Trial Results Summaries Portal
Study sponsors are increasingly expected to share results of clinical trials with the trial participants in a clear and meaningful way and a growing number are demonstrating their commitment to patient engagement by providing trial results summaries in clear language. These initiatives are in parallel to requirements, such as the EU Regulation 536/2014 requires that sponsors provide summaries of study results that are understandable to lay people.
Associations such as the World Medical Association, PhRMA, and EFPIA recognize this requirement, with groups such as MRCT and TransCelerate providing guidance and recommendations. Trial summaries should be written and presented in a non-promotional context. Clinical trial sponsors need a way to present their trial results summaries in an effective yet non-commercial manner to support their transparency efforts.
TrialScope’s Trial Results Summaries portal offers an electronic means of communicating this information which is traditionally passed through paper channels. These traditional paper processes are not tracked and often result in information never making its way to the intended recipient. The Trial Results Summaries Portal is publicly accessible and offers a single location for trial participants to subscribe and receive notifications regarding their trial results summaries. For sponsors, it replaces manual, paper processes and eliminates the need to print, distribute and track paper summaries.
The Trial Results Summaries Portal enables simple, secure posting of trial results summaries and simplifies ongoing communication with trial participants.