Communicating with patients about clinical trials can be a daunting task, especially when many individuals have misconceptions about the nature of clinical trials, confusion about what tasks are involved in participation, or misgivings about what being in a clinical trial implies about their disease prognosis. Health care professionals need to understand what kinds of preconceived ideas and beliefs patients may have going into the clinical trials conversation. Direct and honest communication, with equal time given to both patient and physician to share thoughts, is essential in clarifying any false ideas surrounding clinical trials participation. This will ensure continued medical advancements through research are made for populations as a whole.
The importance of clinical trials in advancing cancer treatment is well established,1 but integrating up-to-date clinical trial enrollment options into clinical pathways and having the actual participation conversation with patients can be a challenge. A number of groups have taken proactive steps to ensure that clinical trial options are embedded in their pathways and that physicians are encouraged to talk to their patients about participating in a study. Via Oncology, for example, uses a platform that works with their cancer centers to identify open trials and screen patients for possible inclusion. Their ongoing efforts have resulted in both increased participation in trials and valuable documentation as to why patients do and do not agree to enroll in studies.2
Still, even with this well-planned and coordinated intervention, the percentage of patients who actually enter trials is relatively low. In the Via data, the most common reasons that patients do not participate are that they do not meet eligibility requirements or that no trial is available at their treatment site. But, significantly, almost 2415 of the 150,001 patients studied said they “were not interested in a trial.”3
The inability to increase awareness and patient accrual to clinical trials is perplexing. There is no doubt that we are seeing very real and, in some instances, remarkable progress in treating a number of diseases, including many types of cancer, HIV, and other serious or chronic conditions. These advances are extending lives, improving quality of life, and even leading to cures for conditions that had routinely led to death. Clinical trials are the engine driving this progress, but the gap between that certainty and patients deciding to be in a trial remains wide.4 The message is not being heard at either the collective or individual level.
This gap is not for lack of trying. Virtually every organization involved in research, advocacy, and education has made efforts to make the case for clinical trial participation with patients and their physicians with publicly targeted campaigns, well-designed materials, websites, and clinical trial matching services, but overall participation has stayed stubbornly in the 3% to 4% range.1 It is tough to sell awareness and acceptance of a complex treatment-related issue to the general population—to people who are not sick and thus lack a pressing reason to care. These individuals have no reason to examine their preconceptions until actually faced with the choice of participation.
Misconceptions We Are Fighting
At the Fall 2018 National Patient Advocacy Policy Consortium, Suleika Jaouad delivered a powerful keynote address about her experience with acute myeloid leukemia, a diagnosis she received shortly after her graduation from college and chronicled in a New York Times series entitled “Life, Interrupted.” Ms Jaouad is a highly intelligent, well-educated young woman who had failed her initial course of standard chemotherapy. She was offered a phase 2 clinical trial in the hopes that it would induce the remission that would make her eligible for a potentially curative bone marrow transplant. This is how she describes her first response to the idea of being in a trial:
When my doctors first recommended that I enroll in a clinical trial...I was skeptical. Well, to be perfectly honest, I was terrified. In my mind, clinical trials were only for the terminally ill—a last resort option, a shot in the dark. The words “experimental” and “trial” conjured up images of mad scientists and guinea pigs.5
These words are clear evidence for the persistence of misconceptions and fears about clinical trials that represent active deterrents to patients when they make decisions about being in a trial. Ms Jaouad went on to describe her own learning process about the clinical trial that saved her life and the real nature of clinical research, but her statement brings to light several of the most common reasons why patients may say they are not “interested.” Despite all the information that is available on the topic, many people believe that trials are just throwing random substances at humans or that they will receive a placebo and end up getting no treatment.
These barriers are confounded when you add historical and cultural barriers to the mix. It is impossible to discuss clinical trials with any African American group without the Tuskegee experiments being mentioned in the first minute or two.6 That legacy of distrust remains a source of deep distrust between that community and the medical profession. Other groups harbor doubts, as well, about being guinea pigs for more privileged groups or not getting optimal treatment.
When and How to Bridge the Knowledge Gap
The bottom line is that it is not enough to make trials available, or even to screen patients for potential eligibility. Presenting a clinical trial to any patient is, in some respects, the ultimate example of shared decision-making. It requires that the physician be able to explain not only the overall benefits of clinical trials and the excellence of the care that patients receive in these studies, but also address the fears, myths, and misconceptions that continue to keep patients and medicine from benefitting from these studies.
The “sell” for clinical trials, then, needs to come at the juncture of the treatment decision-making process when both patient and provider can understand and assess together the potential benefits of clinical trial participation. This means physicians must be aware of available trials for their patients, capable of explaining how trials work, and willing in some instances to refer a patient to another facility or provider. They must also understand the barriers that stand between patients and choosing to be part of a study and not assume that patients share their knowledge of the value of trials either for individuals or for advancing care overall. A photo essay resource titled “Frankly Speaking About Cancer Clinical Trials” provided by the Cancer Support Community features oncologists and patients who speak about clinical trials and their experiences being part of trials.7 This resource may be helpful in facilitating these conversations or for patients to access before clinical trial discussions.
Every patient who is a candidate for a clinical trial hopes to gain individual benefit from that trial, and every patient who participates knows from the outset that there are no guarantees. It is critical to make sure the discussion encompasses the patient’s goals and values, so that the decision can be anchored in the context of that person’s life. Many patients are also capable of understanding and appreciating the greater good that results from clinical trial participation—the concept that, by being part of a research study, they may help other people now and in the future. The knowledge and understanding that leads to the decision to be enrolled in a clinical trial can only come from an open, person-centered discussion between the patient and physician.
1. Unger JM, Cook E, Tai E, Bleyer A. Role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;35:185-198. doi:10.14694/EDBK_1566861
2. Shamah CJ, Saphner TJ. Effect on clinical trial participation by integration of a clinical pathway program into an electronic health record (EHR). J Clin Oncol. 2016;34(suppl 7):167-167. doi:10.1200/jco.2016.34.7_suppl.167
3. Ellis PG, Weese J, Barry A. Clinical Pathways as a Platform to Support Clinical Research. Via Oncology. https://viaoncology.com/wp-content/media/clinical_pathways_as_a_platform_to_support_clinical_research.pdf. Accessed January 23, 2019.
4. Anderson A, Borfitz D, Getz K. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA Netw Open. 2018;1(6):e182969. doi:10.1001/jamanetworkopen.2018.2969
5. Jaouad S. Life, Interrupted: A Test of Faith [blog]. The New York Times. August 22, 2013. https://well.blogs.nytimes.com/2013/08/22/life-interrupted-a-test-of-faith/. Accessed January 23, 2019.
6. Centers for Disease Control and Prevention (CDC). The Tuskegee Timeline. CDC website. https://www.cdc.gov/tuskegee/timeline.htm. Updated December 22, 2015. Accessed January 23, 2019.
7. Cancer Support Community. Frankly Speaking About Cancer Clinical Trials. cancersupportcommunity.org website. https://www.cancersupportcommunity.org/cancer-clinical-trials-1. Accessed January 28, 2019.