Potential Benefits and Risks of Participating in a Clinical Trial
Clinical trials offer you the opportunity to receive the best healthcare available, as well as to help others currently affected by lung cancer and those who will be affected in the future.
By participating, you may also:
- Receive new research treatments before they are publicly available
- Get expert medical care at leading health care facilities during the trial
- Help others now and in the future by contributing to medical research
Your treatment in a clinical trial may be free of charge, and if researchers find that one of the treatments being tested is better than the other is, you will be switched to the better treatment.
There are also potential risks to participating in clinical trials:
- There may be unpleasant, serious or even life-threatening side effects.
- You may not receive the experimental treatment or the experimental treatment may not work.
- You may be required to travel more, receive more treatments, or go through difficult and time consuming procedures than with usual treatment.
Great efforts are made to ensure safety for patients participating in clinical trials. Still, risks remain. These risks are greater in Phase I and II studies than in Phase III or IV studies. Discuss possible risks with your doctor.
Common Concerns about Clinical Trials
Some patients are concerned that they will be "guinea pigs" for medical science if they participate in a clinical trial. While it is true that clinical trials are research studies, you will be monitored closely for side effects, you will not be kept in a clinical trial if the medication or procedure is not helping you, and you are allowed to leave a clinical trial anytime you wish. There are strict ethical guidelines when it comes to medical research, and researchers are not allowed to mislead you to keep you in a clinical trial for the benefit of science
Everyone who joins a clinical trial signs an informed consent form. Informed consent means you have discussed the clinical trial with someone who understands it. It means that you have been told about the possible risks and benefits of participation. Your informed consent means you are participating in the trial because you want to and you have made that choice.
Some patients are also concerned that they will receive a “placebo,” which is an inactive substance that looks like the treatment being tested. In most clinical trials, a patient will at least receive “standard treatment” or the treatment they would normally get if they were not in the study. An experimental treatment may be added to the usual treatment for some in the study while others receive usual treatment and a placebo.
If the usual treatment is “best supportive care,” meaning that there is no recommended active treatment, some in the study may receive a new treatment while others receive a placebo. For example, if you have responded to treatment and would normally just be monitored for recurrence.
If a placebo is used in a trial, you will be informed verbally and in writing about your chance of receiving the placebo.