Clinical Trial FAQs

With any new treatment options, you are sure to have many questions. The information below is intended to give you a brief overview and provide helpful information about clinical trials.  This information is generalized and may not necessarily apply to your care or specific diagnosis.  Please contact your nurse if you have further questions.

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WHAT IS A CLINICAL TRIAL?

A clinical trial is a research study involving people who volunteer to test new drugs and therapies to determine if they are safe and effective. The tests are carefully designed and carried out. People who choose to participate are regularly checked to assess how the drug or therapy is working. Participation in a clinical trial does not substitute for regular medical care. You are encouraged to discuss participation in clinical trials with your physician.

WHY PARTICIPATE IN A CLINICAL TRIAL?

Many common treatments, such as brand name pain killers, would not exist without clinical trials. By participating in a clinical trial you may:

  • Help others by contributing to medical research
  • Gain access to new treatments
  • Receive treatments at low or no cost
  • Be compensated for your time and any inconvenience related to the study

PHASES OF CLINICAL TRIALS

Not all clinical trials are the same. There are multiple phases that a drug or device must go through before it is approved by the FDA. Procedures of clinical trials and size of the groups vary with each phase.

Pre-clinical: Bench work done in early development phase, typically on animals.

Phase I: Safety and Tolerability. The study drug is given to human patients for the first time. It is given at different doses. Side effects are analyzed at each dose in order to determine the safest and most tolerable dosing of the drug. Phase 1 trial groups are small.

Phase II: Efficacy. Safest doses of the drugs have been determined. The effectiveness of the drugs is determined in a larger group than what was tested in phase I trials.

Phase III: Comparison. The study drug is compared to currently FDA approved drugs. There are often multiple arms to this type of study. There is the possibility of either getting the study drug or getting the normal standard of care therapy.

Phase IV: After the drug is already on the market to study long term data. Phase IV are not always performed, but they can be FDA mandated.

ARE YOU ELIGIBLE FOR A CLINICAL TRIAL?

This depends on the question being asked. Some clinical trials look for people with certain diseases, and others need healthy people.

Participation in a clinical trial is based on criteria such as age, gender, certain medical conditions and treatment history, or your daily behaviors (for example, if you smoke). These are used to identify the highest safety standards while addressing the specific research questions.

BENEFITS AND RISKS OF CLINICAL TRIALS

Benefits: Risks:
  • Receive new therapies that are not yet on the market
  • Additional safety and disease monitoring as part of a study procedure
  • Advance the medical research when in turn advances medical knowledge and treatment
  • Benefits future generations
  • The study drug is not guarenteed to provide benefit to the participant
  • The patient may still have disease progression or may not improve
  • Often additional time consumed while complying with study procedures

 

WHAT SHOULD YOU THINK ABOUT BEFORE PARTICIPATING IN A CLINICAL TRIAL?

Learn as much as possible about the study and feel free to ask questions such as:

  • What is the purpose of the study?
  • Who is going to be in the study? How many will participate?
  • Why do researchers believe the experimental treatment being tested may be effective?
  • What kinds of tests and experimental treatments are involved?
  • What are the possible risks, side effects, and benefits of the study treatment?
  • How might this study affect my daily life?
  • How long will the study last? How long will I be involved?
  • Will I have to stay in the hospital?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What kinds of follow-up care will I have to do as a part of this study?
  • Will I receive a copy of my own test results?
  • Will my family physician know about my participation in the study?
  • Will results of the study be provided to me?
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