To set the stage for a column on paperless clinical trials, I’d like to relay a recent conversation with a PI in the U.K. working on a trial sponsored by a major pharmaceutical company.
“Our training for the study involves a presentation that is emailed to the site, and a link to a dummy website where we practice entering adverse incidents. Once we’ve completed the training, site personnel must print off questions and circle the correct answers. Next, they must scan and email the questions to the trial coordinators, after which those coordinators add the person to a paper delegation log. The time involved in this is insane—with multiple people printing, completing and signing the forms; scanning and sending them; and signing the log. We are all practicing clinicians and these activities take us away from patient care. Having this process completed electronically would streamline the process considerably and improve recruitment. Unfortunately, this amount of legwork and paperwork involved can put people off taking part in research.”
Clearly this is an extreme example, but we’ve all seen articles making a strong case for paperless clinical trials, each citing gains in productivity, efficiency and cost savings. If there is a broad agreement on the benefits of paperless trials, then to quote my kids on a long journey (read with whining voice in your head): “Where are we?”, “Are we there yet?” and, of course, “When will we get there?”
Results from the 2017 DrugDev Investigator Survey show that only 8% of sites are paperless across all clinical trials, while 60% are not paperless on any study (n=466 in 13 countries). This represents a similar, possibly marginally improved, experience compared to 2016: 4% use on all studies and 65% of sites have no experience in paperless trials. Based on this data, it appears that the answer to the “Are we there yet?” on paperless clinical trials is still a disappointing “Not yet.”
So what’s slowing the industry down? Data suggests that access to necessary hardware isn’t the limiting factor—83% of sites report that all staff have access to a computer for clinical data collection; for 13% of sites there is access for some staff; and in only 4% of cases no staff have access (DrugDev Investigator Survey 2017).
Site comfort with electronic communications doesn’t seem to be the issue either, as sites are predominantly using email to communicate about clinical trials. In the DrugDev 2016 survey, we asked sites how they preferred to be contacted about clinical trial opportunities; 88% of sites stated to contact them via email, with only 3% requesting contact via fax.
It’s also not about access to wireless technology. In the 2015 DrugDev Investigator Survey, 92% of sites said their staff had access to wifi/internet at their site, and that this extended to the rooms where patient exams were conducted in 83% of cases.
Although technology doesn’t appear to be a contributing factor (wifi, hardware and email all appear to be acceptable to 90% of sites), one possible challenge to the increased prevalence of paperless clinical trials is perceived regulatory challenges. For example, there are a few countries that appear to demand paper signatures, which is unfortunate because the majority of those in the industry recognize that paperless clinical trials will pave the way to a more consistent and streamlined processes, which in turn should have a positive impact on quality and patient safety. Definitely the 10% exception rather than the majority rule.
If the 90% majority of sites appear to have no technology or regulatory barriers to implementing a paperless clinical trial, then, as my children so eloquently put it, “Why aren’t we there yet?” (Again channel your inner whiny voice.) Could it be that sponsors and CROs are still being driven by a single, standard process for the entire study population that drags the site experience down to the 10% minority?
We’re certainly not advising to exclude sites that still need to use paper. We recognize technology or regulatory barriers exist in a small number of countries. Rather, we are asking if the industry is at least ready to give up the fax as a means of communication and use email, or even better, electronic document exchange and eSignatures as offered by online portals and electronic trial applications. In essence, we’ll “be there” when we can ease the “paper pain” of people like my PI friend in the U.K. and stop putting researchers off from taking part in research.
Elisa Cascade is an expert in clinical trial innovation and technology with over 25 years of industry experience. She leads DrugDev’s Data Solutions business working with sponsors, CROs, and sites to improve clinical trial operations through standardization, industry-wide collaboration (including TransCelerate’s Investigator Registry and Investigator Databank), and a beautiful technology experience. Email firstname.lastname@example.org or tweet DrugDev at @drugdevinc.
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