The history of EDC

ElectronicDataCapture

Electronic data capture (EDC) is a system that helps collect and manage clinical data widely used by leading corporations in large-scale and complicated studies. The benefits that EDC offer are recognized by global pharmaceutical companies like GSK, MSD, Novartis,… Only made its appearance over three decades ago, yet EDC with outstanding features have allowed high cost and time efficiency in clinical data management as well as the whole clinical trial process.

The 70s, 80s, and 90s

Back in the days, data collection and management is done by traditional methods with tons of paperwork (which is still utilized by about 30% of trials these days). Though easily navigated and applied, this method retains quite a few cons such as taking forever to resolve a query, having too many versions that cause inconsistent dataset or failing to clarify subjects’ medical statuses.

In an attempt to tackle those disadvantages, in the 1970s, mainframes were introduced and applied to clinical trials in research institutes by one clinical research organization (CRO) called the Institute for Biological Research and Development (IBRD). Dr. Richard Nichol and Dr. Joe Bollert signed a contract to provide IBRD network for pharmaceutical company Abbott: Each clinical investigator had a computer and directly keyed in data into the mainframe, after which IBRD would clean the data and submit reports to Abbott. After a while, users realized that this was a fairly limited and costly method since the majority of the process was dependent on using paper for data entry and data management.

Moving on to the 80s and 90s, remote data entry (RDE) debuted in the pharmaceutical industry. Personal computers were provided to sites, which made expanding and distributing easier compared with mainframes. Users made use of floppy disks and hard drives to collect a large data volume, making way for smoother data transference.

RDE allowed doctors and site staff direct data entry into computers, diminishing the role of third-party in data entry from paper forms. At the same time, RDE offered primary data verification program. For example, the range values and dates would be flagged for approval before data were stored and computers were connected to phones to transfer or record data onto the disks for sponsors.

EDC was invented and became the next generation computer application specially designed to cater for the demands of pharmaceutical, biotechnological and medical device industries. From the middle towards the end of the 1990s, technological companies started to introduce applications now known as commercial off-the-shelves (COTS).

Present and future EDC

In the beginning of the 2000s, there was a rapid improvement in applying COTS in clinical trials. While EDC gained more popularity, this industry also recorded a diverse change in identifying, managing and transferring data from one site to another.

EDC constantly evolved ever since the RDC revolution with the latest technologies. There appeared more and more service providers on the market with already existed or newly invented software, including vendors with customizable services in accordance with requests from customers and trial phases. The EDC do-it-yourself (DIY) solution are being developed by various companies, allowing users to set up eCRF on their own. This feature brings in a lot of critical benefits for users such as:

  • Saving time: Normally, it takes an EDC provider weeks, even months of preparation before the actual studies, while this process can be cut short if the company designs the CRF by itself.
  • Saving money: The cost of self-building is much lower than depending on the vendors.
  • Gaining more flexibility
  • Having more easily monitored procedure.

About 70% of currently conducted research are using EDC. Regulatory agencies such as FDA have also acknowledged EDC through the standards of CDISC. In the future, EDC will continue to flourish in terms of quality as well as scalability. Other eClinical tools that complement EDC such as ePRO, CTMS, and IVRS will be more diverse. Technologies in clinical trials are to bring more breakthroughs to this industry.