Use of Electronic Health Data in Clinical Development

In clinical research and development, the scientific possibilities for analyzing large volumes of data are still not used to the extent that it is possible in other sectors (e.g. finance, consumer behavior). Health data are often widely distributed and locked in individual databases, standards are highly inconsistent, and data privacy protection complicates data consolidation and data use. This results in complex clinical protocols with often unrealistic selection criteria, and trials are still too often assigned to inappropriate sites. Furthermore, patient recruitment continues to be one of the major problems in the execution of clinical trials. The use of electronic health data (real world data) allows alignment of protocols to actual medical conditions, formulation of realistic inclusion and exclusion criteria and testing their effects on recruitment using real data. In addition, trials can be assigned to sites that have a proven number of patients in their databases, and patients can be identified at the site. Various providers are players in the field of “big data” and it is not always easy to assess which system is best suited to meet the demands of clinical development. Therefore, a requirements specification is presented in the following.

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