Palo Alto Weekly

- November 8, 2006

Clinical trials: To participate or not?

Informed consent is the key

by the Stanford Health Library

Advances in medical care are dependent on the results of clinical trials.

Before new and better medical treatment becomes widely available it must go through a period of rigorous and carefully controlled research using human volunteers to verify both safety and efficacy. Sponsored by both government and industry, tens of thousands of clinical trials will be conducted in the United States this year, addressing a wide range of medical conditions. There is an ongoing need for people willing to volunteer to become subjects in clinical trials.

Potential subjects must be aware that there are both risks and benefits to participating in clinical trials. Participants have access to new research treatments before they are widely available; they receive medical care at leading health care facilities; and they can appreciate knowing they are helping others by contributing to medical research.

On the down side, the experimental treatment may not work, and there may be unpleasant, serious or even life-threatening side effects to the treatment. The concept of informed consent, in which patients must learn and understand the facts about a clinical trial before deciding whether or not to participate, is key to successful research.

"Informed Consent: A guide to the risks and benefits of volunteering for clinical trials" by Kenneth Getz and Deborah Borfitz (Thomson Centerwatch, 2002) is a book that provides consumers with a thorough understanding of the world of clinical trials. It explains how trials work and how trials have developed historically. For those considering trial participation, there are chapters that discuss the factors to consider before participating, including questions to ask before agreeing to participate, how to find trials, how to learn about the details and how to evaluate the informed consent form.

The book addresses the significance diversity plays in clinical trials, particularly those involving women and minorities, as well as critical issues for vulnerable populations including children and seniors. There is also a chapter that helps people know what to do if things go wrong. Appendices include a glossary of clinical trial terminology, copies of regulatory documents and listings of trial sponsors.

"Informed Consent" is published by CenterWatch, a company dedicated to providing information clinical research. Their Web site, www.centerwatch.com, provides an extensive list of approved clinical trials, as well as a list of therapies newly approved by the FDA (Food and Drug Administration).

There are a number of other Web sites for those interested in clinical trials. Clinical Trials.Gov (www.clinicaltrials.gov), sponsored by the National Institutes of Health, lists federally and privately supported clinical research in human volunteers. Cancer clinical trials can be found on the National Cancer Institute's Web site: (http://cancer.gov/clinicaltrials). These and other valuable online resources addressing clinical research can be found on the Stanford Health Library Web site: (http://healthlibrary.stanford.edu/resources/internet/therapy_trials.html#clinicaltrials).

To learn more about clinical trials taking place locally at Stanford, see http://clinicaltrials.stanford.edu/research/.

Cancer is a diagnosis that often leads people to seek out participation in a clinical trial. The book, "Making the Decision: a cancer patient's guide to clinical trials," by Marilyn Mulay, R.N. (Jones and Bartlett, 2001) focuses on cancer clinical trials but actually contains information applicable to trials of all types. There are chapters explaining the lengthy process of drug development and the business of clinical research. A chapter entitled "Patient Rights" discusses the process of informed consent.

Searching for clinical trials is an imperfect science. This book does an excellent job, steering people through the complex steps of finding a trial and determining eligibility. The potential financial impact of trial participation is also considered.

The final chapter, "Making the Decision," ties it all together, guiding the patient through the steps to decide if participating in a clinical trial is appropriate. This book helps people make informed decisions about cancer treatment in general, as well as participation in clinical trials.

In addition to the books discussed above, other books, videos and online resources are available from the Stanford Health Library. For help learning more, visit, call or e-mail the Stanford Health Library. Research assistance is provided free of charge. Branches are located at the Stanford Shopping Center near Bloomingdales'; on the third floor of Stanford Hospital or on the main level of Stanford's new Cancer Center. Call the Health Library at 650-725-8400, visit our Web site at http://healthlibrary.stanford.edu or send an e-mail to healthlibrary@stanfordmed.org.

Comments

Posted by Thiago daLuz, a resident of Adobe-Meadows
on Feb 25, 2014 at 7:02 am

I am usually just fine participating in clinical trials. A lot of times I actually have a lot fun doing the trials. I actually only got sick once. Thiago | Web Link


Posted by Cyril Connolly, a resident of Another Palo Alto neighborhood
on Feb 25, 2014 at 2:27 pm

There really are not many clinical trials in the US anymore, especially compared to Europe and Asia. I have found through my own research, that the huge majority of clinical trials are in China, France, and Germany.

Even my doctor tried to find clinical trials for me to participate in, since it would be a way to get cheap or free medication. Yet, all of the studies being done on my particular disease were in Beijing or Berlin, and the Beijing studie indicated that Caucasians were not welcome. With the Berlin studies, I would have had to live in Berlin for two years, or commute back and forth every ten days. Expensive and impractical.

So I am stuck with very expensive medication with a 30% copay ($950/month), which is not sufficiently effective.


Posted by trial participant, a resident of Menlo Park
on Feb 26, 2014 at 10:12 am

Did it once - worked well for me. Seriously **worked well** for me.

Was a pill that had been approved years ago for other uses in the US. Approved overseas for the new use also - so I felt it was safe (clinical trials hate what you can find in google!)

I clearly did not get the placebo - my lifelong, chronic condition cleared up. Has slowly tried to come back post-trial, but not anywhere near as bad. A true quality of life improvement.

Post trial, talked to the trial doc, he felt I was previously under-treated by my series of 'normal' docs. Was educational, enlightening.

To this day, I thank heavens I didn't get the placebo. Even if I had, I still had access to better info and help than before; that may or may not apply to other trials, of course.

See the Stanford trial list. Easily searchable, and links to the NIH trials in other areas (no international, iirc.) If you're in the Stanford area, you're really lucky to have the option.


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