Phase I

General & cross-cutting

pain 12#67volume 817#33

Pain rank 67 of 76, volume rank 33 of 76 by industry trials. Trials here amend about 0.5x and fail enrollment about 0.6x 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 19 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 $9M at stake per 100 trials. Across the roughly 817 industry trials here, the floor is $70M.

If amendments fell by10%$7M30%$21M50%$35M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors12pain index
Eligibility amendments
19%vs map 40%proxyn = 42sampled
Enrollment failure
8%vs map 13%n = 673concluded
Startup lag
33 dvs map 45.5 dn = 393with dates
Median duration
5.0 mon = 804completed
All sponsors18pain index
Eligibility amendments
23%proxyn = 86sampled
Enrollment failure
11%n = 1,714concluded
Startup lag
60 dn = 1,168with dates
Median duration
11.4 mon = 2,427completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (17 of 55 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.

Sponsor decision17 (31%)
Low accrual11 (20%)
No enrollment recorded (inferred)inferred4 (7%)
Business or funding4 (7%)
Safety or tolerability4 (7%)
Logistics or operations3 (5%)
Efficacy or futility3 (5%)
Technical or device issue3 (5%)
Not reported2 (4%)
Completed or objective met1 (2%)
Never initiated1 (2%)
Superseded by another study1 (2%)
External or regulatory1 (2%)
n = 55terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT06768658TakedaterminatedSponsor decision
NCT06462924DeepMedswithdrawnLow accrual
NCT06225336Auregen Biotherapeutics, SAterminatedLow accrual
NCT06077903Grit BiotechnologyterminatedSponsor decision
NCT06000891Zealand PharmaterminatedSponsor decision
NCT05903274Jasper Therapeutics, Inc.terminatedEfficacy or futility
NCT05724576Taiwan Bio Therapeutics Inc.terminatedSponsor decision
NCT05664100Frequency TherapeuticsterminatedSponsor decision
NCT05622058Aileron Therapeutics, Inc.terminatedLow accrual
NCT05609942Blueprint Medicines CorporationterminatedSponsor decision
NCT05323110Capella Bioscience LtdterminatedSponsor decision
NCT05128786Shanghai PerHum Therapeutics Co., Ltd.terminatedSponsor decision

General & cross-cutting at other phases