Big Data and Pharmacovigilance: ICMRA Working Group Looks at Opportunities and Challenges

Regulatory NewsRegulatory News | 15 February 2018 |  By 

The International Coalition of Medicines Regulatory Authorities’ (ICMRA) pharmacovigilance working group’s “big data” sub-group has released a policy paper examining the opportunities and challenges for big data and analytics, within the context of pharmacovigilance and to facilitate international collaboration when feasible.

The sub-group, including experts from the European Medicines Agency, Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency, has held a series of meetings to develop the policy paper and an inventory of big data initiatives in pharmacovigilance, both of which have been endorsed by ICMRA.

“The spontaneous reporting systems (SRSs) described by sub-group members contain structured data in quantities that could reasonably be processed on a single machine,” the draft paper says.

But the paper also notes that the number of reports received cannot determine the incidence of a reaction “as neither the total number of reactions occurring in the population nor the number of patients exposed to a health product is known.”

In addition, the structured and unstructured data collected “often have limited patient information including medical histories, concomitant treatment(s), pre-existing conditions, time to onset, etc.” and there “is under-reporting of adverse reactions with both voluntary and mandatory surveillance systems, and reporting rates may vary widely for drugs as well as for jurisdictions.”

All members, according to the policy paper, also agreed to share more experience and knowledge in utilizing big data to further identify common challenges, in addition to gaps in regulatory harmonization and collaboration on using big data in pharmacovigilance.

The following recommendations were made from the sub-group members to the ICMRA Management Committee to promote additional collaboration:
  • “A standing working group should be formed to facilitate knowledge transfer between ICMRA members with respect to leveraging big data analytics for pharmacovigilance.
  • All ICMRA members should be invited to notify partners of on-going research initiatives and validation studies in using non-conventional data sources to complement existing pharmacovigilance activities, to minimize redundancy.
  • All ICMRA members should be invited to share the results of research initiatives and validation studies in using big data sources to complement existing pharmacovigilance activities, when they become available.
  • Best practices, including coding standards, for combining multiple sources of real-world data, including EHRs, EMRs and AHD with traditional SRS data, should be developed and shared.
  • Develop a common observational study protocol on a project of common interests for each member to conduct within their databases. Findings are then analyzed and shared within members.
  • Develop a meta-analysis study protocol with common data extraction procedure for each member’s databases.”
Pharmacovigilance Big Data Sub-WG: Policy Paper and Inventory


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