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Cross-sectional assessment of patient attitudes towards participation in clinical trials: does making results publicly available matter?
  1. Christopher W Jones1,
  2. Valerie A Braz1,
  3. Stephen M McBride1,
  4. Brian W Roberts1,
  5. Timothy F Platts-Mills2
  1. 1Department of Emergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA
  2. 2Department of Emergency Medicine, University of North Carolina Chapel Hill, Chapel Hill, North Carolina, USA
  1. Correspondence to Dr Christopher Jones; jones-christopher{at}cooperhealth.edu

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.

  • trial registration
  • publication bias
  • informed consent

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors CWJ conceived the study idea, performed data analysis, and drafted the manuscript. CWJ, VAB, BWR, and TFP-M designed the study. SMM and VAB performed data collection. All authors contributed to critical revision of the manuscript. All authors read and approved the final manuscript.

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests CWJ is an investigator on studies sponsored by Janssen, Astra Zeneca and Roche Diagnostics.

  • Ethics approval Cooper Hospital Institutional Review Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Requests for access to the complete data set may be sent to the corresponding author CWJ at jones-christopher@cooperhealth.edu.

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