By Clinical Informatics News Staff

October 23, 2015 | A DrugDev survey reveals surprises in technology uptake for clinical trials sites, particularly in terms of which technologies are available and about which solutions investigators are most hopeful.

“We were hearing so much in the news and the clinical trial media about innovations in technology and cross-company collaborations—lots of new companies with an awful lot of very innovative stuff. But a lingering concern from my conversation with investigators was, ‘Are sites ready for this?’” explained Claire Sears, director of investigator engagement for DrugDev.

In order to gauge that, DrugDev collected surveys from 572 clinical trial investigators from nine countries in its investigator network from mid-February to mid-April this year. Investigators were asked about their trial experience, therapeutic areas, their access to technology, and the types of technology they believe will be most helpful in the future.

To be sure, DrugDev was in some ways polling the choir; members of the DrugDev Network already clearly value technologies that facilitate clinical trials.  But members of the network are varied and the findings are still informative.

The finding that Sears found most surprising was that 85% of respondents listed a desktop computer as one of the primary devices provided to collect clinical trial data. Respondents could check all that applied, and a laptop was the next most common device at 38%. For as many new mobile and tablet technologies we’ve seen in the past year, only 23% of those surveyed said that their primary device for data collection was a tablet or mobile devices. (Of that 23%, it was almost evenly split between Apple and Android platforms: 12% vs 11%.)

The survey also rated which technologies would be most impactful in the future by asking respondents which they believed were very or extremely likely to become gold standards in the industry within three years, and which technologies would be likely reduce investigators’ administrative burden.

The top answer to both questions was the same: e-signature on clinical trial documents. 70% of respondents called it a likely gold standard and 69% believed it was extremely or very likely to decrease investigator burden. When the respondents were separated by experience—investigators who had completed less than five studies compared with investigators who had completed five or more studies—e-signature was the only technology deemed more likely to become a gold standard by the senior researchers.

Beyond the clear frontrunner, responses were mixed. Technologies that more than half of the respondents viewed as likely to become a gold standard in the next three years included EMR to recruit patient (64%), trial data source records from EMR (57%), paperless clinical trials (56%) and risk based monitoring (53%).

Most the same list was viewed as extremely or very likely to decrease investigator burden by more than half of the survey takers, with the notable exception of risk-based monitoring. The top technologies to decrease investigator burden were e-signatures (69%), paperless trials (64%), e-source (58%), EMR recruiting (57%) and electronic drug adherence solutions (53%).

Sears was particularly surprised by the low rating for risk based monitoring and in-home biometric monitoring.

“A lot of sponsors and collaborations are putting significant time and effort into those, but less than 50% of sites are thinking that risk-based monitoring or in home patient biometric monitoring is likely to decrease investigator burden,” Sears said. “It really gave us the message that there’s still quite a bit of work to do there. One, to persuade sites that these technologies are going to improve things for them, and two in demonstrating that the actual technologies work well enough for the sites to have confidence in them.”

The burden of winning over investigators lies with sponsors and CROs, Sears said.

“If sponsors and CROs don’t appreciate that they need to invest in training investigators and sites, then adoption and use of these technologies will suffer,” she said. “But equally if they do go the route of proactively providing education and training, then access to the technology becomes another way of encouraging investigators to participate in trials.”

For risk-based monitoring in particular, Sears said more education is needed to reassure investigators that the method won’t result in lost relationships and can be done well.

The findings that Sears was most pleased about were those related to electronic medical records. Using EMR to recruit patients and using EMR data for trials both ranked in the top four technologies likely to become gold standards and to decrease investigator burden.

Use is still fragmented: 67% of US respondents reported using an EMR at the site while only 21% of South African respondents did. But interest is high; more than 69% of respondents agreed that they would be extremely or very interested in using EMR to identify potential patients, cross check eligibility, populate case report forms, and other activities.   

“What was heartening there, I think—and this underlines the fact that if you can get the technology right, investigators and sites are enthusiastic and want to embrace new technologies—was the significant amount of interest that was displayed in the survey for using EMR to support a number of different clinical trial activities,” Sears said. “Investigators can really see the value in using EMR to help with patient recruitment. They really are interested and enthusiastic about using technology in trials as long as it’s introduced correctly and with the requisite amount of support.”