What is a clinical study?
A study or a clinical trial collects, under strict medical supervision, within a very rigorous regulatory framework and according to specific protocol, various information on the product tested, whether it’s a new drug or an existing one.
Phase I is the study of healthy volunteers and patients aimed at assessing the safety and pharmacological activity of a molecule. Phase II study confirms the results of phase I and helps in adjusting the effective doses of the medication on a small number of patients, with a view of choosing the most effective dosage for Phase III.
Who are those involved in conducting in a clinical study? Some definitions:
The promoter is the pharmaceutical company that discovered a new molecule to treat or improve the treatment of a specific disease.
The investigator is a specialized and experienced doctor responsible for the conduct of the study.
The healthy volunteer is a person without any diagnosed disease, willing to participate in a clinical study for the development/advancement of therapeutic researches.
The volunteering patient is a person suffering from a medical condition who agrees to bring his contribution to development of therapeutic research for that disease.
The regulations on biomedical research:
The Clinical Trial Act
The Clinical Trial Act aims to harmonise the legal and administrative regulations relating to the implementation of good clinical practice in the conduct of clinical trials on medicines for human use.
The Ethics Committee (EC)
The Ethics Committee (EC) consists of experts who ensure the ethical nature of each study and give their opinion on the relevance of the project: They act as the guarantor for the protection of the interest of participants to clinical studies.
The Clinical Research Regulatory Council (CRRC)
The Clinical Research Regulatory Council (CRRC) allows the execution of the medical study.
The Pharmacovigilance Committee (PC)
The Pharmacovigilance Committee’s (PC) role is to monitor clinical trials while ensuring that the Good Clinical Practice (GCP) are correctly followed. These GCP have gathered all the procedures that will ensure the safety of volunteers / patients and guarantee the authenticity and quality of scientific data.
After reading the information on the product to be tested and how the study will be conducted, the volunteer / patient acknowledges having been duly informed and expresses his agreement by signing with the investigating physician, the Information Sheet and Consent Form.
People have the choice to participate or not to do so. If they are consenting, participants are then invited to sign the Consent form, a document which includes all relevant information about the clinical trial. If the modus operandi is convenient to the participant, a doctor will explain once more all the procedures and will then proceed with a health check and medical examination.
Depending on the study, participants may be hospitalised and monitored for periods lasting between one to several weeks. It is important to note that all clinical studies are strictly confidential. As such, each volunteer / patient receives an allowance to compensate for the constraints imposed by a study (time spent in hospital, travelling to and fro the clinic, blood tests …)