Getting Closer to Source Data

As one stands in the booth hall of any conference on clinical trials, one will see an array of different technology vendors all looking to fill a space in the technology front of clinical research. Though the proposed new developments are not necessarily aimed to fill the same void, there is one specific area which seems to be getting more attention than others, eSource. After many years, the clinical trial environment is moving towards a hand-held device solution to capture patient data rather than paper sources, which we have been relying upon for so many years. We are already familiar with the benefits of eCOA (electronic Clinical Outcome Assessment), specifically ePRO (electronic Patient Reported Outcome) devices in collecting data directly from our patients. These include, but not limited to, better participant compliance and engagement, increased data quality and shorter periods needed for closing the database. However, obvious benefits in electronically capturing source data (for CRF entry) are becoming more predominant. There are indeed different ways to go about this, most enticing is an approach where the “EDC” platform is replaced by an eSource data capturing platform. Of course one could go the route of capturing data on an eSource platform and then integrate them with an EDC platform, however, the relative costs of 2 database builds and maintenance, along with the maintenance of 2 data platforms from the site perspective, does bring this solution into question.

Then, there is the thought of using applications to link/integrate EMRs (already being used by the sites for daily activity) to EDC systems. This would definitely be more resourceful, since sites would already be familiar with EMRs, however they still might be left with 2 systems to maintain (eSource/EMR and EDC). No matter which option is chosen, it is clear that adopting this approach will entail an overhaul in data collection approach for both, sites and companies. The initial concern, when choosing the new approach, should, by no doubt, address the convenience for the site. What will they use effectively? Are they willing to forgo their comfortable paper source system, and brave eSource capture? Is it at all possible to link their EMR with an EDC platform? It goes without saying that without site (and all site staff including investigators) buy-in, the use of the chosen data collection platform would be impossible.

Other issues, equally important, have to do with the procedural novelty and data access. Implementing new ways of collecting highly sensitive personal information is expected to face more restricted demands on privacy, data transfer and security. Way should be found to ensure the best possible protection (Vogel, Combs and Kessel, Frontiers in Oncology, 2017). Additionally, everybody involved, including participants, medical staff and principal investigators should be educated on the new approach with all its relevant specifics. It is clear, however, that while there are certain barriers, especially the data privacy laws, the advantages outweigh the limitations.