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Prospects for and challenges of an open source clinical trials data management systemGreg Fegan

Shameless plug of friends’ bookCoding and data entry are the Cinderellas of survey method, attracting little academic interest or concern compared with sampling, interviewing and tests of significance. Anne Cartwright A & Clive Seale, The Natural History of a Survey, 1990 Quoted in Data Management for Surveys & Trials By Steve Bennett, Mark Myatt, Damien Jolley & AndrzejRadalowicz , 2001 EpiData Association

What is the needSince WWII requirements for demonstrating the “correctness” of clinical trials data has increased Guidelines have proliferated FDA + EU  ICHBelief that as more burdensome requirements have become the norm the ability of non-industry led research has been diminished“Academic clinical research in cancer seems to have no future in Europe” BMJ 2006;332:501–2 indeed some have stated that GCP is barely a “bronze standard” that occurred partly because of an industry dominated “informal consensus” that “academic researchers… did not participate in…” Lancet 2005;366:172-4.Current bespoke CT software systems run to the tune of many tens of thousands of £

http://www.who.int/trialsearch 200+ in Africa & 500+ AsiaWhich maybe leads to this

…butSource: caBIG™ Primer: An Introduction to caBIG™, NCI-NIH December 2006

Haven’t we been here before? Worked on everything (including the Sony Playstation!)but Needed to be a somewhat expert visual basic programmer just to setup a studyNo standard database behind itCouldn’t get the data outTechnical support was somewhat lackingCostly

Borrowing StrengthCancer in the US & caBIGUS$72B spent on cancer treatment in US paA long term NIH/NCI funded pilot from 2004-07 $20M paPilot deemed “success”  Enterprise PhaseSimilar ventures in “openness” have recently lead to changes that were unthinkable a few years ago

caBIG™ Principles Open Access: Participation in caBIG™ and the products delivered by caBIG™ are open to all, enabling access to tools, data, and infrastructure by the cancer and greater biomedical research community. Open Development: Software development projects are assigned to particular participants, but are carried out iteratively with multiple opportunities for review, comment, further modification and development. Open Source: The software code underlying caBIG™ tools is available to software developers for use and modification. Software funded through caBIG™ is licensed as open source to promote the reuse of existing code, hence optimizing the full benefit of the research dollars spent. However, the open source license is industry-friendly, fostering industry interest and innovation, while still adhering to the principle of open source for caBIG™-funded activities. Federation: caBIG™ software and standards enable local organizations, such as cancer centers, to share computing or data resources with the larger cancer care and research community, and to use resources contributed by others. Within the grid, these resources can be aggregated from multiple sites to appear as an integrated research tool set or large database, while the individual resources remain under the control of the local organizations. This strategy of organizing and providing distributed access to locally-managed tools and data is referred to as “federation” and represents an alternative to centralized large-scale repositories and systems.

What kind of software is requiredStandards basedWell known  many skilled practitioners availableReadily mastered and modified Should run on any platformShould be affordable for small groups in resource constrained countries

Why an open source approachPotential advantages of Open Source solutionCheaperMore amenable to changeNo vendor lock inMore able to be integrated with other systemsLikely to be well documented Designed to be multilingualOpen source software works eg R, Apache, MySQLUsed by major IT players eg Google, HP & IBMHas been argued provides better software saved the Human Genome Project according to Lincoln Stein

OpenClinica an Open Source Clinical Trials Management systemSpawned by the caBIG pilot  Akaza Research a company that in addition to being the driving force behind the OC community offers additional fee based supportDeveloped using completely OS components NotablyPostgresSQL database

Tomcat application server that runs J2EE applicationsThese can be run on either Linux or Windows serversFREE to download and use!!Started in November 2005 and by the end of 2007 there had been over 8300 downloads with more than 2500 registered members

Our experience so far with OpenClinicaA diploma level IT person was able to down load, install and setup the softwareWe invested in “free” software Akaza delivered two week training and strategic consultation program (Cost ~ $25,000) Kilifi data managers at AMANET workshop in Mali earlier this month introduced to OCHave entered the data for one small safety study (n<50)

Challenges to meetAre we ready for web apps in SSA?No experience to date with the underlying source codeDevelop expertise in the underlying packageNeed Java programmer/sTranslate the interface into local language(s)Get mentoringIdentify gaps in the system that make it less useful for tropical research workHow will we be able to fund this workMCTA support for hardware + 2 people for 2 years Wellcome Trust Project Grant to build a team to drive specific areas of further developmentApply for Google’s Summer of Code as openmrs.org have donePartner with other groups in the region to subcontract work

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OTN Gambia 2008

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OTN Gambia 2008