title: Dynamically allocating treatment when the cost of goods is high and drug supply is limited.
abstract: Large-scale production of proteins by cell culture and subsequent purification for use in novel medical therapies is a slow and complex process. During the early phases of development of manufacturing processes, contamination and replication errors cause entire batches of material to be wasted. As a result, the cost of goods for large-molecule therapies in early clinical development can be significant, and the supply limited. When designing clinical trials to test expensive biological compounds with limited supply, sponsoring companies want to minimize the waste of drug, that is, to maintain small inventories of drug at the investigational hospitals. We must, however, weigh the benefits of smaller inventories against the costs of increased numbers of shipments to resupply when rapid enrollment causes shortages of drug. A well-planned randomization scheme may be able to balance these objectives. This paper demonstrates how a dynamic randomization algorithm can be used to maintain smaller drug inventory at hospitals than a typical permuted block randomization list plan, and how well it automatically restores balance when the shortage of drug causes assignment of alternate treatments.
authors.affiliation: DynaRand, LLC, San Francisco, California 94114, USA.
authors.forename: S A
authors.initials: SA
authors.lastname: Hamilton
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001688:Biological Products / Q000191:economics* / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D003363:Cost Control; D016527:Drug Costs; D017598:Efficiency, Organizational; D006801:Humans; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy; D010960:Plasminogen Activators / Q000191:economics / Q000627:therapeutic use; D011897:Random Allocation; D010959:Tissue Plasminogen Activator / Q000191:economics / Q000627:therapeutic use
chemical_list: D001688:Biological Products; D010960:Plasminogen Activators; D010959:Tissue Plasminogen Activator