Clinical Trials - What You Need to Know

Clinical trials are organized research programs designed to study and test the safety and effectiveness of a new therapy. The term trial indicates that the treatment is experimental, however, clinical trials are a crucial first step in obtaining U.S. Food and Drug Administration (FDA) approval and bringing lifesaving drugs to market. They begin life with Phase 1 trials, which serve foremost to establish the maximum safe deliverable drug dosage.


Clinical Trials Offer Hope and Groundbreaking Discoveries

Clinical trials offer hope to patients with advanced or difficult-to-treat types of cancer. In many cases, patients have tried multiple standard treatments that have not delivered optimal results. Numerous clinical trials result in innovative new therapies that extend patients’ lives. The breast cancer treatments available today – including Herceptin, tamoxifen, aromatase inhibitors, and more – are available because large numbers of women chose to participate in clinical trials.


Potential Benefits

  • Access to new treatments early in their development.
  • Clinical trial research teams that typically include top doctors and scientists.
  • Close monitoring and personalized attention.
  • Treatment that may be free or low cost.
  • The chance to contribute to research that may save the lives of future patients.
  • The feeling that you are taking an active role in your treatment.


Potential Risks

  • Not being able to choose which drug you take, for example, you may get a placebo.
  • The new treatment may not work for you, even if other people in the trial experience positive results.
  • Worse side effects than current treatments; more likely with Phase I or Phase II trials.
  • All costs may not be covered by your insurance company or the trial site.
  • Being subjected to an increased number of tests and doctor visits.


Important Questions to Ask

Some trials only accept people who have been diagnosed, but not yet treated for cancer, while others accept people who have advanced cancer that has not responded to prior therapies. If you have just been diagnosed with cancer, talk with your doctor about how quickly treatment should begin. The FDA and the Office for Human Research Protections require that potential participants in a clinical trial receive a written informed consent which will explain the purpose and risks involved. If you are considering participating in a clinical trial, there are important questions you should ask the trial coordinator, including:

  • Is the trial still open? Clinical trial listings are not always updated.
  • What is the main purpose of the trial? Is it to slow the growth or spread of cancer, lessen the severity of cancer symptoms or the side effects of treatment? You may be able to get the trial protocol document which will explain this and more, so ask if it is available.
  •  What is promising about this new treatment and is this trial based on positive findings from prior studies? Keep in mind that outcomes from human studies are stronger than laboratory or animal studies.
  • Am I eligible for the entry criteria listed in the trial based on my health situation? You may need to ask your doctor to make the call to the trial coordinator on your behalf, because he or she may ask complex clinical questions you cannot answer.
  • Where is the trial taking place? Many cancer trials are multicenter, giving people from different geographic locations the opportunity to participate. If travel is involved, you need to find out if the sponsor is picking up any of the travel costs.
  • Who will ensure my safety while participating in the trial? Many clinical trials are governed by the Institutional Review Board (IRB), ensuring that correct safety protocols are followed.
  • Is there any compensation associated with participation? Some clinical trials pay patients to participate.


Where to Find Clinical Trials

Your oncologist may be aware of and suggest clinical trials, but there are various online resources should you wish to explore this option on your own.

  • American Cancer Society (registration required)
  • Breast Cancer
  • Cancer Connect
  • Center Watch
  • Clinical
  • Emerging Med
  • National Cancer Institute
  • Trial Check (registration required)


Clinical Trials are Invaluable to Patients and Doctors

Clinical trials allow innovative treatments to be developed, such as new cancer drugs. They offer hope to patients who may have tried standard therapies that did not produce adequate results. They yield invaluable insights that often lead to improved patient outcomes, lifesaving therapies, and additional treatment options for doctors to utilize. If you have tried other treatments that have failed to achieve a positive outcome, you might want to consider enrolling in a clinical trial. Check out the online resources and consult with your personal physician who can provide further guidance.