Much has been written about the escalating costs, slowing cycle times, and long time-to-publication for clinical trials. Despite significant effort to harmonize regulations, develop sophisticated data systems and rethink outmoded practices, transformation in clinical research has been much slower than in other industries.
The first off-the-shelf electronic data capture (EDC) systems emerged in the late 1990’s. Despite demonstrated tangible benefits , it took more than 10 years before EDC was widely adopted in the pharmaceutical industry; adoption in academic trials has been even slower. On the site startup side, some 30% of pharmaceutical and medical device companies, as reported in a 2013 NextDocs survey, were still using paper-based files and only 24% were using a dedicated electronic trial master file (eTMF) system. Adoption of centralized (risk-based) monitoring, adaptive designs and similar business and technological innovations has also been painfully slow.
Certainly, a number of factors come into play, but a core obstacle may be that, by definition, clinical trials involve large numbers of people — and people (or their institutions!) can be highly resistant to change. In an informal 2009 clinical site survey by ClinPage, 26% of 629 respondents, 71% being study coordinators, said EDC data were being initially entered from a paper CRF rather than direct data collection. This is surprisingly worse than the 21% in their earlier 2001 survey. Whether this reflects human cultural hesitation, growing institutional fears (over HIPPA, European Data Directive, etc.), or just the ever increasing complexity of studies, much of the value of an EDC system is lost if its implementation does little more than transfer the task of entering intermediary paper case forms (“data collection worksheets”) from the sponsor to the investigator.
BIOS’ experience with the MISTIE clinical development program is a good example of how transformational technology and business process change can reduce time and cost while improving quality. But, more importantly, it serves as an example of how innovation, to be successful, must be implemented in the context of a well-designed plan executed by a skill project management team.