Background

An Independent Data Monitoring Committee (IDMC) reviews the accumulating data of an ongoing trial and monitors patient safety and treatment efficacy data. IDMCs are particularly crucial in situations where there are severe risks to patients and in studies with hospitalised populations. 

In this project, Veramed worked with a client developing a new therapeutic for COVID-19. In this novel disease area, an IDMC is crucial to serve the best interests of the patient.  As we have previously discussed, clinical trials in this space are particularly challenging due to the lack of prior knowledge, the fast-moving nature of development and the extreme time pressure experienced by investigators within the hospital environment.  We were contracted by our client to support the trial by providing statistical analysis centre services to inform the Data Monitoring Committee’s decision making.

Challenges

The project involved aggressive timelines, and the first IDMC was scheduled within three weeks of the first patient first visit.

The Veramed team worked intensively to prepare the charters, communication plan and data workflows in record time. Once the project was underway, the sponsor scheduled committee meetings  at regular 2-week intervals.

Solution

We put a comprehensive solution in place to closely manage the project and guarantee adherence to the demanding timelines:

  • We handpicked the team of statisticians and programmers to ensure they had the right therapeutic experience. Veramed has a strong track record in respiratory trials, so we selected individuals with the most relevant domain knowledge.   
  • We assigned an executive leadership team to plan the strategy and provide governance. With exceptionally tight timelines between data cuts and the IDMC meetings, we produced a detailed programming strategy mapping out the data process flow and the delivery timelines to the hour. 
  • In this project, the data and code needed to be usable on Veramed and sponsor systems, so we established a system-independent package. 
  • We created a synthetic database using the CRF and trial endpoints to simulate the data and allow us to conduct the programming in advance.  
  • Between each IDMC meeting, we checked the validation of the programs regularly.
  • In a fast recruiting trial with 50 new subjects a week, continual validation allowed us to handle the challenges of unclean data off the critical path.

Outcomes

We have supported five IDMCs for this client thus far, and have hit timelines on each occasion.  The project is still ongoing.

To learn more about the role of IDMCs and how work underpins their success, download the brochure below.

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