A hitchhiker’s guide to data review in an ongoing (“live”) study – part 2: data review for interim analysis

If you are thinking of a clinical trial, you might ask yourself why and how data review for interim analysis can be a topic for a whole article. However, in a non-interventional study there are certain challenges [...]

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 [...]

By |2019-07-24T17:37:30+01:00September 20th, 2017|Categories: Biostatistics, Study Design|Tags: , , , |

A quick guide to your non-interventional study

Contrary to the outdated image of the non-interventional study (NIS) as a pure marketing instrument, this kind of study is particularly suitable for emphasizing the effectiveness,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. A quick guide for the planning of your NIS.

By |2019-07-24T18:04:46+01:00July 22nd, 2016|Categories: Regulatory, Study Design|Tags: , , , |