Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally not. Key considerations include the complexities of handling publication rights, the impact of tax-exempt municipal bonds on project restrictions, ensuring equal patient treatment, the reality of universities generating revenue from intellectual property, the distinct goals of principal investigators versus institutions, and the necessity of a comprehensive congruence review among documents related to clinical trial agreements.
Points discussed:
1. What are the 6 big areas that large academic medical institutions tend to think about that sponsors or smaller hospitals/private institutions may not be thinking about in the context of clinical trial negotiations? - 2:29- 4:55
2. Are tax-exempt municipal bonds a factor in clinical trial negotiations? 4:58- 12:03
3. What is the impact of the Bayh-Dole Act on publication rights? 12: 04- 13:40
4. Why do we not discuss confidentiality as much as we talk about publication rights?- 13:41- 21:26
5. Should sponsors have the right to be present during an FDA audit in a large medical center?- 21:27- 24:19
6. Should sponsors have a right to review and change a proposed audit in the case of a larger academic medical center? Check out our latest podcast episode to find out. 24:20- 26:20
7. 6 different types of clinical trial transparency. - 26:21- 29:30
Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship.
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