I see more and more patients decline to participate in clinical trials. Simultaneously, I hear patient advocates on the national stage clamoring for better trial access. Why the disconnect? Let’s explore 7 reasons why clinical trial participation is right for you.
1) The smartest minds in medicine designed this for you
Clinical trials are not designed by one doctor on the fly. Most oncology drugs have been studied for at least 6 years prior to entering clinical trial. There are a number of drugs that have proven track records in other diseases or other stages of the same disease. Trial design includes a large collection of many of the brightest minds in medicine—nationally recognized physician thought leaders, pharmaceutical industry pioneers, large collaborative international work groups, and experienced regulatory oversight. Trials compare head-to-head two (or more) therapy options. Those options include the current standard (which is sometimes studied by observation) vs. an experimental option we think might be better. If we didn’t think the experimental arm had a chance to improve outcomes—the trial would never happen.
2) You trust your physician
When your doctor agreed to open this trial at your facility, he/she carefully reviewed the experimental medicine and the background science in careful detail. They agreed the trial is a valid option for treatment regardless of which arm of the study you are randomized to. It is why they are offering it to you in particular. Your physician believes the trial is a great option. Put your trust in their recommendation.
3) Institutional Review Boards that protect your rights
An institutional review board (IRB) is an independent body designated to evaluate and monitor all clinical research at your hospital/health system to protect the rights and welfare of human research subjects. The process is unique to trials and doesn’t exist in standard practice. There is no independent group of people reviewing your care and watching out for your best interest unless you are on a clinical trial. The review boards were established as a result of research abuses that occurred in the 20th century. They ensure clinical trials are conducted both ethically and safely for all participants.
4) Clinical trials staff who closely monitor you
When you are on a clinical trial, every last part of your care is monitored not only by your physician, but by a trained set of clinical research staff members. They look at every lab, every medicine, every symptom, and carefully interrogate the impact on you, your care, and your outcome. They adhere to protocols making sure labs, imaging, and medications are all done exactly right. I do not think enough can be said for the value of adding people to your cancer-fighting team. It takes a village.
5) Science needs this
Trial participation is altruistic. There may or may not be benefits to you, but the trial results will significantly benefit patients that come after you because it helps us to see what is working and what is not. Science needs this. The former Vice President, Joe Biden, launched the Cancer Moonshot Initiative to increase cancer research and make more therapies available to more patients. The only hope to shoot the moon is to have more patients enrolling in trials. Science needs this. Trials are often widely criticized for not having enough gender, age, race, geographic, or socioeconomic diversity. Your participation may fill an under-represented bucket. Science needs this. Every press release you see about a new promising therapy, every news story about a new miracle was made possible by clinical trial participants just like you. Science needs this.
6) Kids are doing it
Only 5% of adults with cancer are participating in clinical trials. Yet we hear regular outcries about “finding a cure” and “fighting cancer.” We fight with knowledge. We fight with science. And, do you know who has demonstrated that most eloquently? Children. Childhood cancer survival rates far exceed cancer survival rates in adults. 60% of children with cancer are treated on clinical trial. Coincidence? I don’t think so.
7) Information is power
When you enroll on a clinical trial, you undergo “informed consent”, which means you receive a long detailed document carefully outlining every step with information reviewed by dozens of experts, written in your language, on your reading level. It can be overwhelming. Yet every current standard of care once had an informed consent form. In contrast, when offering standard of care, your doctor may not offer the same comprehensive, individualized written summary of risks and benefits. Informed consents are your right as a patient. You deserve information on your treatment. Information is power. Get all the information.
Physicians and patient advocates alike are fighting for better access to clinical trials and more comprehensive trial options for patients. This desperation speaks to the important role clinical trials play in cancer care. However, trials are not right for everyone. In our one-on-one discussions with patients, we aim to present balanced information between trial participation and standard of care. We never want to coerce a patient into clinical trial participation. We never want to “over sell” the benefits. It is only in large-scale formats like this that we can enthusiastically endorse why trials are so important and so valuable. We want you to feel confident and empowered in your decision. You deserve the best care in your journey with cancer & beyond. Know that your oncologist believes in clinical trials.
Stephanie Graff, MD
Director of the Breast Program at Sarah Cannon Cancer Institute at HCA Midwest Health