13 questions to ask before participating in a clinical research trial

For ObvioHealth

There are more than 270,000 clinical research trials going on in the U.S. and other countries currently listed on ClinicalTrials.gov.

These trials are helping to advance medial research for better treatments of diseases and conditions. However, before decided to participate in one, there are a number of items to consider first. (published site)

What types of trials are there?

There are at least six different types of clinical trials, according to the National Institutes of Health, designed to methodically answer different types of health-related questions. These six trial types include prevention, screening, diagnostic, treatment, behavioral, and quality of life trials.

The type of trial you participate in will involve different degrees of risk. Prevention, behavioral, and quality of life trials generally present low risk, while screening, diagnostic and treatment trials may carry varying degrees of higher risk.

How are clinical trials designed?

No matter the risk, clinical research organizations (like us) are required to design clinical trials to ensure each trial is useful, needed and safe. CROs must thoroughly explain the trial to a panel called an institutional review board (IRB) consisting of both medical and clinical professionals.

Once a trial is approved by the IRB, knowing what the risks are before you agree to participate is part of the process called informed consent. The research team needs to provide each participant with a document that includes details including: study purpose, risks and benefits, required tests or procedures, length of the trial and how long your participation is needed. You can withdraw your consent at any time and pull out of the trial.

13 questions to ask

Here is a list of 13 questions that you need to ask before agreeing to participate in a clinical trial:

1. What is the purpose of the study?
2. Have similar studies already been done and what were the results?
3. Who will fund this study?
4. How will my medical information and privacy be protected?
5. Is there a chance I will receive a placebo, and if so, will the new treatment be given should it prove to be better than current treatments?
6. How long will the study last?
7. What will I be required to do?
8. What are the possible risks and benefits and options if I am harmed?
9. What kinds of treatment, procedures or tests will I undergo during the trial?
10. Who will provide these treatments, tests or procedures?
11. What are the side effects of the tests or treatments?
12. Will I be able to take my regular medications while participating?
13. What costs will I incur?

Agreeing to participate in a clinical trial is a serious decision that should not be entered into lightly. Talk to your doctor or another trusted healthcare provider to help you understand a possible trial.

Also, it is important to note that taking part in a trial is not entirely up to you. You may not be eligible, or you may have some trait or condition that will exclude you from taking part.

The NIH offers additional information about clinical trials to check out before agreeing to participate in a trial.

Source: National Institutes of Health Clinical Trials and You