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Handling and Use of Information Received from Data Monitoring Committees: Points to Consider

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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Handling and Use of Information Received from Data Monitoring Committees: Points to Consider

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  1. Handling and Use of Information Received from Data Monitoring Committees: Points to Consider October 30th, 2007 Jon Haddad

  2. Agenda • What types of recommendations can be received • Appropriate internal recipients • Is it ‘actionable’ • Some examples for discussion

  3. Types of Recommendations • Continue without modification • Stop for safety concern • Stop the study for futility • Stop for success • Change sample size • Modify the trial

  4. 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

  5. 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!

  6. 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…

  7. 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

  8. 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

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