Benefits
Besides making a new and promising treatment available to you, if the treatment proves as beneficial as the preceding research indicates, you will be among the first to benefit from it since these investigational therapies are available exclusively to patients enrolled in clinical trials.
Because of the stringent research reporting criteria, you will also be more closely monitored by our medical team and the trial sponsor than you would be if you were receiving standard treatment in which results and side effects are better known.
As a final benefit, your participation in a trial helps physicians and scientists worldwide learn more about cancer, thus enabling them to develop more effective strategies to help people in the future.
It is important to know that patient responses to a trial’s treatment regimen are collected throughout the period of the trial rather than only at the scheduled trial completion date. In this way, any clear trends can be identified in a timely manner. If a new investigational treatment is achieving outstanding results part way through the trial, the trial may be ended in order to offer the successful regimen to all appropriate patients. In fact, almost all of today’s standard regimens came out of clinical trials. Similarly, if a trend shows poorer responses than standard treatment usually achieves, a trial will be ended and patients are switched to the more successful standard treatment. The ongoing monitoring throughout a clinical trial also allows doctors to share information on side-effects or other issues relevant to patient care.
Risks
Although extensive research has indicated great promise for a new treatment, it is unknown whether it is better than standard treatment or has unexpected side effects that are worse than those of the standard. That is why it’s called a “trial”: not enough people have yet had the treatment to allow physicians and scientists to evaluate it when all factors including side effects and length of remission are considered. This is also why multiple centers around the world simultaneously offer the new treatment so that the results can be pooled and evaluated.
A trial also may involve more visits to our clinic and thus more travel, childcare and housing expenses. You may also need extra tests that can be uncomfortable and impinge on your normal routine. Be sure to ask about these factors and check with your health insurer before enrolling in a clinical trial to assess what will and won’t be covered. Insurers, including Medicare, may cover nationally approved clinical trials unless your policy has a specific exclusionary clause. In any case, our staff will assist you in seeking insurance coverage for your specific trial.
You should also realize that whether you receive standard or investigational treatment, not all patients’ cancers respond alike even when they have the same type of cancer. Patients have different immune responses, physical stamina, and co-existing medical problems making each treatment journey completely unique.
The decision to enter a clinical trial or not is entirely yours. If your doctor suggests one, ask why and study the trial’s Informed Consent Form closely. Make note of questions that occur to you and discuss them thoroughly with your doctor before making your decision.
When considering this decision, you should know that you will never be required to stay in a trial if you and/or your doctor thinks it is no longer in your best interests: you can withdraw at any time and choose other treatment options. Remember: your informed decisions direct your care, and our medical team will never be offended should you opt for a different approach.