What You Should Know Before Participating in a Clinical Trial

Clinical trials are vital to advancing medicine, science, and healthcare. While clinical trials are essential, they can be mysterious and intimidating, especially to those new to the process. Patients who have never participated in a clinical trial might be wary and have questions surrounding the process. In this article, you will find the critical information you need to know about participating in a clinical trial, what you contribute to research, and what to expect regarding care.

What is a clinical trial?

Clinical trials are research studies where scientists, doctors, and other medical professionals conduct studies with patients to:

• Solve medical issues.
• Research the safety and efficacy of new pharmaceutical drugs.
• Research the safety and efficacy of new non-pharmaceutical treatments.
• Study existing treatments to improve the standard of care.
• Gather information on specific populations.

It is important to note that clinical trials must follow strict guidelines and safety protocols to gain approval. If the drug, device, or treatment approach proves safe and effective through clinical trials, it may receive approval from the Food and Drug Administration (FDA). This process can take years to complete. Other countries have their own governing organizations to approve medicines for general market use. Approved market use does not mean people cannot participate in clinical trials as a care option. Clinical trials offer an alternative treatment option for many when the standard of care options are not optimal, or there is no standard of care option.

Who is a good candidate for clinical trials?

Almost everyone can be considered for a clinical trial, even those with a specific medical or mental health condition. That's because researchers often look to study specific treatments and medications on particular populations of the public. All clinical trials have specific eligibility criteria for participants. For instance, a new treatment for a disease or condition might be tested on those with the disease or condition and with co-occurring disorders. These requirements ensure that participants have commonalities and that the trial is as safe as possible. If you are perfectly healthy, you can also be considered as a "control" group, meaning your body, reactions, lab work, and other results will be used to compare against a research group.

If you're interested in participating in a clinical trial, your doctor or a research expert can inform you of a trial if they are conducting research at that location. You can also search online or ask your local public health department, join a national research registry, universities, and non-profit organizations if they have paid or volunteer clinical trials. While you can know certain things about a trial, such as what type of medication is studied and the risks of certain drugs or treatments, you might also be part of a blind study. A blind study is a common type of clinical trial where only the researchers know the specifics of the treatment a patient is receiving.

Is participating in a trial worth the risk?

Taking part in clinical trials can have both benefits and risks. The FDA ensures that anyone considering a trial has access to all the reliable information they need to make an informed choice, including information about the risks. Participating in a clinical trial, whether paid or unpaid, can help advance medicine and science for generations to come and could provide you with new and innovative treatments. While it comes with some risk, a participant can only participate in the clinical trials after signing an IRB-approved informed consent form. This process ensures the participant has received sufficient information and understanding before making decisions about medical care which can only benefit them long-term.

Possible benefits of clinical trials include the following:

• Participants have access to new treatments.
• If a treatment proves successful, participants will be among the first to benefit.
• Participants not in the group receiving a new treatment may receive the standard treatment for the condition, which may be as good or better than the new approach.
• Health is closely monitored and supported by a team of health providers.
• Information gathered from clinical trials adds to scientific knowledge, may help others, and ultimately improves health care.

Possible risks include:

• Standard care for a particular condition can sometimes be better than the study's new strategy or treatments.
• The new approach or treatment may work well for some participants but not necessarily for others.
• There may be unexpected or unforeseen side effects, especially in phase 1 and phase 2 trials and with approaches such as gene therapy or new biological treatments.
• Health insurance and health providers do not always cover patient care and routine care costs for those participating in clinical trials.

Regardless of the risks, people continue to volunteer for clinical trials, understanding how vital they are to advancing medicine and treatments. Without clinical trials, new vaccines, drugs, diagnostic tools, treatments, and many more areas of medicine would be left to the wayside. However, if you are considering participating in a clinical trial, you can sign an informed consent form. You may also ask questions about risks and possible side effects to make an informed decision.

What is informed consent?

After you have learned about the purpose of the trial–including the potential risks and benefits–you can choose to join the study. You will sit down with a researcher and discuss the study in detail and then sign a form stating that you understand all the information and agree to participate. The document you will sign is called the informed consent and must explain the purpose of the research, foreseeable risks of discomfort, and possible benefits. You can always withdraw your consent and leave the study at any time.

