Posts Tagged ‘clinical trials’

Ethnographic Research and REMS

Monday, July 12th, 2010

-Guest Blog by Andrea J. Simon, PhD.-

In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol is becoming more and more important; i.e., when a drug is in widespread use, risks need to be better understood. At the same time, there is a growing sense of uncertainty around ethnography’s legitimate role, how to integrate it into quantitative research, and when to use its information and insights to support or alter a previously defined direction. Along with this greater scrutiny, there is rising debate about ‘best practices’ in observational research processes, especially regarding the need to define protocols to ensure that research is conducted with proper rigor and is producing suitable, credible results. (more…)

The REMS Sensitivity Index

Tuesday, March 23rd, 2010

Below is a qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.

The presence of any attribute increases the probability of a REMS requirement; some items may be more highly weighted than others: (more…)