Who are Cancer Clinical Trials For: Guinea Pigs, Test Pilots or Prize Poodles?

Expert D. Ross Camidge, M.D., Ph.D., offers tips for dealing with the stress of navigating clinical trials for cancer treatment.
Clinical trials establish an unbiased, scientific means to determine the best treatments for specific conditions. But when dealing with a diagnosis of cancer, a suggestion from your doctor that you consider joining a trial can be a source of enormous stress. Understanding more about trials can help alleviate that stress.

Where do trials fit in?

Most clinical trials for cancer are in the advanced disease setting. Although there can be trials of anything — from a diagnostic test to surgery to counseling — most anti-cancer clinical trials involve the development and integration of new drugs. A clinical drug trial can test:

> A new treatment on its own.

> A new treatment added to a standard treatment.

> A new treatment on its own, or added to standard treatment, compared with standard treatment alone (a randomized study).

Randomized studies may be open-label — where you know which of the available treatments you are getting — or it may be “blinded.” A blinded study means that you, and probably your doctor, won’t know which treatment you are getting, or if you are even getting a real medicine or a placebo (dummy treatment).

Do I qualify for a clinical trial?

Most trials ask specific questions and do not have much room to bend their eligibility rules. Sometimes eligibility or ineligibility are easy to determine — for example, if a study is designed for people with a certain type or stage of cancer. The three most common reasons for trial ineligibility are:

> the patient has not had the number or type of prior treatments required (either too many or too few)
> the patient is not fit enough to participate, based on physical health or other factors
> the patient’s health insurance does not cover treatment at the center running the trial

What does being in a trial involve?

To help you decide whether to enroll, all clinical trials offer potential participants a detailed consent form that outlines what is known about the study and any alternative treatments. It describes what being in the study might entail and the risks associated with entering.

Anyone can withdraw consent at any time, although that also means a patient must stop taking any experimental treatment the trial is testing. Most study teams try to be flexible if patients need to miss an appointment or two, but participants are expected to comply with trial rules, including attending when needed and reporting any side effects and missed medication doses — acting like a responsible “test pilots” and accurately letting the “control tower” know how things are going. Patients who fail to comply can be removed from a study by researchers.

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