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To Participate or Not to Participate in Clinical Trials

Facts and Figures

  • Seventy seven percent of respondents to a Harris Interactive poll said they would consider getting involved in an appropriate clinical research study if asked.

  • Only 10% of those eligible to participate in clinical trials do so in the United States.

  • Very few patients are even aware that they are eligible to participate. Only 30% of participants report that they first learned about a clinical trial from their primary/specialty health care provider. (Source: Institute of Medicine)

  • In a recent poll, 94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public say they have little to no knowledge about the clinical research enterprise and the participation process. (Source: CenterWatch)

Patients responding to a Harris Interactive poll said they would be motivated to participate in clinical trials if:

  • “It would benefit me or someone else.” (58%)

  •  “I knew all about the risks.” (48%)

  • “The risk was minimal or if the reward outweighs the risk.” (35.3%)

  • “For a cure.” (35.2%)

  • “My doctor recommended it.” (34.5%)

The more informed you are the better, if you’re considering participating in clinical research. Know and understand the different types of trials for which you may be eligible, what questions to ask of the study team, and your rights as a trial participant (See Bill of Rights and Responsibilities).

Participating in clinical trials will allow you to:

  • Play an active role in your own health care.

  • Receive a thorough pre-clinical health assessment.

  • Receive closely monitored medical treatment from a well-respected physician or hospital.

  • Gain access to helpful new research treatments that would otherwise not be available to you.

  • Potentially receive treatments, tests, and medications at no cost.

  • Help others by contributing to medical research.

Some of the risks involved in clinical trials include:

  • Experimental treatments may have unpleasant, serious or even life-threatening side effects, some of which appear during treatment, and others that may not surface until after the study is over. Additionally, some side effects are temporary and end when the treatment is stopped; others can be permanent.

  • The experimental treatment may not be effective for every participant.

  • Participants who receive a placebo, as part of a control group, may have to forego an approved treatment while in the clinical trial.

  • Patients sometimes must stop other treatments.

  • The protocol or study plan may require more time and attention (e.g. trips to the study site, more treatments, hospital stays or complex dosage requirements) than would a non-protocol treatment.

(Source: ClinicalTrials.gov)

Before agreeing to participate in a clinical trial, ask yourself:

  • How disabled are you?

  • Are other treatments working for you?

  • How long do you have to live if you don’t try a new treatment?

  • How likely is it that the treatment will work based on previous studies?

  • What phase is the drug development in? Phase I trials are done on healthy people to test the safety of a drug and side effects are less predictable. Phase II and III trials involve patients with diseases the drug is intended to treat, and there is more research to base expectations on.

  • What level of risk you are willing to accept when weighed against potential benefits?

  • Is the study team answering your questions promptly and honestly?

(Sources: Art Levin, Center for Medical Consumers; Dr. Stewart Factor, Albany Medical Center.)

To prepare for your meeting with the research coordinator or study doctor,

  • Plan ahead and write down possible questions to ask.

  • Ask a friend or relative to come along for support and to hear the responses to your questions.

  • Bring a tape recorder to record the discussion to replay later.

Following are some questions you may want to ask of the study team:

  • What is the purpose of the study?

  • Who is sponsoring the study?

  • Who are the other study participants?

  • Why do researchers believe the new treatment being tested may be effective? Has it been tested before?

  • What are the potential risks and benefits?

  • What kinds of tests and treatments are involved?

  • How do the possible risks, side effects, and benefits associated with the investigational new drug compare to those associated with my current treatment?

  • How might this trial affect my daily life?

  • How long will the trial last?

  • Will hospitalization be required?

  • Do I have to pay for any part of the trial?

  • Will I be reimbursed for other expenses?

  • What type of long-term follow-up care is part of this study?

  • How will I know that the treatment is working? Will results of the trials be provided to me?

  • Who will be in charge of my care and what are their credentials?

  • How will my safety be monitored?

  • What happens if I am harmed by the trial?

  • Can I opt to remain on this treatment, even after termination of the trial?

Source: ClinicalTrials.gov

www.centerwatch.com  Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials



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All rights reserved. Revised: 01/26/12.