Are clinical trials safe?

The safety of participants is a high-priority issue. In every trial, scientific oversight and patient rights contribute to their protection. The FDA regulates scientific studies through Good Clinical Practice (GCP) to ensure that those conducting clinical trials follow ethical and appropriate procedures. GCP compliance provides the public with confidence that the safety and rights of participants are protected.

GCP aims to:

• Protect the rights, safety, and welfare of participants.
• Guarantee that data collected is reliable, has integrity, and is of an appropriate quality.
• Provide guidelines and standards for the conduct of clinical research.

All clinical trials conducted in the United States must follow GCP.

Who oversees the safety of clinical trials?

The Institutional Review Board, or the IRB, is under FDA regulations and formally designated to review and monitor biomedical research involving human volunteers. The purpose of IRB review is to assure, both in advance and by periodic review, that those conducting clinical trials follow appropriate steps to protect the rights and welfare of people participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to protect the rights and welfare of research participants. Clinical trials must also receive IRB approval for those trials involving live humans before any research activities may begin.

Will I get medical supervision?

All clinical trials will involve some level of intervention from a medical professional or researcher. This research can range from, but not limited to:

• Measuring daily vital signs
• Reviewing daily logs detailing your experiences
• Stopping a clinical trial if adverse effects occur
• Conducting interviews in the beginning, middle, and end phases of the clinical trial

Each clinical trial is different, so it's a good idea to ask questions so you can know what type of medical supervision and intervention to expect during the process.

Federal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions. Such conditions include:

• You must be eligible for the trial.
• The trial must be an approved clinical trial.
• The trial does not involve out-of-network doctors or hospitals if out-of-network care is not part of your plan.

Also, if you join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.

Health plans are not required to cover the research costs of a clinical trial. Examples of these costs include extra blood tests or scans that are done purely for research purposes. In such cases, the trial sponsor will cover the costs. You should review this with the researchers before signing an informed consent form to ensure you understand the specific medical and diagnostic care and labs covered. Also, plans are optional to cover the costs of out-of-network doctors or hospitals if the plan does not usually do so. But if your plan covers out-of-network doctors or hospitals, they must cover these costs if you participate in a clinical trial.

What are treatment groups?

For some trials, those conducting the trials split participants into groups. Some groups will receive different doses of the study drug; others may even receive a dummy pill or placebo. Medical professionals regularly monitor all groups throughout the study. These groups are essential to research because they help researchers determine how well the new treatment works compared to other care options.

How are treatments evaluated?

During the clinical trial, researchers will do tests and watch for side effects of the new treatment. They will ask you to answer questions and sometimes ask you to keep a daily diary to record progress. Researchers will also ask about the treatment's lifestyle impact, such as your ability to engage in day-to-day activities, how your work life is affected, and your overall quality of life. It is essential to follow the steps of the trial accurately and report everything to the team you are working with on the trial. 

What about the results?

When the trial ends, the results are sometimes available to participants who would like them. Researchers often publish the study results to help the work of other scientists. Not all clinical trials require posting the results, so be sure to ask when starting a trial if you want further information to be made available.

Participating in clinical trials can be valuable for many who want to help advance medicine or choose a new treatment option. Considering the risks and benefits of any trial is an integral part of the patient process. Preparing for a conversation with the research providers allows participants to make the best choice for them. Now that you know more about clinical research and are prepared to consider your options, ask your provider or the research experts for more information about the trial(s) you are interested in learning about.

Here are the top 10 questions to ask your healthcare provider when considering a clinical trial:

1. What’s the purpose of the trial?
2. How long will the trial last?
3. How frequently will I come in for visits?
4. What are the possible risks and benefits of the trial?
5. What kinds of tests and treatments are involved?
6. Will I have to pay for any treatments or tests?
7. Will the results of the trial be shared with me?
8. Are there any patients currently in the trial I can talk to?
9. What happens if I decide to leave the trial?
10. How does the trial treatment compare to standard treatment options?