Our company has been integrally involved in the cross-sectoral (industry/academia/regulators/patients/HCPs) initiatives coordinated by the TransCelerate and Harvard MRCT (Multi Regional Clinical Trials) Center, aimed to improve communication of study results to participants and the wider community through the development and dissemination of plain language summaries (PLSs). We also served on the Health Research Authority Task Force, a multi-stakeholder working group responsible for developing the EU Regulatory Guidance on Layperson Summaries (release August, 2017). These initiatives will address the requirements of the upcoming EU regulation (2018) to publish a PLS within 12 months after LSLV (last subject last visit) of a study and support efforts to provide study result to participants.
In 2014, we started their internal work to ensure good preparedness and smooth delivery of this initiative within the company, reach the PLS quality criteria in line with the requirements, and address their patients’ expectation to have results communicated as early as possible after a study completion. This early work, well ahead of the applicability of the EU CT Regulatory requirement*, enabled us to understand the challenges and identify pragmatic solution to help inform external work in this area. We also wanted to ensure that the developed PLS would be understandable and clear for patients and the general public (all of whom are patients as well).
The following are two examples of feedback sprints authors conducted:
Pilot PLS (COPD) reviewed by EUPATI trainees (2015) and
2 PLSs review (COPD study 113108 and study 115151 SLS) via Crowd sourcing Amazon Turk online platform (2017).
Detail on the methodology:
1) Summaries of Clinical Trial Results for Laypersons released June 2017
2) Layperson Summaries of Clinical Trials: An Implementation Guide (Download here)
3) Clinical Data Transparency
* EU Regulation No 536/2014, see https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf