Bert Spilker's Pharma Principles of The Week
Posted by: Bert Spilker
- Avoid procedure bloat, which occurs when a clinical trial protocol is prepared by taking the previous one and adding some additional tests. This is fairly common as a drug passes through the development path.
- As soon as patient enrollment decreases below projections by a fixed number determined in advance of the trial, seek to learn the cause. Determine if this is evident at all or only some sites (i.e., is it site-specific or protocol-specific). Either adjust the protocol or change the recruitment strategy. Do not simply add sites until you determine that that is a reasonable action and is likely to address the problem.
- Monitors must understand the intensity and latitude they are allowed in their monitoring activities. Sometimes it may only be necessary to monitor the high enrollers, or a random group of sites in large trials. In mega-trials it is impossible and not regulatoraly required to monitor these trials as extensively as pivotal trials.
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).