Phase IV

Infectious Disease

pain 45#43volume 899#27

Pain rank 43 of 76, volume rank 27 of 76 by industry trials. Trials here amend about 1.1x and fail enrollment about 0.8x the map median.

What this is worth

The amendment proxy, priced. Order of magnitude, anchor cited, assumptions on the table.

Per 100 industry trials in this cell, about 43 rewrite their eligibility criteria at least once. At the industry average of $450k direct cost per amendment, with the 6+ weeks of delay each not even counted, that is at least $19M at stake per 100 trials. Across the roughly 899 industry trials here, the floor is $176M.

If amendments fell by10%$18M30%$53M50%$88M

Assumes $450k direct cost per amendment (industry average; Phase II median runs lower, Phase III higher, and delay cost is excluded), applied to the proxy rate. The proxy counts only trials with at least one eligibility change, so this understates the true exposure. How this is derived.

The signals

Industry sponsors first, since that is the commercial buyer, each figure shown against the map median. All-sponsor figures follow. A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.

Industry sponsors45pain index
Eligibility amendments
43%vs map 40%proxyn = 46sampled
Enrollment failure
11%vs map 13%n = 783concluded
Startup lag
43 dvs map 45.5 dn = 352with dates
Median duration
14.0 mon = 823completed
All sponsors52pain index
Eligibility amendments
36%proxyn = 88sampled
Enrollment failure
15%n = 3,091concluded
Startup lag
65 dn = 2,148with dates
Median duration
21.2 mon = 4,149completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (37 of 85 stopped). A keyword pass runs first; free text it could not place was sorted once by a frozen AI classification into these same categories, auditable rather than a live model. "No enrollment recorded (inferred)" is not a stated reason: it is read from a zero enrollment count, meaning the trial never enrolled anyone. "Not reported" means the sponsor left the field blank, shown rather than hidden.

Low accrual37 (44%)
Not reported14 (16%)
Sponsor decision11 (13%)
No enrollment recorded (inferred)inferred6 (7%)
External or regulatory4 (5%)
Other stated reason4 (5%)
Logistics or operations3 (4%)
Business or funding3 (4%)
Efficacy or futility1 (1%)
Safety or tolerability1 (1%)
Change in standard of care1 (1%)
n = 85terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell. Each links to its ClinicalTrials.gov record.

TrialSponsorStatusStated reason
NCT05788991Medinova AGterminatedLow accrual
NCT05057897AstraZenecaterminatedLow accrual
NCT04999098A. Vogel AGterminatedLow accrual
NCT04656691Daniel GriffinterminatedExternal or regulatory
NCT04565392drpykessupplements.comwithdrawnBusiness or funding
NCT04003818SanofiterminatedLow accrual
NCT03923010Janssen Research & Development, LLCterminatedLow accrual
NCT03231228B. Braun Medical Inc.terminatedExternal or regulatory
NCT03192371GlaxoSmithKlinewithdrawnLogistics or operations
NCT03183492GlaxoSmithKlinewithdrawnSponsor decision
NCT03143998Merck Sharp & Dohme LLCwithdrawnSponsor decision
NCT03070314A. Vogel AGwithdrawnLow accrual

Infectious Disease at other phases