About Dr. Alexandre Patchev

formerly Head of Medical Advising and Clinical Safety @ GKM Gesellschaft für Therapieforschung mbH

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 [...]

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 [...]

By |2019-07-24T17:37:23+01:00November 8th, 2017|Categories: Data, eCRF & Technical, Safety|Tags: , , , , |

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 [...]

Pragmatismus gefragt – Herausforderungen und Chancen für die klinische Forschung im Zeitalter der frühen Nutzenbewertung in Deutschland

In einer Hinsicht sind sich Interessenvertreter der Industrie und der Kostenträger einig – das Arzneimittel-Neuordnungs-Gesetz habe sein Ziel verfehlt. Doch was haben wir gelernt?

By |2019-07-24T18:05:59+01:00November 17th, 2015|Categories: Study Design, Value Dossier|Tags: , , , |