Note: This Interview may be conducted face-to-face or by telephone.
General Demographic and Background Information
I plan to gather much information on the key informants degree(s), roles, overall experience, etc. prior to the interview and simply ask them to confirm it. This will allow me to align each key informant with the appropriate stakeholder group (industry, regulatory, academia). This information will not be used to identify the informant in the dissertation paper. Such information will include:
a. Major roles in medical R&D (e.g. clinical researcher, “bench” scientist such as biochemist or molecular biologist, statistician, etc.)
b. Years of experience in drug discovery and development, medical diagnostic and/or device R&D
c. In what settings (e.g. academia, pharma, biotech, CRO, regulatory agency, insurance company)
d. Education and training (both degrees and field of study) e. Demographics (sex, age, race, etc.)
Introduction and Verbal Informed Consent
Note: Confirm that verbal informed consent is given prior to beginning interview and/or audio recording.
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I am Timothy King, a student in the Doctor of Public Health Program at UNC-Chapel Hill. The information I collect is for my dissertation research and is confidential. Within the dissertation you will not be identified (by name, title, or institution). Please let me know if we can begin the interview and whether I may record our conversation. [If Yes, then] Please let me know if you want me stop the recording at any point in our interview.
[If verbal consent granted, then]
Thank you for agreeing to participate in this interview to discuss innovations in pharmaceutical research and development (R&D), in particular the concept of open- science drug research and development (OSRD).
Interview Questions
1. Main Question: What are your thoughts on the current process for drug R&D in terms of quality and efficiency?
Potential Follow-up Questions:
Please describe your understanding or impressions on Open Science R&D approaches for orphan diseases and/or NTDs.
How do you define quality? Efficiency?
Prompt KIs to respond in terms of the various categories of issues -- e.g. scientific, regulatory, legal, policy, financial, operational, business development such as in- or out-licensing, etc.
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Now, in considering the hypothetical OSRD approach… (note: refer the key
informant to the brief OSRD description in Appendix 4 for the remaining questions as needed)
2. Main Question: Would OSRD, implemented more widely than just for orphan conditions/neglected tropical diseases, have a positive, negative, or neutral impact on the quality of clinical research design, conduct, analysis, and results overall?
Potential Follow-up Questions: How do you define quality?
Please elaborate on any impact on research design/conduct/analysis/ results. Prompt KIs to respond in terms of the various categories of issues -- e.g. scientific, regulatory, legal, policy, financial, operational, business development such as in- or out-licensing, etc.
3. Main Question: Would OSRD, implemented more widely than just for orphan conditions/neglected tropical diseases, have a positive, negative, or neutral impact on the efficiency (time and/or costs) of clinical R&D overall?
Potential Follow-up Questions: How do you define efficiency?
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Prompt KIs to respond in terms of the various categories of issues -- e.g. scientific, regulatory, legal, policy, financial, operational, business development such as in- or out-licensing, etc.
4. Main Question: What might a broadly adopted OSRD approach look like? Potential Follow-up Questions:
Are there components of the proposed OSRD approach with which you disagree? [Note Appendix 4 for types of information that might be shared]
If so, should they be deleted or modified? Please elaborate. Prompt in terms of discovery, pre-clinical and/or clinical information.
Are there components that should be added, that is, more kinds of information shared?
What about the timing of sharing information, such as on-going (“real time”), or waiting until certain conditions are met? If so, what conditions.
5. Main Question: What would be barriers to a broader implementation of an OSRD approach to more mainstream pharmaceutical R&D?
Potential Follow-up Questions:
Prompt KIs to respond in terms of the various categories of issues -- e.g. scientific, regulatory, legal, policy, financial, operational, business development such as in- or out-licensing, etc.
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6. Main Question: Discussions about OSRD are essentially about innovating and improving clinical research. Are there other and potentially better innovations that should be considered?
Potential Follow-up Questions:
Prompt KIs to respond in terms of the various categories of issues -- e.g. scientific, regulatory, legal, policy, financial, operational, business development such as in- or out-licensing, etc.
Note to Interviewer: Briefly ask the interviewee if there are any additions, deletions, or clarifying comments they wish to make. Time permitting, confirm your notes on each question to ensure you have correctly understood the interviewees comments.
Interview Conclusion
Thank you for your time today to discuss Open-Science R&D. This has been very helpful to me and my doctoral research. If you have any additional thoughts or
questions, please contact me. Also, may I contact you in the future if I have follow-up questions? [Note YES or NO]. Finally, if you are interested, I would be happy to share the results of my research when the final report has been approved and accepted by UNC (expected 2013). [Note YES or NO].
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