Phase IV

Musculoskeletal

pain 61#29volume 273#65

Pain rank 29 of 76, volume rank 65 of 76 by industry trials. Trials here amend about 1.0x and fail enrollment about 1.5x 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 40 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 $18M at stake per 100 trials. Across the roughly 273 industry trials here, the floor is $50M.

If amendments fell by10%$5M30%$15M50%$25M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors61pain index
Eligibility amendments
40%vs map 40%proxyn = 47sampled
Enrollment failure
20%vs map 13%n = 237concluded
Startup lag
48 dvs map 45.5 dn = 72with dates
Median duration
20.0 mon = 231completed
All sponsors64pain index
Eligibility amendments
31%proxyn = 87sampled
Enrollment failure
20%n = 1,215concluded
Startup lag
73 dn = 800with dates
Median duration
22.0 mon = 1,639completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (17 of 48 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 accrual17 (35%)
No enrollment recorded (inferred)inferred5 (10%)
Sponsor decision5 (10%)
Safety or tolerability4 (8%)
Not reported4 (8%)
Investigator decision or departure4 (8%)
Feasibility or operational failure3 (6%)
Efficacy or futility1 (2%)
Other stated reason1 (2%)
External or regulatory1 (2%)
Completed or objective met1 (2%)
Business or funding1 (2%)
Logistics or operations1 (2%)
n = 48terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT05204667Aziende Chimiche Riunite Angelini Francesco S.p.AterminatedFeasibility or operational failure
NCT04472000Lindenhofgruppe AGterminatedLow accrual
NCT03955458Pacira Pharmaceuticals, IncwithdrawnLow accrual
NCT02981355Piramal Healthcare Canada LtdterminatedBusiness or funding
NCT02465099Ethicon Endo-SurgeryterminatedSafety or tolerability
NCT02255877ZipLine Medical Inc.withdrawnSponsor decision
NCT02161016RTI SurgicalterminatedLow accrual
NCT01874236SI-BONE, Inc.terminatedFeasibility or operational failure
NCT01631513Janssen Scientific Affairs, LLCwithdrawnSponsor decision
NCT01480167DFINE Inc.withdrawnLow accrual
NCT01475604Amp Orthopedics, Inc.terminatedSponsor decision
NCT01457742Amp Orthopedics, Inc.terminatedSponsor decision

Musculoskeletal at other phases