A New Dawn-Using Teletrials for Early Phase Drug Development: A Practical Guideline.

Abstract

Introduction: Access to early-phase cancer clinical trials is heavily skewed toward urban patients treated at tertiary centers, creating significant inequity for regional/rural (R/R) populations. For early drug development (EDD) trials, travel requirements are a major barrier to R/R participation. Growing public and governmental policy pressure on pharmaceutical stakeholders and trial centers has driven the exploration of innovative solutions to improve access. Among these, the teletrial model, which has been effective in later-phase studies, presents an opportunity to address recruitment challenges in phase 1 trials. This article provides practical guidelines for implementing teletrials in EDD.

Methods/results: This review outlines key operational, regulatory, and logistical considerations for phase 1 teletrials, covering site evaluation, ethics and governance, resource allocation, and funding models. Several teletrial frameworks are presented, tailored to the varying capabilities of satellite sites and the complexities of early-phase trials. Lessons learned from successful pilot initiatives are integrated into the recommendations to help guide site conversion and trial design.

Discussion: Phase 1 teletrials are a necessary evolution in clinical trial conduct, driven by increasing demands for equitable access to life-saving therapies. Challenges, including resource-intensive set-up, cost management, and oversight requirements, are acknowledged. However, with proper planning and stakeholder collaboration, teletrials offer significant benefits: increased trial recruitment, improved R/R patient access, and reduced geographic disparities. The expansion of teletrials will be crucial for meeting the recruitment challenges posed by biomarker-driven and rare-disease studies while maintaining safety and scientific integrity.