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
• plain language clinical trial results summaries
• lay language clinical trial results summaries

Article highlights

• The timely and effective communication of clinical trial results plays an essential role in informing clinicians, clinical research professionals, patients and the public about the care, diagnosis, and development of new treatments for medical conditions.

• Although progress has been made in the return of technical clinical trial results summaries to the scientific and professional community, very little progress has been made to meet the ethical obligation to return plain language clinical trial results summaries to patients.

• There are a number of perceived barriers that have been addressed by recently published frameworks and guidelines and by research sponsors voluntarily disclosing their clinical trial results to study volunteers.

• The expected tightening of regulation and its enforcement in the European Union and North America will stimulate more widespread adoption ultimately facilitating higher levels of patient engagement and trust in the clinical research process.

Acknowledgments

The authors thank Behtash Bahador and Jill McNair for their ideas that helped shape the outline for this article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.