What is a non-interventional study?
Non-interventional studies include database research or review of records where all the events of interest have already happened (this may include case-control, cross-sectional, cohort or other study designs making secondary use of data).
What phase is a non-interventional study?
Phase IV refers to large studies, interventional or non-interventional, that are often used to assess serious adverse effects in a sizeable population, but that are sometimes also used to approve additional uses of a drug or to introduce physicians and patients to new treatments [1].
How much does clinical trials pay in South Africa?
In South Africa, at present, clinical trial participants tend to be paid R150 per visit. The Medicines Control Council (MCC) has recommended that trial participants be reimbursed a minimum of R150 per trial visit.
Is a non-interventional study a clinical trial?
Medicines used during an NIS must be prescribed according to the label indications; no “off-label” (e.g. experimental or non-FDA approved) medications are allowed. If this condition is violated, the study is classified as a clinical trial.
Does GCP apply to non-interventional studies?
ICH GCP is not applicable to non-interventional studies from a legislative and regulatory compliance perspective. You are free to follow the principle of ICH GCP (e.g., informed consent process and trial mster file content), but you are not legally obliged to do so.
“Non-Interventional Study or Non-Interventional Trial is a study where the medicinal product (s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation.
Will this non-interventional study interfere with treatment prescription by investigators?
This non-interventional study will not interfere with treatment prescription by Investigators. Accordingly, the Investigator will decide in advance the best therapeutic strategy for each patient according to current practice, regardless of the potential participation of this patient in the study.
Is there any study required for non-interventional treatment of multiple sclerosis?
Since this is a non-interventional study, there will not be any study required clinical interventions and laboratory assessments. Population RRMS patients who have discontinued their initial MS treatment and for whomMS treatment is required according to the decision of the HCPand patient.
How important are non-interventional and observational trials in the healthcare industry?
Many stakeholders in the healthcare industry are demanding more data and information on the effects of marketed drugs in the real world. Thus non-interventional and observational trials become incerasingly important to suppyl information on drug use after its market approval.
