Transparency and disclosure of clinical trial information has been growing in importance. Providing previously confidential clinical study results for public consumption is a key step toward increasing trust between the public and the industry and encouraging information sharing that could lead to new products or therapeutic approaches.
But data sharing carries risk, especially with regard to personally identifiable information (PII), patient protected data (PPD), and company confidential information (CCI) that is referenced throughout regulatory submittal packages.
Under Policy 70, which became effective Jan. 1, 2015, the European Medicines Agency is making all clinical study reports (CSRs) that support an approved marketing authorization publicly available. This presents a significant risk for companies who must accurately identify and redact the myriad references to PII, PPD and CCI in these documents.
So what are a company’s options?
Sponsors must now identify solutions and processes to enable them to comply with Policy 70 and additional regulations under development. In light of today’s technology advances, it is unnecessary to burden highly qualified regulatory teams with manual processes for managing redaction.
Written by Guest Writer Keith M. Kleeman. Kleeman is president of Synchrogenix, Certara’s regulatory and medical writing consultancy, and leads the company’s transparency and disclosure services. Previously, he was founder and CEO of ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Synchrogenix purchased ClinGenuity in January 2015. www.synchrogenix.com
This article was reprinted from Volume 22, Issue 05, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact email@example.com. Subscribe >>