ABSTRACT
It is impossible that all drug development programs succeed—there will be both successes and failures. This chapter discusses a particular clinical program that failed due to the absence of a real PK model, exaggerated expectations, a wrong label, and misinterpretation of the randomized controlled trial (RCT) results. The clinical program consisted of 21 studies starting from phase I and including two pivotal phase III studies. Most of the Hemoglobin-based oxygen carriers failed—usually after pivotal phase III RCTs. The longer and the bigger the clinical development program is the worse—there is simply not enough manpower and time to request, obtain and reconcile all these issues properly. Many of the mistakes could have been avoided if the clinical development program was properly planned from the outset. Common knowledge among physicians is that big pharma forced the use of separated blood components into clinical practice. The triangle health authorities-academia-industry provides a very powerful platform for the open scientific discussion.
