Although the literature on the early stages of the pharmaceutical decision-making process is not extensive, there is some research that has characterized the process. We used this information to help define the components of the model. Some examples are the work performed at the Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership organization hosted by Duke University.4
Our literature search targeted several categories of literature: peer-reviewed articles in scientific journals, unpublished papers and presentations, white papers, gray literature, and news stories and occasional pieces appearing in newspapers and magazines or other print media outlets. Our search methodology featured systematic inquiries of the following databases:
- PubMed for peer-reviewed healthcare and biomedical journals;
- Lexis/Nexis academic for mass media and other periodical publications; and
- PAIS, Scopus, Web of Knowledge, and Embase for gray literature.
The search strategies differed for each category of literature and related database, but each query employed search terms in various combinations using logic strings, such as “clinical trial AND cost*,” “barrier* AND clinical trials,” “phase 1 clinical trial* AND cost*,”etc.
4 CTTI comprises more than 60 organizations from across the clinical trial enterprise. Members include representatives of government agencies (the FDA, Centers for Medicare and Medicaid Services, Office of Human Research Protections, National Institutes of Health (NIH), and other national and international governmental bodies), industry representatives (pharmaceutical, biotechnology, device, and clinical research organizations), patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties (Clinical Trials Transformation Initiative (CTTI), 2011).