The number of adverse events collected by biopharmaceutical companies and reported to regulatory authorities is increasing 10 – 20 % per year. There is evidence that this increase is not only caused by individual patients or health care providers reporting their adverse experience to companies or regulatory authorities, but is mainly driven by the identification of adverse events through patient support programs, social media etc. There is no evidence that this type of volume growth has resulted in a more rapid signal detection or better protection of public health; given the increasing amount of effort required to collect, analyze and report on this type of information, it needs to be recognized that our ability to detect a new safety risk may be hindered. In addition, differences exist across biopharma companies in defining how these various sources of information should be collected, processed and submitted to the regulators, either as aggregate or individual safety reports.
The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for single high value valid cases and develop a proposed method for aggregate reporting of lower value cases. This hierarchy of values will be based on the evidence derived from the collective experience of drug companies and other stakeholders. The Initiative will present a proposal to global health authorities.
This initiative will benefit patients, sponsors, and regulators through:
- Improved patient safety by enhancing safety signal detection
- Increased efficiencies for sponsors and regulators by sharpening the focus on the highest value safety information
This initiative will deliver the following assets and activities:
- Adverse events data source definitions and inventory
- Perspective regarding hierarchy of value for collecting, processing, analyzing and reporting of adverse event information
- Evidence to illustrate the high/low informative value of adverse event data sources
- Outreach to regulators regarding the initiative’s intent and draft hierarchy
Interpretation of Guidances & Regulations
The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of ambiguous regulatory requirements and guidances in both the pharmacovigilance and clinical areas.
Clinical Data Transparency
The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.