Blog
A hitchhiker’s guide to data review in an ongoing (“live”) study – part 1: data review for pharmacovigilance purposes
In a way, data review for pharmacovigilance purposes is the simplest and yet most demanding kind of data review, as time is a pressing matter in this context. The data are reviewed in different time frames according to the potential risks that arise from them [...]
What to consider when planning the sample size for a non-interventional study
The determination of an "adequate" sample size is an essential part of the statistical planning process. Depending on your type of non-interventional study design and your specific study objectives, there are different approaches for the planning of your sample size [...]
Acting out? Points to consider when planning to involve actigraphy measurements into your study design
From a medical perspective, addressing concepts of physical activity and activity capacity, vital signs (like heart rate or blood pressure), and/or sleep quality in a real-time manner rather than a snap-shot at a visit, make perfect sense and could enrich the value story of novel therapies. However, when planning to involve actigraphy measurements into your study design, there are several points to be considered, including issues of validity, data transfer and data analysis [...]
Don’t panic: It’s only the Simpson’s Paradox
Your results on the overall patient level contradict results on the subgroup level? There is no need to panic. With a deeper look into the data, one can get to the bottom of this observation. [...]
Das Bewertungsverfahren für Medizinprodukte: erste Erkenntnisse und Empfehlungen
Für welche Medizinprodukte ist die Bewertung relevant, wie läuft das Bewertungsverfahren ab und welche Lehren kann man aus den bisherigen Verfahren ziehen? [...]
Verpflichtung zur klinischen Nachbeobachtung (PMCF) von Medizinprodukten
Die klinische Bewertung ist fortan während des gesamten Lebenszyklus des Medizinprodukts anhand von klinischen Daten zu aktualisieren, die aus der klinischen Nachbeobachtung und der Überwachung nach dem Inverkehrbringen stammen.