Phase IV

Neurology

pain 58#31volume 545#46

Pain rank 31 of 76, volume rank 46 of 76 by industry trials. Trials here sit close to the map median on both amendments and enrollment failure.

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 38 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 $17M at stake per 100 trials. Across the roughly 545 industry trials here, the floor is $94M.

If amendments fell by10%$9M30%$28M50%$47M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors58pain index
Eligibility amendments
38%vs map 40%proxyn = 47sampled
Enrollment failure
15%vs map 13%n = 481concluded
Startup lag
61 dvs map 45.5 dn = 241with dates
Median duration
21.4 mon = 494completed
All sponsors57pain index
Eligibility amendments
30%proxyn = 87sampled
Enrollment failure
19%n = 1,445concluded
Startup lag
69 dn = 990with dates
Median duration
24.5 mon = 1,971completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (32 of 70 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 accrual32 (46%)
Not reported10 (14%)
Sponsor decision8 (11%)
No enrollment recorded (inferred)inferred8 (11%)
Other stated reason4 (6%)
Safety or tolerability2 (3%)
Efficacy or futility2 (3%)
Investigator decision or departure1 (1%)
Logistics or operations1 (1%)
Business or funding1 (1%)
External or regulatory1 (1%)
n = 70terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT06411145Dompé Farmaceutici S.p.AwithdrawnLow accrual
NCT05532163BiogenterminatedSponsor decision
NCT05284019H. Lundbeck A/SterminatedLow accrual
NCT05269667Hoffmann-La RocheterminatedLow accrual
NCT05208840Hoffmann-La RochewithdrawnExternal or regulatory
NCT04878211Novartis PharmaceuticalsterminatedSponsor decision
NCT04246619KRKAterminatedLow accrual
NCT04050293Supernus Pharmaceuticals, Inc.terminatedLow accrual
NCT03912337AmgenterminatedLow accrual
NCT03743103Cristália Produtos Químicos Farmacêuticos Ltda.terminatedLow accrual
NCT03126760Mallinckrodt ARD LLCterminatedLow accrual
NCT02575365Novartis PharmaceuticalsterminatedLow accrual

Neurology at other phases