Data analysis and interpretation of the data are two separate processes, even if they are conducted 30 milliseconds apart by a single person. Data analysis, however, is usually conducted by a statistician and data interpretation by a scientist or clinician.
The regulatory cascade consists of laws leading to regulations, which lead to guidelines, which lead to points to consider, which lead to formal recommendations, which lead to informed comments and finally to gossip.
Without pharmaceutical and biotech research, mankind has little hope of major advances in treating disease, but public support for clinical research is a mile wide and an inch thick.
Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).
