How To Participate in a Clinical Trial

Toni Hurst Health Guide
  • On tonight's evening news, I heard a story about cancer patients who participated in a drug trial who got great results. At the end of the piece, the reporter said that the results were so good that the Food & Drug Administration (FDA) would fast-track its studies on the drug, meaning it might be on the market in a year or two.

     

    I thought, "If I had cancer, I'd sure want this drug faster than that." I wondered how I could be part of a study where I could get my hands on that drug (if I needed it).

     

    Then I thought about my hot flashes and it turns out there are lots of studies going on all the time involving women going through menopause. Some are on new drugs, some on natural remedies, some on massage and acupuncture and all kinds of things that might make menopause more bearable.

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    I did a little research and found it's really pretty simple to find a clinical trial in which you can participate. Many are run by the National Institutes of Health (NIH), a federal agency, and they don't let humans participate in tests of really wacky out-there stuff, stuff that hasn't been deemed pretty safe already. The study must be approved and monitored by an independent committee of doctors and other scientists who agree that the risks are outweighed by the benefits.

     

    If you are at your wits end with hot flashes or other menopausal symptoms, being a subject in a study might offer you some hope and possibly relief. At the very least, you'll be helping the scientific community and your fellow females.

     

    Researchers are always looking for volunteers to take part in their studies, people of every age, color, culture and lifestyle. Most seem to be looking for women of our age who are having hot flashes but who don't have any underlying health problems (like diabetes). But you never know--there could be some researcher trying to find out if women with diabetes suffer less or more than those without it. So it is worth your time to try to find a study tailored for you.

    Studies are often sponsored by pharmaceutical companies but also can be funded by foundations, medical institutions such as hospitals, and federal agencies like NIH.  If you want to find out more, go to: http://www.clinicaltrials.gov and you can search by conditions in alphabetical order, so choose M for menopause, or this link will take you directly there: http://clinicaltrials.gov/ct2/results?cond=%22Menopause%22

    You can also search by region of the country. There are 369 clinical trials listed for menopause going on right now! You can check back frequently to see if there is a study taking place near you.

    Other ways to find a study:

    ~Contact a hospital or medical center near you, especially larger ones that are affiliated with medical schools.

    ~Research the large pharmaceutical companies to see if they're conducting studies. The big 10 are: Pfizer, Johnson & Johnson, GlaxoSmithKline, Hoffman LaRoche, Sanofi Aventis, Novartis, AstraZeneca, Abbott Labs, Merck and Bristol-Myers Squibb. For example, I mentioned in my last blog that GlaxoSmithKline is researching a new drug. If you go to their website www.GlaxoSmithKline.com and click on Research & Development, and then click on Clinical Trials, you'll see what they're up to.

  • ~Large, well-known clinics such as the Mayo Clinic conduct trials. Find out more at www.mayoclinic.com

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    Talk to your doctor or health care practitioner before you decide to do this. Plus, it's important to ask questions. The NIH suggests that you find out:

    • What is the purpose of the study?
    • What types of tests and experimental treatments are involved?
    • Why do researchers think the treatment being tested may be effective? Has it been tested before?
    • Will the study directly benefit me?
    • What are the risks?
    • How do the possible risks, side effects and benefits of the experimental treatment compare with my current treatment?
    • How much of my time will be involved? Will hospitalization be required? What about outpatient visits?
    • Who pays for the experimental treatment? Will I be reimbursed for other expenses?
    • Who is responsible for my care during the study? What type of follow-up care will be provided?
    • How will I learn about the trial results?

    If you're chosen for a clinical trial, you'll be asked to sign an agreement that you understand the risks. The fact is you can BACK OUT OF THE TRIAL AT ANY POINT, whether you have signed something or not.

    I'm curious if any of our readers are participating in a clinical trial now and if so, what's your experience? Let us know!

     

Published On: June 24, 2009