Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

INTRODUCTION: The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. MATERIALS AND METHODS: A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. RESULTS: Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. CONCLUSIONS: The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond.

Internet in clinical research based on a pilot experience.

Computing has become an integral part of many disciplines nowadays, turning it into an evermore necessary working tool. Internet provides a fast and easy way to collect scientific data and is becoming a more and more effective and safe way to transmit data. It is also an efficient means for interaction and information sharing within a work group that provides the necessary flexibility. A pilot project was conducted replacing the traditional hardcopy version of the case report form for an electronic one (e-CRF) and with access to Internet within the Naturalistic Randomized Clinical Trial of the Effectiveness of Olanzapine and Risperidone in the Treatment of Schizophrenia. Carrying out this pilot project has given us the opportunity to determine the advantages electronic data collection (EDC) by Internet has to offer both researchers and sponsors. The results have optimized time management, since it is easier to work in real time; data quality is improved, since intermediates are eliminated, and it facilitates communication amongst the different parties involved in the project. The use of this technology requires updated Internet connections and adequate personal computers, since the possibilities offered by the computer system and high-speed connection are critical in conducting the project. Obviously, this may involve a higher initial investment, but the results have revealed to us that these start-up costs are later offset by lowering personnel costs or by decreasing the number of monitoring visits. On the basis of our experience and that of the participating investigators, certain recommendations for future clinical trials using e-CRF can be made. We will go into these recommendations in greater depth throughout this paper. In short, EDC can dramatically improve the clinical trial process, opening the door to new technologies in the world of clinical research, not only for sponsors, but also for clinicians.