Firewalls and DMC Management
One of the critical steps in maintaining trial integrity with adaptive clinical trials is ensuring that information is only made available to the appropriate trial participants. Regulatory agencies have a key concern on the protection, security and safeguards against the introduction of operational bias in adaptive trials. The logistics of ensuring controlled and timely access to data at the interim analysis step gets more complex in adaptive trials. This may involve the randomization schema, statistical analysis as well as logistics around drug supply. In addition to the normal participants in a clinical trial, the addition of interim analyses involves the inclusion of other groups, such as the Data Monitoring Committee (DMC). Aptiv Solutions has adhered to the following principles when developing their integrated IT platform, SOPs and work processes for execution of adaptive trials:
- Ability to get clean data quickly under tight, well-defined deadlines
- Ability to undertake automated statistical analysis
- Control of communication flow — for example separation/independence of the DMC from general trial activities
- Transmission of the recommendations of the DMC in a way that does not disclose subsequent changes to other members of the clinical trial team or Principal Investigators
A key starting point in the deployment of effective firewalls is the development of, and adherence to, a defined set of standard operating procedures (SOPs). These SOPs govern workflow processes that control who sees what when, and ensure that the appropriate data is delivered to the appropriate set of trial participants.