Module 5 Presentations

19/07/2024

Case Study 1 (2)

• Te Genero: Northwick Park Trial – 8 healthy volunteers administered treatment at 20 minute intervals – 6 subjects (all who received IMP) suffered catastrophic cytokine release syndrome – Sponsor had only £2M insurance coverage and little capital – Claims brought against CRO in negligence

The Organisation for Professionals in Regulatory Affairs

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Case Study 2 (1)

• Davis v Jacobs - Trial subject had a macroprolactinoma for which he received standard treatment and then entered Phase III trial of new dopamine agonist - Subsequently convicted of criminal offences and his business became insolvent - Asserted he had developed hypomania and change in character as a result of IMP - Initially claimed under no fault compensation regime - Then brought Court proceedings in negligence against investigator and sponsor and in strict liability against sponsor

The Organisation for Professionals in Regulatory Affairs

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