What’s the Risk?
Any medical treatment or procedure has a certain level of risk, and clinical trials are no different. However, there are strict rules and regulations in place to help ensure patient safety during clinical trials.
Multiple teams of reviewers, such as an Institutional Review Board or an Ethics Committee, must approve all clinical trials. These groups work to review the study design and treatments to ensure that there is no unnecessary risk to the patients. There is also continued safety monitoring throughout the duration of the trial.
While patient safety is always at the forefront of clinical trial design, it is important to remember the potential risks and weigh them carefully when making your decision.
Some possible risks to consider:
- Side effects of new medication
- Effectiveness of new medication (may not be as effective as current treatment)
- Risks associated with any tests performed during the study
- Interruption of your schedule for study activities
- Potential restrictions on other medications you can use during the course of the study
Withdrawing From a Trial
Patients are always able to withdraw from a trial at any time and for any reason. If you wish to withdraw from a clinical study, you must notify the study doctor that you no longer wish to participate. The study clinician or doctor can also stop your participation in the clinical study if he or she believes it is in your best interest. Should you want or need to stop participating in the clinical trial, you may want to talk to your doctor first. If after you talk to your doctor, you still decide that discontinuing is in your best interest, your doctor can help you take the proper steps to notify the research center and be removed from the study.
Once you have withdrawn, your regular doctor can help you determine the next steps in your treatment plan.