Assessing the adoption of clinical trial results summary disclosure to patients and the public

Abstract

Introduction: There is a broad global acknowledgment that the timely and effective communication of clinical trial results is not only essential to the development, diagnosis, and treatment of medical conditions but also meets an ethical obligation to inform patients and the public. Areas covered: At this time, less than 2% of all clinical trials completed or terminated within the past three years returned plain language summaries to study volunteers. This estimate is far below our forecast made 10 years ago when we evaluated a pilot effort to demonstrate a feasible and efficient process for communicating summary results to patients. At that time, we anticipated that research sponsors would embrace the obligation and in so doing would improve their relationship with and trust among their study volunteers and patient communities. This article discusses why adoption remains low and suggests that the absence of clear regulatory requirements and their enforcement are the primary cause. Expert opinion: The authors anticipate that the regulatory environment will tighten and that public, patient and patient advocate appetite and expectation for the disclosure of clinical trial results summaries in plain language will intensify during the next 18 months. These pressures will compel research sponsors to accelerate adoption.

Keywords: Clinical trial results disclosure; clinical trials transparency; lay language clinical trial results summaries; plain language clinical trial results summaries.