Pursuing Clinical Trial Costs

Clinical trials are becoming more complex in terms of regulatory compliance and the scope of studies. The FDA is increasingly stressing data integrity,and in December 2018 it finalized a draft of “Data Integrity and Compliance with CGMP Guidance”for the industry. The number of drug GMP warning letters hasalso continuously increasedover the previous years: theFDA issued almost 200% more warning letters in 2018 than in2015. There has also beenan increase in the number of total procedures per protocol involved in a typical clinical trial. Apart from increasing operational complexities, consolidation within theCRO industry in recent years has increased sponsor companies’ concerns regardingcosts. They must nowbe more vigilant and thorough when planning and overseeing outsourced clinical trials. Consequently, it isnowmore important than ever forprocurement teams to develop a clear understanding of the various cost drivers in theoperation ofclinical trials.

Clinical Trial Cost DriversAlthough numerous factors affect the cost of a clinical trial, some of the major ones are:

• Increased costs of clinical supplies and equipment:The cost of clinical supplies is affected by many procedures and factors such as auditsof manufacturers and packagers, specific training in the SOPs,andraw material and shipment costs

• Extended timelines of clinical trials:Inclusion of more proceduresand protocols has increased clinical trial timelines