Lundbeck Pharmaceutical is finding a way to power its EDC systems with eSource data. As eSource data are saved or updated in the EDC system, the company creates a controlled PDF copy that is automatically stored in a trusted third party's secure facility. These controlled PDFs may be viewed—but not modified or overwritten—by both the sponsor and the site, and used to verify data integrity should the need arise. In this way, Lundbeck meets regulatory guidelines: It maintains immediate access to the data, yet there is still a separate source for verification.

Challenges Identified

Significant benefits can be accrued through collaboration by both the healthcare and research worlds in effectively and efficiently sharing data. Without such collaboration, as the use of EMR/EHRs grows, both the healthcare sector and biotech and pharmaceutical companies will be obliged to spend valuable resources on duplicate tasks. The challenge is to develop systems and processes that will allow for direct use of patient electronic medical data for both prospective and retrospective clinical research, in a way that meets data protection, and regulatory and ethical research requirements. In meeting this challenge, all stakeholders must focus their efforts on:

• creating, or adapting from existing clinical research systems, a mechanism for satisfying regulatory and clinical research requirements
• determining data standards for EDC, interpretation, and exchange that will meet the needs of both the medical and clinical research communities
• developing controlled, secure processes for releasing and transferring data from and to EHRs that are consistent with personal data privacy, clinical trial regulations, and bioethical considerations
• establishing a solution that would satisfy the needs of the research community without violating anti-kickback regulations (e.g., US Stark legislation) or having direct ties to specific biopharmaceutical manufacturers.

As the increasing number of recent initiatives demonstrates, the pharmaceutical industry has great interest in further exploring the potential of eSource for improving clinical trials. However, it is important that, as vendors, sponsors, and regulatory agencies work out the issues surrounding the use of eSource, the entire medical system work together to create data that can match the regulatory standards for clinical trials and the regulations for electronic health record systems.

This article is based on a white paper developed by the eClinical Forum and PhRMA EDC/eSource Taskforce. It has been presented at a few industry events, including DIA's Annual Meeting. For more information, including an extensive listing of citations and sources, visit http://www.eclinicalforum.com/