By Allison Proffitt

September 24, 2019 | “I think that the sponsors have neglected the impact of the site and have treated them just like paid help,” a very frank Steve Rosenberg told Clinical Research News. But Rosenberg is optimistic: “I think that’s beginning to change, because the site is becoming key. The relationship between the site and the patient is becoming key.”

Rosenberg, senior vice president and general manager for Oracle Health Sciences, was commenting on the latest research on clinical trial sites, a survey conducted by the Society for Clinical Research Sites and sponsored by Oracle: “Impact Assessment of eClinical Technologies and Industry Initiatives on Sites”. The survey results were released today and can be downloaded from Oracle. 

“I do think we’re starting to see a slight shift in the way sites are treated in this crazy ecosystem,” he said.

The research was conducted between April and June 2019 by SCRS via an online survey. The target population was clinical researchers working at investigative sites globally; 97% of respondents are currently active in clinical trials. The survey garnered 505 qualified respondents with 85% from North America and 15% from other countries.

Part of the survey used questions from a 2016 ACRP/CenterWatch Study to compare changes within the industry since 2016. Comparisons show a marked decrease in site satisfaction with the solutions available to them.

When asked how well software applications meet sites’ needs, 77% of 2016 respondents answered very well or somewhat well. This year, only 62% of respondents agreed that software applications met their needs well.

“The increase in negative sentiment is pretty substantial to be honest. I think it was a lot more than we were anticipating,” said Craig Morgan, Head of Marketing, Study Startup at Oracle Health Sciences.

Rosenberg and Morgan attribute this dissatisfaction to the increasing number duplicative work and the growing number of point solutions that sites must learn, log in to, and use. When asked to rank the biggest challenges to using software applications to conduct a clinical trial, 90% of respondents chose “too many systems with different processes and logins/credentials” and 74% chose “duplication of training each time a new study is started.” The third most chosen answer was “systems are incompatible, requiring duplicate data entry across systems.”

These redundancies were highlighted in the survey respondents’ priorities for future improvements to clinical trials as well. “A single point of data entry that flows through to all the necessary parts of the trial/eliminate repeated duplicate data entry” was the most requested improvement, followed by single sign-on, and the ability to “enter site specific information only once.”

Many systems come from many different sponsors and CROs, and Rosenberg was surprised by how many clinical trials each site does on an annual basis and how many different sponsors and CROs one site will work with. “That just makes the complexity of what they’re doing off the charts.”

Nearly all the sites surveyed—97%—are what Morgan calls “professional” sites, sites that participate in several studies per year and are very actively engaged in clinical trials. Those sites do have the most experience with the industry’s needs, but Morgan noted that the “one and done” sites—sites that don’t conduct more than one clinical trial—were not well represented. “We tried desperately to try to get as many sites to respond to the survey as possible,” Morgan said, acknowledging that these sites likely have insights not captured in this research.

But Morgan worried about deeper issues of dissatisfaction that could be plaguing sites. “It’s not just the increasing point solutions; it’s not just sites working with more sponsors. I do think some of the negativity, if you like, is also related to things that are changing in the industry. Maybe some of these industry initiatives haven’t really been working,” he said.

Trends Spotting

The SCRS survey expanded beyond the questions from the 2016 ACRP/CenterWatch Study to dig into these industry trends and initiatives. The survey asked sites about consolidated investigator platforms, site networks, and decentralized clinical trials.

Consolidated investigator platforms (CIP) fared somewhat badly, with only 17% of sites currently using such a platform and 70% responding that they had no plans to do so.

Respondents using a CIP reported actual advantages of increased efficiencies and reduced administrative burden beyond what they anticipated as the most important benefit. However, anticipated benefits associated with an increase in intra-company collaboration were not realized. They found the CIP easier to integrate with existing systems than they expected, but were most often surprised when the sponsor or CRO wouldn’t accept the CIP.

Site networks, on the other hand, have experienced substantial growth. Site network membership was tracked in the 2016 ACRP/CenterWatch Study. In 2016, only 17% of the surveyed sites were members of a site network. In 2019, that number had grown to 41% with another 7% interested or planning to join one. A vast majority of sites surveyed reported that membership in a site network improved access to clinical trials (97%) and the site’s exposure or profile as a valid trial site (86%).

Sites’ Takes on Decentralized Trials

To gauge sites’ reactions to new trial formats, sometimes called virtual or even siteless trials, SCRS wanted to start with a common definition for decentralized clinical trials.

“There’s a lot of press—almost daily—around the concept,” Morgan explained. “And I think there’s a lot of disagreement about what does it actually mean.”

The survey used the Avoca Quality Consortium definition: “Decentralized clinical trials (DCT) deploy a wide range of digital technologies to collect safety and efficacy data from study participants, normally from the comfort of the patients’ own home. The specific digital technologies used for data collection vary by study but can include telemedicine, wearable/sensor devices, eConsent, electronic clinical outcome assessments (eCOA), and electronic health (eHealth) records.”

The survey asked sites about their expectations for decentralized clinical trials, rather than actual experience. “There are very few sites that I know of that are actually engaging in decentralized clinical trials at the moment,” Morgan said. “I think everyone sees it as an opportunity to address not only patient enrollment, but patient retention issues and make clinical trials easier for patients to participate in, but they have concerns.”

Sites certainly agreed that there are challenges with patient enrollment and retention. Distance to a study site and the frequency of required visits was mentioned by all sites as an enrollment challenge. Nearly as universally mentioned, though, was an impression by patients that the benefit of a study doesn’t outweigh the standard of care. For retention, the top challenges were time spent participating in the study and time spent gathering and entering repetitive patient information.

Sites expected decentralized clinical trials to help improve patient participation and improve access to the right patients. Nearly two thirds of the sites—63%—also expected a decentralized model to reduce costs.

But there will also be many challenges, respondents expected. Sites expressed concern about the overall study data quality with a decentralized model, and 65% worried that the patient’s safety would be at risk with a decentralized model. Increasing complexity for sites and site staff was a concern, and more than a third of respondents worried that fewer sites or fewer study staff would be needed to run decentralized trials.

While conceding different types of trials could address decentralization different, Rosenberg at least partially allayed those fears.

“If you’re putting experimental medicine inside a human being, you’re going to have to have a site that’s responsible from a safety standpoint,” he said. “As long as patient safety is job one—which it is!—and trials are interventional and diseases are serious there will always be a responsible site.”