Drafting And Negotiating Clinical Trials Agreements

Overview of the legal/policy landscape as it affects the terms of CTAs

• What is a clinical trial?
• EU regulatory framework: What are the key regulatory considerations relevant to conducting a clinical trial?
• Introduction to the parties to the CTA and key roles and responsibilities
• Policy issues in public hospitals, e.g. UK NHS approval
• Other ethical/legal issues
• Standard contracts, e.g. NHS standard CTA
• Implications of Brexit

CASE STUDY

Negotiating and drafting CTAs

• Overview of issues that frequently come up in the negotiation/drafting of CTAs
• Introduction to case study
• Discussion of case study
  • Definitions
  • Intellectual property and publication provisions
  • Use of data generated during the trial
  • Data protection, medical records, freedom of information, etc

CASE STUDY

Negotiating and drafting CTAs • Continued discussion of case study:

• Manufacture of the investigational medicinal product
• Warranties and indemnities
• Liabilities and insurance requirements
• Termination and its consequences

Additional considerations

• Introduction to differences between US, UK and Continental European legal systems and how they may affect contract drafting
• Unlicensed product vs off-label use
• First-in-man studies
• Investigator initiated studies
• Compliance and anti-corruption issues

PRACTICAL EXERCISE – Negotiation