Why participate in a clinical trial? The reasons for doing so are varied, from supporting science or accessing a new treatment to treat a particular disease to receiving financial remuneration or other benefits.
Participating in a Clinical Trial: Risks vs. Benefits
Benefits of participating in a clinical trial
Risks of participating in a clinical trial
Possibility of access to new treatments
Potential side effects
Contribution to science and society
You can receive a placebo
Need for frequent trips to the hospital or research site where the trial is taking place for follow-up
Access to quality medical services
Treatment may not be effective
Clinical trials are scientific investigations designed to validate the efficacy and safety of new medicines, vaccines, diagnostics, or therapeutic procedures in controlling and preventing specific diseases. They are normally carried out to considering national and international ethical and legal standards and following the provisions of a protocol.
This kind of research is essential for the authorization of use and commercialization of a new product or treatment to be approved by the Food and Drug Administration (FDA).
Each clinical study carries benefits and risks, and it is critical to weigh risk versus reward. Let’s analyze these elements below so that you can draw your conclusions at the end and decide whether or not participating in a clinical trial makes sense for you.
1. Access to new treatments that are currently unavailable. On many occasions, these trials evaluate treatments for diseases for which there is still no treatment or the drug being tested may be more effective than those that already exist in the market.
2. You can contribute to the development of science and medicine and the discovery of treatments that offer a cure or a better treatment, including for critical conditions. The impact that clinical trials have on the lives of patients is enormous.
3. Sometimes, sponsors of clinical trials pay for all or part of the medical care and other expenses for the duration of the trial.
4. You can access quality medical care and sometimes receive a considerable financial benefit.
1. You may experience side effects from using the new treatment that may or may not has been identified by research.
2. You will have to go to the place where the test takes place for check-ups, which implies time and transportation.
3. You may receive a placebo, so you will not automatically benefit from the new treatment. However, patients receiving a placebo are often given the treatment after the end of a trial.
4. If you are sick, the treatment may not be effective for you, even for other volunteers.
Evaluating each of these elements is critical to deciding whether to participate in a clinical trial. You can assess all these factors with your doctor and together make a decision.
After analyzing the benefits and risks of participating in clinical trials and finding out what the people who have done so think, we can conclude that enrolling in research of this type involves several risks. Undoubtedly, one of the biggest is that participants may experience adverse effects. However, it must be taken into account that clinical trials are carried out in controlled environments and that participants are monitored regularly so that if there is any adverse event, they can be attended in a timely and safe manner.
Despite this and the rest of the risks, being part of a clinical trial is an excellent opportunity to benefit from access to novel biopharmaceuticals that would otherwise be impossible to use and, secondly, the possibility of being financially remunerated for participating in a trial.
If you have agreed to participate in a clinical trial, it is important to know that you can find trials available in your community. Sometimes your doctor or other health personnel can tell you about these studies.
You can also know clinical trial recruitment notices through social media, local or community press, and radio. Some media outlets dedicate regular spaces to this subject.
In the United States, most ongoing clinical trials appear in the ClinicalTrials.gov database, administered by the US National Library of Medicine. There you can find the data of the clinical studies carried out in the country and worldwide financed with public and private funds. Some websites help match people to specific trials. For example, the National Institutes of Health (NIH) have an Internet-based registry called Research Match that people can use to connect with researchers looking for trial participants. CenterWatch is another service that lists thousands of trials currently recruiting people.
It depends on the characteristics and the objective of the clinical trial. Each study establishes specific eligibility criteria to determine whether a person can participate in the trial. These eligibility criteria are always related to age, sex, state of health, previous medical treatments, and health condition.
If you’ve read or heard about clinical trials, you’ve probably encountered the term “informed consent.” This term is used to refer to the process by which the person interested in participating in a clinical trial receives all the information necessary to decide whether or not to make their participation effective. The information provided includes a detailed explanation of the aspects of the trial, the possible results, the risks you may face, who is the trial’s sponsor, and what happens if you experience any problems due to your participation in the trial.
In general, they are pretty long documents. Still, in case you are considering enrolling in an investigation of this type, it is essential that you analyze it carefully and, if possible, that you discuss it with your doctor or a health specialist.
In general, clinical trials can last from several months to several years. In the case of exceptional situations, these times can be considerably reduced as long as the procedure is carried out considering the requirements established by each country’s regulatory and health authorities. It happened, for example, after the start of the Covid-19 pandemic.
Usually, clinical trials can last from one to around ten years. Still, in case of exceptional situations, the duration can be considerably reduced as long as the procedure fulfills the requirements established by the health authorities. It happened, for instance, after the outbreak of the COVID pandemic, when trials to test the vaccines against this disease were developed on fast track.
Not all clinical trials are created equal; they can be divided according to some classifications, the main ones are listed next:
1. According to the controlled group: controlled trials or uncontrolled trials
2. According to the method of organization: Randomized trials or non-randomized trials
3. According to the understanding of the participants and investigators: Open trials or closed trials
4. According to the results: Superiority Trial, Bioequivalence Trial, or Inferiority Trial
5. According to the Structure: Parallel trials, crossover trials, or sequential trials
The people participating in a clinical trial cannot choose which research group they will join. Assigning study subjects to control, placebo, or treatment groups is done randomly to reduce the chances that people in one group will vary too much from those in the other group, which could affect the results. Also, investigators can make allocation at investigators’ expense, but under no circumstances can participants influence this decision.