Things to Consider About Clinical Trials
Clinical trials are an important step in developing new treatments, but participation involves a number of important considerations.
Clinical trials are research studies that explore whether a medical device, treatment or strategy is safe and effective for humans. Laws and regulations governing clinical trials differ from country to country, but reputable clinical trials share important criteria, including respect for participants’ rights, strong scientific evidence, oversight by independent committees and compliance with appropriate laws and regulations concerning research on human subjects.
Not all clinical trials are created equal. If you are considering a clinical trial, below are questions you should ask of yourself and the trial provider, and that you should discuss with your primary care physician and other trusted members of your healthcare team.
Learn more about clinical trials here.
What do I hope to gain from participating in a clinical trial?
Clinical trials help researchers and doctors build knowledge and uncover better ways to understand, prevent, diagnose and treat human diseases and conditions. Many people find strength in knowing they have something to contribute, and that they are part of a collective effort to fight their disease or condition, even if they themselves do not benefit.
Clinical trials are not primarily intended for the direct benefit of the participants. Researchers first test safety and secondly factors like proper dosage and side effects. In some trials, not all participants receive the test treatment, some receive an existing treatment or a placebo, in order to make a comparison.
A possible benefit for participants is access to medical care from experts in the disease or condition being studied, but they may not see any improvement in their health, or it may even get worse.
Clinical trials are not right for everyone. Think carefully about what you hope to gain. You should never feel pressured to participate in a clinical trial if the trial doesn’t feel like the right option for you.
What is the main purpose of the clinical trial I am considering, and who is eligible to participate?
Make sure you understand what doctors and researchers hope to learn from any trial you are considering and assure their goals align with your expectations. Clinical trials aim to answer specific questions and evaluate certain criteria depending on their phase. Learn more about the phases of a clinical trials here.
Be thoughtful and honest about factors impacting your own eligibility. You may be at greater risk if you fail to disclose something you should have, or you may become ineligible for other trials or treatments.
What does the protocol consist of? What is asked of me?
Clinical trials begin with the development of a clinical protocol, a document that describes how the trial will be conducted, the objectives, design, methodology and organization. You should be provided with a patient information sheet with basic information about the protocol and an outline of your obligations as a potential participant. If this patient information sheet is not offered, request it.
Being part of a clinical trial can be demanding. Before you commit, know where and how often the treatment will be administered, the location of the clinic, whether it is an in-patient or out-patient setting, the frequency and length of your visits and any expectations of you outside the clinic. For example, some trials require you to keep track of your diet and/or your activity and to refrain from certain activities. Participants do not normally pay for participation in clinical trials, though there may be indirect costs; you should confirm this is the case. Make sure the trial, and all of the associated responsibilities, will work with your life and schedule for the trial duration, whether that is a few months or many years.
What are the potential risks and possible benefits?
Every clinical trial has risks. A trial treatment is still being tested, so some of the risks won’t yet be known. Nor will it be known whether the treatment will work. In early trials, effectiveness isn’t necessarily being tested. However, researchers or their representatives should be able to tell you what they anticipate the risks (including side effects) and benefits to be. In a carefully regulated trial, a medical ethics committee should have evaluated the design of the trial to determine that the possible benefits justify the risks for the participants.
If someone tells you there are no risks associated with a treatment, it is a red flag that the trial is not being operated with transparency and proper oversight. All medications have some side effects, even aspirin, one of the safest medications ever developed.
How will participation in the trial affect my regular healthcare or other treatment options?
One of the challenges of participating in clinical trials is not knowing how the new treatment might affect your regular healthcare. Talk to your healthcare team about the pros and cons, and ask them to be frank about any concerns they may have. Participation in a given trial may change your eligibility for participation in other trials, different treatments or even for continued or new health insurance.
Will I receive any follow-up care when the trial ends?
Trial administrators should tell you upfront what sort of care or monitoring is planned for participants once the trial formally ends. This is especially important to consider in later phase trials where there may be some amount of health benefit from the treatment. Ask careful questions:
- Will I have access to the treatment when the trial ends?
- If so, will I be expected to pay for it myself? What are the costs?
- Will you share the results of the trial with me and my regular healthcare providers?
- If I develop side effects after the trial has ended, is help available?
What costs are associated with participating in the trial?
Typically, the cost of testing a new treatment and monitoring the trial is defrayed by the company developing it, a foundation, government funding or a combination of these. In fact, many countries mandate that clinical trials are free to participants, and any suggestion of costs should be a red flag. In other countries, clinical trials can pass some expenses to participants, but only with regulatory oversight. In either case, some of the tests or doctors’ appointments may be considered to be routine medical care and not covered by the trial funding. You may be responsible for these costs, in addition to incidental costs such as travel to and from the treatment location.
Before you enroll, find out what aspects of your medical care you may be charged for, get estimates and familiarize yourself with local trial regulations. Talk with your insurance company to make sure you understand what is covered and what is not.
What are the markers of a “good” clinical trial?
In evaluating whether a trial is credible, it is important to consider:
- Whether the trial is registered. Registration does not guarantee credibility, but be cautious if a trial is not registered at all. Most widely accepted international and national guidelines call for registration of clinical trials in a publicly accessible database.
- Whether the trial is approved by regulatory authorities and/or meets national regulations. Regulation of clinical trials varies by country; be familiar with what patient protections are in place.
- Whether there is independent oversight, i.e. that the trial has been evaluated by experts who are not part of the trial. For example, all trials should go through a medical ethics review process that weighs potential benefits against potential risks and ensures that participation is voluntary and based on informed consent.
- Whether there are any conflicts of interest. For example, do any of the researchers have any financial stake in the company funding the trial?
- The qualifications of participating researchers and healthcare providers.
Where can I find information on active clinical trials?
Remember, every clinical trial has both inclusion and exclusion criteria for enrolling participants. To join a trial, you must meet these criteria, which may include factors like your age, general health, stage or severity of disease and treatment history.
Here are some resources to help you find active clinical trials:
Remember, clinical trials are not right for everyone. Think carefully about what you hope to gain, and then look for trials that align with your goals and expectations. Dig deep, because not all clinical trials are created equal. Consider the markers of a “good” clinical trial and compare your options. Ask a lot of questions and seek input from your healthcare providers.