Some of the information needed to characterize the decision process of a drug sponsor came from semi-structured discussions with our team of experts and other industry experts, FDA personnel, drug sponsors, CROs, and primary clinical research centers, including University of Massachusetts, Johns Hopkins University, University of Michigan, and the Mayo Clinic.
As the decision process varies between pharmaceutical and biotechnology companies as well as small and large firms, we interviewed representatives from these sectors and company sizes. We limited the number of interviews involving the same set of questions to fewer than 10. In total, we interviewed representatives from four small pharmaceutical/biotechnology companies; two large pharmaceutical/biotechnology companies; two CROs; and three independent expert consultants in addition to our team of experts. The expertise of those interviewed covered a wide range of therapeutic areas, including arthritis/pain/inflammatory diseases, cardiology, gastroenterology, immunology, metabolic diseases, ophthalmology, oncology, and infectious diseases. Of the six pharmaceutical/biotechnology companies interviewed, three had only a single U.S. office, while the other three had offices in multiple countries, which, in combination, span six continents.
We first emailed potential participants a cover letter explaining the purpose of the study and encouraging participation in our interviews. Almost everyone contacted for the study agreed to be interviewed. Next, we scheduled interviews with those who responded and were willing to participate. Appendix A presents the protocol used in these interviews. In general, the questions asked in each interview were targeted to the background of the interviewee, but most interviewees were asked about all three topic areas (the clinical trials decision-making process, barriers, and costs).
From these interviews, we collected information about how sponsors make the decision to move forward with the development of a new drug, the significance (in the respondents’ opinion and experience) of various cost components and barriers mentioned in the literature, and the types of changes they would advocate to address what they perceive as the most problematic barriers to conducting clinical trials in the U.S. This information helped us refine our model and was also used to more fully characterize the barriers to clinical trials and develop a list of potential barrier mitigation strategies.
In addition to our interviews with industry representatives, we also spoke with individuals involved in CTTI and the MIT Center for Biomedical Innovation (as noted earlier; specifically, the New Drugs Development Paradigm project). These groups are working to enhance the drug development process through joint research with stakeholder groups in the public and private sectors.