Improving protocol design feasibility to drive drug development economics and performance

Area of Science:

• Drug development
• Clinical trial design
• Health economics

Background:

• Protocol design complexity has risen over the last decade.
• This trend has negatively affected drug development economics and performance.
• Increased complexity leads to higher costs and operational inefficiencies.

Purpose of the Study:

• To review findings from two major Tufts Center for the Study of Drug Development studies.
• To quantify the direct costs associated with protocol procedures and amendments.
• To discuss indirect costs and delays resulting from complex protocol designs.

Main Methods:

• Review of two Tufts Center for the Study of Drug Development studies.
• Quantification of direct costs of protocol procedures and amendments.
• Discussion of indirect costs (personnel time, workload, cycle time delays).

Main Results:

• Complex protocol designs incur significant direct costs from unnecessary procedures and amendments.
• Indirect costs, including personnel time and delays, further exacerbate the economic impact.
• The financial burden of complex protocols affects overall drug development performance.

Conclusions:

• Research sponsors are actively seeking methods to enhance protocol design feasibility.
• Simplifying protocols can lead to improved drug development economics and performance.
• Addressing protocol complexity is crucial for efficient and cost-effective drug development.