CBC In Depth
INDEPTH: DRUGS
Clinical trials
Should you sign up?

CBC News Online | March 15, 2006

If you're interested in participating in a clinical trial, your first stop is your doctor's office. Talk with your doctor about the treatments you're interested in. Ask your doctor whether he or she has a list of scientifically sound and ethical trials currently taking place in your city.

There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you can:

  • Take an active role in your own health care.
  • Possibly gain access to new treatments that are not available to the public. This may be especially useful if you have not responded well to existing treatments.
  • Obtain expert medical care at leading health care facilities during the trial. Typically, a volunteer in a clinical trial receives more medical attention, more lab tests, and will be closely monitored by researchers, who are often leading specialists in their field.
  • Help others by helping to further medical research.
Clinical trials also have risks:
  • There may be unintended and possibly dangerous adverse reactions and side effects to medications or treatments.
  • The new drug/treatment may not be any more effective than the previous drug/treatment.
  • The protocol may require a lot of your time for trips to the study site, treatments, hospital stays, or complex dosage requirements.
  • You may be placed in the "control group," meaning that instead of receiving the new drug, you may get a placebo.

Do your own research

After discussing the matter with your doctor, if you're still interested in participating in a particular trial you'll need to meet with the doctor or nurse managing the trial for a screening interview.

You should know as much as possible about the research study before you meet with the trial representative. You should feel comfortable asking questions and the staff should answer them in a way you can understand.
  • Plan ahead and write down the questions you want to ask.
  • Ask a friend or relative to come with you for support and to hear the responses to your questions.
  • Take notes, or bring a tape recorder so you can replay the discussion after you get home.
Some questions you might ask about the research include:
  • Why is this research being done?
  • What is the purpose of the study?
  • Who is sponsoring/paying for the trial?
  • Who has reviewed and approved this study?
  • Why does the research team think the treatment, drug, or medical device will work?
Some questions about your participation in the study include:
  • Where is the trial being conducted?
  • What kinds of therapies, procedures, and/or tests will I have during the trial?
  • Will they hurt? If so, for how long?
  • How will the tests in the study compare to tests I would have outside the study?
  • How long will the trial last?
  • How often will I have to go to the study site?
  • Who will provide my medical care after the study ends?
  • Will I be able to take my regular medications during the trial?
  • What medications, procedures, or treatments must I avoid while in the study?
  • What are my responsibilities during the study?
  • Will I have to be in the hospital during the study?
  • Will the study researchers work with my doctor while I am in the study?
  • Can anyone find out that I am participating in a study?
  • Can I talk to other people in the study?
  • Will I be able to find out the results of the trial?
  • Can I opt to remain on this treatment, even after termination of the trial?
Questions about risks and benefits include:
  • How do the possible risks and benefits of the study compare with approved treatments for me?
  • What are the possible immediate and long-term side effects?
  • How will patient safety be monitored?
  • What happens if I am harmed by the trial?
Other questions include:
  • What are the alternative treatments besides the one being tested in the trial?
  • Will I have to pay anything to participate in the study?
  • What are the charges likely to be?
  • Is my insurance likely to cover those expenses?

How much does a trial pay?

Some clinical trials will pay you for participating, while others will not. In some programs, researchers will reimburse you for expenses associated with participating in the research. Such expenses may include transportation costs, childcare, meals and accommodations.

Other points to consider:

Drug companies hire for-profit companies to find patients and conduct the study on time and on budget. Physicians are increasingly being offered payment for enrolling patients in clinical trials. This creates a conflict; a physician's role should be to advise their patients about what is in their best interest without regard for personal profit. To speed up the approval process, drug companies often employ for-profit ethical review committees rather than volunteer committees that have no vested interest in the study.

Never feel pressured into joining a clinical trial. If your questions are not fully answered by the research nurse or doctor at the outset, discuss the benefits and risks of participating with your family doctor before signing a consent form.

If you have any concerns during the trial, contact the clinician in charge or the head of the institution's ethics committee that approved the trial. (You should have been given the committee's telephone number). If the ethical approval was by a for-profit company, seek advice from your family physician as to whether it's advisable to continue in the trial.

You can withdraw from the study at any time for whatever reason. If you plan to stop participating, you might let the research team know why you are leaving the study, although you are not required to explain your decision for withdrawing to anyone.

[Sources: CBC News: Marketplace, Health Canada, myhealthCANADA, U.S. National Institute of Allergy and Infectious Diseases, Medbroadcast]

» MORE: Glossary of drug trial terminology




^TOP
MENU

MAIN PAGE ASPIRIN CRYSTAL METH NEEDLE EXCHANGE PROGRAM VIOXX, CELEBREX: Concerns over popular arthritis drugs COX-2 INHIBITORS AND THE ADR DATABASE
STATINS: STATINS STATINS AND THE ADR DATABASE
CLINICAL DRUG TRIALS: A booming business What you should know before signing up Glossary of drug trial terminology
DRUG TESTING: The Truth Behind Drug Testing The dangers of EPO
RELATED: CBC Marketplace: Drug trials Adverse Drug Reaction Database Marijuana Health Concerns

QUICK FACT
In Canada, a clinical research nurse/clinical research associate with two to four years experience can expect to make between $25,000 and $32,900 US. A comparable nurse in a U.S. hospital or clinical site stands to earn $50,000 - $60,000 US.

(Source: Industry Canada)
EXTERNAL LINKS:
CBC does not endorse and is not responsible for the content of external sites. Links will open in new window.

Canada's Food and Drugs Act: Regulations Amending the Food & Drugs Act - Clinical Trials

Good Clinical Practice Consolidated Guidelines – International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use

Guidance for Clinical Trial Sponsors: Clinical Trial Applications – Health Canada
MORE:
Print this page

Send a comment

Indepth Index