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A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.
The taskforce considered six subgroups of data sources (genomics, bioanalytical ‘omics, clinical trials, observational data, spontaneous adverse drug reactions data, and social media) to determine the use and benefit of these data to assess the benefits and risks of medications. Each subgroup provided recommendations on priorities and future actions for evaluation and use of data.
“The overarching conclusion is clear: much may be gained from the rational use of Big Data in a regulatory context for approval and monitoring of efficacy/effectiveness and safety of medicines, medical devices, and combinations thereof. Indeed, many future activities necessary for regulatory progress will not be possible without the use of Big Data technologies. AI [artificial intelligence] technologies offer particularly promising advances in these fields. It is however clear that without a systematic, coordinated and integrated European approach many of these advantages may not be gained,” the report states.
The taskforce includes drug regulators from 14 national competent authorities and EMA. Comments on the report by stakeholders and the public are being accepted until April 15, 2019.