Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients - Scientific guideline

This document provides guidance for the evaluation of new medicinal products in the primary prophylaxis of venous thrombo-embolic risk in the non-surgical setting.

Keywords: Prevention, venous thromboembolism, bleeding, non-surgical patients, cancer, chemotherapy

Current effective version

Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients

Adopted Reference Number: EMA/CPMP/EWP/6235/04 Rev. 1 Legal effective date: 01/07/2017

Document history - Revision 1

Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients

Adopted Reference Number: EMA/CPMP/EWP/6235/04 Rev. 1 Legal effective date: 01/07/2017

Overview of comments received on 'Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients (formerly CPMP/EWP/6235/04 Rev.1)'

Reference Number: EMA/452872/2016

Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism in non-surgical patients (formerly CPMP/EWP/6235/04 Rev.1)

Draft: consultation closed Consultation dates: 16/11/2015 to 15/05/2016 Reference Number: EMA/CHMP/41252/2015 Summary:

Venous thromboembolism (VTE), comprising deep vein thrombosis and pulmonary embolism, is the third leading cause of death due to circulatory diseases, only behind myocardial infarction and stroke. It is also an important source of morbidity in acutely ill patients. A key element in the benefit-risk assessment of drugs used for prophylaxis of VTE is balancing their antithrombotic effect versus the risk of bleeding.

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients

Draft: consultation closed Consultation dates: 15/07/2014 to 15/10/2014 Reference Number: EMA/CHMP/283524/2014 Summary:

A key element in the benefit-risk assessment of medicines used for prophylaxis of venous thromboembolism (VTE) is balancing their antithrombotic effect with the risk of bleeding. Since the publication of the Committee for Medicinal Products for Human Use (CHMP) guidance on clinical investigation of medicinal products for the prophylaxis of VTE disease, a number of new European Medicines Agency (EMA) guidelines related to clinical investigation with antithrombotics have been released or are being revised. An update of the guideline on non-surgical patients, particularly related to the assessment of safety and bleeding events, is considered necessary to adapt its content to current scientific knowledge and to harmonise it with the content of the new or revised EMA guidelines related to clinical investigation with antithrombotics.

Document history - First version

Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients

Adopted Reference Number: CPMP/EWP/6235/04 Legal effective date: 30/11/2006