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. 2017 Jul 14;3(4):FSO223.
doi: 10.4155/fsoa-2017-0025. eCollection 2017 Nov.

A single center analysis of factors influencing study start-up timeline in clinical trials

Brianna M Krafcik  1   1 , Gheorghe Doros  2   2 , Marina A Malikova  1   1
Affiliations

A single center analysis of factors influencing study start-up timeline in clinical trials

Brianna M Krafcik et al. Future Sci OA. .

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.

Keywords: clinical trials management; process optimization; start-up metrics; start-up phase; trial efficiency.

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Conflict of interest statement

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.

Figures

<b>Figure 1.</b>
Figure 1.. Comparison of number of days to finalize budget and contract, days to Institutional Review Board approval, days to first subject enrollment and total start-up time between different study types.
Total study start-up time is defined as site receipt of the feasibility questionnaire to first subject enrollment. Bars represent standard error for each mean value. IRB: Institutional Review Board.
<b>Figure 2.</b>
Figure 2.. Comparison of number of days to finalize budget and contract, days to Institutional Review Board approval, days to first subject enrollment and total study start-up time with the presence and absence of a Contract Research Organization working on the study.
Total study start-up is defined as date of site receipt of the feasibility questionnaire to first subject enrollment. Bars represent standard error for each mean value. CRO: Contract Research Organization; IRB: Institutional Review Board.
<b>Figure 3.</b>
Figure 3.. Comparison of number of days to finalize budget and contract, days to Institutional Review Board approval, days to first subject enrollment and total study start-up time based on project manager experience.
Total study start-up is defined as date of site receipt of the feasibility questionnaire to first subject enrollment. Forty-eight months was the approximate median experience time for all studies considered. Bars represent standard error for each mean value. IRB: Institutional Review Board.
<b>Figure 4.</b>
Figure 4.. Comparison of number of days to finalize budget and contract, days to Institutional Review Board approval, days to first subject enrollment and total study start-up time based on number of ancillary services required by the study protocol.
Total study start-up is defined as date of site receipt of the feasibility questionnaire to first subject enrollment. Bars represent standard error for each mean value. IRB: Institutional Review Board.
<b>Figure 5.</b>
Figure 5.. Comparison of number of days to Institutional Review Board approval with an Institutional Biosafety Committee approval requirement and without.
Bars represent standard error for each mean value. IBC: Institutional Biosafety Committee; IRB: Institutional Review Board.
<b>Figure 6.</b>
Figure 6.. Comparison of number of days to Institutional Review Board approval using the local Institutional Review Board as compared to using a centralized Institutional Review Board.
Bars represent standard error for each mean value. IRB: Institutional Review Board.
<b>Figure 7.</b>
Figure 7.. Comparison of number of days to finalize budget and contract, days to Institutional Review Board approval, days to first subject enrollment and total study start-up time for interventional (drug, device or biologic) studies as compared with observational studies.
Total study start-up is defined as date of site receipt of the feasibility questionnaire to first subject enrollment. Bars represent standard error for each mean value. IRB: Institutional Review Board.
<b>Figure 8.</b>
Figure 8.. Comparison of the number of days taken to finalize the contract and budget for studies which obtained Institutional Review Board approval and those that were terminated before obtaining Institutional Review Board approval.
The number of days for contract and budget finalization for studies that eventually enrolled a subject are compared to those that were terminated prior to first subject enrollment. Bars represent standard error for each mean value. IRB: Institutional Review Board.
<b>Figure 9.</b>
Figure 9.. The number of days taken to obtain Institutional Review Board approval for studies that eventually enrolled a subject are compared with those that were terminated before the first subject was enrolled.
Bars represent standard error for each mean value. IRB: Institutional Review Board.
<b>Figure 10.</b>
Figure 10.. Cause and effect analysis of delays at the study start-up phase.
Causes specific to a study type are indicated by a symbol, with the legend in the bottom right corner. †Biologic. ‡Device. §Drug. *Observational.
<b>Figure 11.</b>
Figure 11.. Kaplan–Meier-type curve for the study start-up phase based on number of days to finalize the contract and budget.
The lines represent probability of ever obtaining IRB approval and probability of enrolling a first subject, respectively.
<b>Figure 12.</b>
Figure 12.. Kaplan–Meier-type curve for the study start-up phase based on number of days to obtain Institutional Review Board approval.
The lines represent probability of eventually enrolling a first subject. IRB: Institutional Review Board.
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