A Single Center Analysis of Factors Influencing Study Start-Up Timeline in Clinical Trials

Abstract

Aim: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. Materials & methods: The start-up milestones were assessed for 38 studies and analyzed. Results: Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. Conclusion: Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

Lay abstract: Prompt start-up phase in clinical trials is critical to successful execution. The goal of this manuscript was to determine factors contributing to delays. We assessed factors affecting start-up for 38 studies. Total start-up time was shorter for studies of device trials, without outsourcing, using fewer ancillary services and with certain designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. We conclude that different factors can affect timeline of start-up process. An understanding of the impact of each factor allows for optimization.

Keywords::

• clinical trials management
• process optimization
• start-up metrics
• start-up phase
• trial efficiency

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate Institutional Review Board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Authors contributions

Krafcik BM did data collection, data analysis, literature review, manuscript writing, figures and tables creation and input into study design.

Doros G designed the study performed statistical analysis. Malikova MA did study design, data collection, data analysis, manuscript writing, leadership of the project for process improvement.