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How Clinical Trials Work: What to Expect During a Medical Study

trial-guinea-pig-study

Should you become a guinea pig?

by Patricia L. Raymond, M.D., F.A.C.P., F.A.C.G.

Many people are nervous about signing up for clinical trials—especially if they're healthy to begin with. But clinical trials are how we advance medical knowledge—even challenge established practice. Medicine’s flip on hormone-replacement therapy for postmenopausal women? It was through a clinical trial that researchers found an increased risk for breast cancer and cardiovascular disease in women who took estrogen and progestin. Now, for many women, doctors don’t advise what we previously thought was great preventative care.

Let’s review the basics of clinical trials, whether you might benefit from participation and how society surely will.


HEALTHY-VOLUNTEER STUDIES

What they are: Studies that use healthy volunteers (phase I studies) assess the metabolism of a new drug in healthy people to try to determine safety and dosage.

Do you get paid? While you won’t get rich, some studies offer up to a couple thousand dollars for participating, depending upon the degree of inconvenience and invasiveness of procedures involved. It isn’t easy money! Governmental controls require that the amount be reasonable for the risks, discomfort and time, but not coercive. In other words, the pay can't be so extravagant that a person will disregard good judgment in order to participate.


If you share a concern about a disease for which a drug or device is being developed—or if you simply want to earn a few bucks—you might consider getting involved. Healthy-volunteer studies remain an essential first step in innovation in medicine.


TREATMENT STUDIES

What they are: In treatment studies (phases II through IV), potential enrollees have the condition for which the drug or device is being tested. Sometimes, the test is on a new drug or technique. Other times, it’s on an adaptation of an existing treatment (new dosages or dose timing, or changes in equipment) or the long-term safety of a currently available drug.

Do you get paid? Such studies generally offer little or no compensation. What’s more, you pay your usual deductible, and your medical insurance is billed as usual for much of the care and testing you receive. Depending on the study, you may get free drugs and/or tests that are not standard in the care of your condition.


WHAT TO EXPECT DURING A STUDY

  1. You'll be asked to sign a consent form. Careful reading is an essential step in determining whether it behooves you to participate. The consent form, which must be written in sixth-grade English (literally), rather than medicaleeze, details who is eligible to participate, what the study involves, all possible risks (they even cover possible bruising from blood draws) and what compensation (if any) to expect. Take your time reading it, and ask any questions you have.
  2. You'll be placed in the treatment group or control group.
    • The treatment group gets the product being tested.
    • The control group gets a placebo (inactive treatment) or an active drug (“active control”), depending on the study design.
      • The active control may be a competitor's brand, a usual dose of the same drug being tested (the treatment group getting a higher or lower dose) or a different treatment.newsletter-graphic
    What the control group gets is spelled out in the consent form. Since you may be in that group, take careful note. To be a stronger study, the control group typically gets at least the standard of care—that is, what’s normally prescribed for your condition. The treatment group, of course, gets something that the scientists have predicted is better than the standard.


FREQUENTLY ASKED QUESTIONS ABOUT CLINICAL TRIALS

trial-miracle-pill-discoveryCan I choose the group I get placed in?
Most people would rather get the new drug, else why participate? But studies commonly feature blinded randomization. That means you're randomly assigned to a group, and you don’t know which one. Even better, a double-blinded study means your doctor doesn’t know either (although that information can be unblinded if important to your wellbeing).

How do I know what type of study I'm in?
Study design is usually summed up in a string of adjectives in the study title. For example, the one you’re in is called a “double-blinded, randomized crossover trial of Lemonizine versus Pepperika to control hangnails.” As you can see, you’ll be randomly assigned to using Lemonizine or Pepperika, with exposure to both treatments by the end of the study, and neither you nor your physician will be aware of which group you’re in.

Do the researchers watch out for my safety?
Although you, your physician and the pharmaceutical company won’t know what you’re taking until the end of the study, an unaffiliated study monitor (to prevent bias) will assess your study’s data at intervals for safety. That person knows what you’re on.

If midway through your study, Lemonizine is clearly superior to Pepperika, the study will be prematurely terminated, and all will get the option of being placed on Lemonizine. If Lemonizine is shown to have unanticipated side effects, all participants (whether or not on Lemonizine) will be notified of the new potential risk.

 

What types of people do clinical trials need most?

  • Cancer patients: Less than 5 percent of people with cancer choose to participate in research. Many don’t even know it’s an option. Ask your oncologist about trials that may be available for your form of cancer.
  • Women: Women are not men with breasts. Because so many studies have been done solely on men, we don’t really know how best to treat women. Consider joining studies that investigate women’s health.
  • People of various races: All races need to enroll to enhance their own health. For example, black people, justifiably leery due to the Tuskegee Syphilis Study, have not participated fully in research. (In that trial, researchers followed poor black males with syphilis from 1932 to 1972 and didn't give them treatment, despite the fact that penicillin was accepted as standard of care mid-study.) Effective treatments can differ among races.


Interested? Start researching! Society, and hopefully you, will benefit.

trial-guinea-pig-2PATRICIA RAYMOND, M.D., F.A.C.P., F.A.C.G., has participated as a researcher in several pharmaceutical companies’ phase III studies and acted as a lab rat in a low-paying study while in medical school. She's a board-certified gastroenterologist with Simply Screening in Chesapeake, Va.; author of Colonoscopy: It'll Crack U Up!; and assistant professor of clinical internal medicine at Eastern Virginia Medical School.

Last updated and/or approved: May 2010. Original article appeared in fall 2006 former print magazine. Bio current as of fall 2006. This article is not meant as individual advice. Please see our disclaimer.

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