Clinical trials play a key role in helping to advance medical research. Clinical trials are scientific studies that ultimately aim to find better ways to prevent, treat, and diagnose diseases. If you have ever considered volunteering to participate in a clinical research trial, it’s important to understand how clinical trials work.
Clinical trials are done in different phases. Each phase has different criteria and a different purpose.
- Phase I studies are meant to assess the safety of a drug or device and usually include 20-100 volunteers. About 70% of drugs will pass this phase.
- Phase II studies are designed to test the effectiveness of a drug or device, while continuing to monitor and assess safety. Several hundred volunteers may take part in phase II trials and they can last from several months to two years. About one-third of drugs successfully complete phase I and phase II studies.
- Phase III studies involve several hundred to several thousand volunteers. The purpose is to test effectiveness and to monitor for any adverse reactions. About 25-30% of drugs will make to the next phase.
- Phase IV studies test the safety and effectiveness of treatment and carried out once the drug or device has been approved by the FDA.
No matter the phase, each clinical trial is led by a Principal Investigator, or PI. The PI, who is often a board-certified physician, works with a medical team and follows a master plan called a protocol. The protocol explains detailed information about what will be done during the clinical trial. Even if the same study is being conducted in a different part of the country, the exact same protocol will be followed.
Before deciding whether or not to participate in a research study, volunteers are provided with key information that explains the details of the study. This is called the informed consent process. Informed consent is more than just signing a document, it involves providing appropriate time for potential participants to ask questions and discuss any questions and concerns before deciding to participate. Throughout the study, informed consent is maintained with participants through the disclosure of any newly discovered potential risks, and the ongoing disclosure of information as the research progresses.
Choosing to participate in a clinical trial is a very personal decision. Participating may give you the opportunity to access potential new treatment options and give you a better understanding of your condition. ActivMed understands the importance of clinical research and the value that participants bring to the advancement of medical knowledge. ActivMed is currently enrolling for studies in a variety of conditions. Qualified candidates who participate will receive study-related care at no cost and receive compensation for travel. To learn more about how you or someone you love may qualify to participate in a clinical research study at ActivMed, click HERE.