Clinical trials: a guide for patients
Clinical trials are research studies that seek to find an answer to specific questions about a condition or disease. They are highly regulated, making them a safer and faster way for researchers to prevent, diagnose and treat illness in humans.
When you participate in a clinical trial, you have access to the latest accepted medicines. Plus, you may potentially access new treatments before they are available as a standard of care — often receiving study-related medicines at no or low cost. Clinical trial participants also help others who may benefit from these therapies in the future.
Rights and responsibilities of clinical research participants
There are hundreds of clinical trials currently underway; your doctor can help you decide if one is right for you. If you meet the selection criteria for a trial, you’ll be given a thorough description of the study, including possible benefits and risks. While agreeing to be in the study allows you to participate, you have the right to withdraw at any time, for any reason.
Patients involved in a clinical trial work closely with a research coordinator. This individual serves as a bridge between the doctor and patient, ensuring patient needs are met and their questions are answered.
The time commitment associated with a clinical research study may be greater than with standard treatments. By agreeing to participate, you are also agreeing to keep all scheduled appointments to the best of your ability. Other responsibilities include:
- Following the directions provided by the researchers
- Providing an accurate medical history
- Informing researchers if any of your medications change or if you experience any negative side effects while involved in the study
- Asking any study-related questions when you have them
- Getting care for unrelated medical conditions throughout the study period
- Keeping your contact information updated
Types of clinical trials
There are different kinds of clinical trials. Each has a specific purpose and a different level of engagement for the patient. Types of trials include:
Screening trials: These look for new ways of diagnosing a health issue, like a new imaging test or laboratory process. They may also be used in identifying what risk factors certain diseases have in common.
Observational clinical trials: These trials observe people or groups of people in their natural environments over time to learn more about a disease or condition. They may look at common genetic factors or symptoms in people with similar disease states.
Interventional clinical trials: These are focused on treatment and prevention. They test new devices, experimental treatments or different formulations of existing medicines to see if they have a positive impact on a disease. Sometimes these studies look at whether a medication or a device can help prevent a disease or health issue.