Enrolling in a clinical trial is a treatment option that can be beneficial for both the patient and others who can benefit from the findings. Almost all current treatments started out being tested in clinical trials. Medicine would not advance without the use of trials and people to participate in them.
Trial participants have a unique opportunity to test a new therapy, so people who volunteer should carefully consider the risks and benefits before enrolling. Our own resource, UMClinicalStudies.org, is a free and secure tool for healthy volunteers or someone with an existing medical condition looking for health research studies at the University of Michigan. The following information applies to anyone, anywhere in the United States, who has thought about enrolling in a clinical trial. It can help you decide if a clinical trial is an option to consider.
Is this clinical trial an option for me?
Each clinical trial has a specific list of traits that all patients must have to participate in the study. These guidelines, called eligibility criteria, include factors such as the type and stage of cancer, prior cancer treatment, age and overall health of the participant. In addition, each trial has exclusion criteria which list any medical conditions, medicines, or other diagnosis that would not allow trial participation.
How do I know what the trial is testing?
Clinical trials are divided into four separate phases: The first phase is phase I which is small (usually under 30 participants) and is used to determine if the treatment is safe. The second phase, phase II uses a larger population (under 100 participants) to determine if the treatment is effective. Phase III involves an even larger number of participants (in the thousands) to compare the new treatment to the current treatment. The last phase, phase IV, can involve several thousand participants and examines the long-term safety of the new treatment.
What else should I know?
It is important to understand the risks and benefits of the trial as well as the costs involved. Some people assume that trials will be free but that is not always the case. Make sure to check with the study coordinator or principal investigator beforehand. The risks and benefits of the trial are listed on the study protocol. This is a written document given to all participants or potential participants and explains what will happen to them in the trial and who to contact if they have questions or problems. It also explains your rights as a trial participant.
Lastly, only a doctor can determine if a patient will be a good fit for a trial so make sure to contact your doctor before agreeing to enroll in a trial.
Volunteering for a clinical trial is a contribution to the future of medicine that only you can make. You can learn more from the U-M Comprehensive Cancer Center’s Introduction to Clinical Trials webpages.
Still have questions? Call the U-M Cancer AnswerLine™: 1-800-865-1125
The Cancer AnswerLine™ is a dedicated phone line at the Comprehensive Cancer Center that is staffed by oncology nurses five days a week, 8 a.m. – 5 p.m. at 800-865-1125. They have a combined 105 years of experience helping patients and their families who have questions about cancer.
The University of Michigan Comprehensive Cancer Center’s 1,000 doctors, nurses, care givers and researchers are united by one thought: to deliver the highest quality, compassionate care while working to conquer cancer through innovation and collaboration. The center is among the top-ranked national cancer programs, and #1 in Michigan for cancer patient care. Seventeen multidisciplinary clinics offer one-stop access to teams of specialists for personalized treatment plans, part of the ideal patient care experience. Patients also benefit through access to promising new cancer therapies.