Cost-Benefit Assessment of the Electronic Health Records for Clinical Research (EHR4CR) European Project

The EHR4CR 4-year research partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) has developed a platform for the trustworthy reuse of hospital electronic health records’ data for clinical research. A cost-benefit assessment (CBA) was conducted from the pharmaceutical industry perspective to assess the value of the first two EHR4CR clinical research scenarios (S): Protocol feasibility assessment (S1), and Patient identification and recruitment (S2), either used individually or sequentially within a clinical trial workflow, versus current practices. The EFPIA partners have conducted a resource utilization assessment to calculate the actual person-time and cost of performing S1 and S2 for one oncology clinical study (Phase II or Phase III) as reference case. Assuming that an estimated 50% reduction in actual person-time and cost under EHR4CR conditions would directly translate in accelerated time to market (TTM), potential benefits to global pharmaceutical industry were derived using global market values (2012) of oncology products1. Absolute cost-benefit analyses were conducted using Monte-Carlo simulations. Compared to current practices, individual EHR4CR scenarios S1 and S2 have yielded efficiency gains of 134 days and 37 days respectively, and of 171 days when used sequentially. Should these efficiency gains from study design optimisation translate in faster TTM, corresponding estimated benefits for the global pharmaceutical oncology franchise could reach 160,45, and 205 Million €, respectively. This CBA is the first to assess the value of EHR4CR scenarios for oncology clinical trials. The results confirm that the EHR4CR platform could generate substantial added value for pharmaceutical industry should its efficiency gains translate in faster TTM. Further benefits are expected from the EHR4CR platform in other therapeutic areas.