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Clinical program rescue

An ambiguous readout is not the end of the program

Most rescue decisions get made under time pressure, with sunk cost pulling one way and panic the other. This hub helps teams diagnose what is salvageable fast, and choose between rescue, redesign and stop with evidence instead of hope.

Get the rescue readiness checklist

Start here: the Rescue Readiness Checklist

A six-point diagnostic for a program after an ambiguous or missed readout: what is salvageable, what is not, and the data to pull together before any rescue conversation, internal or external. Points 1 and 2 decide most of what follows, be honest with those two. Free, and yours to keep.

Download the checklist

The Cost of Delay Index

Original research on what a month of delay costs at each phase, with the calculator to run your own numbers.

Get the calculator

Brief: The stop condition

The most useful sentence in a board pack is the stop condition. How to write one that earns trust. Four pages, free.

Get the brief

More free briefs on this topic: The wrong shape of problem

Watch: the video series

Latest from this hub

Subgroup rescue: pre-specification is the weakest defence in the room

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

When a subgroup is the last thing standing after a Phase 2 miss, pre-specification alone will not save it. What regulators actually check.

Read the article
When to kill, pivot or partner a program

When to kill, pivot or partner a program

A decision guide for the three hardest words in drug development, with the criteria that make the call honest.

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Re-indication: the failure you don't diagnose comes with the molecule

Re-indication: the failure you don't diagnose comes with the molecule

The problem you never diagnosed does not stay behind when a molecule moves to a new indication, it travels with it.

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A Study In Failure: Learning From The Aducanumab Clinical Development Story

A Study In Failure: Learning From The Aducanumab Clinical Development Story

A close read of the Aducanumab program and the lessons it leaves for anyone facing an ambiguous readout.

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Case study: Learning from The Pembrolizumab Story

Case study: Learning from The Pembrolizumab Story

How the Pembrolizumab story separates a credible responder subgroup from a convenient one.

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Using RWE to bridge a failed or missing comparator

Using RWE to bridge a failed or missing comparator

When real world evidence can repair a broken comparison, and when it cannot.

Read the article

Staring at a readout like that now?

Time matters more here than anywhere else on this site: runway burns while the program waits. Get in touch and we will tell you quickly, and honestly, whether there is something to work with.

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