title: Participants' perspectives on safety monitoring in clinical trials.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: Duke Clinical Research Institute, Duke Translational Medicine Institute, Durham, NC, USA. kflynn@mcw.edu
authors: Kathryn E
authors: KE
authors: Flynn
authors: Judith M
authors: JM
authors: Kramer
authors: Carrie B
authors: CB
authors: Dombeck
authors: Kevin P
authors: KP
authors: Weinfurt
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000592:standards; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D061214:Patient Safety; D036301:Qualitative Research; D035842:Research Subjects / Q000523:psychology*; D017751:Safety Management