Let’s Get This Thing Started

Clinical Researcher—March 2020 (Volume 34, Issue 3)


Jim Kremidas


We all know how difficult it can be to get a clinical trial launched successfully. Whether it’s patient recruitment and retention, supply chain challenges, contracting complexities, or myriad other obstacles and challenges, it’s no wonder some of the study start-up statistics remain discouraging.

However, we are missing an opportunity if we don’t examine how sites with certified personnel consistently post faster rates of study start-up and patient enrollment, and with fewer deviations along the way. It’s clear that further professionalizing the clinical trial workforce with performance-driven certifications, aligned job titles, and clear roles and responsibilities will help improve those tough study start-up stats.

Several contributors to this issue of Clinical Researcher address various technological and process-oriented approaches to study start-up challenges directly, while others touch on the topic at least partially by way of considering the overall environment of study complexity and regulatory approaches for expediting drug development globally.

I hope you find the information and insights in this issue to be helpful to you in your career as we work together to elevate the entire clinical trial industry.

I’d also like to take this opportunity to celebrate two new members of the Partners in Workforce Advancement (PWA), a multi-stakeholder collaborative initiative to grow the clinical research workforce and to set and support standards for workforce competence. In February, we welcomed Dartmouth-Hitchcock Health as the Elite Partner of the PWA, and this month, we welcomed TRIO (Translational Research in Oncology) as a Workforce Champion PWA member.

The PWA members—who now include more than 25 sponsors, contract research organizations, investigator sites, academic institutions, regulatory agencies, and more—provide strategic direction and support for initiatives to grow the workforce and to define, align, and validate competence standards.

Organizations aligned with ACRP’s mission are working together to improve clinical trial quality and outcomes for patients by focusing where others have not—on workforce planning, development, and assessment. Why? Because in clinical research, people are everything. We are thankful for the support of Dartmouth-Hitchcock Health and TRIO, and look forward to working together to overcome these critical challenges.

Jim Kremidas (jkremidas@acrpnet.org) is Executive Director of ACRP.