Phase III

Immunology & Inflammation

pain 68#22volume 1,956#12

Pain rank 22 of 76, volume rank 12 of 76 by industry trials. Trials here amend about 1.3x and fail enrollment about 1.0x 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 55 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 $25M at stake per 100 trials. Across the roughly 1,956 industry trials here, the floor is $480M.

If amendments fell by10%$48M30%$144M50%$240M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors68pain index
Eligibility amendments
55%vs map 40%proxyn = 44sampled
Enrollment failure
14%vs map 13%n = 1,634concluded
Startup lag
56 dvs map 45.5 dn = 1,112with dates
Median duration
22.0 mon = 1,865completed
All sponsors56pain index
Eligibility amendments
44%proxyn = 88sampled
Enrollment failure
15%n = 2,010concluded
Startup lag
63 dn = 1,446with dates
Median duration
23.8 mon = 2,462completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (61 of 221 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 decision61 (28%)
Low accrual40 (18%)
Efficacy or futility38 (17%)
Safety or tolerability36 (16%)
Not reported15 (7%)
No enrollment recorded (inferred)inferred14 (6%)
External or regulatory6 (3%)
Feasibility or operational failure3 (1%)
Other stated reason2 (1%)
Business or funding2 (1%)
Superseded by another study1 (0%)
Logistics or operations1 (0%)
Change in standard of care1 (0%)
Technical or device issue1 (0%)
n = 221terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT06654726NGM Biopharmaceuticals, IncwithdrawnFeasibility or operational failure
NCT06570772Alvotech Swiss AGterminatedSafety or tolerability
NCT06488911Intercept PharmaceuticalsterminatedExternal or regulatory
NCT06456567Vor BiopharmawithdrawnSponsor decision
NCT06128369OculisterminatedSafety or tolerability
NCT05962788Aurinia Pharmaceuticals Inc.terminatedSafety or tolerability
NCT05784129Janssen Research & Development, LLCterminatedSafety or tolerability
NCT05681481argenxterminatedSponsor decision
NCT05679401Hansa Biopharma ABterminatedSafety or tolerability
NCT05678959Novartis PharmaceuticalsterminatedSponsor decision
NCT05644665Bristol-Myers SquibbterminatedSponsor decision
NCT05637710Eurofarma Laboratorios S.A.withdrawnSponsor decision

Immunology & Inflammation at other phases