Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

Amani Abu-Shaheen,Eissa Ali Faqeih,Isamme Alfayyad,Adel Al Qutub,Ahmad Al Badr,Mohamad Altannir

doi:10.4172/2167-0870.1000358

Abstract

Abstract Objective The start-up phase of a clinical trial (CT) plays a vital role in execution of novel drug development. Hence, this study aims to identify the factors responsible for delaying the CT start-up phase. Further, it focuses on streamlining and reducing the cycle time of the start-up phase of newly sponsored CTs. Methodology Thirteen sponsored CTs conducted (between 2016 and 2017) in clinical research department at King Fahad Medical City, Riyadh were analyzed to identify the data specific start-up metrics using Find an improvement area-Organize a team-Clarify current practices-Understand source of variation/problem-Select a Strategy-Plan-Do-Check-Act (FOCUS-PDCA) cycle. Five measures incorporated in the metrics were: date of initial contact with site to the signing of confidentiality agreement; date of receiving questionnaire from sponsor to date of its completion; time taken to review protocol and approve investigational drug service (IDS) form; time taken to review protocol and approve pharmacy and pathology and clinical laboratory medicine (PCLM) form and date of receipt of institutional review board (IRB) submission package to final IRB approval. Fishbone analysis was used to understand the potential causes of process variation. Mean time was calculated for each metrics prior to and post implementation of the intervention protocol to analyze and compare percentage reduction in the mean cycle time of CTs. Results Of the various potential factors of delay identified through Fishbone analysis, the two major ones were lack of well-defined timeline for approval and review of the study protocol; and inconsistent IRB meetings. Post introduction of the new intervention protocol, the entire CT lifecycle was reduced by 45.6% (24.8 weeks9 vs 13 weeks, before and after intervention, respectively). Conclusion Varied factors are responsible for delay of the start-up phase of CTs and understanding the impact of each factor allows for optimization and faster execution of the start-up phase of CTs.

Highlights

Clinical trials (CTs) are essential for testing new drugs, devices and development of new treatment [1]
The team was charged with the responsibility to assess the current situation and shorten the time needed for the start-up phase of the newly sponsored clinical studies using Find an improvement area-Organize a team-Clarify current practices-Understand source of variation/problem-Select a strategy Plan-Do-Check-Act (FOCUS-PDCA) cycle [9]
The metrics incorporated five measures: (i) the date of initial contact with the site to the date of actual signing of the confidentiality agreement; (ii) the date of receiving the feasibility questionnaire from the sponsor to the date of its completion; (iii) time taken by the investigational drug service (IDS) pharmacy to review the study protocol and approve the IDS form; (iv) time taken by the pathology and clinical laboratory medicine (PCLM) to review the study protocol and approve the PCLM form (v) date of receipt of the institutional review board (IRB) submission package by the site through the date of submission to the IRB and date of final IRB approval

Summary

Introduction

Clinical trials (CTs) are essential for testing new drugs, devices and development of new treatment [1]. From our experience at the research center in King Fahad Medical City (KFMC), Saudi Arabia, the cycle time of startup phase of any new sponsored CTs is unusually prolonged owing to various factors which negatively impacts the trial conduct.

Results

Conclusion