Clinical trials do have risks and some downsides, such as the following.
- The new strategies and treatments being studied aren't always better than current standard care.
- Even if a new approach benefits some participants, it may not work for you.
- A new treatment may have side effects or risks that doctors don't know about or expect. This is especially true during phase I and phase II clinical trials. The risk of side effects might be even greater for trials with cutting-edge approaches, such as gene therapy or new biological treatments.
- Health insurance and health care providers don't always cover all patient care costs for clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage.
You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in.
Important Factors
Clinical trials may involve risk, as can routine medical care and the activities of daily living. When weighing the risks of research, you can think about these important factors:
- The possible harms that could result from taking part in the study
- The level of harm
- The chance of any harm occurring
Clinical trials may pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental treatments. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to consider and sign before participating in research. Also, a member of the research team will explain the study and answer any questions about the study. Before deciding to participate, carefully consider risks and possible benefits.
