Technology for Clinical Trial Supply Planning

The 2010 Optimizer User Conference recently ended and I am happy to report a surge in discussion around technology for clinical trial supply planning. I think this speaks well to the growth of the Optimizer product and greater acceptance of the application of more sophisticated tools to the clinical supply planning process in general.

There were a number of roundtable discussions and open training sessions, which were as valuable for me as I believe they were for the attendees.

During one of the training sessions there was a lengthy discussion on the best practice for early clinical trial supply planning of variable dose or titration studies.  

These protocols present a unique challenge - early on there typically is not a lot of information available regarding how the subject population will respond to or tolerate certain doses. Typical Floor/Ceiling or Safety Stock resupply algorithms are very inefficient at managing these studies. The ability to add prediction of the variable dose visits to these protocols can be extremely effective at minimizing excess drug supply while ensuring the correct dose is available, at the right place, at the right time. Through automation, different resupply algorithms and settings can be modeled and simulated providing valuable information to the clinical trial supply planning process.

For example, what happens if I predict the existing subject dose plus the potential for one titration up, or what if I predict for all possible titrations, some or all of the time?

I welcome your thoughts and any discussion on clinical trial supply technology and best practices.