Parkinson's Clinical Trial Companion Navigating Clinical Trials - Page 11

people known to be taking the drug, but they also could uncover potential new uses for the therapy to treat other conditions. The Clinical Trial Process + + Strict protocols direct each study. Each trial follows an extensive and carefully monitored protocol, which is a plan that spells out the entire study process. This details how many volunteers are needed, who is eligible, what tests will be used to evaluate participants’ health at the beginning and throughout the study, how long the study will last, what information will be recorded and other considerations. Similar to how a team delivers your medical care, a staff of doctors, researchers, nurses and study coordinators carry out clinical trials. The principal investigator, typically a doctor, leads the entire team and trial. + + Informed consent is obtained before you enroll. Before you join a study, you’ll meet with the trial team so they can discuss relevant aspects of the protocol, answer your questions and go over a consent form. This document, referred to as informed consent, lists your rights as a volunteer, the potential risks of participation and what you can expect during the study. Once you understand what the trial entails and you feel comfortable and want to enroll, you sign the informed consent. This isn’t a binding contract; you can still withdraw at any time for any reason. (You also can refuse study tests or treatments, but doing so may exclude you from continuing in the trial.) conference. (You can inquire with your trial team and search online for the published results.) At trial conclusion, teams also determine next steps for the therapy. They may recommend evaluation in the next phase of clinical trial testing, or, equally as important, they may suggest no further study because safety and efficacy data are not compelling. People who have enrolled in a placebo-controlled trial often wonder whether they received placebo or the study drug. If the protocol allows, this information is made available when all participants complete the trial. Some participants also want to know if they can continue to get a study drug once a trial ends. Often this is not possible, but the trial protocol and informed consent documents spell out in advance what will happen should this question come up. And if the therapy continues to the next phase of clinical testing, people who have participated in earlier research may be given an option to continue on with it. Because of many factors, though, enrolling in the next study phase may not guarantee that a person will continue the study drug. (A new study may require re- randomization, for example.) + + Independent committees review and approve studies. An Institutional Review Board (IRB) — an independent group of physicians, researchers and others (usually at least one “non-scientific” person who represents the patient voice) — evaluates and approves each study’s protocol and informed consent document. This committee also monitors ongoing study activities. The IRB is in place to protect the rights and welfare of people participating in a study. What Happens When the Study Ends Once a clinical trial is over, the trial team analyzes the data, distills key findings, and publishes the results or presents them to other researchers at a Chapter 1 — Clinical Research Basics 9