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Keiko Sato, Tosiya Sato, Junji Furuse, Hiroshi Kasugai, Masaru Konishi, Tomoo Kosuge, Akiko Saito, Yo Sasaki, Ken Takasaki, Takuji Okusaka, A Conundrum for Randomized Controlled Trials: Experience from a Small Hepatocellular Carcinoma Trial, Japanese Journal of Clinical Oncology, Volume 40, Issue 10, October 2010, Pages 949–953, https://doi.org/10.1093/jjco/hyq074
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Abstract
The aim of this study was to explore why patients accepted or declined to participate in a randomized clinical trial, which was subsequently discontinued because of a low recruitment rate.
Forty-one patients were invited to participate in a randomized clinical trial that aimed to compare local ablation therapies and surgery to treat small asymptomatic hepatocellular carcinomas. These patients were then asked to answer a questionnaire that assessed patient perception and reasons for accepting or declining to enroll in the randomized clinical trial. When patients had a strong preference for a specific treatment, the questionnaire assessed why, how and when they had chosen it.
The response rate was 6/6 (100%) and 30/35 (86%) for the participant and non-participant groups, respectively. Among the 30 non-participants, 23 had a strong preference for local ablation therapies, which was less invasive and offered shorter hospitalization. Patient preference for a specific treatment often stemmed from their consultations with a clinician who referred them to a specialist hospital. Patients without strong preference for a specific treatment participated in the randomized clinical trial because of altruistic motivations.
When new treatments that are innovative and less burdensome become widespread, they are difficult to compare with standard therapy utilizing a well-designed randomized clinical trial. Consequently, when an innovative treatment is developed, investigators should consider designing a randomized clinical trial as early as possible.
