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Related Experiment Video

Updated: Mar 18, 2026

High-throughput Fluorometric Measurement of Potential Soil Extracellular Enzyme Activities

High-throughput Fluorometric Measurement of Potential Soil Extracellular Enzyme Activities

Published on: November 15, 2013

[Not Available].

Sophie Stamenkovic¹, Anne Solesse¹, Laura Zanetti¹

¹Unité Méthodologie et Études Post-Inscription, Direction de l'Évaluation Médico-Économique et de Santé Publique, HAS, Paris, France.

|July 10, 2016

Summary

This summary is machine-generated.

Health technology assessments often face uncertainty. This guideline offers benchmarks for post-registration studies, ensuring robust data collection and analysis for reassessment.

Keywords:

conditions réelles d’utilisation epidemiology health technology assessment methodology méthodologie post-registration studies real-life study épidémiologie études post-inscription évaluation des technologies de santé

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Area of Science:

Health technology assessment
Post-registration studies
Methodological guidelines

Context:

Health authorities require post-registration data due to uncertainty in health technology impact.
Industry is responsible for data collection; HAS evaluates methodology.
Guidelines address practical benchmarks for post-registration studies.

Purpose:

To provide practical benchmarks on methodological aspects of post-registration studies.
To guide the selection of study types (databases, cohorts, European studies) based on objectives.
To emphasize critical elements for study design and execution.

Summary:

The guideline details study types, emphasizing scientific committees, clear objectives, and justified methodologies.
It stresses documenting representativeness, limiting patient loss and missing data, and describing statistical analysis.
Key considerations include bias assessment and impact on results.

Impact:

Ensures reliable reassessment of health technologies post-market entry.
Promotes rigorous scientific evaluation and transparent reporting of study outcomes.
Facilitates informed decision-making by health authorities regarding technology adoption and management.