Silicon Valley BioTalks – Paper Trials vs. EDC Solutions

29 January, 2015, by ClinCaptureTeam

ClinCapture hosted the 10^th session of Silicon Valley BioTalks on “Paper Trials vs. EDC Solutions – Benefits, Challenges, and Best Practices” on Wednesday, February 25^th at the HP headquarters in Palo Alto, CA. The panel was composed of life science industry leaders including Esmeralda Sanjust, Sr. Director of Clinical Affairs at Elixir Medical Corporation and Ana Puildo Ferrer, CEO at Digitaliza TXT, a leading technology provider for CROs in Latin America. The panel will be moderated by Marc Desgrousilliers, CTO of ClinCapture . The event will include a networking session to facilitate discussions amongst attendees on the latest trends surrounding the clinical trials industry. Our panelists will discuss the benefits and challenges of paper trails and EDC systems, latest industry trends, items to consider before selecting the appropriate EDC solution, and best practice to implement a successful transition from paper-based trials to EDC.

Abstract:

Since its beginnings in the 1990’s, Electronic Data Capture (EDC) solutions have been well adopted and the advantages of EDC are recognized throughout the industry. However, according to Applied Clinical Trials, the leading clinical trials online source, only half of all new FDA-regulated clinical trials are captured using EDC, leaving 50% of the market relying on paper. Non-FDA trials increase the percentage of using paper-based clinical trials to nearly 80%.

In paper-based clinical trials, data entry is a time consuming and error-prone process, clinical data can be manipulated or altered, and monitoring remains a cumbersome process. The printing and logistics of paper forms also present hidden time and cost burdens that increase with study size. As an example, Novartis reported a cost of $17 million by needing to print CRFs on NCR paper for 400 clinical trials. Other challenges include data quality, data readability for analysis, and regulatory compliance.

On the other hand, the benefits of EDC solutions are well known across the board, including improved data quality, faster data entry, and an overall 30% reduction in clinical development duration. In a case study led by Applied Clinical Trials comparing a paper query management system with an EDC solution using edit checks, a 65% reduction in the number of queries was detected. Single data entry, remote monitoring, and reduction in the number of queries each save a considerable amount of time. In addition, with EDC software, forms are safely stored and backed-up in a cloud-hosted system allowing users to remotely access a fully searchable central location from anywhere. EDC adoption also leads to fewer site visits, shorter patient recruitment time, reduction or elimination of printing cost and faster data entry resulting in significant reduction in cost.

Despite the tangible benefits of Electronic Data Capture, the adoption of EDC has remained to a surprising 50% due to the complexity and time of EDC implementation. The upfront cost of EDC is also a major deterrent to its adoption, especially for preclinical, non-drug or Phase I trials with lower budgets. Switching from paper to EDC also implies structural changes – It alters the way study and forms used to be designed, changes the skillset needed to run clinical trials, and requires a learning curve to the new technology. In recent years several technologies have been developed that address these challenges. Latest solutions empower users by offering a combination of low cost, ease of use and fast adoption. Our panelists will share their experience with both paper-based and electronics clinical trials, they will discuss benefits and challenges of each, and share best practices for a successful implementation.