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OTN Gambia 2008
 

OTN Gambia 2008

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Talk a gave at Oxcford Tropical Network Meeting regarding OpenClinica

Talk a gave at Oxcford Tropical Network Meeting regarding OpenClinica

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    OTN Gambia 2008 OTN Gambia 2008 Presentation Transcript

    • Prospects for and challenges of an open source clinical trials data management system
      Greg Fegan
    • Shameless plug of friends’ book
      Coding 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 need
      Since WWII requirements for demonstrating the “correctness” of clinical trials data has increased
      Guidelines have proliferated FDA + EU  ICH
      Belief 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+ Asia
    • Which maybe leads to this
    • …whereas we are only after
    • …but
      Source: 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 study
      No standard database behind it
      Couldn’t get the data out
      Technical support was somewhat lacking
      Costly
    • Borrowing Strength
      Cancer in the US & caBIG
      US$72B spent on cancer treatment in US pa
      A long term NIH/NCI funded pilot from 2004-07 $20M pa
      Pilot deemed “success”  Enterprise Phase
      Similar 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 required
      Standards based
      Well known  many skilled practitioners available
      Readily mastered and modified
      Should run on any platform
      Should be affordable for small groups in resource constrained countries
    • Why an open source approach
      Potential advantages of Open Source solution
      Cheaper
      More amenable to change
      No vendor lock in
      More able to be integrated with other systems
      Likely to be well documented
      Designed to be multilingual
      Open source software works eg R, Apache, MySQL
      Used by major IT players eg Google, HP & IBM
      Has been argued provides better software
      saved the Human Genome Project according to Lincoln Stein
    • OpenClinica an Open Source Clinical Trials Management system
      Spawned by the caBIG pilot  Akaza Research a company that in addition to being the driving force behind the OC community offers additional fee based support
      Developed using completely OS components
      Notably
      • PostgresSQL database
      • Apache web server
      • Tomcat application server that runs J2EE applications
      These can be run on either Linux or Windows servers
      FREE 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 OpenClinica
      A diploma level IT person was able to down load, install and setup the software
      We 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 OC
      Have entered the data for one small safety study (n<50)
    • Challenges to meet
      Are we ready for web apps in SSA?
      No experience to date with the underlying source code
      Develop expertise in the underlying package
      Need Java programmer/s
      Translate the interface into local language(s)
      Get mentoring
      Identify gaps in the system that make it less useful for tropical research work
      How will we be able to fund this work
      MCTA support for hardware + 2 people for 2 years
      Wellcome Trust Project Grant to build a team to drive specific areas of further development
      Apply for Google’s Summer of Code as openmrs.org have done
      Partner with other groups in the region to subcontract work
    • Thanks
    • The Role of Akaza Research
      • Commercial Support and Services
      • Installation
      • Hosting & System Support
      • Training & User Support
      • Validation
      • Customization/consulting
      • Services to Partners
      • Certification
      • Licensing of materials
      • Use of infrastructure
      PartnerProgram
      Support and Coordination of Community
      Official distribution
      User groups, Electronic mailing lists
      Support wikis
      (www.openclinica.org/dokuwiki)
      Bug/issue tracking
      Documentation
      OpenClinica.org