Key Topic 2: Non Interventional Studies
In general terms, a non-interventional study is observational in nature. The product is prescribed in the usual manner, in accordance with the terms of the marketing authorization, without any additional investigations, monitoring or interventions. The decision to treat is taken separately from the decision to include the patient in the study.
Collected data should undergo formal analysis.
Non-Interventional Studies must address a scientifically and medically valid question to which AstraZeneca needs the answer.
Valid questions might include:
- Safety and/or effectiveness
- Medical practice and drug utilisation
- Disease and clinical epidemiology
- Burden of disease
- Costs and Quality of Life
- Patient reported outcomes
- Compliance/adherence to therapeutic regimen
Any decision to conduct a Non-Interventional Study must be based on genuine scientific need. Non-Interventional studies are never conducted to influence prescribing practice.
All the principles of the Good Clinical Practice IGH guideline apply, including the need for informed consent and collection of adverse event data if the study involves use of an AZ product.
