Harvard Medical School Center for AIDS Research

Client Situation

By 2004, the Harvard Medical School Center for AIDS Research (HMS CFAR) clinical research agenda had grown rapidly in scope, magnitude, and complexity.  However, each institution had varying levels of technical capability and used different methods of data collection, making collaboration an enormous challenge.  For example, one institution used the data field “M/F” to designate gender, while another used “0/1” for the same purpose.  Moreover, each institution used different measurements when collecting clinical research data, as well as nuanced query methods to find and retrieve information from their databases.   In light of these challenges, the HMS CFAR program needed an enterprise-wide IT solution that would provide a unified source of information, efficient collaboration, centralized database capability, and seamless data exchange between participating institutions. 

HMS CFAR enlisted Digital Infuzion to assess the current clinical environment, identify technical capabilities at the participating CFAR institutions, and determine the feasibility of a comprehensive IT solution. 

The Digital Infuzion Solution

Digital Infuzion began assessing HMS CFAR's clinical environment in March 2004 by scheduling intensive knowledge acquisition (KA) sessions with key staff members.  Focused on collecting information related to the HMS CFAR program’s specific goals, these KA sessions covered:

  • Complete mapping of data fields across the institutions under HMS CFAR

  • Establishment of corrective factors for data where sites use different measurements

  • Development and testing a set of common (“most frequently requested”) queries

  • Initiation of an ongoing quality assurance program

  • Efficient links to future CFAR specimen repositories

  • Future development of a central CFAR database

As a result of the investigation, Digital Infuzion learned that each institution’s varying technical capabilities and data collection methods revealed that collaboration was an enormous challenge. At the same time, the HMS CFAR institutions had a high level of collective IT preparedness, along with other capabilities that made a Harvard-wide Clinical Research Database a feasible solution. Ultimately, the following major factors contributed to Digital Infuzion's final assessment:

  • Database capability already existed at several of the HMS CFAR institutes, providing a foundation for further development
  • There existed a high degree of support for the Clinical Research Database amongst HMS stakeholders
  • Other clinical research institutes—such as NCI, NHLBI, and NIAID—had overcome similar challenges with an enterprise database solution

Digital Infuzion produced an in-depth Gap, Impact, and Sensitivity Analysis (GISA) report that detailed findings and recommendations.

Benefits 

  • Return on Investment
    • The GISA report not only carefully documented the current state of things, but also provided justifications for an institution-specific research database, recommended workflows, projected costs, and potential challenges. With this information, the HMS leadership could make informed, cost-effective choices regarding their approach to an integrated clinical IT system that would meet their specific needs.

Digital Infuzion's report did more than just focus on the problems of the present; it provided forward-looking strategic direction.  Specifically, for the next phase of the project, Digital Infuzion recommended that the HMS CFAR staff develop a set of critical success factors, clinical database specifications, data exchange guidelines, and a global library of common data elements on HIV, helping ensure a smoother transition into a large IT undertaking.