AI in clinical trials.
The practical map of AI in trial conduct sorts use cases by what they support, what records they touch, and how mature the governance posture is. Some are routine operational tools, some need validation and human review, and some remain experimental.
AI in clinical trials.
Use cases · what each replaces or augments · maturityThe practical map of AI in trial conduct sorts use cases by what they support, what records they touch, and how mature the governance posture is. Some are routine operational tools, some need validation and human review, and some remain experimental. iFeed keeps the boundary clear: AI can support trial work, but it does not remove sponsor accountability for protocol fidelity, participant protection, and data integrity.
Cohort enrichment · site selection.
Patient matching to inclusion criteria; demographic targeting; geographic optimisation. Replaces manual eligibility screening; augments site selection. Standard 2024+ at Medidata, IQVIA, Syneos. Inspection risk low — site selection aid, not protocol violation.
Real-time eligibility screening at site.
Augments inclusion/exclusion documentation accuracy. Emerging 2024–2026, not yet standard. Regulator gates on protocol fidelity, not AI mechanism. Risk: if AI screen misses an exclusion, FDA cites protocol deviation — not the model.
Adaptive design optimisation.
AI-assisted sample-size recalculation; dose-escalation sequencing; interim-analysis decisions. ICH E20 traditional framework mature; AI-extensions under discussion. PCCP framework (device-side) may extend conceptually. Adaptive design already complex; AI adds a layer.
AI-assisted SDV.
Augments manual record review. Vendors piloting 2024+. No specific framework yet. Risk medium — overreliance on algorithm vs. auditor judgment. Inspectable when paired with risk-based monitoring SOP.
Safety signal detection.
AE signal identification across pharmacovigilance datasets. Deployed in some CROs and sponsors. Sits in PV regulation (E2A) rather than CT regulation. Risk low — supplementary to human review.
Synthetic control arm curation.
AI can support real-world data review and external-control cohort exploration, especially where conventional randomisation is difficult. Representativeness, endpoint comparability, missingness, and data provenance remain the core evidence questions.
Informed consent simplification (NLP).
ICF readability assessment. Research-stage. No specific framework. Risk low if used for readability check only, not authorship.
DCT logistics optimisation.
Telemedicine visit scheduling; direct-to-participant IMP shipment routing. Operational tool, not protocol-affecting. Emerging 2024–2026. Risk low.
Generative AI authoring · protocols, ICF, CSR.
Generative AI can assist drafting, summarisation, and consistency checks, but clinical-trial documents still need accountable human authorship, review, source traceability, and version control. The risk is not the tool itself; it is unreviewed generated content entering protocol, consent, CSR, or regulatory records.
Official source register.
GCP / trial conduct anchorsGood Clinical Practice Step 4.
Official ICH E6(R3) Step 4 guideline. Use as the primary GCP anchor for participant protection, quality-by-design, sponsor oversight, and proportionality.
General considerations for clinical studies.
Official ICH E8(R1) guideline. Use for quality-by-design and critical-to-quality thinking before trial execution begins.
Estimands and sensitivity analysis.
Official ICH E9(R1) addendum. Use for aligning trial objectives, intercurrent events, estimands, and statistical interpretation.
Clinical electronic structured harmonised protocol.
Official FDA-hosted ICH M11 page. Use for structured protocol thinking and protocol information that can become more reusable across systems.
Clinical trials with decentralized elements.
FDA guidance page for decentralized trial elements. Use for remote visits, local healthcare providers, direct-to-participant processes, and oversight expectations.
Diversity Action Plans for clinical studies.
FDA guidance page for Diversity Action Plan expectations. Use for enrolment goals, rationale, and operational measures where applicable.
Regulation (EU) 536/2014 on clinical trials.
Official EUR-Lex anchor for the EU Clinical Trials Regulation. Use for EU authorisation, transparency, reporting, and trial-conduct context.
WHO guidance for best practices for clinical trials.
WHO 2024 clinical-trials best-practice guidance. Use for quality, relevance, ethics, and operational credibility across resource settings.