This is a very personal choice, the reasons to join a clinical trial are different for each volunteer. You might want to play an active role in your own healthcare, or maybe you are just interested in the advancement of science. Volunteering in a clinical trial can sometimes give you access to new treatments before they are available to the public.
All clinical trials have some criteria about who can participate, called eligibility criteria. These criteria are listed in the clinical trial protocol and will be different for each study. The list of things a participant needs to have to be able to participate are called inclusion criteria, and those that they cannot have if they want to participate are the exclusion criteria. These eligibility criteria are usually based on factors such as age, gender, medical history, previous treatments. To participate in the study, the investigator should confirm that the participant meets all the criteria, before they join the study.
Side effects are any undesired actions or effects of a drug or treatment. These are specific for each drug. Usually, the most common side effects are mild (e.g. headaches). In medication you buy at the pharmacy, this information is included in the product label. In clinical trials, information on potential side effects is explained in the protocol and informed consent form. Immediate or short-term side effects are evaluated during clinical trials, but to determine the long-term side effects of a drug, information on side effects must be collected even after the drug is marketed. To collect this data, doctors will report any side effects their patients might suffer.
Patient safety and wellbeing are the top priorities in a Clinical Trial according to the Good Clinical Practices (ICH GCPs). During a Clinical Trial, participants have access to the medical team whenever they need. The medical team is there to assess whether it is safe for the participant to take the drug or continue taking it. If there is any concern for the safety of the participant, they will be taken off the drug, and follow up will be done to ensure the participant’s wellbeing. Click here for more information on ICH GCPs.
No preparation in advance is needed. All your doubts or questions will be answer by the doctor so you will have all the information you need before enrolling in the trial. You must feel comfortable with your decision, so if you feel that you need it, you can also ask for a companion when you meet with the doctor.
Yes. The medical care given in a clinical trial will include visits, treatments and tests related to the study. It does not replace the role of your primary healthcare provider. However, a participant should inform the investigator of any changes in their regular treatment to ensure these changes do not conflict with the study protocol.
Yes. Anyone participating in a clinical trial has the right to revoke their consent at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
It usually come from the researchers. When a new drug or treatment is discovered or developed, pre-clinical studies will be carried out in the laboratory and in animal studies. Once the way the new drug works is demonstrated, and results from pre-clinical studies are favorable, the drug can be tested in humans through clinical trials.
The sponsor could be a pharmaceutical company, or the study could be funded by individuals such as physicians, medical institutions, foundations, voluntary groups, or federal agencies.
A protocol is a study plan that states all the essential information about the trial, and how it will be carried out. This plan is designed to ensure the wellbeing of the volunteers and that the main objectives of the study are achieved. The protocol will include the scientific background of the drug/treatment, information on the trial objectives, eligibility criteria, schedule of visits and procedures, duration of the trial, etc.
In some clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. This allows to evaluate the effectiveness of the experimental drug compared to the standard treatment, or no treatment.
The chance of being given the placebo is different for every clinical trial. Not all trials use a placebo. If the possibility of receiving the placebo exists, the investigator will inform you of what the probability of receiving it will be.
No, the sponsor of the clinical trial usually covers costs related to the study.
Yes, there are some clinical trials where children can participate. However, children cannot give their informed consent, and will require their parent or guardian’s consent to be able to participate in a clinical trial.
Clinical trials come with certain risks. New drugs or treatments being studied in a clinical trial might not work as well expected, and therefore not have the expected efficacy. It is important to note that in early clinical studies, the safety, side effects and effectiveness of the treatment are still being studied.
Volunteering in a clinical trial could involve having some diagnostic tests and procedures during the trial, on-site visits, filling out questionnaires, etc. What a participant will have to do during the trial will be explained in detail by the investigator before the participant decides to join the trial. All this information is included in the informed consent form and the trial protocol.
As part of ensuring a participant’s wellbeing, clinical trials are covered by their own insurance. This means that the cost of the trial is covered by the sponsor of the clinical study. Routine care that the patient requires, that is not related to the study, will have to be paid by the patient, or their health insurance provider. If you have any questions, you can ask the clinical trial staff and your insurance provider to determine which costs are covered.
Depending on the clinical trial, and the country’s regulation, volunteers might be paid for participating in the trial. If patients are compensated, the amount and other relevant information, such as when and how they will be paid, will be explained to them by the trial investigator.
People can talk to their doctor, find a trial on clinicaltrial.gov or visit websites like this one.
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