A Brief History & Look at the Future of Electronic Data Capture
The Clinical Trials Industry continues to look for opportunities to effectively and efficiently manage data collected in clinical trials to deliver meaningful treatments to those in need. Electronic Data Capture (EDC) has traveled a long road to acceptance within the pharmaceutical industry. As technology advanced rapidly over the past 3-+ years, the use of an EDC tool within the industry has lagged behind the innovation.
The use of paper-based data collection systems, while easy to learn and implement continue to have the same shortcomings:
Paper forms need to be developed and completed across countries and languages, which poses transcription and logistical problems
Legibility issues are noted
The time between the completion and review of the forms to the generation of queries (clarification/questions regarding the forms) are delayed, typically several weeks or even months
Multiple versions are made, thereby increasing the possibility for inconsistencies in the paper records
The study participant’s medical status is not transparent, or at best delayed
In order to address some of these shortcomings, the use of mainframe computers was introduced in the late 1970’s, particularly in the academic institutions equipped to conduct clinical trials. ‘Dumb terminals’ were placed near the clinical sites to allow for direct entry of data into the mainframes. This soon proved to be a very limiting methodology as well as a costly means to capture the data, and the process still relied on the more traditional paper-based approach to capture and handle the clinical data.
In the 1980’s and 1990’s, remote data entry (RDE) was introduced into the pharmaceutical industry. Personal computers were provisioned at clinical sites, thereby making them easier to scale and distribute when compared to the mainframe terminal configurations. Technology became more connected; a signal sent by telephone line made the transfer of data easier.
Floppy disks and a smaller hard diskette were developed and used to collect greater amounts of data which were easy to transport. RDE also allowed the doctor or clinical site staff to enter the data directly into the computer, eliminating the need for a third party to enter/transpose data from the paper forms. In doing so, the RDE computer programs could provide a first level of programmatic ‘checks’ on the data entered. For example, dates and range values could be flagged for verification before saving the data to the computer and either connecting the computer to the phone to transfer the data or write the data to a disk to send to the sponsor.
In the 1990’s, Electronic Data Capture (EDC) became the next generation of computer applications specifically designed to address the needs of the pharmaceutical, biotechnology, and medical device industries. Early adopters were sponsoring companies with IT departments who built their own applications. In the mid-to-late 1990’s, specialized vendors such as Fountayn began to introduce applications in what we know today as commercial-off-the-shelf (COTS) solutions.
Since the early 2000’s, there has been rapid improvement in the COTS applications available for companies to use when conducting clinical trials. These applications have grown to include aspects of the clinical trial that exceed just the collecting and handling of the clinical trial data. As there was a rapid growth in the number of EDC applications, the industry also noted there was a considerable amount of variability in how the data were defined, handled, and transferred from one site to another, and unless this was addressed, broad acceptance of EDC throughout the industry and by the regulatory agencies worldwide would be limited.
Clinical Data Interchange Standards Consortium (CDISC)
In the late 1990’s a consortium of industry companies collaborated and defined global standards aimed to streamline clinical research. The mission of CDISC is “to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.” (Cahill). Since its inception, CDISC and the standards that have been developed have gained broad acceptance throughout the industry and have provided a standard backbone upon which EDC has evolved. With the level of acceptance spanning industry and now regulatory agencies, CDISC standards have become accepted as the global standard for the development and implementation of not only EDC specific applications but of those applications having a broader and more holistic view of the eClinical environment, from trial planning to regulatory submission and beyond.
Current EDC Landscape
Today, many EDC applications approach clinical trials in a more holistic manner taking into account the broad ‘eClinical’ landscape. In defining ‘eClinical’ as encompassing the entire clinical process of data collection, not only the trial-specific patient data but that of third-party laboratory results, the use of coding systems, safety systems, and clinical trial management systems.
An estimated 70% of all active clinical trials are using EDC, in some fashion.
This indicates that the use of EDC has gained acceptance throughout the industry. Regulatory bodies, such as the FDA, have also embraced EDC via the use of the CDISC standard. Guidelines and laws, such as PUDFA IV Section 12 mandate that all new drug submissions will need to comply with CDISC standards by the year 2017, demonstrate how EDC has become engrained into the fabric of the drug development process and has replaced the paper process.
Regulatory agencies in the EU and Japan have also implemented very specific regulations and guidelines. For example, the Japanese FDA is considering the mandate that all data submitted for agency review to be in CDISC format by 2016. While this proposal is being seriously considered, it may not come to fruition; however, it does indicate that regulatory agencies worldwide are united in ensuring clinical data standards are uniform and universal.
In some areas of the world however EDC acceptance has lagged, particularly in China and India where their drug development industries are still in development. For example, in China most of the clinical trials are done using paper forms. The regulatory oversight in China is evolving rapidly and new guidelines on the use of data standards, such as those developed through the CDISC organization, are being defined. Soon, the landscape of vendors in China will begin to change as many small vendors who have not developed CFDA compliant EDC applications will be forced out of business and compliant applications will become prevalent.
Future of EDC
As we look to the future, EDC continues to evolve and grow in scope and breadth in terms of capabilities. The cornerstone of the eClinical industry, additional software solutions have developed to complement EDC, including CTMS, PRO, Imaging, and more. Technology, introduced to the clinical trials industry through EDC, has created more opportunities, and will require more standards to achieve the full potential of efficiency made possible by the evolution of technology.
With the growing use of electronic medical/health records (EMR’s or EHR’s), there will be the need to introduce standards similar to those defined by CDISC to assist in normalizing data structures and providing guidelines in the security of personal information. Additionally, as these standards are put into place, the quality standard of the data will also need to be defined and accepted throughout the various key users of these data. With the continued development of these standards, the use of EMR’s will be a significant growth area in the coming years.
The next evolution in EDC applications will leverage the expanding power of technology to ‘virtualize’ the clinical trial process. Some clinical trials might be able to be conducted with minimal visits to a doctor’s office or clinic and could potentially occur via real-time computer and video feeds. Studies that use direct entries of clinical data (eSource) are being conducted today and are another rapidly evolving segment of the industry.
Many of the successful companies that provide EDC applications to the industry struggle to move data into a single repository in order to facilitate the easy access of these data in the form of reports or computer searches for information. Those companies with unified clinical databases will have the advantage as there is no need to move or manipulate these data into a single repository. This advantage is also noted as a key feature by regulatory agencies in their ability to review new drug applications as approximately 45% of the time needed for a FDA review is wasted in moving data (taken from comments made by J. Woodcock CDISC Conference November 2012).
The EDC industry will continue to evolve, leveraging the expanding power of technology to manage global clinical trials and the related data in an effort to bring meaningful treatment to those that need it.
Cahill, Dan. “Survey Reveals Technology Gap in Managing Clinical Trial Documentation.” . PR Newswire, 09 Oct 2013. Web. 7 Apr 2014. <http://www.prnewswire.com/news-releases/survey-reveals-technology-gap-in-managing-clinical-trial-documentation-227049571.html>.
*Fountayn Formerly Known as Datatrak