Phase I

Gastroenterology

pain 10#70volume 598#43

Pain rank 70 of 76, volume rank 43 of 76 by industry trials. Trials here amend about 0.7x and fail enrollment about 0.4x 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 27 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 $12M at stake per 100 trials. Across the roughly 598 industry trials here, the floor is $72M.

If amendments fell by10%$7M30%$21M50%$36M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors10pain index
Eligibility amendments
27%vs map 40%proxyn = 45sampled
Enrollment failure
6%vs map 13%n = 525concluded
Startup lag
29 dvs map 45.5 dn = 345with dates
Median duration
7.0 mon = 587completed
All sponsors8pain index
Eligibility amendments
24%proxyn = 90sampled
Enrollment failure
10%n = 735concluded
Startup lag
38 dn = 499with dates
Median duration
9.5 mon = 910completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (13 of 31 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 decision13 (42%)
Safety or tolerability7 (23%)
Low accrual7 (23%)
Efficacy or futility2 (6%)
Not reported2 (6%)
n = 31terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT06272058Boehringer IngelheimterminatedSponsor decision
NCT05517226AstraZenecaterminatedSafety or tolerability
NCT05490030Novartis PharmaceuticalswithdrawnSponsor decision
NCT05407766Ossium Health, Inc.withdrawnSponsor decision
NCT05376839AbbVieterminatedSponsor decision
NCT05259085Alexion Pharmaceuticals, Inc.terminatedSponsor decision
NCT05126329SanofiterminatedSafety or tolerability
NCT05006950Stryker EndoscopyterminatedLow accrual
NCT04655599Arena PharmaceuticalsterminatedSponsor decision
NCT04332523Janssen Research & Development, LLCterminatedSafety or tolerability
NCT04252417MedDay Pharmaceuticals SAterminatedEfficacy or futility
NCT04136444UCB Biopharma S.P.R.L.terminatedSponsor decision

Gastroenterology at other phases