Cross-sectional assessment of patient attitudes towards participation in clinical trials: does making results publicly available matter?

open access
November 24, 2016

 It is unknown whether potential research participants are aware that failure to publicly release trial data is a problem, whether the release of trial results is important to potential study participants, and whether awareness of the possibility of non-publication might influence decisions about trial participation. The primary objective of this investigation was to examine how the possibility of non-publication might influence attitudes towards trial participation.

Abstract

Objectives Previous studies have shown that a majority of patients cite altruistic motives, such as contributing to generalisable medical knowledge, as factors motivating clinical trial participation. We sought to examine the impact of making trial results publicly available on patients' willingness to participate in clinical research.

Design Cross-sectional analysis using a questionnaire developed by a panel with expertise in publication bias, informed consent and survey design.

Setting A single urban, academic emergency department (ED) in the Northeastern USA.

Participants 799 ED patients.

Outcome Measures We assessed (1) participants' attitudes towards clinical trial participation, and (2) the impact of whether study results would eventually be made publicly available or not on willingness to participate in a trial.

Results Of 799 patients surveyed, 36% (95% CI 32% to 39%) reported that they would generally like to participate in a trial, and another 50% (95% CI 47% to 54%) reported that they would consider participation depending on study details. For the majority of participants, the publication of trial results was either important (36%; 95% CI 33% to 40%) or very important (48%; 95% CI 44% to 51%). Most (63%; 95% CI 59% to 66%) reported they would be less likely to participate in a trial if investigators had not publicly released results from a prior study. Additionally, 85% (95% CI 82% to 87%) felt that it was important or very important to receive information about the publication track record of sponsors and investigators during the informed consent process.

Conclusions The majority of patients in this sample would consider participation in a clinical trial. Patients value the public release of trial results, and believe that the informed consent process should address the possibility of non-publication.

Strengths and limitations of this study

• This study is unique in that it offers insight into the problem of non-publication from the perspective of research participants.
• The study used a pilot phase, recruited patients via random time block sampling, and assessed test–retest reliability in order to limit study bias.
• This is a single-centre study involving an urban emergency department in the USA; results may not be applicable to other patient populations.
• The results from this cross-sectional study are subject to selection bias.