Optimizing the study planning phase in an investigator-initiated multicenter clinical trial: Mapping the process into a blueprint.
- 1Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Abstract
Introduction
Efficient, precise operationalization of the clinical trial planning phase is critical to timely trial initiation and overall success. Early missteps - imprecise protocols, unclear manuals, delayed training, or incomplete regulatory preparation - create cascading inefficiencies across submissions, data systems, contracting, and site onboarding. Although literature recommends streamlining procedures, mapping the process, and using checklists, there is limited guidance on how to operationalize the planning phase into an executable, time-bound plan.Methods
Drawing on operational experience from more than 30 multicenter trials and stakeholder interviews, we developed a study planning "blueprint" that maps milestones, roles, tasks, dependencies, and deliverables across a pre-award run up period and planning year (∼15 months). The blueprint prescribes a multi-team structure (Data Analysis and Statistical Reporting; Data Systems Integration; Data Management; Operations and Clinical Affairs; Protocol and sIRB; Financial Operations) to enable parallel work streams, with quarterly milestones aligned to funder performance-based expectations.Results
The blueprint details quarter-by-quarter deliverables - from pre-award risk assessment to site activation and first enrollment. It emphasizes the centrality of a dedicated project manager, predecessor-successor milestones and tasks, dependency-aware project tools, and routine leadership monitoring to identify and mitigate delays. The model is scalable: smaller teams can consolidate roles and extend timelines while preserving parallelism where feasible.Conclusion
Formalizing the planning phase with a visual, team-assigned blueprint of parallel work streams may increase operational precision, reduce avoidable delays, and accelerate transition from award to participant enrollment. Future work should quantify milestone- and task-level time and cost metrics to optimize blueprints for diverse trial types.
Related
- Effectiveness and Patient Compliance of a Needle-Free Injection System in Controlled Ovarian Stimulation in IVF Cycles: A Real-World, Investigator-Initiated, Retrospective, Multicenter, Observational Study
- Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial
- Positive end-expiratory pressure versus sham valve/zero end-expiratory pressure in cardiopulmonary resuscitation during manual ventilation toimprove neurological outcomes in adult patients suffering an out-of-hospital cardiac arrest - an investigator-initiated, pragmatic, registry-based, multicenter, parallel-group, triple-blind randomized controlled superiority clinical trial in the ARREST registry (REVIVE-PEEP protocol Stage-1 Registered Report)
- Intensity-modulated radiotherapy combined with albumin-bound paclitaxel and platinum-based chemotherapy for locoregional recurrent cervical cancer: a single-institutional phase II investigator-initiated nonrandomized clinical trial
- Efficacy and biomarker analysis for nivolumab in cancer of unknown primary: results from an investigator-initiated expanded access program
BibTeX
@article{hillery2026optimizing,
title = {{Optimizing the study planning phase in an investigator-initiated multicenter clinical trial: Mapping the process into a blueprint.}},
author = {Shannon Hillery and Ryan Majkowski and Esther Woo and Elizabeth Holthouse and Andrew Mould and Lindsay M Eyzaguirre and Nichol McBee and Karen Lane},
journal = {Journal of clinical and translational science},
year = {2026},
month = jul,
doi = {10.1017/cts.2026.10792},
url = {https://europepmc.org/article/MED/43011273},
note = {CC BY},
}
RIS
TY - JOUR
TI - Optimizing the study planning phase in an investigator-initiated multicenter clinical trial: Mapping the process into a blueprint.
AU - Shannon Hillery
AU - Ryan Majkowski
AU - Esther Woo
AU - Elizabeth Holthouse
AU - Andrew Mould
AU - Lindsay M Eyzaguirre
AU - Nichol McBee
AU - Karen Lane
PY - 2026
DA - 2026/07/22
JO - Journal of clinical and translational science
DO - 10.1017/cts.2026.10792
UR - https://europepmc.org/article/MED/43011273
AB - Introduction Efficient, precise operationalization of the clinical trial planning phase is critical to timely trial initiation and overall success. Early missteps - imprecise protocols, unclear manuals, delayed training, or incomplete regulatory preparation - create cascading inefficiencies across submissions, data systems, contracting, and site onboarding. Although literature recommends streamlining procedures, mapping the process, and using checklists, there is limited guidance on how to operationalize the planning phase into an executable, time-bound plan.Methods Drawing on operational experience from more than 30 multicenter trials and stakeholder interviews, we developed a study planning "blueprint" that maps milestones, roles, tasks, dependencies, and deliverables across a pre-award run up period and planning year (∼15 months). The blueprint prescribes a multi-team structure (Data Analysis and Statistical Reporting; Data Systems Integration; Data Management; Operations and Clinical Affairs; Protocol and sIRB; Financial Operations) to enable parallel work streams, with quarterly milestones aligned to funder performance-based expectations.Results The blueprint details quarter-by-quarter deliverables - from pre-award risk assessment to site activation and first enrollment. It emphasizes the centrality of a dedicated project manager, predecessor-successor milestones and tasks, dependency-aware project tools, and routine leadership monitoring to identify and mitigate delays. The model is scalable: smaller teams can consolidate roles and extend timelines while preserving parallelism where feasible.Conclusion Formalizing the planning phase with a visual, team-assigned blueprint of parallel work streams may increase operational precision, reduce avoidable delays, and accelerate transition from award to participant enrollment. Future work should quantify milestone- and task-level time and cost metrics to optimize blueprints for diverse trial types.
SN - 2059-8661
ER -