation as a volunteer in a research project is free.
Q: What is clinical research?
A: Studies performed in humans (patients or healthy volunteers) that are intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population.
Clinical research is aiming to develop new therapies or techniques by investigating the efficacy and safety (triggering possible side effects) of a new therapy.
A clinical research project can also be conducted in order to identify the best way of administering the drug: how to take it? What dosage (tablets, capsules, spoonful)? Duration? to obtain satisfactory clinical response...
Sometimes, the research protocols may involve approved drugs, either to test them in new indications, or to determine the most convenient way to administer them.
On consequence, clinical trials always contain a part of uncertainty.
The CIEC commits to the fact that the clinical research projects are always conducted in the fundamental respect of the integrity of every individual and in conformity to international guidelines and regulations (Good Clinical Practices, the directives of the European Union, local laws and regulations).
The clinical studies include several phases:
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Phase I
Phase I: during a phase I study, an experimental treatment is administered to a small number of patients (10 to 40). This treatment was already tested in laboratory, on cellular cultures and on animals, but nobody still knows how will react the human beings. The physicians will investigate the best ways to administer safely the treatment and monitor attentively possible side effects.
Phases I are often realized on healthy volunteers, persons dedicating some time to the clinical research and to new developments of the pharmaceutical industry.
Sometimes phase I trials can be conducted in patients with an advanced pathology (cancer patient) where no other known treatment is effective. Although the therapeutic effect is not known at the time of the phase I, patients could be helped by their participation. -
Phase II
Phase II studies aim at studying the efficacy of a study drug given for a particular pathology. Besides the immediate efficacy, the safety of the study drug is also investigated in phase II studies. Phase II studies usually require the inclusion of 40 to 80 patients. -
Phase III
In case the results of phase II trials suggest that the treatment is effective, phase III are conducted to compare the new treatment to the best known treatment (or reference treatment). In the absence of alternative treatment, the new molecule is compared to placebo (a simple tablet without an active compound, or injection of a physiological salt solution in case of a treatment by injection).
A small difference in efficacy can have an important impact: for example, an increase of only 5 % of survival for an active anticancer treatment represents several thousand human lives saved in Europe only. Studies of phase III are large-scale (several hundreds to thousand patients).
Phase III studies constitute a crucial stage, as they precedes the marketing and availability of new more effective and\or less toxic treatments. The new treatment can also be associated either to other medicines, or to surgery and\or radiotherapy, in new therapeutic procedures still improving survival and\or quality of life of the patients.
Q : What is the role of the National Research Ethics Committee?
A : The role of the ethics committee is necessary and compulsory to guaranty the rights and safety of the participants by ensuring that:
- the patients are not exposed to questionable risks. The Committee examines the study protocol, as well as any additional information available regarding the experimental treatment, to assure that the research project is safe.
- the information presented to the participants explains correctly and in an understandable language the study allowing them to give their informed consent.
- the research team supplies updates on the progress of the studies, including any information about serious side effects. Such adverse event effects often require that the information supplied to the participating patients is updated.
The National Research Ethics Committee also formulates requirements and recommendations. And has the power to assert his decisions, by preventing, if required, the study from taking place.
Q : Why to decide to participate in a clinical study?
A : By agreeing to participate in a clinical trial, you decide to collaborate in the development of new therapies. It is for you an opportunity not only to improve your chance of recovery but also the treatment options for other patients.
With your participation you contribute to accelerate the process of availability of new therapies to a larger community, by taking an active part in the application of newly gained knowledge to useful treatments.
In many cases, clinical research allows an earlier access for the patients to new medicines or techniques, well before their launch on the market. Clinical trials constitute to the patient a real treatment option when all the standard treatments were exhausted.
By participating in a clinical trial, the positive effects of the treatment can not always be guaranteed, and it is however possible that, in several studies, you receive an already available treatment, or a product with no “active" compound.
The informed consent
Before participating in a clinical study, you have to consider the advantages and possible risks and inconveniences of the study treatment, as well as any potential treatment alternative.
To help you there, the physician or his research team, will explain you, verbally and in writing, the known risks and the possible advantages of a study participation.
You have to understand the treatment as good as possible, as well as the existing differences between this treatment and alternative treatments. Do not hesitate to question your physician about the study or any intervention. Also speak with reliable persons, as for example, your family doctor or your spouse about the study.
This process, which consists in receiving information and to declare then verbally and in writing your consent to participate, is called informed consent. For the minors and the children, the informed consent informed of one or both parents is required. The teenager also needs to give his informed consent.
Having received complete information, you can decide not to participate in the clinical study. In this case, you will have access to standard healthcare. Thus, you will have no access to new and not registered medicines.
If you decide to participate in a clinical trial, you can very easily, during the study, obtain precision or further information.
Q : Can I refuse that I participate in a clinical trial?
A : Yes. The studies contain extremely rigorous criteria as for the selection of the patients. It is completely possible that you are retained in a phase of selection or "screening", without being allowed to participate in the active phase of the study.
Q: Can I choose the medicine which I am going to receive?
A : In a clinical trial comparing two medicines, neither you, nor the doctor, can choose the treatment you will receive. The treatment will be chosen at random (randomisation procedure). Often even, neither you nor your doctor will know which medicine you receive (double blind study).
Q : What are the obligations connected to a participation in a clinical study?
A : They are diverse and more or less mandatory:
- be present at the visits and according to the established schedule,
- agree not to take certain medicines during the study, to fill out questionnaires or to keep a diary...
Q: Can I change opinion along the way?
A: In the majority of the cases, you can withdraw from the study in which you participate. It is possible that the treatment is irreversible (in case of a surgery, for example) or some time is required before a treatment can be stopped. However, even after your withdrawal from a study, the investigating physician can, for safety reasons, ask you to continue the planned visits.