Meeting the Obligation to Communicate Clinical Trial Results to Study Volunteers

Kenneth Getz; Zachary Hallinan; Diane Simmons; Marla Jo Brickman; Zhanna Jumadilova; Lynne Pauer; Marc Wilenzick; Briggs Morrison

Disclosures

Expert Rev Clin Pharmacol. 2012;5(2):149-156. 

In This Article

Abstract and Introduction

Abstract

Although the overwhelming majority of study volunteers want to receive information on the results of their participation in clinical trials, research suggests that most study volunteers never do. CISCRP – an independent nonprofit organization – in collaboration with Pfizer, conducted a study evaluating the feasibility and impact of a new process to inform study volunteers of the results of their clinical trials. Two process components were evaluated via surveys, focus groups, and interviews with volunteers and investigative site staff: a series of ongoing post-trial communications to set expectations for when trial results would be received; and routine development and delivery of the lay language trial results summary. The results of this assessment show that study volunteers and investigative site staff are extremely receptive to receiving clinical trial results and that the process of preparing and disseminating clinical trial results is feasible and generally easy to execute. The results also indicate that study volunteer comprehension of basic facts about their clinical trial pre- and post-test increased by as much as 65.6 percentage points, and suggest that this communication initiative may positively impact volunteer recruitment, retention and long-term trust in the clinical research enterprise.

Introduction

Study volunteers want to know that their participation mattered.[1] Regardless of the outcome, people who agree to participate in clinical research want to know that their involvement informed medical knowledge about disease and how to treat it. Studies have consistently shown that 90% of all study volunteers typically wish to receive their clinical trial results.[2] Studies have also shown that principal investigators and research center staff are highly supportive of communicating trial results to participants.[3]

In accepting the responsibility to protect the safe and ethical treatment of study volunteers, the research community is obligated to inform its study participants about the outcome of the study.[4] To date, however, although industry is required to publicly post clinical trial results online in compliance with federal law when the drug/device is approved or within 1 year of study completion, the routine communication of those results in nontechnical, easy-to-understand lay language to study volunteers and patients is not occurring. Cox et al. reported that 86% of cancer trial participants were not offered the opportunity to receive their trial results.[5] A 2003 study found that less than 5% of study volunteers received their cancer clinical trial results, and that few institutions have the mechanisms in place to communicate those results.[6]

In an effort to improve disclosure and transparency of clinical trial results information, in March 2011, the US FDA adopted final amended informed consent regulations requiring informed consent forms to include a statement indicating that data from the clinical trial has been or will be entered into the ClinicalTrials.gov registry.[4] The FDA intends to enforce this rule for informed consent documents that are initiated on or after 7 March 2012. However, recent assessments on the use of the ClinicalTrials.gov registry show that study volunteers, patients and the general public are not the primary audience for this information.[7]

Although a growing number of industry- and government-funded clinical trial results are posted online via the ClinicalTrials.gov trial registry, the parties primarily accessing this highly technical information are professional researchers, policymakers and analysts monitoring data trends.[7] Not all study volunteers have access to the internet or the ability to locate their specific trial. Even if they were able to find their specific clinical trial, most study volunteers are not comfortable or able to interpret the results.[8] As such, summary results of interventional studies posted on the ClinicalTrials.gov trial registry[101] are of very limited utility to patients and – most importantly – fail to satisfy the critical obligation to communicate trial results to study volunteers.

At the conclusion of their participation, most study volunteers feel that they are "no longer valued".[9] Their connection with the clinical research enterprise has been severed. Unless they are deeply self-motivated to share their experiences, most study volunteers choose not to advocate clinical research among patients who are considering participation.[10]

A unique opportunity exists to build a stronger connection with study volunteers after their participation has ended by ensuring the systematic disclosure of clinical trial results.[11] Ultimately, through this connection, the clinical research enterprise will more effectively engage clinical research participants, their family members and their support network (e.g., healthcare providers) as ambassadors and advocates for clinical research. This opportunity is particularly strong in severe, chronic and terminal illness areas, such as oncology, immunomodulation and certain CNS diseases. Here, patients and their families take part in clinical trials that may hold limited therapeutic benefit, but that provide insights into disease mechanisms and treatments that will benefit family members and other patients in the future. Many chronic conditions are not terminal but they adversely affect many aspects of the quality of life of those dealing with these illnesses.

In late 2009, the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP), in collaboration with Pfizer, designed and conducted a small-scale initial pilot study to evaluate the feasibility of translating technical scientific clinical trial results into nontechnical lay-language summaries. The promising results of this pilot study were published in October 2010.[12] In June 2011, the CISCRP and Pfizer completed a larger-scale assessment of the feasibility of a routine mechanism to communicate trial results, of volunteer comprehension and receptivity of the nontechnical lay summaries, and of study staff reaction to both the summaries and the overall process. This second study also tested the process of setting volunteer expectations prior to disclosing the lay summaries. This article summarizes the results of this second study, and discusses insights into meeting the obligation and opportunity to communicate trial results to study volunteers.

processing....