At this year’s CNS Summit, held in Boca Raton, Florida November 1 – 4 2017, attendees participated in a panel discussion that considered the characteristics that investigator sites will have in the future. Many of the panelists contemplated the role that digital technology might have on the way that clinical trial sites will function. It is anticipated that electronic informed consent forms and electronic source documents will become increasingly commonplace in the coming years. It also is possible that these applications ultimately will integrate with electronic medical records at hospitals, clinics, and dedicated research facilities. It was noted that the drug development industry tends to be very conservative regarding the adoption of new methodologies, but in this case, the industry seems to be more than cautious; it is trailing behind other sectors that have fully embraced electronic documents.
Cost is one consideration with regard to the adoption of electronic source documents. These applications require the electronic infrastructure to support applications, and also potentially are associated with maintenance and validation fees. Additional expenses may come into play when investigator site staff require training to implement electronic applications. Another limiting factor relates to the need for backup systems when the primary electronic system fails. Some sites participating in the conference noted that they have lost subjects due to the failure of their electronic consent form applications. Not only does it become impossible to obtain informed consent, subjects who have reserved their time for participation are dissatisfied when they cannot proceed.
Despite the challenges implementing electronic source documentation in clinical trials, most conference attendees view their use as an inevitability. Not only will electronic source documents improve the completeness and accuracy of documentation, they will significantly raise efficiency by providing for the immediate review and monitoring of source data. This can reduce the overall amount of time that it takes to complete a clinical trial Without compromising quality. Bill Carson, President & CEO of Otsuka, envisions that electronic systems eventually will enable sponsors to collect large amounts of clinical data, using insurance company and other databases, so that they can test the efficacy and safety of drugs on a large-scale basis, reducing the need for smaller studies conducted at investigator sites.
According to Dr. Gary Zammit, President & CEO of Clinilabs Drug Development Corporation, “at this point in history, we expect to see acceleration in the adoption of technology in clinical trials. Once we reach the tipping point, the common use of paper source documents is likely to be displaced by the use of electronic source in just a few years.”