non-interventional study

non-interventional study

A clinical study in which the medicinal product of interest is prescribed in accordance with the terms of marketing authorisation. Assigning a subject/patient to a particular therapeutic arm is not decided in advance by a protocol but falls within current practice; prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are used, and epidemiological methods are used to analyse the collected data.
References in periodicals archive ?
After obtaining the informed consent; participants were equally assigned to interventional and non-interventional study groups through stratified randomization.
Additional results from the emicizumab clinical development program will be presented during the meeting, including preliminary data from the Phase III HAVEN 4 study exploring emicizumab prophylaxis administered every four weeks in people with hemophilia A with and without inhibitors, as well as real-world data from a non-interventional study in children under 12 years of age with hemophilia A with inhibitors.
Together, the two companies are harnessing the power of crowdsourcing for research sponsors seeking non-interventional study participants outside the usual academic/clinical trial investigative sites.
METHODS: A prospective, descriptive, non-interventional study method was used.
The quoted clinical study was a non-interventional study performed in two medical departments at two separate medical centers.
The purpose of the A-SURE multicentre, non-interventional study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period.
The first cohort from a non-interventional study of people with hemophilia will be presented, including real world safety and efficacy data from patients with inhibitors to factor VIII replacement therapy treated with current standard of care according to routine clinical practice.
A non-interventional study is defined in the Code as a study where the medicine in question is prescribed in the usual manner in accordance with its marketing authorization.
The QualiCop study is a prospective, observational, open label, multicenter non-interventional study of treatment-naove and previously treated RRMS patients.
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