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 ?
Our non-interventional study will increase our knowledge of eslicarbazepine acetate's efficacy and tolerability in routine practice when used to treat adults who are less refractory than those included in standard Phase III adjunctive therapy clinical trials.
Gregory Di Russo, Senior Vice President of Clinical Development at CytoSorbents stated, "Pending institutional review board (IRB) approval at our selected sites, we look to rapidly execute the feasibility study and advance the non-interventional study.
A new, longitudinal, non-interventional study that included 155 Alzheimer's disease patients/caregiver pairs across the U.
The QualiCop study is a prospective, observational, open label, multicenter non-interventional study of treatment-naove and previously treated RRMS patients.
XANTUS is a prospective, international, observational, post-authorization, non-interventional study designed to collect safety and efficacy data on the use of XARELTO[sup.
EXTEND is a multicenter, international, observational, longitudinal, non-interventional study of non-selected adult patients with CKD not undergoing dialysis to assess the efficacy and safety of switching to an extended sub-cutaneous dosing regimen (Q2W/QM) of Aranesp(R).
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