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Inovia Bio Insights

Keep Up To Date With All Things Inovia Bio &
Drug Development

An FDA advisory committee reviewing a single-arm trial's external control arm limitations before an ODAC vote.

The silence tax: disclosing your single-arm trial's limitations to an FDA advisory committee before a panellist does

Illustration contrasting claims, EHR, registry and chart-abstraction data sources for an external control arm, showing why data curation and matching are what regulators actually scrutinise.

Where the comparator patients come from: why an external control arm is won or lost after you've picked the data source

Illustration of the sensitivity analysis menu for an external control arm study: alternative matching specifications, missing-data handling, and quantitative bias analysis, as reviewed by FDA and EMA assessors.

One robustness check is not a menu: the sensitivity analyses that make an external control credible

Two-column diagram comparing external control arm cost savings against the recruitment cost of a randomised comparator arm in clinical trial design.

RWEStrategyReal world evidenceexternal control armsdrug development

The "brochure delta": why the cost saving from an external control arm is not a number anyone can quote you

Chart comparing a single pivotal trial FDA approval pathway with the traditional two-trial programme, showing how to right-size sample size and duration

Strategyregulatory strategydrug development

How much trial do you actually need? Right-sizing the pivotal programme to the first-approval decision

Illustration of real-world evidence bridging an external control arm to rescue a failed clinical trial comparator

Answer-blind or answer-first: what real-world evidence can rescue after a comparator fails, and what no regulator will let it rescue

Illustration of subgroup analysis credibility in clinical trials, weighing biological plausibility and replication against pre-specification alone

Subgroup rescue: "we pre-specified it" is the weakest defence in the room

Timeline illustrating FDA accelerated approval, surrogate endpoints and confirmatory trial requirements tightening after FDORA.

Surrogate endpoints and accelerated approval after FDORA: the standard didn't move, the reckoning got faster

Four-quadrant kill, pivot or partner decision framework mapping drug asset value against organisational fit

Kill, pivot or partner: the two questions you keep answering as one

Ten-question external control arm feasibility self-assessment grouped into disease, effect-size, regulatory-precedent and data-quality checks for ECA-readiness.

Is your indication ECA-ready? A 10-question self-assessment

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