Eight years after the introduction of the first eClinical technologies, many sponsors and CROs remain uncertain about their plans to adopt newer and less common technologies, while use of more established tools continues to grow.
More than a decade ago, Electronic Data Capture (EDC) created buzz among sponsors, CROs and software vendors, promising greater trial efficiency and an effective means for reporting results. Other technology solutions—including Clinical Trial Management Systems (CTMS), Randomization and Trial Supply Management (RTSM)/Interactive Response Technology (IRT), electronic Patient Reported Outcomes (ePRO) and electronic Clinical
Outcome Assessment (eCOA)—further promise more efficient and accurate approaches than paper reporting methods.
A closer look at usage and adoption rates in 2014—eight years later—shows while usage and awareness of these more established eClinical technologies are growing, the newer tools available—including Regulatory Information Management (RIM) Systems, patient engagement tools, patient portals and Structured
Content Management (SCM)—are the least commonly used.
That’s the finding of a new survey from the Tufts Center for the Study of Drug Development (CSDD) that examined the perceptions of eClinical awareness and usage by sponsors, CROs and vendors.
“Biopharma and CRO respondents reflect a high degree of uncertainty about current and planned usage for specific tools,” concluded the study, which surveyed 296 respondents from sponsors, 146 from CROs and 73 from vendors. Participants primarily included managers, project managers, directors, associate directors, senior managers and programmers.
The survey showed a higher rate of eClinical tool usage among biopharma companies than at CROs. Among users of portals, investigative sites had higher usage than CROs.
Tufts also examined data from actual clinical trials conducted by the same sponsors and CROs as were surveyed to measure actual eClinical usage.
Data from 52 completed trials and 75 active trials found greater usage of EDC and eTMF tools in active studies than in completed ones, 98% v. 78% for EDC and 62% v. 39% for eTMF. But for CTMS and RTSM eClinical solutions, the anlaysis found higher usage among the completed trials than the active ones, 74% v. 47% for CTMS, and 51% v. 47% for RTSM use.
In the survey, barriers to adopting eClinical solutions were primarily cost-related. Asked about specific barriers aside from cost, the most commonly cited by sponsors, CROs and vendors (for clients) were:
● Complexity of adopting new systems
● Current systems and processes working adequately
● Insufficient time to investigate available tools
● Having to maintain old systems in addition to new systems
● Problems arising due to data migration
● Problems associated with retiring older systems.
“We looked at active studies and found that aside from using more data standards today, eSource is not as widely used, because of the challenges addressing the barriers to adoption,” said Mary Jo Lamberti, senior research fellow at Tufts CSDD and study leader. “Beyond costs, there are concerns about adopting new systems and investing in training and teaching to learn eClinical tools and how to use them.”
Varied adoption rates
The survey also revealed a relatively low level of eSourced data collected by sites for sponsors and CROs. Sponsors said just 26% of sites collected eSourced data, while CROs surveyed said 18% of sites used eSourced data. One third of respondents overall said they were unsure about whether data collected was eSourced by sites in their organizations’ studies.
The Tufts CSDD study found wide variation in the use of ePRO. While the survey showed it was widely known among respondents, usage depended on each company’s portfolio and the specific trials that were conducive to subjective patient reported outcomes.
Phil Lee, president of PHT, a provider of ePRO diaries for clinical trials, explained, “Unlike EDC, which is an enterprise solution used all the time, ePRO is based on individual studies, so it is a different adoption model.”
“We find acceptance of ePRO soaring,” added Lee, who said electronic data arrives at its final destination much more quickly and clean than paper recorded data. “We see ePRO adoption rate at 40% to 50%. Rarely do sponsors and CROs go back to using paper documents after they worked with ePRO technology.”
Major eClinical tools such as eTMF, CTMS and RTSM were used most widely in phase III studies. In 20 phase III studies analyzed by Tufts, EDC use was 100% and RTSM was used by 90%, followed by eTMF usage at 75% and CTMS at 70%.
Looking at just EDC usage by therapeutic area, analysis of active studies showed 100% usage across Oncology, Metabolics/Endocrine, CNS/Neuroscience and Hematology trials.
“We asked survey participants if recent adoption of eClinical by the FDA to rely more on eSourced data instead of paper changes their plans for using eClinical trial tools—33% of respondents said no,” said Lamberti.
She said survey responses showed some participants, based on their job functions, had more experience with eClinical technologies than others, the survey did not break out responses to specific questions by user level.
For Jules Mitchel, founder and CEO of Target Health, a New York City-based CRO, the acceptance of EDC and eSourced documents is a money saver. However, he said, some companies try to keep using the same familiar processes rather than accept and adopt innovative changes. Target has developed its own eClinical software with applications for its sites. “We found that with 25 sites, we had nearly a 100% adoption rate with eSourcing, and only one that stuck with paper record-keeping,” said Mitchell. “Sites say they can handle twice as many patients using eSourced software, and the cost savings can be as high as $10,000 per year.”
Another factor holding back broad adoption of eClinical solutions is the training required to use the different tools and the management of multiple passwords, said Kristen Snipes, project director at Rho, a CRO in Chapel Hill, N.C., which currently is considering an eTMF system.
“Some barriers besides cost are the time and the processing of revisions to move from paper-based to an electronic system, as there is a shift in accountability, training and education that needs to occur,” said Snipes.
Some eClinical technology tools, notably RTSM, which uses telephone and web technology to manage the complex randomization and dispensing of trial supplies, are more specialized. RTSM is designed to replace low-cost manual systems. “If there is no strong driver to use RTSM, the costs outweigh the benefits,” said Fiona Geiger, senior director of global project management at Cenduit, an RTSM developer. “But if the sponsor has some very expensive drugs that are in short supply with limited shelf life and handling, the company will spend the money to gain the benefits.”
Looking ahead The bigger concern for the coming years is the huge volume of data that will be generated for each trial participant, and how sponsors will manage and warehouse the voluminous amount of information. Genomics alone will play a big part in understanding and segmenting patient populations.
“Data from lab tests, diaries, genomics, passive devices and other sources are continuing to increase and must be collected and analyzed, so the challenges in dealing with those data are vast,” said Steve Rosenberg, senior vice president and general manager at Oracle Health Sciences. “That is on top of the widespread use of electronic medical records which, under the Affordable Care Act, has accelerated. The problems ahead include understanding the source of data and the strength of data, to where the issue is less about collection and more about understanding the quality of the information in clinical research.”
The Tufts survey asked software vendors what impact external forces would have on the future of eClinical innovation. Of 34 responses, 65% said they would become “end-to-end” clinical managers, including creating “global libraries” and master data repositories. Only 35% of vendors said they would increase the type of data collected directly by patients, such as through devices and wearables such as Fitbit and LifeShirt. And 47% of vendors said they would who embrace the trend toward “bring your own device,” which involves study participants collecting data using apps downloaded to their personal tablets or smartphones, rather than the sponsor providing hardware or devices.
“When you have a disruptive innovation such as eSourcing in clinical trials, it’s time to reevaluate and try not to fit old processes into the new solutions,” said Mitchell of Target Health. “The biggest challenge is to avoid continuing with existing workflows, so trash what you are doing and reassess.”
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This article was reprinted from Volume 22, Issue 02, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>