The Clinical Research department King Fahad Medical City, Riyadh, Saudi Arabia conducted research to analyze and identify study startup metrics performance and found that varied factors are responsible for delays of the startup process; the delays can be broken down into factors and understanding the impact of each factor enables greater optimization and faster study startup execution within this prominent Saudi Arabian research site.

The King Fahad Medical City team sought to study their study startup performance for clinical trials as this phase of clinical trials plays a vital role in the execution of novel drug development. The Saudi team sought to identify the factors responsible for delaying the clinical trial startup phase within King Fahad Medical City. Moreover, the team had a specific interest in exploring how to streamline and reduce clinical trial study startup cycle time.

Key Clinical Trial Study Startup Factors Studied at King Fahad Medical City

The team studied 13 clinical trials conducted at King Fahad Medical City between 2016 and 2017. They employed a specific methodology titled FOCUS-PDCA. Five measures incorporated in the metrics included the following Factors:

  • Date of initial contact with site to the signing of the confidentiality agreement
  • Date of receiving a questionnaire from sponsor to date of its completion
  • Time is taken to review the protocol and approve investigational drug service (IDS) form
  • Time is taken to review protocol and approve pharmacy and pathology and clinical laboratory medicine (PCLM) form
  • Date of receipt of IRB submission package to final IRB approval

The King Fahad team employed fishbone analysis to understand the potential causes of process variation. Meantime 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 clinical trials at King Fahad Medical City.

Results

Interestingly, the two most influential factors were 1) lack of a well-defined timeline for approval and review of the study protocol and 2) inconsistent IRB meetings. Post introduction of new intervention protocol, the entire clinical trial lifecycle was reduced by 45.6% (24.8 weeks vs 13 weeks before and after the intervention, respectively).

Conclusion

The King Fahad Medical City team found that multiple and varied factors are responsible for the delay of the start-up phase of clinical trials within the institution. Understanding the impact of each factor enables better optimization and faster execution of the clinical trial study startup phase within King Fahad Medical City.

Lead Research/Investigators

Category: Study Startup, Optimization, King Fahad Medical City,

Source: bioRXiv

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