In 2004, approximately 35,000 federally and industry-sponsored phase I-III clinical trials were conducted in the United States on a wide variety of medical conditions. These trials were sponsored by the government and by pharmaceutical, biotechnology and medical device companies. Clinical trials aren’t limited to studies of medical treatments for the desperately ill, and they aren’t all conducted at famous universities. Clinical trials are conducted at more than 10,000 locations around the country including physicians’ offices, stand-alone clinical research centers, government-owned and -operated hospitals and large academic medical centers.
Clinical trials are only one type of medical research involving people. In 2005, industry and government spent approximately $21.5 billion dollars on a wide variety of clinical research programs. These are primarily research programs of new medical treatments that have yet to be introduced into the market. Other clinical research programs involve activities such as studying blood and tissue samples and evaluating genetic maps of patients and their families. Research programs may entail testing artificial organs and mechanical devices used in (or in place of) surgery; evaluating human behaviors and the impact of nutrition on disease; and watching the long-term progression of illnesses.
Nationwide, there is growing interest in clinical trials as treatment options. The patient community and health professionals have become more aware of investigational medicines as important considerations when planning their treatment regimens. Every year, millions of people participate in trials. In some cases, clinical trials may offer access to treatments that can dramatically improve and extend the lives of people suffering from severe and chronic illnesses. But along with promise and hope, there are also numerous risks in clinical trials.
Even the best run clinical trials are not completely free of risk despite the fact that the research process is highly regulated, it is managed by experienced professionals, and it has many built-in safeguards to help protect study volunteers. It is important for you to know the facts about clinical trials before choosing whether or not to participate in one. That is what Informed Consent is all about.
Over the past several years, you may have noticed advertisements seeking clinical trial volunteers in your doctor’s office or in a health center, on television, radio, billboards, newspapers and on the Internet. Throughout the country, research centers are looking for new ways to reach the patient community and the general public in order to solicit participation.
At the present time, many people are open to learning about clinical trials, and many people are volunteering for them. You may not be happy with your current treatment and would like to try a new therapy that is only accessible through a clinical trial. You may be interested in volunteering for a clinical trial because you want to help researchers better understand how to treat illnesses in the future.
The purpose of this information is to assist you in making an informed decision about participating in a clinical trial. What should you expect? What kinds of questions should you ask? How can you minimize your risk? We want to prepare you to the fullest extent possible to participate in a clinical trial. We also want to give you enough information about clinical trials so that you can remove as much risk from the experience as possible. But no web site, no book, no brochure, no regulatory body can remove all risk. As a subject in a clinical trial, you are always exposing yourself to risk. You have to decide whether that risk is acceptable to you or not.
The following information is organized in a very straightforward manner. It begins with a brief history about the industry, a discussion of the drug development process and what is involved in bringing a new drug to market. We’ll then talk about your rights as a study volunteer. What is informed consent, for example, and what are specific federal regulations and guidelines that protect your safety and ethical treatment? Next it describes the process of participating in a clinical trial: How do you volunteer for a study? How can you identify the appropriate trials for your condition or that of a family member or friend?
The advancement of medical knowledge and the discovery of life-saving and revolutionary new treatments require a partnership between scientists, professionals and patients. Your role as a participant is integral to this partnership, and it begins with your informed consent.
Next Section: Clinical Trials – A Very Human Enterprise
Introduction