non-interventional study


Also found in: Acronyms.

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 ?
An observational non-interventional study of patients with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study.
It was a case control non-interventional study that spanned a period of one year from February 2013 to January 2014.
Methods: A1chieve was a 24-week, international, prospective, multicentre, open label, observational, non-interventional study designed to evaluate the safety and clinical effectiveness of 66,726 people with T2DM who were initiated with basal insulin detemir, fast actinginsulin aspart, and BIAsp 30 (30% soluble insulin aspart, 70% protamine-crystallized insulin aspart).
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.
This non-interventional study is designed to explore the experience of FSAD and evaluate the relevance of the selected PRO measures based on patients' own experiences and determine patients' understanding of the items, instructions, and response options of the selected PRO measures.
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, non-interventional study, in which women attending the Antenatal clinic at Sangameshwar Hospital attached to M.
FocalView will be tested in a prospective, non-interventional study to evaluate the app's efficacy and usability in assessing visual function.
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.
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