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Do patient recruits ever ask the question, "Are clinical trials safe?" Chances are, they do.
Naturally, patients are hesitant to participate when questions are left unanswered or risks aren’t adequately explained. The best method to ease fears and answer questions is to educate patients beforehand, says Christopher P. Steidle, MD, a researcher for AmericasDoctor and medical director of Northeast Indiana Research in Fort Wayne. AmericasDoctor is a Chicago-based clinical research company with more than 213 investigative sites and over 550 studies ongoing in urology, rheumatology, pulmonology, women’s health, and endocrinology, to name just a few.
"While the Food and Drug Administration closely monitors the majority of clinical research, it’s important for prospective volunteers to learn everything they can about the study, including whether it is sanctioned by the FDA," says Steidle.
Steidle, a urologist and researcher on male and female sexual dysfunction, offers several tips on helping patient participants make an informed choice before entering a clinical trial. Here are ways to help participants determine if a trial is right for them:
• Do your homework. Find information on clinical trials by visiting local health fairs, checking with a local teaching hospital or medical school, or browsing sites on the Internet. Always verify the credibility of the site you are visiting to gather information. Steidle recommends AmericasDoctor.com, which has a series of educational articles about the clinical trial process, from an overview to a detailed discussion of such issues as institutional review boards and the informed consent process. Other good resources include CenterWatch.com and clinicaltrials.gov, which offer both trial listings and information about the entire research process.
• Seek expert knowledge. Talk with your doctor or health care provider before reaching any final decisions. Ask your doctor if he or she or a physician they know and trust has done any research, and what other concerns should be addressed, given your medical history.
• Get all the information available. Leave nothing to chance, and don’t be afraid to ask as many questions as you need to feel comfortable. Find out all you can, including benefits, dangers, duration, and location, for each research study. Make sure you get the particulars up front so you can make an informed decision. Many trials have a new drug brochure to help you cover all the bases.
• Network: Check with trusted family and/ or friends who may have been in a research study about their feelings and experiences. But be warned: What might be right for one person may not be right for another.
• Pay constant and careful attention: Read consent forms through to the end before signing on the dotted line. These all-important documents lay out your rights and responsibilities, as well as every intricate detail, including any known risks and benefits associated with the clinical trial. Again, ask as many questions as you need.
• No matter what, you have the option to drop out of a trial at any time, for any reason. Don’t worry that once you’ve made the commitment, you’re stuck in something that doesn’t work for you. Naturally it is the goal of researchers to complete a trial in order to benefit as many patients as possible. But your chief concern is your own safety. The laws are there to protect your rights. Know the process and everyone wins.