The latest issue of Applied Clinical Trials included an article with some interesting statistics regarding clinical trial sites (see ‘Characterizing the Real Cost of Site Regulatory Compliance’ by Kenneth A. Getz). The statistics quoted come from a survey conducted at the end of 2014 involving 164 U.S. sites. I found some of the data particularly pertinent in the context of the implementation of electronic trial master file technology (eTMFs) by clinical trial sponsors and the equivalent implementation at the investigator site (electronic investigator site files/eISFs).
80% of sites questioned reported storing their clinical and regulatory documents using a combination of paper and electronic formats, with only 25% storing in paper format only. Whilst some of those using electronic storage means may have their technology provided by the sponsors or a CRO (an eISF), I think it likely that the sites themselves have actually moved into the digital age and are managing their own records electronically. This is born out by comments I have received from trial monitors who report that many sites maintain much of their documentation at the site in electronic form. It is surprising therefore that clinical trial monitors are still going out to site and requesting hard-copy documents for filing in the sponsor TMF, sometimes requesting paper documents which are then scanned back at the sponsor site and converted to digital format…. when they could be made available electronically by the site. Old habits die hard! At pre-study visits, the sponsor should be asking the site what format their records are routinely held in and what is the feasibility of the site delivering documents such as CV’s, IRB/IEC approvals etc electronically rather than in hard-copy.
The survey also reported that at least 20% of physical office space is dedicated to storage of paper regulatory documents, including printouts of emails and their electronic attachments. With 44% reporting that they exchange information electronically with IRBs/IECs, it begs the question why sponsors are still asking sites to maintain ISFs in paper. Commercial sponsors are increasingly exchanging documents with the site via email and web portals but the regulatory site binders are still maintained as hard-copy files. And this has a financial impact on the site. The survey estimated that sites are being reimbursed less than 50% of the true cost of regulatory compliance activities, such as maintaining and archiving files in binders and storage boxes.
We can see a gradual emergence of eISF solutions but given the significant uptake in sponsor eTMF technology over the last 5 years – currently over 44% using an eTMF and a further 48% evaluating, planning for or actively implementing an eTMF – I think it is time for sponsors to “give the sites a break” and help facilitate a shift from an inefficient paper paradigm to an efficient digital one.