A recent article titled, “Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?”, published in PLoS (Public Library of Science) proposes that “international health research organisations combine their efforts and spending power and assist with the development of systems that are open to all.” This is a bold statement with, in my opinion, solid rationale.
The authors, Greg W. Fegan and Trudie A. Lang, manage numerous clinical trials for the Kenya Medical Research Institute–Wellcome Trust Collaborative Research Programme in Kilifi, Kenya. Like many other research organizations in developing countries, their work largely focuses on finding treatments for “neglected diseases” such as malaria, hookworm, and encephalopathies. They clearly communicate the inability for proprietary eClinical software to be a widely useable solution in such settings due to costly and restrictive licensing.
However, Fegan and Lang define the appeal of open source as something greater than financial savings (although this is a strong motivation). In addition to freedom from license fees, open source clinical trial software built with open components and open standards is more “modifiable and amenable for use with existing software already employed.” Perhaps the most significant point made is that open source can be a more powerful way to promulgate standards and better leverage the collective efforts of disparate research institutions.
Indeed, the authors also point out that the impact of a well designed and supported open source eClinical system “can be beneficial to all clinical researchers” and urge “international health research organisations to combine their efforts and spending power and assist with the development of systems that are open to all and truly fit for purpose.”
The paper closes with the following call to action:
“Research organisations and funders should combine efforts to produce an open-source solution for trial data management. A shared platform could then be easily established, and would bring wider benefits such as electronic submission to regulators, automated sharing of data, and contribution to important public databases such as pharmacovigilance and drug-monitoring registries.
We believe that an open-source approach to a truly designed-for-purpose data-management system for clinical trials is attractive. Such a system would save money by eliminating the reliance on the use of expensive database software systems and their administrators. This would empower and enable a wider variety of people to conduct trials, as the question of capturing, cleaning, and extracting data would not be overly daunting or expensive. This point is significant, as it may encourage more investigators in resource-poor settings to take part in high-standard research that would otherwise be out of reach and beyond their capacity. Surely this would increase the scope and variety of trials that are conducted. Our hope for this article is that it will begin a debate on this topic, and lead to a concerted effort to lobby the international research and donor community to make sure this barrier to trial conduct is understood and addressed.”
I encourage you to read the full article online at the PLoS website.
Filed under: Industry Commentary Tagged: | clinical research, clinical software, clinical trial management, clinical trials, CTMS, eclinical, EDC, electronic data capture, encephalopathies, Greg Fegan, hookworm, international health, KEMRI, Kenya, malaria, neglected diseases, open source, PLoS, Public Library of Science, Trudie Lang, Wellcome Trust