Model agreements for contract commercial drug trials and medical device investigations in the NHS

1
Model agreements for contract commercial drug
trials and medical device investigations in the
NHS

• Dr Mark Lewis
• Clinical Research Management Consultant
• Commercial Research and Clinical Trials Advisor,
  DH

Mark Lewis Consulting
2
The original aspiration

• A model contract format for
• ALL commercial pharmaceutical trials
• sponsored by
• ALL pharma companies
• in
• ALL NHS Trusts
• that would be available off-the-shelf, with
  minimal need for trial-specific negotiation
• Became a key tool for addressing the UK trial
  performance issues identified by PICTF in 2001
• i.e. late starts and poor recruitment

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... has been extended to development of versions
of the format for

• CRO-managed pharma trials
• Medical device investigations
• CRO-managed medical device investigations
• Pharma trials in Primary Care
• IVD performance evaluations
• May 2009
• Q1 2010
• 2010

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What are contracts for?

• To meet governance requirements?
• Tools for managing risk
• Control trusts liabilities
• Protect trusts interests
• Protect patients interests
• To set out the responsibilities and obligations
  of the parties
• To guarantee trial registration
• To ensure trial outcomes are published
• To facilitate trial initiation

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Principles underlying use of the mCTAs and mCIAs

• The templates satisfy the contracting
  requirements of most pharma, medical technology
  and CRO companies and the NHS for most Contract
  Commercial Clinical Trials/Investigations
• A large majority of companies are committed to
  using the templates whenever possible and
  appropriate.
• Agreed guidance makes clear that when
  circumstances require it, the templates should be
  amended.
• The templates should not be used in situations
  for which they are not appropriate e.g. IITs and
  collaborative device developments

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Handling sponsors requests to modify the
templates

• (A valid reason for NHS bodies requiring changes
  has not yet been logged)
• 2 scenarios
• Requests made to CRNs
• Requests made to individual trusts
• 2 routes to resolution of issues
• Explain the logic of the model terms and agree
  to use the template without modification
• Devise (or agree to use) different terms to
  address justified deficiencies in standard terms
• Most issues can be handled without legal support
  (provided manager has authority...... )

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Common issues raised by Sponsors 1

• Inclusion of references to FDA Acts in governance
  clauses covering compliance with relevant laws
• Inclusion of wording covering compliance with
  requirements of U.S. Foreign Corrupt Practices
  Act 2007
• Inclusion of references to U.S. CFR 21 Part 11
  (electronic signatures)
• Modification of capping of liabilities (removal
  of, or symmetry in, cap)
• Issues related to debarment of clinicians
• Changes to parties required to be signatories
• Wording of insurance clause
• Objections to Compensation Guidelines/FoI

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Common issues raised by Sponsors 2

• Objections to FOIA terms
• Removal of references to Investigators
  obligations
• Changes to IPR terms
• Additional terms covering
• DP data transfer outside EEA
• Archiving of data
• Despite workshops, presentations and published
  Guidance, some companies need the agreements
  content explaining

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Support and assistance to NHS managers covering
issues of relevance to NHS trial sites in general
Contact
Mark.Lewis_at_MarkLewisConsulting.co.uk