WHAT IS A TRIAL?
Clinical trials provide an organized and codified framework for validating research undertaken to develop a new drug, as well as non- medical treatments such as surgery, radiation therapy or innovative therapeutic strategies.
The development of a new drug or treatment is long, and is conducted in several phases.
Phase I trials: First administration of a new molecule in humans to assess toxicity and determine the maximum tolerated dose.
Phase II trials: Patient trials to determine optimal dosage in terms of efficacy and tolerance.
Phase III trials: Trials conducted on representative patients or the population for which the treatment is intended. These are most often comparative trials where the experimental treatment is compared to a reference treatment. These tests aim to demonstrate the therapeutic efficacy of the treatment.
Phase IV trials or pharmacovigilance phase: Trials carried out, after the marketing of the treatment, on a very large number of patients in order to perfect the knowledge of treatment side effects.
Why participate in a trial?
BENEFITS FOR CLINICAL RESEARCH
Cancer research has advanced considerably in recent years, but much progress has still to be made. The participation of patients in clinical trials is essential to improve the treatment of cancer in the future: it involves diagnostic methods, treatments, combinations of molecules, surgical procedures, radiotherapy … These advances are aimed to significantly improve the management of the pathology, reduce the symptoms of a disease, and allow a better quality of life. By participating in clinical trials, patients contribute to the improvement of medicine and research in general.
Participating in a clinical trial therefore
- Advances research by testing a new treatment or combination of drugs and proving its effectiveness but also its tolerance in humans;
- Contributes to providing promising new molecules to patients resistant to conventional treatments, within a legal, well-defined and secure framework;
- Provides patients with new and effective drugs, while trying to prove their superiority to standard treatments.
BENEFITS FOR THE PATIENT
Participating in a clinical study allows patients to access innovative therapy, especially when existing treatments are moderately effective or not very well tolerated.
In addition, patients participating in a clinical trial will benefit from specific treatment, and more follow-up as defined by the protocol. In addition, the care team is reinforced by the clinical research team to ensure maximum patient comfort and attention during treatment and the follow-up period.
Also, if the treatment tested in a clinical trial proves more effective than the standard treatment, the patients of the trial will have been the first to benefit from it, even before its marketing.
What happens in a clinical trial?
Where are clinical trials taking place?
Clinical trials are conducted in hospitals and clinics and mainly in University Hospitals and Cancer Centers. They are organized and conducted by researchers and investigating physicians.
How are clinical trials usually conducted?
PROPOSAL TO THE PATIENT
Investigating physicians suggest that their patients participate in a clinical trial either immediately after diagnosis or during treatment. Patients can also report to their doctor that they would like to participate in clinical trials or they can search for information on clinical trials recruiting patients via the internet.
The physician proposes that a patient participate in a trial, and must validate the ability of the patient to participate in the trial. Indeed, each clinical study has its own criteria (inclusion / exclusion) and all the criteria must be respected, otherwise participation in the clinical trial is not possible. Validation of the patient for the trial may necessitate additional biological or radiological examinations.
INCLUSION OF THE PATIENT IN THE TRIAL
The investigating physician must receive informed consent from the patient to participate in the clinical trial. This is a form that the patient must date and sign by hand. Informed consent means that the patient agrees to participate in the clinical trial and has been informed of the trial’s aims, risks and patient rights.
Throughout the trial, the patient will be kept informed of all important data related to the efficacy and / or safety of the treatment.
Patients to whom participation in a clinical trial is proposed by Lacassagne will have a consultation with a clinical research associate. This consultation will explain the information already given by the doctor in simplified terms.
THE RESEARCH PROTOCOL
The conduct of a clinical trial is based on a clinical trial protocol. A protocol is a strict treatment plan that physicians and patients must follow to ensure the quality of the clinical trial. The signature of the CT attests to the understanding of the commitment, agreement to participation and adherence to the protocol (RDV, examination …). This signature does not relieve the investigator of his duty of care. A patient included in a clinical trial must also report any effects experienced during treatment by sometimes completing a so-called quality of life questionnaires. The patient may need to avoid certain types of medications or foods during treatment. All information will be collected in a special folder and the data will be saved in a secure database. All this information and the identity of each patient will remain confidential.
HOW ARE CLINICAL TRIALS FINANCED?
The money used to finance clinical trials comes from different sources: usually pharmaceutical companies but also public funds from universities, national or international institutes and private funds from non-profit organizations.
WHAT ARE YOUR RIGHTS ?
The Huriet-Sérusclat Law (1988) emphasizes the rights of participants and the protection of individuals by an obligation of information and informed consent in the field of biomedical research. As part of the transposition of European Directive 2001/20 / EC, this law was revised by the law of 9 August 2004 on public health policy, which came into force on 27 August 2006.
RIGHTS OF PARTICIPANTS IN A CLINICAL TRIAL
- The investigating physician is required to inform the patient in a fair and thorough manner.
- Participants are voluntary: they are free to accept or refuse to participate in a clinical trial.
- When accepting, participants remain free to leave the test at any time without any justification.
- Consent is given in writing, or attested by a third party if it is not possible.
- At the end of the test, the patient should be kept informed of the overall results of the research if they so wish.
- Exceptions can be made for emergencies where family members or trusted persons can give their consent while waiting for the patient’s consent to be obtained as soon as possible.