Phase IV

Cardiovascular

pain 69#20volume 930#25

Pain rank 20 of 76, volume rank 25 of 76 by industry trials. Trials here amend about 1.2x and fail enrollment about 1.1x 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 47 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 $21M at stake per 100 trials. Across the roughly 930 industry trials here, the floor is $196M.

If amendments fell by10%$20M30%$59M50%$98M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors69pain index
Eligibility amendments
47%vs map 40%proxyn = 47sampled
Enrollment failure
15%vs map 13%n = 834concluded
Startup lag
59 dvs map 45.5 dn = 299with dates
Median duration
21.1 mon = 829completed
All sponsors56pain index
Eligibility amendments
30%proxyn = 89sampled
Enrollment failure
17%n = 3,207concluded
Startup lag
73 dn = 1,976with dates
Median duration
24.1 mon = 4,381completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (38 of 125 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 accrual38 (30%)
Sponsor decision28 (22%)
Not reported19 (15%)
No enrollment recorded (inferred)inferred10 (8%)
Safety or tolerability5 (4%)
Change in standard of care5 (4%)
Efficacy or futility5 (4%)
Other stated reason3 (2%)
Completed or objective met2 (2%)
Investigator decision or departure2 (2%)
Never initiated2 (2%)
External or regulatory2 (2%)
Logistics or operations2 (2%)
Superseded by another study1 (1%)
Feasibility or operational failure1 (1%)
n = 125terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT06708611Sarfez Pharmaceuticals, Inc.withdrawnLow accrual
NCT05473715BayerterminatedSafety or tolerability
NCT05312970Boston Scientific CorporationterminatedLow accrual
NCT04955990ActelionterminatedSponsor decision
NCT04702789Laboratorios Sophia S.A de C.V.terminatedSponsor decision
NCT04491136Novartis PharmaceuticalsterminatedSponsor decision
NCT04435782ActelionterminatedLow accrual
NCT04140279Bausch & Lomb IncorporatedwithdrawnNever initiated
NCT04088266Teva Pharmaceuticals USAwithdrawnLogistics or operations
NCT03851276ECRI bvwithdrawnSponsor decision
NCT03851263ECRI bvwithdrawnSponsor decision
NCT03694197Regeneron PharmaceuticalsterminatedSafety or tolerability

Cardiovascular at other phases