The HMS CFAR’s clinical research agenda had grown in scope, magnitude, and complexity while, at the same time, institutions involved with the Center had varying levels of technical capability and different ways of collecting and organizing data. Collaboration was 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 retrieve information from their databases. The HMS CFAR needed an enterprise-wide IT solution that would provide a unified source of information, efficient collaboration, centralized database capability, and seamless data exchange.
Our task was to assess the current clinical environment, identify technical capabilities at participating CFAR institutions, and determine the feasibility of a comprehensive IT solution. We began by conducting intensive knowledge acquisition (KA) sessions with key staff.
In KA sessions our multidisciplinary teams addressed:
- 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.
KA sessions confirmed collaboration challenges and key reasons to move forward with an enterprise solution—HMS CFAR institutions had high levels of IT preparedness, database capability already existed at several institutes, and HMS stakeholders broadly supported the idea.
We produced an in-depth Gap, Impact, and Sensitivity Analysis (GISA) report that detailed findings and recommendations.
The GISA report not only carefully documented the current state of things, but also provided other benefits including:
- Helping HMS leadership make informed, cost-effective choices regarding their approach to an integrated clinical IT system by detailing justifications for an institution-specific research database and recommending workflows, projecting costs, and flagging potential challenges.
- Providing strategic direction. For example, we 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, to help smooth their transition into a large IT undertaking.