Table 1.

Key design features of the RECOVERY trial, exemplifying the application of quality-by-design principles to clinical trials and the production of rapid, reliable results

Design feature	Rationale
Randomised	Avoidance of systematic error (bias).
Large	Avoidance of play of chance. Provide adequate statistical power to detect moderate, but important, treatment effects across a broad range of circumstances.
Simple	Focus on critical components of quality that preserve safety and reliability. Do not include extraneous procedures. Streamlined study procedures at set-up, training, recruitment, randomisation, treatment delivery and follow-up facilitate timely results for patients and protect busy healthcare staff.
Inclusive	Facilitates prompt recruitment. Provides translatable results for all patients (both in and outside the UK).
Objective clinical outcomes	Clinically relevant results. Resistant to bias. Allow data linkage for complete follow-up.
Linkage to national healthcare datasets	Reduced data collection by local research teams. Complete follow-up improving study reliability. Rapid collection of data to inform data monitoring committee analyses. Low-cost long-term follow-up.
Collaborative	Buy-in from stakeholders at every level into study quality. Transparency facilitates trust in study procedures, safety and results. Resources are not wasted.
Robust web-based systems	Accessible to site staff. Reliable randomisation. Built-in options on online forms encourage consistency and completeness of data.
Data quality monitoring	Study procedures are subject to ongoing and continuous quality evaluation during the trial.
Trial oversight	Investigators at local hospital best placed to oversee high-quality study conduct locally. Experienced data monitoring committee meeting regularly provide reassurances on efficacy, accountability and safety.