Conceptual framework for outcomes research studies of hepatitis C: an analytical review

Urbano Sbarigia,1 Tom R Denee,1 Norris G Turner,2 George J Wan,3 Alan Morrison,4 Anna S Kaufman,4 Gary Rice,5 Geoffrey M Dusheiko6,7 1Janssen Pharmaceutica, Beerse, Belgium; 2Johnson & Johnson Health Care Systems, Inc., Titusville, NJ, 3Mallinckrodt Pharmaceuticals, St. Louis, MO, USA; 4ScribCo, Effort, PA, USA, 5Diplomat Specialty Pharmacy, Flint, MI, USA, 6The University College London Medical Institute for Liver and Digestive Health, London, UK; 7Kings College Hospital, London, UK Abstract: Hepatitis C virus infection is one of the main causes of chronic liver disease worldwide. Until recently, the standard antiviral regimen for hepatitis C was a combination of an interferon derivative and ribavirin, but a plethora of new antiviral drugs is becoming available. While these new drugs have shown great efficacy in clinical trials, observational studies are needed to determine their effectiveness in clinical practice. Previous observational studies have shown that multiple factors, besides the drug regimen, affect patient outcomes in clinical practice. Here, we provide an analytical review of published outcomes studies of the management of hepatitis C virus infection. A conceptual framework defines the relationships between four categories of variables: health care system structure, patient characteristics, process-of-care, and patient outcomes. This framework can provide a starting point for outcomes studies addressing the use and effectiveness of new antiviral drug treatments. Keywords: chronic hepatitis C, humans, treatment outcome, combination drug therapy, antiviral agent

Reflections on the Future of Pharmaceutical Public-Private Partnerships : From Input to Impact

Public Private Partnerships (PPPs) are multiple stakeholder partnerships designed to improve research efficacy. We focus on PPPs in the biomedical/pharmaceutical field, which emerged as a logical result of the open innovation model. Originally, a typical PPP was based on an academic and an industrial pillar, with governmental or other third party funding as an incentive. Over time, other players joined in, often health foundations, patient organizations, and regulatory scientists. This review discusses reasons for initiating a PPP, focusing on precompetitive research. It looks at typical expectations and challenges when starting such an endeavor, the characteristics of PPPs, and approaches to assessing the success of the concept. Finally, four case studies are presented, of PPPs differing in size, geographical spread, and research focus