Phase III

Hematology

pain 87#8volume 881#30

Pain rank 8 of 76, volume rank 30 of 76 by industry trials. Trials here amend about 1.6x and fail enrollment about 1.2x 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 63 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 $28M at stake per 100 trials. Across the roughly 881 industry trials here, the floor is $251M.

If amendments fell by10%$25M30%$75M50%$125M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors87pain index
Eligibility amendments
63%vs map 40%proxyn = 239sampled
Enrollment failure
16%vs map 13%n = 722concluded
Startup lag
79 dvs map 45.5 dn = 547with dates
Median duration
24.0 mon = 832completed
All sponsors89pain index
Eligibility amendments
55%proxyn = 330sampled
Enrollment failure
18%n = 1,173concluded
Startup lag
94 dn = 942with dates
Median duration
25.3 mon = 1,501completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (30 of 112 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 accrual30 (27%)
Safety or tolerability20 (18%)
Sponsor decision16 (14%)
Not reported13 (12%)
Efficacy or futility9 (8%)
External or regulatory8 (7%)
No enrollment recorded (inferred)inferred5 (4%)
Other stated reason4 (4%)
Feasibility or operational failure4 (4%)
Superseded by another study1 (1%)
Business or funding1 (1%)
Logistics or operations1 (1%)
n = 112terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT06568302ApcinteX LtdterminatedSponsor decision
NCT06297486Spark Therapeutics, Inc.withdrawnSponsor decision
NCT05951205Vertex Pharmaceuticals IncorporatedwithdrawnSponsor decision
NCT05695391Laboratoire français de Fractionnement et de BiotechnologiesterminatedLow accrual
NCT05632354PfizerterminatedFeasibility or operational failure
NCT05561140PfizerterminatedExternal or regulatory
NCT05348915PfizerterminatedSponsor decision
NCT05261646Jiangsu HengRui Medicine Co., Ltd.withdrawnSponsor decision
NCT05228834PfizerterminatedEfficacy or futility
NCT05131204Regeneron PharmaceuticalsterminatedSafety or tolerability
NCT05082584Akebia TherapeuticswithdrawnSponsor decision
NCT05082571Akebia TherapeuticswithdrawnSponsor decision

Hematology at other phases