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.
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
- determining data standards for EDC, interpretation, and exchange that will meet the needs of both the medical and clinical
- 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.
The transition from disparate systems to a truly integrated EHR/CR environment is likely to be an evolutionary process that
occurs over a number of years. However, the good news is that regulatory agencies are showing interest in furthering eSource.
At the January 2006 meeting between the Division of Scientific Investigations and the PhRMA EDC/eSource Taskforce, DSI representatives
explored several pressing issues facing the development of eSource today—and expressed their belief that those discussions
needed to continue.
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