White Paper – Decentralized Clinical Trials: Perspectives for Clinical Research Professionals

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White Paper – Decentralized Clinical Trials: Perspectives for Clinical Research Professionals

Decentralized Clinical Trials (DCTs) are revolutionizing the trial landscape. Papers and conferences have focused on the technology, the regulatory challenges, and the potential benefits to patients. But there’s been almost no discussion about the clinical trial front-line professionals who will actually roll up their sleeves and ultimately determine how effective DCTs will be. 

Until now. 

A new position paper from noted thought leaders and the Association of Clinical Research Professionals provides the much-needed voice of the clinical trial professional.

To download the paper: https://acrpnet.org/download/decentralized-clinical-trials-perspectives-for-clinical-research-professionals

INTRODUCTION

This position paper presents the views of Association of Clinical Research Professionals (ACRP) Fellows about the impact of increased use of decentralized clinical trial (DCT) elements in clinical research and the evaluation of test articles. The paper describes the potential impact on subject safety, human rights, data integrity, electronic communication, and study financials, and provides guidance on the changes required to clinical research plans, facilities, equipment, and training. The wide variety of study objectives and designs that use DCT elements does not allow for the development of simple rules that fit all or even most situations. Out-of-the-box thinking is required; traditional SOPs and clinical operation practices based on site-centric assumptions must be rewritten. Adapting to the range of models is key with an emphasis on training clinical research professionals to carefully consider every study individually and customize study plans.

Assessing the impact of DCTs on both clinical trial validity and clinical research stakeholders is of pressing importance due to the increased use of DCT elements during the COVID-19 pandemic — a trend that is forecast to continue. This recent surge represented a major disruption to traditional clinical trial operational models and clinical researcher roles. As CenterWatch (December 6, 2021) writes, “Industry is approaching a watershed moment, with sponsors and CROs planning for the first time to conduct more hybrid trials than traditional site-based trials, a trend that is expected to play out across all trial phases and therapeutic areas.” The publication quotes a recent survey by Science 37, in which respondents viewed the top three advantages of hybrid trials as being better study subject experience, better patient retention and faster recruitment.2

Developing this position paper is in accordance with ACRP’s mission to promote clinical research professionalism, and its vision that clinical research must be performed ethically, responsibly, and everywhere in the world. Our commitment to the ethical tenets of our profession will be referred to within this paper, with protection of our study subjects and the collection and documentation of clean, unadulterated data during clinical trials first and foremost.