Phase I

Hematology

pain 28#59volume 404#54

Pain rank 59 of 76, volume rank 54 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 35 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 $16M at stake per 100 trials. Across the roughly 404 industry trials here, the floor is $63M.

If amendments fell by10%$6M30%$19M50%$32M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors28pain index
Eligibility amendments
35%vs map 40%proxyn = 43sampled
Enrollment failure
12%vs map 13%n = 324concluded
Startup lag
35 dvs map 45.5 dn = 205with dates
Median duration
9.3 mon = 397completed
All sponsors58pain index
Eligibility amendments
34%proxyn = 89sampled
Enrollment failure
17%n = 523concluded
Startup lag
68 dn = 400with dates
Median duration
14.0 mon = 725completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (11 of 39 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 decision11 (28%)
Not reported8 (21%)
Low accrual8 (21%)
Safety or tolerability5 (13%)
External or regulatory2 (5%)
No enrollment recorded (inferred)inferred1 (3%)
Logistics or operations1 (3%)
Change in standard of care1 (3%)
Other stated reason1 (3%)
Technical or device issue1 (3%)
n = 39terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT07431398Fulcrum TherapeuticsterminatedSponsor decision
NCT06291415HutchmedwithdrawnSponsor decision
NCT05660265GlaxoSmithKlineterminatedSafety or tolerability
NCT05238207Bond BiosciencesterminatedSponsor decision
NCT04925206EdiGene (GuangZhou) Inc.terminatedSponsor decision
NCT04594031ExCellThera inc.withdrawnChange in standard of care
NCT04443907Novartis PharmaceuticalsterminatedSafety or tolerability
NCT04409080Regeneron PharmaceuticalsterminatedSponsor decision
NCT04176653Silence Therapeutics plcwithdrawnLogistics or operations
NCT04091737CSL BehringterminatedSafety or tolerability
NCT03996486BayerwithdrawnSponsor decision
NCT03346083Alexion Pharmaceuticals, Inc.terminatedSponsor decision

Hematology at other phases