Guest Column | September 16, 2011

Compliance Matters In Clinical Trials

By Kai Langel, Senior Director, Technical Support, CRF Health

Subject compliance is a hot topic in the industry right now. Some of the discussions out there can be a little misleading since ‘compliance' means different things to different people / companies. Many eDiary vendors focus on a subject's compliance with data entry, whereas Sponsors are more interested in the subject's compliance with the study procedures, and clinicians are interested in the subject's compliance with their medication / treatment.

I think it's important that we define what we mean when we use the term because it can mean any of the above items. It is also important that we carefully define the reports and metrics collected in clinical studies. I see many studies attempt to come up with a single metric for ‘total compliance', which includes a number of different things, like compliance with different medications, diary entry, etc. By doing this, they are actually hiding some important details. Individual metrics for individual items would most likely be much more useful. If a subject is having issues with their medication compliance, it should be addressed separately from their compliance with the entering of information into their eDiary.