Glossary Term
Interim Analysis
Definition
Interim analysis refers to the evaluation of data collected from an ongoing clinical trial before its formal conclusion. It is conducted at predefined points to assess safety, efficacy, or other critical endpoints and can guide decisions about trial continuation, modification, or early termination.
Relevance to the MedTech Industry
Interim analysis ensures patient safety during clinical trials and allows for the early identification of significant efficacy or risks. By providing timely insights, it supports ethical trial management and efficient resource allocation, while maintaining the integrity and scientific validity of the study.
Additional Information & Related Terms
Key Components of Interim Analysis
Predefined Analysis Plan
Specifies when and how the interim analysis will occur, ensuring transparency and compliance with regulatory and ethical standards.
Stopping Rules
Includes criteria for early termination due to overwhelming efficacy, unacceptable safety risks, or futility.
Blinding and Data Integrity
Maintains blinding to prevent bias unless unblinding is necessary for safety reasons.
Data Monitoring Committee (DMC)
Independent committees review interim data to provide recommendations while preserving trial integrity.
Related Terms
Data Monitoring Committee (DMC): Reviews interim data to ensure unbiased recommendations about trial progression.
Risk-Benefit Analysis: Informed by interim results to evaluate the safety and efficacy of a device.
Adaptive Clinical Trial: A trial design that uses interim analysis to allow modifications during the study.
Regulatory Compliance: Interim analysis must adhere to guidelines like Good Clinical Practice (GCP).