Evaluating the Barriers affecting Clinical Trial Proceedings using AHP analysis

Abstract

Purpose

The clinical trial industry is directly dealing with the prospects of wellbeing of the humans and hence any obstruction or barriers that affects the smooth conduct of clinical trials needs attention. The clinical trial progress studies have become of major importance in recent times owing to the pandemics like COVID-19 and the need for vaccine like never before. The main purpose of this study is to identify and prioritize the barriers affecting clinical trial proceedings so as to mitigate and minimize the risks and in turn reduce the overall cycle time for the completion of the trial proceedings.

Design

The evaluation is based on the AHP (analytical hierarchy process) framework. There are 6 barriers and 14 sub barriers that are listed and classified under the head barriers – behavioral, patient accrual, supply chain complexity, regulatory, financial and infrastructural barriers. These barriers were used as a criterion in the AHP and with the help of literature review and expert opinion the priority was devised. The selection of barriers was done based on the knowledge of clinical trials requirements and literature studies, while the weight assignment was made with the help of subject matter expert opinion.

Findings

Result shows that regulatory compliance was the highest-ranked barrier followed by the supply chain complexity, patient accrual, behavioral, financial and infrastructural barriers spread across the rankings. The priority list of the barriers can be considered while designing the clinical trial studies to have mitigations strategies at each stage of clinical trial and also have contingency planning that can avoid the redesigning of the clinical trials and in turn saves the cycle time of completion. This also gives an insight on the relative importance of these barriers.

Originality

The study analyses the potential barriers in the proceedings of the clinical trials and ranks these barriers as per their relative importance using AHP framework to help the clinical trial industry in reducing the timelines and better prepared for the foreseeable barriers as the trial progresses.