Phase I

Musculoskeletal

pain 36#53volume 261#66

Pain rank 53 of 76, volume rank 66 of 76 by industry trials. Trials here amend about 0.9x and fail enrollment about 0.7x 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 37 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 261 industry trials here, the floor is $43M.

If amendments fell by10%$4M30%$13M50%$22M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors36pain index
Eligibility amendments
37%vs map 40%proxyn = 46sampled
Enrollment failure
9%vs map 13%n = 210concluded
Startup lag
48 dvs map 45.5 dn = 124with dates
Median duration
9.7 mon = 239completed
All sponsors43pain index
Eligibility amendments
27%proxyn = 90sampled
Enrollment failure
14%n = 480concluded
Startup lag
76 dn = 335with dates
Median duration
14.7 mon = 680completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (6 of 19 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 decision6 (32%)
Not reported4 (21%)
Low accrual4 (21%)
Other stated reason2 (11%)
Efficacy or futility1 (5%)
Safety or tolerability1 (5%)
Superseded by another study1 (5%)
n = 19terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT06236308BioTissue Holdings, IncwithdrawnSponsor decision
NCT05956509AbbVieterminatedSponsor decision
NCT05317013Canopy Growth CorporationterminatedLow accrual
NCT05082831HistogenterminatedLow accrual
NCT04974359H. Lundbeck A/SterminatedLow accrual
NCT04835389VIVEX Biologics, Inc.withdrawnSponsor decision
NCT04483297Asahi Kasei Therapeutics CorporationterminatedSponsor decision
NCT03602872Clinica Santa Clarita, MexicowithdrawnSuperseded by another study
NCT03246399Biosplice Therapeutics, Inc.terminatedLow accrual
NCT03065959Astellas Pharma Global Development, Inc.terminatedEfficacy or futility
NCT02337387Eli Lilly and CompanyterminatedSafety or tolerability
NCT01159873CephalonterminatedSponsor decision

Musculoskeletal at other phases