A quick guide to your non-interventional study (NIS planner)
Contrary to the outdated image of the non-interventional study (NIS) as a pure marketing instrument, this kind of study is particularly suitable for emphasizing the effectiveness, efficiency and safety of a drug under real life conditions. Within the recent years, the call for observational real-world-data gained in its strength, as well as the demand for insights into the patients’ requirements, wishes and preferences. Therefore, NIS experience a well-founded period of blossom.
However, the field of NIS is broad – depending on the scientific question of the project, one can choose from a large variety of NIS subtypes determined by different study designs. The following NIS planner infographic serves as a quick guide for the planning of your NIS. It navigates you along the core pillars of study conceptualization and helps you to determine the fundamental cornerstones of your NIS.
What to keep in mind when planning a non-interventional study?
Type of NISdecisive: scientific question
design: sample size, observation period, endpoints?
– single-arm observational study
– comparative study (two- or multiple-arm)
– hypothesis free study (e.g. registry)
Countries of interestlicensing and marketing authorization?
healthcare situation and clinical routine?
geographic & cultural features?
process of ethics’ submission?
notifications and authorities?
Site selectionresident doctors vs. hospitals
contracts & reimbursement
strategy of site recruitment?
number of centers?
experience in clinical research?
Data documentationdata structure?
categorical variables vs. free text
EDC vs. Papernumber of patients?
intervals between documentation?
requirements for data availability?
requirements for sharing information?
cleaning and plausibility checks?
adverse drug reactions (ADR) reporting
vs. full safety reporting
informed consent for access of
third parties to patient file
Further information & contact
For further details, please also refer to our recent publication in “Pharmazeutische Medizin” 02/2016, where we elaborate on the most frequently asked questions during the planning of a NIS. The article is available in German, only.
Picture: @chaiyapruek /Fotolia.com