Operational Pilot Studies
Penny S. Reynolds · 2023
Operational pilots are a crucial preliminary to determine logistic feasibility of planned experiments (‘Can it work?’). Quality can only be built into the experimental process from the beginning by minimising variation associated with all procedures and tasks. Trial-and-error adjustment of experiments already in progress will seriously compromise data integrity, so procedures should be stabilised before animals are used. Tools used to identify and control process variation include workflow maps, checklists, and run charts. Pilot study success is determined by stabilisation of all procedures and attainment of pre-specified target performance standards. Deliverables include standard operating procedures (SOPs), consistent skill levels for all technical personnel, and compliance with all experimental protocols. Performance benchmarks must be relevant to major operational objectives and be simple, quantifiable, and transparent to everyone involved with the project. Operational pilots do not require statistical significance testing and may not even need animals. If complex large experiments are planned, researchers should be prepared to invest up to 20% of resources (time, personnel, budget, and equipment) in operational pilots.