Phase III

Nephrology & Urology

pain 65#25volume 618#41

Pain rank 25 of 76, volume rank 41 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 43 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 $19M at stake per 100 trials. Across the roughly 618 industry trials here, the floor is $121M.

If amendments fell by10%$12M30%$36M50%$61M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors65pain index
Eligibility amendments
43%vs map 40%proxyn = 46sampled
Enrollment failure
12%vs map 13%n = 519concluded
Startup lag
76 dvs map 45.5 dn = 259with dates
Median duration
22.0 mon = 556completed
All sponsors62pain index
Eligibility amendments
31%proxyn = 93sampled
Enrollment failure
16%n = 991concluded
Startup lag
91 dn = 594with dates
Median duration
24.0 mon = 1,250completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (19 of 63 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 accrual19 (30%)
Not reported12 (19%)
Sponsor decision10 (16%)
Efficacy or futility6 (10%)
Business or funding4 (6%)
No enrollment recorded (inferred)inferred4 (6%)
External or regulatory2 (3%)
Superseded by another study2 (3%)
Other stated reason1 (2%)
Safety or tolerability1 (2%)
Change in standard of care1 (2%)
Feasibility or operational failure1 (2%)
n = 63terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT05356403Cara Therapeutics, Inc.terminatedSponsor decision
NCT05342623Cara Therapeutics, Inc.terminatedSponsor decision
NCT05208866Palladio BiosciencesterminatedBusiness or funding
NCT05056727AstraZenecaterminatedLow accrual
NCT04968184KBP BiosciencesterminatedEfficacy or futility
NCT04786574Otsuka Pharmaceutical Development & Commercialization, Inc.withdrawnLow accrual
NCT04705051SanofiterminatedEfficacy or futility
NCT04641975Astellas Pharma Global Development, Inc.terminatedEfficacy or futility
NCT04152837Palladio BiosciencesterminatedBusiness or funding
NCT04146012Artegraft, Inc.terminatedSponsor decision
NCT04064346Palladio BiosciencesterminatedBusiness or funding
NCT03997318Cook MyoSitewithdrawnLow accrual

Nephrology & Urology at other phases