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Participants' perspectives on safety monitoring in clinical trials.

Publication ,  Journal Article
Flynn, KE; Kramer, JM; Dombeck, CB; Weinfurt, KP
Published in: Clin Trials
August 2013

BACKGROUND: Minimizing the risk to study participants is an essential requirement of ethical research. Respecting the rights of subjects is also paramount, which includes respecting their autonomy by making available important information about the evolving safety profile of an investigational product as the trial progresses. Little is known about what trial participants understand and expect regarding monitoring and communication of serious adverse events during the conduct of a trial in which they have agreed to participate. PURPOSE: To explore understanding and expectations of potential trial participants concerning monitoring and communication of serious adverse events during a clinical trial. METHODS: A professional moderator led four 90-min, in-person focus groups: two groups with individuals who had never participated in a clinical trial and two groups with people who had. After relevant research terms were defined and existing regulations were explained, discussion focused on how participants expected safety to be monitored and communicated during the conduct of a clinical trial. Group comments were video-recorded and transcribed and then analyzed by the investigators. RESULTS: The 27 racially diverse focus group members were largely unaware of existing safeguards and regulations to manage risk in clinical trials. Many people expressed a desire for increased transparency about serious adverse events during the trial as well as shortened reporting deadlines. Focus group members also spontaneously expressed concerns about potential financial conflicts of interest in monitoring and reporting serious adverse events. LIMITATIONS: This was a single-site, qualitative study and is not meant to establish the prevalence of beliefs. CONCLUSIONS: Potential trial participants have limited understanding and a wide range of expectations about how safety monitoring in clinical trials should be managed and communicated. The overall tenor of opinion suggests unease about participant safety and a desire to have more information conveyed by sponsors to investigators and, in some cases, by investigators to participants. Additional study in other regions and settings may be useful to more broadly explore the range of participants' beliefs and expectations. In the meantime, engaging patient advocates in the design of clinical trials and clearly communicating to trial participants the plan for oversight of their safety may help ease the types of concerns expressed in this study.

Duke Scholars

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

August 2013

Volume

10

Issue

4

Start / End Page

552 / 559

Location

England

Related Subject Headings

  • Statistics & Probability
  • Safety Management
  • Research Subjects
  • Qualitative Research
  • Patient Safety
  • Patient Education as Topic
  • Male
  • Humans
  • Health Knowledge, Attitudes, Practice
  • Focus Groups
 

Citation

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Flynn, K. E., Kramer, J. M., Dombeck, C. B., & Weinfurt, K. P. (2013). Participants' perspectives on safety monitoring in clinical trials. Clin Trials, 10(4), 552–559. https://doi.org/10.1177/1740774513484394
Flynn, Kathryn E., Judith M. Kramer, Carrie B. Dombeck, and Kevin P. Weinfurt. “Participants' perspectives on safety monitoring in clinical trials.Clin Trials 10, no. 4 (August 2013): 552–59. https://doi.org/10.1177/1740774513484394.
Flynn KE, Kramer JM, Dombeck CB, Weinfurt KP. Participants' perspectives on safety monitoring in clinical trials. Clin Trials. 2013 Aug;10(4):552–9.
Flynn, Kathryn E., et al. “Participants' perspectives on safety monitoring in clinical trials.Clin Trials, vol. 10, no. 4, Aug. 2013, pp. 552–59. Pubmed, doi:10.1177/1740774513484394.
Flynn KE, Kramer JM, Dombeck CB, Weinfurt KP. Participants' perspectives on safety monitoring in clinical trials. Clin Trials. 2013 Aug;10(4):552–559.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

August 2013

Volume

10

Issue

4

Start / End Page

552 / 559

Location

England

Related Subject Headings

  • Statistics & Probability
  • Safety Management
  • Research Subjects
  • Qualitative Research
  • Patient Safety
  • Patient Education as Topic
  • Male
  • Humans
  • Health Knowledge, Attitudes, Practice
  • Focus Groups