Exploristics offers support for all statistical and programming roles and activities involved in IDMC planning and execution.
We understand the importance of technical and operational excellence to deliver critical results in compressed timeframes with assured quality to maintain trial integrity. Our statisticians can support this with extensive experience working within Independent Data Monitoring Committees (IDMCs) and Independent Statistics and Programming Teams (ISPTs).
What is an IDMC?
An IDMC is a panel of independent experts who operate outside a study to assess its progress, safety data and in some cases the critical efficacy endpoints. Their role is to ensure that the ethical and clinical interests of study patients are prioritised, and that their participation provides a favourable benefit-risk ratio. IDMCs also ensure the scientific integrity of the study throughout its duration, in the interim between initiation and completion.
When are IDMCs necessary?
Clinical trials face multiple uncertainties when assessing the risks and benefits of novel therapeutics. To ensure that participants are not exposed to unnecessary risks, some studies are carried out over long durations with large numbers of patients. Not all studies require an IDMC. However, IDMCs are usually needed to analyse interim data for large, randomised studies, particularly where they involve multiple sites and key clinical endpoints such as disease progression or survival.
What do statisticians do within IDMCs?
It is a requirement to have a statistician on an IDMC. They are involved in:
- Data review and monitoring
- Interim Analysis
- Safety Evaluation
- Efficacy Assessment
- Sample size reassessment
- Providing statistical guidance and advice
- Report preparation
- Communication and confidentiality
What is an IDMC?
An IDMC is a panel of independent experts who operate outside a study to assess its progress, safety data and in some cases the critical efficacy endpoints. Their role is to ensure that the ethical and clinical interests of study patients are prioritised, and that their participation provides a favourable benefit-risk ratio. IDMCs also ensure the scientific integrity of the study throughout its duration, in the interim between initiation and completion.
When are IDMCs necessary?
Clinical trials face multiple uncertainties when assessing the risks and benefits of novel therapeutics. To ensure that participants are not exposed to unnecessary risks, some studies are carried out over long durations with large numbers of patients. Not all studies require an IDMC. However, IDMCs are usually needed to analyse interim data for large, randomised studies, particularly where they involve multiple sites and key clinical endpoints such as disease progression or survival.
What do statisticians do within IDMCs?
It is a requirement to have a statistician on an IDMC. They are involved in:
- Data review and monitoring
- Interim Analysis
- Safety Evaluation
- Efficacy Assessment
- Sample size reassessment
- Providing statistical guidance and advice
- Report preparation
- Communication and confidentiality
Does my study need an IDMC?
For IDMCs our statisticians and programmers offer:
Experience
Our consultant statisticians have in-depth experience of IDMCs and knowledge of their requirements.
Infrastructure
We provide the programming expertise and secure processes needed to deal with unblinded data for an ongoing trial as required to maintain study integrity.
Clarity
We have experience in communicating complex statistical decision rules and concepts to non-statisticians, balancing the benefits and risks of any decisions made within the trial.
Flexibility
We can support the additional analyses and unplanned IDMC requirements that can arise at short notice.
Quality
We deliver high quality reports that are simple to access and navigate by IDMC members.
