THOUGHT LEADERSHIP

The accurate analysis and reporting of data is necessary to the evaluation of new treatments for human diseases. Regulatory authorities must weigh the risks with the benefits of treatments in their approval decisions. Often, regulators will ask sponsors to provide information about the analyses, such as the datasets and data selection criteria used to generate the results. The Clinical Data Interchange Standards Consortium (CDISC) has described their newest initiative to standardize analysis results in the form of tables, listings, and figures (TLF) and reporting of data across the industry.

Drug Safety & Pharmacovigilance professionals have long awaited consistency in the manner in which the US Food and Drug Administration (FDA) accepts Individual Case Safety Report (ICSR) submissions. For years, the industry has navigated different submission procedures for FDA compared with other regions, as well as differences between Investigational New Drug (IND) reporting and post-marketing pharmacovigilance reporting. The FDA has been working towards harmonization of ICSR submissions and the final guidance is here! FDA will require that both premarket and post-market safety reports be submitted electronically in the ICH E2B(R3) format, the format that is currently the standard in the EU. Let us explore the current FDA practices, the need for updated processes, timelines for implementation, and what pharmacovigilance professionals need to do to prepare for the change.

Current European law prohibits businesses from sending personal information about European citizens to companies in the United States (US) without specific contractual obligations to protect the privacy of the information.  However, the current Data Privacy Framework (DPF) allows US companies that are “Certified” under the Framework to import and process personal data of European citizens without these contractual requirements.

Pharmacovigilance is one of the most essential functions in the drug development process as it is vital for the continued safety evaluation of a product from the first time it is administered to a person through the post-marketing setting. A Pharmacovigilance program must be set up to detect, assess, understand and prevent adverse effects or other possible drug-related problems, and these activities require extensive documentation and monitoring. The global safety database is the primary tool to support Pharmacovigilance activities as it allows us to review safety cases across an entire investigational program rather than study-by-study. It is the Pharmacovigilance provider’s responsibility to ensure that the database is updated and maintained by inputting individual case safety reports (ICSRs) in a consistent, standardized, and timely manner.