Trial procedure
Trial procedure

Trial procedure

In order to complete the development of a vaccine, clinical trials are essential. No vaccine can be authorized for commercialization without the clinical trials results. These tests evaluate the security, the immune response, as well as the efficacy of a vaccine on volunteers. 

Becoming a volunteer for a clinical trial is therefore a social engagement, allowing the protection of the most vulnerable of and also of the whole population. This contribution is crucial for the elaboration of a vaccine and is therefore needed to slow down an epidemic in the medium term, and perhaps to eradicate a disease in the long term. 

Nevertheless, deciding to volunteer can be difficult and may raise some concerns for some of us. In spite of the complexity caused by the numerous hazards in the vaccine development, as well as the long participation period, clinical trials are conceived to minimize the risks, especially since they are all regulated and submitted to the national agency for medicine and medical products security (ANSM) for authorization and people protection comity (CPP) for favorable opinion.

Vaccines are not the only studies we do. The CIC Cochin-Pasteur is capable of conducting other types of trials. Some studies on therapeutical products in biotechnology, as well as other studies in physiopathology are often subject to research.

You will find listed below frequently asked questions on the different stages in a clinical trial, as well as some commonly asked question by the participants.

F.A.Q.

Trial enrollment can be done in various ways: your doctor can direct you towards a clinical trial, you can directly contact us, answer to a call for volunteers after seeing a poster in a public space…etc. 

Following your mark of interest, a preselection process is set up. A first call will be made to inform you and verify the main eligibility criteria. After a period of thinking, and your decision being taken, a meeting will be arranged by the CIC’s secretary. 

You will then meet the investigator of the study (a medical doctor), who will be your point of contact. During this visit, the investigator will give precise information about the procedures and will collect your consent, which must be free and informed. It is only when this consent form is signed, that the trial can really begin. 

This same doctor will be in charge of the selection visit, which is another important part of the trial procedure. Criteria like gender, age, medical background, as well as other characteristics are taken into account. A medical check-up (exam) is essential in order to evaluate your state of health. From the entirety of these information, the doctor will make sure that you meet the appropriate criteria as defined in the protocol.  

Inclusion criteria may differ and be related to the presence of a pathology or to some other biological parameters, including gender and age. Exclusion parameters also exist and can keep a volunteer out from participating. These exclusion criteria can be diverse and can be defined by the presence of a serious illness or certain medication intake. 

After you agree to participate in a trial and pass all the selection phases, you will have regular follow-up with the investigators in charge of the study. A planning of visits and/or phone calls will be set up for the entirety of the study. During the different consultations, complementary exams will be to be completed, as well as some questionnaires to be filled-in. 

Importantly, volunteers are assured that all the collected information is strictly confidential, because covered by medical confidentiality and French legislation on Clinical research. The volunteer can exert its right to withdraw from the clinical trial at any time and stop its participation at any time, with no justification. He must be informed of every modification in the protocol concerning him.

In order to take part in a trial, it is essential to volunteer. 

The selection of volunteer is performed through very specific criteria, in order to allow the realization of the trail in the most optimal conditions. In the same way, the selection can be done according to a population, which pathology corresponds to the studied medical dispositive.

The investigator in charge of the study is responsible for the assessment of the patient and for his eventual ability to participate in a trial. Inclusion and exclusion criteria are defined during the selection phase. 

All clinical trials are conducted on men, women and elderly people, provided that they are covered by social security or a similar regime. 

Women can participate in clinical trials. Nevertheless, a particular vigilance is provided over the used contraceptive methods, in order to avoid pregnancy during the trial. 

A specific attention is given to certain categories of people, considered as vulnerable. This includes, among others: pregnant women, breastfeeding women, immunosuppressed individuals, overweight individuals, etc. These individuals can take part in the trial, if the expected personals benefit exceeds the risk. In this case, the foreseeable risks must be reduced to a minimum.

The investigator in charge of the study must give clear and precise information about numerous elements, also described in the information notice given to the participant: 

  • The objective and the duration of the study,
  • The tested product and the possibility of a placebo, 
  • The precise research procedure (visits description, check-ups, the calendar, the length of the participation, the main eligibility criteria…),
  • The eventual benefits expected and the anticipated risks, 
  • The opinion of the national agency for medicine and medical products security (ANSM) and the opinion of the people protection comity (CPP).  
  • The data confidentiality and their processing, according to the applicable regulations,
  • Costs coverage, 
  • The global research results. 

The volunteer’s daily-life can be more or less affected, depending on the type of the trial. 

These constraints are described in the information notice. They can be low (mere phone calls) or very severe. These constraints can be related to medicinal intake, medical visits, follow-up reviews and biological sampling.

Before deciding to participate or not in a trial, it is important to review the information notice in order to evaluate the impact that the participation can have on your professional and family life, your hobbies… etc.

Different mechanisms permanently ensure the protection of people during a clinical trial: 

  • The responsibility of the investigator; he must examine the patient during regular visit, call the volunteer, in order to learn more about the evolution of eventual symptoms. 
  • The national agency for medicine and medical products security (ANSM) is responsible for the implementation of the vigilance system for clinical trials and takes appropriate measures, if needed. 
  • An independent research comity can be set up by the promoter. This comity if informed of every new efficiency or security gathered data, that is discovered during the trial. 

All the protection measures are described in the protocol, submitted to validation by the ANSM and the CPP.

Here are some questions that one can ask oneself before deciding taking part in a trial: 

  • What are the study objectives? 
  • What is the study length?
  • What impact this trial will have on my daily-life? 
  • What kind of vaccine/treatment will I possibly receive? 
  • What are the side effects and anticipated risks?
  • What does my personal physisician think?
  • Have I spoken enough with my close circle?
  • Who will I be followed-up by?
  • Who can I join at any moment in case of a problem?
  • What will happen at the end of the trial?
  • Is a compensation expected? 

A decision is important and have to be well-considered. A time to think is given before giving consent.