By Benjamin Ross

October 11, 2017 | It must be survey season. Several clinical surveys have been released recently, all illuminating the clinical trial industry, especially as it applies to trial data. Independently-conducted surveys from Tufts Center for the Study of Drug Development in partnership with Veeva Systems, Research!America, and Insight Pharma Reports, a sister publishing arm to Clinical Informatics News, all asked experts ranging from CROs to sponsors, as well as voices from the general public, for insight into the problems and challenges facing the clinical trial field.

EDC Growing Pains

250 clinical trial managers were surveyed by Tufts and Veeva, revealing that while 100% of them use electronic data capture (EDC) systems to gather patient data for clinical trials, 77% of those surveyed reported challenges loading data into their EDC systems.

The EDC landscape, at least “web-based” EDC databases, began almost 20 years ago, Vice President of EDC at Veeva, Hugo Cervantes, told Clinical Informatics News. EDC has assisted those in the life sciences industry with various tasks including collecting data from patients in clinical trials, as well as storing that same data within the database. However, there have been challenges in those 20 years when it comes to adapting several types of data to the web-based database, such as lab data, patient diary data, medical imaging data, or whatever non-CRO clinical data there might be.

Cervantes pointed to outdated technology and practices for most of the issues regarding data capture. “These technologies were architected in the 90s,” he said, referring to EDCs. “And with that it’s pretty slow, it’s expensive, and it’s cumbersome to try to rebuild a [new database]… In general, there’s a lack of flexibility as well in the architecture and actual designs of these systems… Vendors should have the responsibility to make the technology flexible.”

“EDC has been widely adopted to accommodate the management of electronic clinical data, but this landscape is changing dramatically,” Ken Getz, Director of Sponsored Research Programs & Research Associate Professor at Tufts, told Clinical Informatics News in an email interview. “EDC systems have been handling increasingly complex global clinical trials requiring the collection and management of a very large volume of data. And data is coming from a wide variety of sources including not only case report forms, but also mobile devices, biomarker and genetic data, and social media. Our research is examining this changing landscape and the projected impact that this will have on data management practices.”

The Tufts/Veeva survey showed that protocol changes during a trial can impact a company’s EDC. In fact, the most common cause for database build delays is protocol changes (45%), followed by user acceptance testing (17%), and database design functionality (15%).

“At an individual sponsor, pharmaceutical company level… the clinical scientist or statistician may decide on some changes to the approach of which that study may be conducted,” Cervantes said. “And, therefore, they update the clinical protocol, which therefore has implications on how the data is collected and how the EDC system is designed and built. Those changes can happen very, very late in the game.”

Working Against The Clock

According to the results of the Veeva/Tufts survey, there is a time management issue as well. On average, it takes 68 days to build and release a study database, 8 days from patient visit to enter data in the EDC system throughout the study, and 36 days from the study’s last patient visit to database lock.

“What was a real surprise for us was that the upfront delay—when [CROs and sponsors] release the database after the patients are coming in and the data is being collected—[causes] significant downstream delays on the part of all of the other key data management entities,” Cervantes said. “Companies that are delivering their database late will see it be twice as long for the data to be collected, and 75% longer for the study database to be locked.”

Cervantes went on to say that delays in releasing EDC can also affect the time spent for analysis on the data collected, as well as delaying the release of drugs to market.

But the start-up delay wasn’t the same across the board. The survey showed that sponsors take about 40% longer than CROs to build their database (73 days for a sponsor vs. 53 days for a CRO). “CROs are so much quicker. They have focused on these activities and core constancies, and have refined their processes around the building and locking of the databases around the development of standards libraries. I think there’s a big opportunity there for sponsors as well to make sure they follow the best practices that we see CROs applying,” Cervantes said. “I think that gives us a lot of hope to the organizations that don’t use a CRO to build or manage their clinical database for EDC.”

Calling All Resources

The Tufts/Veeva survey wasn’t the only one to highlight the challenge of timing and study startup. According to the Insight Pharma Reports survey, 54% of CROs, sponsors, and Patient Recruitment Organizations  said that hitting recruitment deadlines was the major challenge in patient recruitment.

Getz diagnoses the fundamental cause of patient recruitment problems. “The underlying, root cause of patient recruitment and data management challenges is protocol design complexity,” Getz said. “As our studies have become more complex and demanding, patient recruitment and retention rates have gotten worse and the data management burden has increased substantially.”

Recruitment and retention rates are certainly low. According to Research!America, fewer than 10% of Americans participate in clinical trials.

Minority participant recruitment and retention was the focus of their most recent survey, which asked over 1,700 members of minority groups about their perception of the clinical trial space. The results showed trust in the clinical trials process has improved since the group’s 2013 survey. However, an overwhelming number of those asked said that a lack of information was still a major barrier to clinical trial participation. The majority of those asked also said that doctors and other healthcare providers have the greatest responsibility in educating the public about clinical trials.

Mobile Trends

The emergence of mobile technology in the past decade has also increased interest from both the public and the industry to use the technological boom properly. When asked by Insight Pharma Reports when they expected mobile technology to streamline trials globally, 38% of the CROs and sponsors surveyed said at least five years.

Security plays a key role in the advancing the use of mobile devices. In fact, security concerns are the largest hurdle to using mobile technology for the majority of Insight Pharma Report’s survey respondents (61%). Security is also a concern for the public, but the subjects of the Research!America survey were overwhelmingly enthusiastic about the idea of using apps, phones, and monitoring devices to share their data for clinical research. When asked if they would be willing to share their personal health information, 77% non-Hispanic white, 74% Hispanic, 71% Asian, and 70% African-American all said Yes.

Recent developments in security, such as the facial recognition capability of the new iPhone X, could be answers to the issue. However, time will tell if such innovations live up to their potential.

Data management systems are fragmented, Getz said. “The potential lies with solutions and approaches that integrate disparate systems and drive compatibility and interoperability.”