Phase III

General & cross-cutting

pain 67#24volume 836#32

Pain rank 24 of 76, volume rank 32 of 76 by industry trials. Trials here amend about 1.2x and fail enrollment about 0.9x 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 50 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 $23M at stake per 100 trials. Across the roughly 836 industry trials here, the floor is $188M.

If amendments fell by10%$19M30%$56M50%$94M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors67pain index
Eligibility amendments
50%vs map 40%proxyn = 40sampled
Enrollment failure
12%vs map 13%n = 718concluded
Startup lag
63 dvs map 45.5 dn = 386with dates
Median duration
14.0 mon = 807completed
All sponsors41pain index
Eligibility amendments
30%proxyn = 81sampled
Enrollment failure
13%n = 1,880concluded
Startup lag
74 dn = 1,127with dates
Median duration
18.8 mon = 2,530completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (21 of 87 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 accrual21 (24%)
Sponsor decision15 (17%)
Not reported13 (15%)
Safety or tolerability11 (13%)
Efficacy or futility10 (11%)
No enrollment recorded (inferred)inferred5 (6%)
Superseded by another study3 (3%)
Technical or device issue2 (2%)
External or regulatory2 (2%)
Logistics or operations1 (1%)
Other stated reason1 (1%)
Never initiated1 (1%)
Business or funding1 (1%)
Feasibility or operational failure1 (1%)
n = 87terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT07191912Applied Therapeutics, Inc.withdrawnLow accrual
NCT06963216Kedrion S.p.A.withdrawnSafety or tolerability
NCT06952686Sarepta Therapeutics, Inc.withdrawnSponsor decision
NCT05926349AstraZenecawithdrawnSponsor decision
NCT05788497Faes Farma, S.A.terminatedLow accrual
NCT05709093TJ Biopharma Co., Ltd.terminatedSponsor decision
NCT05683574Eurofarma Laboratorios S.A.withdrawnSponsor decision
NCT05568888CSL BehringterminatedSafety or tolerability
NCT05262517PfizerterminatedSafety or tolerability
NCT05238116Pulmocide LtdterminatedEfficacy or futility
NCT05206591Novartis PharmaceuticalswithdrawnSponsor decision
NCT05111600Holostem s.r.l.terminatedSponsor decision

General & cross-cutting at other phases