Making decisions about clinical trial enrollment: What’s important to the patient?
Authors: Meyer Larissa Alejandra , Schneider Amy K. , Huepenbecker Sarah Page , Adjei Naomi N. , Estrada Gladys M , Sun Charlotte C. 
Published: June 2023

e18658

Background: Understanding patient (pt) perspectives on clinical trials is paramount for trial accrual. We qualitatively explored factors pts felt were important when deciding to enroll in clinical trials. Methods: Pts with recurrent ovarian cancer took part in semi-structured interviews which were audio-recorded, transcribed, and consensus coded. Results: 40 pts were interviewed. Median age = 62.4 yrs (41.2, 79.0), 82.5% (33/40) were white, 60% (24/40) were college educated. Median time from diagnosis = 5.5 yrs (0.80, 17.8); 42.5% (17/40) had prior enrollment in a clinical trial. Most pts cited hope for clinical benefit and desire to help others as key motivators for trial participation. Quality of life (QoL) was also an integral factor. Many expressed a willingness to sacrifice QoL for clinical benefit: “I don’t want to, you know, spend the last months suffering…but, if they say ‘Well, we can try this….Maybe you’ll get 6 more months out of it’, which we know that’s hope for 6 more months. So then the suffering might be worth it.” Others would refuse enrollment due to fear of compromised QoL, or poor outcome: “ If I was healthy at the time, I would have difficulty going into a clinical trial. Because my thought would be…“I’m healthy. I feel good. You wanna place me on a clinical trial, and what if it goes bad? What if it doesn’t work?” Another asserted: “I would not participate in a clinical trial if it was going to make me feel worse before it supposedly made me feel better.” A motivator and potential barrier was trust in providers. “I would like to know… this is their…business or work, they're serious about doin' it…and they kind of professional people, someone…that believe in doin' a good job on somethin', not just get up and do it because maybe they gonna get this amount of money for it, but somethin'…at heart that they really believe in…I'll have to know somethin' about the person or the persons that's in charge of that clinical trial.” Another noted: “I would have gone with whatever [my doctor] recommended…at the end of the day, it’s trust. If I didn’t trust my doctor, I’m not so sure I would just jump into this…” Pts cited trial logistics as potential barriers to participation: “Was it something that I would be able to incorporate into my life, both travel-wise and…taking the drug? Was it going to really be a demanding schedule in terms of meals, in terms of sleep…? Those are all things I looked at. ’ Access and affordability were other barriers cited by pts. Conclusions: Pts weigh many factors when considering clinical trials. QoL information is highly desired. Inclusion of patient-reported outcomes in developmental therapeutic trials may inform QoL for future pts. While motivators for participation were apparent, efforts to overcome potential barriers to enrollment by building trust with providers, and increasing education, navigation and decentralized trials may help diversify and improve representation in trial accrual.