Assessment of real-world clinical practice before data analysis

Description:
Capturing real-world clinical data and its analysis is different from randomized clinical trials in many ways. One of the differences is that there is that patients’ visits to the attending physician are scheduled is a less strict manner than in trials and reflect clinical practice in different hospitals and countries. This should be taken into account when assessing time-dependent endpoints, such as time to disease progression, time to first hospitalization etc., since they can be potentially biased by time intervals in which patients come to a follow-up visit.

Links:
https://en.wikipedia.org/wiki/Progression-free_survival
https://www.lawinsider.com/dictionary/clinical-practice

Keywords:
Progression, survival, treatment, chronic disease

Motivation:
A difference of a few weeks in the scheduled assessment of disease progression may lead to biased comparative assessment of e.g. progression-free survival. It is therefore important to check the frequency of visits in different patient cohorts that enter an analysis and reflect eventual differences in the final interpretation.

Requirements/Prerequisities:
a skilled statistician

Level:
concret: specific best practice (e.g. use microservice)

Application domain:
Medicine/Healthcare, Data science (analysis & visualisation)

Main phase:
Data Science: Preparation/Integration

Related literature:
https://www.valueinhealthjournal.com/article/S1098-3015(18)30349-8/fulltext
https://empire.registry.cz/index-en.php?pg=publications

In which projects do/did you use this practice?
EMPIRE