The Impact of Clinical Design on patient participation in a hypothetical Clinical Trial of the treatment for DCIS
Jason T Connor, Berry Consultants  *Lea Rebecca Meir, UCF College of Medicine  

Keywords: Adaptive Design, Clinical Trial, Randomization, Trial Designs

Advancements in screening methods have led to the over diagnosis of the earliest stage of breast cancer known as Ductal Carcinoma In Situ (DCIS). Over diagnosis may lead to overtreatment which poses unnecessary risk to patients. Enhancement of the treatment and management of breast cancer has historically improved following the usage of clinical trials. Entry in a clinical trial may therefore prove beneficial for women with DCIS in revealing which treatment option might be better (lumpectomy + radiation vs. active surveillance + hormone therapy). Unfortunately, only about 2% of adult cancer patients will participate in a clinical trial. Many due to the dislike of randomization involved in a randomized control trials (RCT).

In order to observe if the clinical design influences patient participation, this study analyzed patient participation in three hypothetical clinical designs including: Fixed Randomized Control Trials (RCT), Preference Trials, and Response Adaptive Randomized Trials (RAR). 33 participants were randomized to each of these three clinical designs. Each participant was shown a video explaining a hypothetical scenario of a woman diagnosed with DCIS, a short educational video on their specified clinical design, and was then offered entry into their assigned clinical design.

This study concluded that there was a statistically significant difference found amongst the clinical trial designs (P=.007). In specific, participants in the RAR group were significantly more likely to enroll in their assigned clinical trial over the RCT (P=.005) or the Preference Trial (p=.03). 81.8% of individuals assigned to RAR intended to enroll into this clinical trial over 54.5% of individuals in the Preference trial, or 45.5% in the fixed RCT.

This study demonstrates that an alternative design to a RCT called a Response Adaptive Randomization Trial (RAR) aids in addressing this concern and enhances the participation rate in clinical trials. This finding is significant as increasing the patient participation rate in clinical trials is essential in both the treatment evaluation and the advancement of patient care.