Reassessing site engagement activities

Drug development sponsors and CROs increasingly recognize the impor­tance of investigative sites having a stronger, more respected voice in the clini­cal research community and have begun adopting initiatives designed to incorporate site viewpoints into improving clinical de­velopment processes. Leading players, under increasing pres­sure to streamline R&D operations, have created programs that actively include inves­tigators and site personnel early in the devel­opment process to solicit feedback on study design and execution. An increasing number of site networks and partnerships have also been formed that facilitate clear commu­nication about issues that contribute to site burdens and allow for greater collaboration in developing solutions.

The need for—and barriers to—adopting eSource

Electronic data collection responsibility borne by investigative sites to support each clinical trial is onerous, with little to no re­lief in sight. In many instances, these responsi­bilities are being managed at the same time that paper data collection processes are prevalent. Sites are inputting medical and medication information into electronic medical records (EMR), data into electronic data collection (EDC) systems, and site personnel are creating and completing study-specific source data doc­ument templates to capture case report form (CRF) and site activity and management data. According to a new 2017 CenterWatch study, conducted in partnership with Clini­cal Ink and the Society for Clinical Research Sites (SCRS), investigative site staff are jug­gling the use of disparate systems and they are spending an inordinate amount of time—an average of 19 hours per study—cre­ating source document templates typically in Microsoft Word, Excel or PDF format.

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