Legal Aspects of Clinical Trials

1
Legal Aspects of Clinical Trials

• Shekhar Potkar
• Director Clinical Research
• Pfizer Limited

2
Why is law necessary in clinical research?
3
Jesse Gelsinger vs University of Penn

• OTC deficiency
• Gene therapy experiment with Adenovirus vector
• No direct benefit, minimal risks, benefit to
  others
• Conducted by Dr Wilson, IHGT at University of
  Penn sponsored by Genovo
• Died of jaundice, kidney failure, lung failure,
  brain death
• Alan Milstein sued the University, Dr Wilson and
  Genovo
• Risks not explained, negligence, conflicts of
  interests of Dr Wilson with Genovo
• 10 million in settlement

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Why Law in Clinical Research?

• Risk management perspective
• Stakeholders interests perspective

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Agenda

• Legal agreements
• Legal implications

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Agreements
7
Elements of a Contract

• Parties
• Offer
• Consideration
• Acceptance
• Remedy

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Major Agreements

• Non Disclosure Agreement
• Investigator undertaking/agreement
• Clinical trial agreement
• Indemnity and insurance
• Services contract

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Non Disclosure Agreement

• PI and Sponsor
• Protection of proprietary information
• Binding on site staff
• Site responsibility

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Investigator Agreement

• Undertaking by a PI to the regulatory agency
• Compliance to GCP and applicable laws
• Legal sanctions in case of violations

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Clinical Trial Agreement

• Bipartite or tripartite
• Nature of work responsibilities and compliance
• Consideration
• Milestones
• Issue resolution

• Publication
• Right to publish
• Data access
• Opportunity to review
• Multi center studies
• Intellectual property
• Sponsor
• Data protection
• Trial related injury

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Indemnity/Insurance

• Indemnity
• Investigator, other staff and institute
• Exceptions -Noncompliance/ Misconduct/ negligence
• Role of a CRO
• Clinical trial insurance

13
Services Agreement

• CROs, Labs, SMOs
• Bipartite
• Nature of services e.g. monitoring, lab analysis,
  site management
• Terms
• Consideration
• Remedies

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Legal Implications
15
Informed consent

• Autonomy
• Valid consent informed, competent (capacity),
  voluntary
• Competence - Understanding, reasoning, values
• Incompetence - Best interests, proxy, substituted
  judgement, advance directives
• Consent form as mechanism and evidence
• Battery versus Negligence - e.g. partial
  colectomy

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Confidentiality

• Fiduciary role
• Patient autonomy
• Implied promise
• Virtue ethics
• Consequentialism
• Balancing of public interests
• HIPAA covered entities should use PHI for TPO
  only, consent necessary for any other use

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Conflict of interests

• Therapeutic misconception
• Financial conflicts
• Disclosure

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Conclusions
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Conclusions

• Ethics and law for human subject protection
• Legal framework for commercial aspects for
  research

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Role of Ethics committee

• Check risk management framework
• Informed consent process,
• Patient confidentiality
• Conflict of interest
• Financial aspects including trial related injury
• Publication policy