Telehealth consultations and recruitment trends in clinical trials: A retrospective analysis at investigational cancer therapeutics, a dedicated phase I department at The University of Texas MD Anderson Cancer Center.
Authors: Torrado Carlos , Brink Amanda , Gouda Mohamed Alaa , Kang Lei , Osburn Jessica , Patterson Clover J , Charles Sheena , Poullard Anna , Urschel Gabriele E , Dumbrava Ecaterina Elena , Karp Daniel D. , Naing Aung , Piha-Paul Sarina A. , Pohlmann Paula R , Rodon Ahnert Jordi , Tsimberidou Apostolia Maria , Yap Timothy A. , Hong David S. , Meric-Bernstam Funda , Fu Siqing 
Published: May 2024

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Background: Recruitment to phase I/II clinical trials have been reported to vary between 30% and 55% across centers, primarily relying on in-person visits. However, with the onset of the COVID-19 pandemic, there has been a noticeable surge in telehealth consultations. Consequently, there is currently a dearth of data available regarding this approach within the context of early phase-clinical trials. Methods: Data on patient’s first visits to the Investigational Cancer Therapeutics (ICT), a dedicated Phase I department at The University of Texas MD Anderson Cancer Center (MDACC), were retrieved from the institution's electronic platform. The ICT department offers phase I-II clinical trials for patients with advanced cancer. We included first visits between January 2020 and December 2023. Initial telehealth visits were conducted via video or telephone, with patients from either Texas or other states in the United States. Visits were classified into two groups: internal referrals, originating from other departments within MDACC, and new patient visits, including patients who had not been seen at MDACC prior to the ICT visit. Recruitment was defined as the percentage of patients who consented to participate in a clinical trial. Statistical analysis was performed using Statistical Package for Social Sciences (SPSS). Results: A total of 6,965 patients had a first visit in the Investigational Cancer Therapeutics Department between January 2020 and December 2023. Of these, 4,321 patients (62%) had their initial in-person visit, while 2,644 patients (38%) opted for telehealth consultations. Internal referrals accounted for 6,304 patients (90.5%), while new patient visits comprised 661 patients (9.5%). Among the entire cohort, recruitment rate for phase I-II clinical trials was 53.2% (n= 3,702). Patients with initial telehealth consultations had a recruitment rate of 55.1%, compared to 52.0% among those with in-person consultations (χ2=6.538, p<0.011). Recruitment was higher among internal referrals at 53.7% compared to 47.5% for external referrals (χ2= 9.355, p=0.002). Notably, recruitment was statistically higher in internal consults that underwent telehealth versus in-person visits (55.4% versus 52.6%, p=0.027), while there were no statistical differences in new patient visits (47.4% vs. 47.8%, p=0.939). Conclusions: Telemedicine consultations emerge as a valuable alternative for evaluating and discussing treatment options for patients with advanced solid tumors, thereby enhancing accessibility to early-phase clinical trials. The flexibility of conducting initial visits remotely may mitigate geographical and logistical challenges and allow for a more inclusive and diverse participant pool, fostering broader representation in clinical trial research.