Glossary Term
Follow-up Clinical Study
Definition
A Follow-Up Clinical Study is a clinical investigation conducted after the initial approval or market release of a medical device to collect additional data on its safety, performance, and effectiveness in real-world settings. These studies are often required by regulatory bodies as part of post-market surveillance (PMS) or to explore new indications for use.
Relevance to the MedTech Industry
Follow-up clinical studies provide critical evidence to confirm the long-term benefits, risks, and overall impact of medical devices. They help manufacturers demonstrate continued compliance with regulatory requirements, refine product designs, and build clinical trust among healthcare providers and patients.
Additional Information & Related Terms
Participant Retention
Maintaining engagement with study participants over extended periods can be challenging, especially in long-term studies.
Data Collection ComplexityReal-world settings introduce variables such as clinician practices and patient adherence, requiring robust data collection and analysis strategies.
Regulatory Mandates
Follow-up studies must meet stringent regulatory and ethical requirements, including detailed protocols and compliance with Good Clinical Practice (GCP).
Cost and Resource Allocation Conducting follow-up studies requires significant financial and operational resources, particularly for large-scale or multi-country investigations.