PARAGON HELPS NHLBI MEASURE SCIENTIFIC RETURN ON INVESTMENT
The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung and blood diseases and enhance the health of all individuals so they can live longer and more fulfilling lives. NHLBI is the third largest of 27 institutes and has an annual budget of approximately $3 billion. NHLBI accomplishes its mission through internal research as well as funding of external research. Much of NHLBI's budget goes to funding external research by universities, non-profits, and private sector organizations that annually submit applications for funding.
Much of the grant money NHLBI uses to advance the state of life sciences in heart, lung and blood goes to clinical studies and trials with human subjects. These studies can be very large, complex and expensive. When they succeed, new drugs, devices and therapies are discovered that save lives, promote the health of U.S. citizens and fuel growth in healthcare industries. When they fail, millions of dollars can be spent with little scientific return on investment. Paragon arrived at NHLBI in 2008 to manage and staff the Institute's Software Engineering Branch (SEB). At that time, NHLBI did not have a central, enterprise registry of clinical studies. While individual grant awards are supported by an NIH-wide IT system, the clinical studies they fund were managed using spreadsheets, email and word processing documents. Scientific and medical program officers were challenged for time and accuracy whenever questions came down for profiles of the studies NHLBI funds, whether it be questions about how many studies involve statin therapies or how many studies involve children and asthma. More complex questions about study design, investigational drugs and devices, therapeutic interventions and disease conditions were impossible to answer accurately or in a timely manner. Other questions about study performance and return on scientific investment required massive efforts in manual research and inhibited the ability of the Institute to ensure that taxpayer funds were being put to the best use. Which studies were not accruing patients as they should in order to meet scientific objectives? Which studies were making progress in accordance with funding burn rates?
HOW PARAGON HELPED
Paragon's R&D engineering team quickly prototyped a tool (later named ClinPort) that enabled program officials to visualize patient accrual targets and performance gaps in a dashboard format and demonstrated an extremely powerful drill-down analytic tool for tagging and categorizing studies according to established medical terminology schemes, or ontologies, such as SNOMED, ICD-9 and others. Within a year, Paragon had built the Institute's first centralized registry of clinical studies and shortly thereafter integrated financial performance data to help the office of the director identify studies in jeopardy and control funding to ensure optimal return on the taxpayer investment. Paragon also established and managed the stakeholder governance for both the IT and the program side, earning accolades from key program executives. Paragon's professionals employed frequent prototyping and wireframes that kept committee members engaged in iterative requirements development and managed the meetings and associated working groups with efficiency and creativity.
TANGIBLE BUSINESS RESULTS
Thanks to Paragon's conception and development of ClinPort, NHLBI now can track and analyze studies for performance and manage them to better results. When better results are not in the offing, the Institute can terminate under- and non-performing studies to reclaim future funds for more fruitful investments. The Institute is also building a rich foundation of data about studies, performance and performance intervention. This business intelligence allows program scientists and officials to predict future results based on study design parameters, demographics and other variables. Paragon's work directly improves the future direction and shape of life sciences in heart, lung and blood for the nation and for the health and well-being of its citizens.