Phase I

Immunology & Inflammation

pain 33#56volume 1,101#22

Pain rank 56 of 76, volume rank 22 of 76 by industry trials. Trials here amend about 0.7x 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 30 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 $14M at stake per 100 trials. Across the roughly 1,101 industry trials here, the floor is $146M.

If amendments fell by10%$15M30%$44M50%$73M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors33pain index
Eligibility amendments
30%vs map 40%proxyn = 44sampled
Enrollment failure
13%vs map 13%n = 856concluded
Startup lag
39 dvs map 45.5 dn = 638with dates
Median duration
11.7 mon = 1,073completed
All sponsors47pain index
Eligibility amendments
35%proxyn = 86sampled
Enrollment failure
18%n = 1,219concluded
Startup lag
49 dn = 1,008with dates
Median duration
15.0 mon = 1,665completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (40 of 109 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 decision40 (37%)
Low accrual17 (16%)
Safety or tolerability15 (14%)
Not reported11 (10%)
Efficacy or futility6 (6%)
Other stated reason5 (5%)
No enrollment recorded (inferred)inferred4 (4%)
Superseded by another study3 (3%)
External or regulatory2 (2%)
Logistics or operations2 (2%)
Business or funding1 (1%)
Feasibility or operational failure1 (1%)
Never initiated1 (1%)
Completed or objective met1 (1%)
n = 109terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT07049081Nanjing Legend Biotech Co.terminatedSponsor decision
NCT07029971Vial Australia Pty LtdterminatedEfficacy or futility
NCT06866080Nanjing Legend Biotech Co.withdrawnSponsor decision
NCT06752876Caribou Biosciences, Inc.withdrawnSponsor decision
NCT06681389NIBEC Co., Ltd.terminatedSafety or tolerability
NCT06548620Nanjing Bioheng Biotech Co., Ltd.withdrawnSponsor decision
NCT06524687IGM Biosciences, Inc.terminatedSponsor decision
NCT06522035Enlivex Therapeutics Ltd.terminatedSponsor decision
NCT06429800Atara BiotherapeuticswithdrawnBusiness or funding
NCT06413511GlaxoSmithKlinewithdrawnSponsor decision
NCT06411639Novartis PharmaceuticalswithdrawnSponsor decision
NCT06377228TakedawithdrawnSafety or tolerability

Immunology & Inflammation at other phases