Phase II

Hematology

pain 96#1volume 664#37

Nothing on the map is more painful, volume rank 37 of 76 by industry trials. Trials here amend about 1.5x and fail enrollment about 1.8x 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 61 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 $27M at stake per 100 trials. Across the roughly 664 industry trials here, the floor is $182M.

If amendments fell by10%$18M30%$55M50%$91M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors96pain index
Eligibility amendments
61%vs map 40%proxyn = 236sampled
Enrollment failure
24%vs map 13%n = 530concluded
Startup lag
84 dvs map 45.5 dn = 381with dates
Median duration
20.8 mon = 618completed
All sponsors95pain index
Eligibility amendments
57%proxyn = 326sampled
Enrollment failure
26%n = 1,065concluded
Startup lag
85 dn = 911with dates
Median duration
25.2 mon = 1,507completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (36 of 129 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 accrual36 (28%)
Sponsor decision33 (26%)
Safety or tolerability18 (14%)
Not reported11 (9%)
Business or funding7 (5%)
Efficacy or futility6 (5%)
No enrollment recorded (inferred)inferred5 (4%)
Superseded by another study4 (3%)
Logistics or operations3 (2%)
Feasibility or operational failure2 (2%)
External or regulatory2 (2%)
Other stated reason1 (1%)
Completed or objective met1 (1%)
n = 129terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT07172022Hoffmann-La RochewithdrawnSafety or tolerability
NCT07155031Cerus CorporationwithdrawnBusiness or funding
NCT06611436Be BiopharmaterminatedSafety or tolerability
NCT06435845RallybioterminatedSponsor decision
NCT06286046Agios Pharmaceuticals, Inc.withdrawnLow accrual
NCT05927012Keros Therapeutics, Inc.withdrawnLow accrual
NCT05789537ApcinteX LtdterminatedSponsor decision
NCT05789524ApcinteX LtdterminatedSponsor decision
NCT05785819Veralox TherapeuticsterminatedSponsor decision
NCT05741346BioCryst PharmaceuticalsterminatedSponsor decision
NCT05565092Alexion Pharmaceuticals, Inc.terminatedSponsor decision
NCT05445128EnsomaterminatedSafety or tolerability

Hematology at other phases