When new participants are recruited by current participants to become part of a study sample, it is called “snowball sampling.” This is a non-probability sampling technique that can be a practical way to identify and recruit individuals with certain characteristics to...
The U.S. Food and Drug Administration (FDA) issued a draft guidance suggesting the agency adopt an International Council for Harmonization (ICH) to a 1998 clinical trials statistics guideline. The original ICH guideline (ICH E9) focused on the use of sensitivity...
How should clinical trials be executed during a crisis such as an epidemic? Which aspects, if any, of the clinical trial process will change? Who needs to be involved and when do people need to act to ensure efficient management of the research? The National Academies...
Describing the rise of medical “wearables” in the U.S. and global marketplace as meteoric seems fitting given the rapid growth of the industry over the past decade. Wearable technology has been around for decades (check out an amusing history of some medical and...
The European Medicines Agency (EMA) released a report on Tuesday that analyzed over 100 applications submitted for medicines in the fields of psychiatry or neurology between 1995 and 2014. In the report, EMA concludes that various challenges can arise in the...
Clinical research, when done correctly, provides a plethora of benefits to the researchers involved in the process as well as patients enrolled in the trials. Setting up a successful clinical trial process was the topic of a recent breakout session led by Daniel R....