Improving the Performance of Supply Chains in Clinical Trials with Delays: an Optimization Approach to Determining the Number of Recruitment Sites

Clinical testing accounts for almost 70% of the R &D expenditure in the pharmaceutical industry and most clinical trials experience considerable delays that result in extra costs. One of the major sources of these delays is the patient recruitment process. It is estimated that about 48% of the recruitment sites of a clinical trial fail to meet their deadlines due to slow recruitment rates and 11% do not recruit a single patient. Thus, determining the correct number of recruitment sites is paramount for more efficient supply chains in clinical trials. The calculation of the number of recruitment sites in clinical trials is based on factors such as the target number of patients, their estimated recruitment rates, and the associated operational costs. However, these calculations typically ignore the time needed for sites to be operational. In this paper, we analyze the impact of incorporating these site activation delays in determining the optimal number of clinical sites. Our study shows that ignoring these delays leads to overestimating the number of sites needed, thus resulting in an excess of expenditure. Consequently, the insights herein explained help quantify the impact of making better decisions in designing more efficient operations in clinical trials, both in terms of time and money.