Real-World Evidence
Real-World Evidence (RWE) is clinical evidence regarding the use, potential benefits, and/or risks of a medical therapy. It is derived from the analysis of real-world data (RWD).
Unveiling the Veiled Influences: Bias in Observational Studies and Its Profound Impacts on Medical Research
Observational studies serve as vital tools in uncovering insights into real-world healthcare scenarios. Yet, navigating the intricate landscape of scientific inquiry comes with its own set of challenges, and one of the most elusive adversaries is bias. In the catalogue of bias, developed by scientists of the University of Oxford, around 60 kinds of bias are described that might possibly influence clinical evidence ...
Investigator Initiated Trials (IIT)
Can they demonstrate scientific merits and align with corporate objectives? Often initiated by researchers or investigators as a part of an observation, an Investigator Initiated Trial (IIT) or Investigator Sponsored Trial is one of the kind of clinical trials that take up specific questions from clinical care, such as therapy optimization or off-label use, and are usually of no economic interest.
Arzneimittelzulassung vs. frühe Nutzenbewertung – die Unterschiede
Häufig gibt es Diskrepanzen zwischen den Designanforderungen der Zulassungsbehörden und der Anforderungen an Studien für die Herleitung eines Zusatznutzens nach §35a SGB V. Die Eignung einer klinischen Studie als Basis für eine Arzneimittelzulassung bedeutet nicht zwangsläufig, dass diese Studie auch für die Bewertung eines Zusatznutzens geeignet ist [...]
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 [...]
User-friendly eCRF-design: the key for successful data collection
To ensure a perfectly suited eCRF design many different aspects have to be taken into account also with regard to user-friendliness [...]