OBJECTIVES:

Drug and Device safety is continuous activity from discovery to post launch phase. Apart from spontaneous reporting of adverse events, review of published literature is a well-defined and mandated source to identify following safety insights¹:

1. Individual Case Safety Reports ( ICSR)
2. Relevant information for aggregate reports Periodic Safety Update Report( PSUR/PBRER) and Developmental safety update reports ( DSUR)
3. Safety Signal Surveillance for proactive identification of new adverse events or new aspect of known drug adverse event causality.
4. Ad hoc requests from competent authority, Marketing Authorization Holder’s specific request and inputs for Risk Management Plans, Safety Signal Management and Risk Benefit Analysis of a Drug/Device.

METHODS: These activities are regulated and/or guided by various Health Authorities including European Medicinal Agency ( EMA) Good Pharmacovigilance Practices Module VI² and US FDA Regulations (21 CFR 314)⁵ with a well-defined process for literature search and management

RESULTS:

These key activities is to generate safety evidence from published literature sources is similar to well defined systematic literature review process for generating literature evidence. Both these key literature review activities have similar challenges like:

• Volume of scientific literature
• Spike in numbers of references i.e conferences, grey literature
• Duplicate references
• Search strategy creation and management
• Lack of trained resources
• Time bound activities with respect to safety literature search for ISCR
• Lack of oversight of outsourced search services
• Unclear attribution to the Drug/Device and the Event from the Author

CONCLUSIONS:

There is an opportunity to consolidate these literature review activities. The following approaches can help to consolidate, harmonize, standardize and automate these activities.

• Best practices in search Strategy, abstract & full text review and data extraction³
• Identifying Duplicates and remove Redundancy⁴
• Common set of trained resources with similar skill sets
• Common set of standardized automation use cases to enable AI/ML enabled centralized workflow enabling real time literature review