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Handling and Use of Information Received from Data Monitoring Committees: Points to Consider October 30th, 2007 Jon Haddad. Agenda. What types of recommendations can be received Appropriate internal recipients Is it ‘actionable’ Some examples for discussion. Types of Recommendations.

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Presentation Transcript
slide1

Handling and Use of Information Received from

Data Monitoring Committees:

Points to Consider

October 30th, 2007

Jon Haddad

agenda
Agenda
  • What types of recommendations can be received
  • Appropriate internal recipients
  • Is it ‘actionable’
  • Some examples for discussion
types of recommendations
Types of Recommendations
  • Continue without modification
  • Stop for safety concern
  • Stop the study for futility
  • Stop for success
  • Change sample size
  • Modify the trial
internal recipients
Internal Recipients
  • Evaluate potential impact (in advance!)
  • Look at your organization specifically (Wyeth and Synta are not the same)
    • Is there another geographic location/operating unit that is sufficiently removed
    • Is it realistic to expect recommendation to remain undisclosed
  • What is the ‘real’ need to know?
    • How does the Sponsor evaluate the recommendation
    • Is the recommendation automatic based on pre-defined/agreed criteria
    • Can one do anything with the information once it’s known
  • Remember, the goal of the DMC is to add independence to risk:benefit evaluation and to avoid comprising the study team with inappropriate information
internal recipients cont
Internal Recipients, cont.
  • Define internal procedures
    • What data will be made available
    • Who will have access to these data
    • What protections will be implemented to contain the information within the company
  • Data Flow and Release procedure
    • Covers internal and external release of the information
    • Some companies (e.g., Lilly) have entire departments for release of clinical trial information
    • Sarbanes/Oxley!
is it actionable
Is it ‘Actionable’?
  • Continue without modification
    • Is a press release necessary
    • Does it tell one anything? Anything ‘material’?

Check with your lawyers…

  • Stop the study
    • Do you have to accept a DMC recommendation
    • How do you know if the DMC recommendation is justified
    • Who will make this assessment
      • Steering Committee
      • Internal, non-project staff/committee
      • Independent agent for sponsor
      • Input from regulators

Check with your lawyers…

  • Continue with modifications
      • Assess impact
      • See above…
some examples for discussion
Some Examples for Discussion
  • Continue without modification
    • Will have to be disclosed to the operational study team
  • Modify sample size
    • Clearly gives some indication of how things are going
    • A precise number may be revealing too much
    • Pre-define incremental blocks (25-50; 51-100, etc)
  • Stop for efficacy
    • How in-depth is the sponsor’s review
    • How can this be done without team unblinding
    • If Sponsor decides to keep going, how to protect study from bias going forward
wrap up
Wrap up
  • Pre-Consider the potential recommendations that may be received
  • Decide and document a process for handling recommendations a priori
  • Take great care in protecting the study team from information that may introduce bias/appearance of bias
  • Consider carefully the appropriate way to communicate (or not) to the public domain