Study Design
Move Closer to your Patients in order to Improve Recruitment
Digital solutions - such as online study portals – can bring patients, researchers, and industry closer together. Thereby, they can provide value to sponsors during the planning and patient recruitment stages of clinical trials or observational studies.
Vom Aussterben bedroht – gefährdet der Brexit klinische Prüfungen in UK?
Aktuell laufen ca. 1.500 klinische Studien in verschiedenen EU Mitgliedsstaaten, deren Sponsoren ihren Sitz in UK haben. Schätzungen zu Folge werden 50 % dieser Studien auch nach dem Austritt Großbritanniens aus der Europäischen Union (BREXIT) am 30. März 2019 weiterlaufen. In diesem Zusammenhang stellt sich unweigerlich die Frage: Wie geht es mit den klinischen Prüfungen und der Zusammenarbeit mit UK nach dem Brexit weiter?
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 [...]
The “Do’s and Don’ts” when searching clinical trials registers
Searching clinical trial registers is a “must have” in clinical research and evidence based medicine. However, the different registers have their unique characteristics and there are several issues to be kept in mind when searching clinical trial registers, especially when the standards of evidence based medicine need to be fulfilled [...]
Precision medicine clinical trials – How far are we in personalized medicine?
Using precision medicine as an aid to plan clinical trials catches much attention in the present era of drug development. Several innovative precision medicine initiatives have launched clinical trials for complex diseases.