SP05-46: Plain Language Clinical Trial Result Summaries: Are Participants Getting It?
Undergraduate Research Associate
USC Department of Regulatory Science United States
An evaluation of the development and distribution of plain language clinical trial result summaries (PLCTRS) within major industry sponsors and clinical research professionals (CRPs) in regard to patient engagement and transparency.
Major industry sponsors were identified based upon the number of trials sponsored. On each respective website or trial site a search and analysis was conducted for PLCTRS. Next, an in-person survey was administered to 104 CRPs regarding their experience and views on the PLCTRS development process.
Data collected from major industry sponsors indicated frequencies and percentages of the availability of PLCTRS across 17 companies. If no availability was indicated, the following data were collected: whether plans for future release of PLCTRS was indicated, whether the PLCTRS were translated into a trial sites’ regional language, whether the PLCTRS follows current Regulation European Union (E.U.) 536/2014 guidelines, the Flesch-Kincaid reading ease score, and Flesch-Kincaid grade level. Of the 17 companies, nine U.S. or E.U. based major industry sponsors have PLCTRS available for the public and are written approximately at a high school reading level. The remaining eight companies did not have PLCTRS available, with five indicating availability in the future.
To compare this publicly available data to real-world industry experience, CRPs – Clinical research coordinators, data managers, sponsors, auditors, monitors, IRB, investigators, and students – were surveyed on the following questions: Whether their clinical research team had dedicated personnel for the development and dissemination of PLCTRS and whether guidance through standard operating procedures (SOPs) or a template would aid their team in the development and dissemination of PLCTRS. Survey results indicated that almost a third of CRPs do not have dedicated personnel for development and dissemination of PLCTRS. Over a third of CRP respondents indicated that they did not know if their team had dedicated personnel to develop and distribute PLCTRS. The remaining participants did have dedicated personnel for the development and distribution of PLCTRS. In addition, more than two-thirds of CRPs answered that their clinical research team would benefit from the use of SOPs or a template in the PLCTRS development process – the remaining respondents did not know. In all, the results indicate that the development and distribution of PLCTRS is variable among both major industry sponsors and CRPs.
This study indicates that while some major industry sponsors are developing and distributing PLCTRS online to participants and the public, many are not or are only in the planning stage for developing PLCTRS. Thus, the disparity in clinical trial participants not receiving study results intelligible to them is highlighted. Although, the PLCTRS that were available demonstrated the proactive role of industry sponsors in ensuring patient engagement – notably in various different languages and at a reading level that would be applicable to the targeted audience. However, these results do not take into account that these major industry sponsors have ample funding, personnel, and resources to develop and distribute PLCTRS.
In comparison, investigator-initiated trials (IITs) may lack the resources necessary for PLCTRS development. Considering that over a third of CRP respondents do not have dedicated personnel on their clinical research team to develop and disseminate PLCTRS – or 39.4% simply do not know – the implementation of a standardized process and availability of a user friendly template may help to ameliorate this gap and contribute to patient engagement. Possible templates could be based upon current E.U. regulation 536/2014 strictures and existing PLCTRS published by major industry sponsors. Given the already high rate of non-compliance in publishing results of both industry and non-industry trials, and that receiving study results is an important participation factor for potential participants, lack of transparency and patient engagement could jeopardize future clinical trial enrollment and attitudes.Therefore, this study emphasizes that even major industry sponsors often fail to deliver trial results that participants can comprehend. Thus, the aid of SOPs and/or templates could support the industry as a whole – especially IITs without dedicated personnel that are exponentially challenged by a lack of resources.