We have been talking to many of our customers and colleagues across industry about disclosure compliance, apparent compliance and how companies are navigating the many changes happening in the disclosure arena. There is one thing that remain consistent in all of our conversations: Change is Constant.
Disclosure is growing in scope and complexity. Gone are the days of simply registering a study on clinicaltrials.gov. We expect 2017 to be marked by continued public scrutiny of disclosure practices by regulators, stakeholders and watch dog organizations. Expanded regulations will require broader data disclosure with even tighter timelines. Even the types of disclosure data are changing – tabular summaries, full protocols, sample case report forms, redacted clinical study reports, trial results summaries (also known as lay language or plain language summaries) – the list goes on.
Clinical trial sponsors will have to respond more quickly to QA reviews of their disclosure data which will require greater agility in managing disclosure content processes. A content management approach is required to effectively reuse approved content and distribute to appropriate channels in an efficient manner. This typically requires an enabling technology along with process updates that address review and approval processes and alignment of disclosure content around the world, regardless of venue.
Constant change is pressuring clinical trial sponsors to do more, more efficiently. The dynamic nature of the disclosure landscape requires operational excellence. Thomas Wicks and I recently hosted a webinar where we discussed our predictions for 2017. In the webinar, we also provided some recommendations on how sponsors can successfully navigate the change. Check out the webinar recording.