With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important. In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent statistical services, and ACES software.
Clinical Development Background
Our client was developing a product for an infectious disease. They planned a trial to assess the product’s efficacy and immunogenicity.
The trial involved a number of interim analyses, and so the project team needed to set up an Independent Data Monitoring Committee (IDMC). Our client was facing some patient recruitment challenges, leading to tight timelines.
Our client needed a team experienced with the full range of IDMC activities to provide a seamless solution. Cytel provided a service which included the selection of the IDMC members and their contract negotiation and management, together with Independent Statistical Center (ISC) activities.
The Independent Data Monitoring Committee activities included:
- Identifying suitable IDMC members including clinicians, epidemiologists, and statisticians;
- Conducting contract negotiation and management with the IDMC members;
- Organizing all the IDMC meetings including agendas, presentations and preparing meeting minutes;
- Reviewing the interim analysis Statistical Analysis Plan (SAP) which had been prepared by the sponsor;
- Writing the IDMC charter including the Table, Listing Figure (TLF) shells;
- Preparing the blinded and unblinded statistical analyses and DMC report, and
- Participating as non-voting members in the DMC open and closed sessions and presenting the results to the DMC members.
Cytel software underpinned the solution:
- The transfer of data was conducted securely through Cytel’s ACES software which is specifically designed to support the IDMC workflow.
- Cytel met all required timelines for the project and the client was delighted with the quality of work provided.
- Cytel’s software expertise brought added value to the project since ACES is specifically designed to support interim analyses.
- As a pioneer in adaptive designs, Cytel is a highly experienced advocate of interim analyses and IDMCs.
- Cytel maintains a strong knowledge of the global regulatory requirements for ISCs and IDMC charters.
- A multidisciplinary team was available including a Project Manager to coordinate the DMC selection and organization activities as well as the statistics and programming deliverables of the ISC.
- Cytel assigned a consistent team throughout the project to ensure knowledge retention and efficiency.
- Strong teamwork was established both within the Cytel functions and with the project management group at the sponsor.
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