OTN Gambia 2008

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Talk a gave at Oxcford Tropical Network Meeting regarding OpenClinica

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OTN Gambia 2008

  1. 1. Prospects for and challenges of an open source clinical trials data management system<br />Greg Fegan<br />
  2. 2. Shameless plug of friends’ book<br />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 <br />Quoted in Data Management for Surveys & Trials By Steve Bennett, Mark Myatt, Damien Jolley & AndrzejRadalowicz , 2001 EpiData Association<br />
  3. 3. What is the need<br />Since WWII requirements for demonstrating the “correctness” of clinical trials data has increased <br />Guidelines have proliferated FDA + EU  ICH<br />Belief that as more burdensome requirements have become the norm the ability of non-industry led research has been diminished<br />“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.<br /><ul><li>Current bespoke CT software systems run to the tune of many tens of thousands of £
  4. 4. http://www.who.int/trialsearch 200+ in Africa & 500+ Asia</li></li></ul><li>Which maybe leads to this<br />
  5. 5. …whereas we are only after<br />
  6. 6. …but<br />Source: caBIG™ Primer: An Introduction to caBIG™, NCI-NIH December 2006 <br />
  7. 7. Haven’t we been here before?<br /> Worked on everything (including the Sony Playstation!)<br />but <br />Needed to be a somewhat expert visual basic programmer just to setup a study<br />No standard database behind it<br />Couldn’t get the data out<br />Technical support was somewhat lacking<br />Costly<br />
  8. 8. Borrowing Strength<br />Cancer in the US & caBIG<br />US$72B spent on cancer treatment in US pa<br />A long term NIH/NCI funded pilot from 2004-07 $20M pa<br />Pilot deemed “success”  Enterprise Phase<br />Similar ventures in “openness” have recently lead to changes that were unthinkable a few years ago<br />
  9. 9. caBIG™ Principles <br />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. <br />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. <br />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. <br />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. <br />
  10. 10. What kind of software is required<br />Standards based<br />Well known  many skilled practitioners available<br />Readily mastered and modified <br />Should run on any platform<br />Should be affordable for small groups in resource constrained countries<br />
  11. 11. Why an open source approach<br />Potential advantages of Open Source solution<br />Cheaper<br />More amenable to change<br />No vendor lock in<br />More able to be integrated with other systems<br />Likely to be well documented <br />Designed to be multilingual<br />Open source software works eg R, Apache, MySQL<br />Used by major IT players eg Google, HP & IBM<br />Has been argued provides better software <br />saved the Human Genome Project according to Lincoln Stein <br />
  12. 12. OpenClinica an Open Source Clinical Trials Management system<br />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<br />Developed using completely OS components <br />Notably<br /><ul><li>PostgresSQL database
  13. 13. Apache web server
  14. 14. Tomcat application server that runs J2EE applications</li></ul>These can be run on either Linux or Windows servers<br />FREE to download and use!!<br />Started in November 2005 and by the end of 2007 there had been over 8300 downloads with more than 2500 registered members<br />
  15. 15. Our experience so far with OpenClinica<br />A diploma level IT person was able to down load, install and setup the software<br />We invested in “free” software <br />Akaza delivered two week training and strategic consultation program (Cost ~ $25,000) <br />Kilifi data managers at AMANET workshop in Mali earlier this month introduced to OC<br />Have entered the data for one small safety study (n&lt;50)<br />
  16. 16. Challenges to meet<br />Are we ready for web apps in SSA?<br />No experience to date with the underlying source code<br />Develop expertise in the underlying package<br />Need Java programmer/s<br />Translate the interface into local language(s)<br />Get mentoring<br />Identify gaps in the system that make it less useful for tropical research work<br />How will we be able to fund this work<br />MCTA support for hardware + 2 people for 2 years <br />Wellcome Trust Project Grant to build a team to drive specific areas of further development<br />Apply for Google’s Summer of Code as openmrs.org have done<br />Partner with other groups in the region to subcontract work<br />
  17. 17. Thanks<br />
  18. 18. The Role of Akaza Research<br /><ul><li>Commercial Support and Services
  19. 19. Installation
  20. 20. Hosting & System Support
  21. 21. Training & User Support
  22. 22. Validation
  23. 23. Customization/consulting
  24. 24. Services to Partners
  25. 25. Certification
  26. 26. Licensing of materials
  27. 27. Use of infrastructure</li></ul>PartnerProgram<br />Support and Coordination of Community<br />Official distribution<br />User groups, Electronic mailing lists<br />Support wikis<br />(www.openclinica.org/dokuwiki)<br />Bug/issue tracking<br />Documentation<br />OpenClinica.org<br />

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