REGULATORY PUBLIC DISCLOSURE (RPD) - September
UK National Health Service Transparency Commitment
The UK NHS’ ‘Make It Public’ Health Strategy makes a commitment to research transparency that will focus on:
- Registration (via Policy Framework)
- Reporting results
- Informing participants.
Journal of Data Protection and Privacy
Articles related to data protection for clinical trials appear in J Data Protection and Privacy Vol 3 (3) 2019-20, including GL Rosner’s ‘De-identification as public policy’; and S Bamford’s (J&J) ‘Applications of privacy-enhancing technology to data sharing at a global pharmaceutical company’ – along with a range of other articles for wider reading interest.
Good Lay Summary Practice
Clinical Trials Information System (CTIS) Webinar
On 21 September 2020 EMA will hold a Webinar on their developing Clinical Trials Information System, CTIS, with a dynamic demonstration of the sponsor workspace.
US CIVIL MONEY PENALTIES FOR VIOLATIONS RELATING TO CLINICALTRIALS.GOV DATA BANK
FDA have released final guidance titled ‘Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank’ in August 2020. This Federal Register Notice underpins the guidance.
Prohibited acts include failure to submit, and submitting false or misleading information to www.clinicaltrials.gov
As medical writers, we all see badly written protocols with trial registration information to match – and we know that these will confound the downstream summary clinical trial results posting. This Rule and the FDA guidance should steer sponsors to use professional medical writers to help them appropriately design and author their trial documentation, which will in turn help them to make accurate postings. These civil money penalties will otherwise hit sponsors where they hurt most – in their pockets.