Question: What are Clinical Trials?
From: Bill S. of New York, NY
Answer: Clinical trials are research studies which are performed to determine if new drugs or treatments are safe and effective. The size of the trials may vary from a small group to a large group. They may be at one center in one country to multiple centers in multiple countries. In the U.S., the Food and Drug Administration (FDA) is the health authority to which clinical trials are referred. The National Institute of Health’s website, www.clinicaltrials.gov, provides a list of many clinical trials that are in progress. Another site is CenterWatch Web (www.centerwatch.com) lists more than 41,000 clinical trials. In a clinical trial, the provider or organization conducting the study covers the cost of care. Before participating, you will be provided with a great deal of information, including the risks and side effects. Informed consent for research should contain 3 basic elements: the physician researcher should provide information to the patient, the patient participant should understand the information, and the patient should voluntarily participate in the study. The patient may withdraw from the study at any time. Medical research is highly regulated to protect research participants and to ensure specific findings. I devote a chapter to this topic in my book, 7 Steps to Your Best Healthcare.
Ruthann Russo, PhD, JD, MPH, RHIT, is a healthcare expert with more than 20 years of experience working in and advising healthcare organizations.
