In 2013, the FDA released its final guidance on the use of Electronic Source Data in clinical investigations. In short, the premise of the guidance is that capturing clinical data digitally is better for all parties involved in the research activities. The industry is, and has been for some time, well aware of the benefits of capturing data digitally; eliminating data duplication, reducing transcription errors from handwritten forms, timely reporting, real-time reviews, and improved data accuracy. So what does the FDA guidance provide that isn’t already widely acknowledged?
The FDA’s guidance provides the industry with direction on how to collect digital data in a way that ensures regulatory compliance, implementation of and adherence to best practices, and a degree of integration among systems and with the agency. Unlike paper source documents, electronic data can be easily transformed or moved without any obvious audit trail.
The FDA’s guidance instructs companies on how to use electronic case report forms (eCRF), medical images, lab reports, diaries, EHR/EMR records, electronic trial master files (eTMF), and other data while “ensuring reliability, quality, integrity, and traceability.”
Within the same guidance, the FDA noted that the industry has been slow to adopt electronic source data. The guidance had an express purpose to encourage and promote adoption of electronic source technologies. The clinical trials landscape has changed little since the FDA’s guidance was issued. However, the technology to support the adoption and integration of electronic source data has improved dramatically. Those researchers that are adopting integrated data approaches for their research activities are seeing tremendous benefits. But the challenge has changed from capturing electronic source data to integrating it.
Same Problem, Different Medium
Having moved to capturing source data through digital technologies, many researchers are now facing an issue similar to that which they faced when using paper forms: how to reliably and efficiently get data from once system to another. Many of the same problems that afflicted paper-based processes are still evident when data is captured digitally.
EHR and EMR systems, EDC process, clinical trials management systems, and many other supporting technologies all utilise a common subset of data regarding a patient or subject and his or her medical records. The majority of these systems operate independently from each other. Each of the developers of these systems has uniquely defined requirements for capturing, storing, and using data. In these environments, data duplication issues arise when data needs to be copied from one application to another.
Many of these applications have rudimentary export/import functionality which makes the process of getting data from one application to another difficult and error-prone. Some have such limited functionality that research managers often find it less time-consuming to print a report and have the data entered manually into another system. They’ve now come full circle from the “paper process days”, having nullified many of the gains made in capturing data digitally, most often out of necessity rather than preference because of the limitations of the systems in use.
Achieving the FDA’s Data Integration Vision
To achieve the full advantage of electronic data requires clinical trials research components to share data between among themselves without the need for cumbersome processes or for manually re-entering data that already exists. Too many software vendors, however, are more interested in constraining clients by limiting their ability to share data rather than by developing better functionality. Up until recently, the best solutions for automating data integration involved costly technology projects that were either outsourced to systems integrators or consumed much of the internal IT team’s time.
As more standards emerge and as the FDA continues to push clinical researchers to use electronic data, solutions are emerging from software vendors (including Adaptive Clinical Systems) that remove the burden of costly integration projects. Despite not being a highly visible element among the application components that are comprised by a clinical trials research system, these products nonetheless are a key component in achieving true data integration and systems interoperability. Furthermore, their inclusion in such a technology platform can have tremendous benefits that can’t be achieved otherwise. Our clients have seen these benefits which included:
- 100% elimination of data reentry errors
- 70% reuse of all design content, regardless of the EDC
- 68% reduction in study setup time
- 55% reduction in data management, data transformation, and data aggregation
- 43% reduction in time spend verifying source data
- 27% reduction in resources
Improving the quality and speed of clinical trials can be accomplished in much less time and at much less cost than you might think, especially if the right components are selected and integrated effectively. Clinical trials technology solutions providers like Adaptive Clinical Systems that can demonstrate their commitment and adherence to the evolving FDA guidelines will help ensure your studies remain in compliance. Moreover, those studies will reap the benefits of time and cost savings arising from solid, error-free data integration.