Minimizing Luck In Study Feasibility Part 1: Best Practices

By Ashley Schwalje, Head of Commercialization for Patient Recruitment & Engagement, Citeline and Daniel Chancellor, Thought Leadership & Consulting, Citeline

Two thirds of clinical trial sites are unable to meet original enrollment goals, with half of sites recruiting either a single patient or failing completely. Study sponsors must therefore scrutinize their current approaches to feasibility, as recruitment is such a critical part of overall trial success.

This article, the first of a two-part series, summarizes the current best practices in study feasibility and how the field can harness big data and predictive analytics to augment the overall country/site selection and patient recruitment process. Innovative approaches to study feasibility promise to improve cycle times and the quality of clinical research, while also lowering cost and risk, allowing clinical trial sponsors to tilt the odds in their favor.