Risk management in clinical trials: assessment of current practices at portuguese clinical trial sites

Purpose: Over the last years, in response to theincreasing complexity and demand of clinical trials, there has been a growingconcern with the application of efficient risk management methodologies. Themain objective of this work is to assess the current level of implementation ofrisk management activities by clinical trials sites’ teams and identify pointsof improvement. Methods: A cross-sectional study was conducted through anoriginal, non-validated questionnaire created to assess the risk managementpractices at Portuguese clinical trial sites. The web-based survey was sent bye-mail to the clinical trial sites identified, and it was available for onemonth. Descriptive statistics were used to summarize the findings. Results: Intotal, 46 clinical trial sites accepted to participate in this study. Thesurveys’ answers showed that although 57.0% of sites reported the use of asystematic risk management tool, only nine sites (19.6%) described a standardtool or document that captured systematically the analysis of risks at the sitelevel. Most of the sites (87.0%) showed willing to use a risk management toolspecifically tailored for their operational needs, with the lack of knowledgeabout risk management being the main reason against its implementation.Conclusion: This work indicates that the surveyed clinical trial sitesgenerally recognize the importance of risk management methodologies as anopportunity to anticipate difficulties in the trial conduct and optimize theuse of sites’ resources. However, mainly due to lack of experience with riskmanagement methodologies, sites are not currently implementing these strategiesin the management of their trial-related operations. The development of a riskmanagement tool for sites can be useful in this context. <o:p></o:p>