Phase I

Infectious Disease

pain 20#63volume 2,293#7

Pain rank 63 of 76, volume rank 7 of 76 by industry trials. Trials here amend about 0.7x 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 29 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 $13M at stake per 100 trials. Across the roughly 2,293 industry trials here, the floor is $302M.

If amendments fell by10%$30M30%$91M50%$151M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors20pain index
Eligibility amendments
29%vs map 40%proxyn = 41sampled
Enrollment failure
10%vs map 13%n = 1,990concluded
Startup lag
32 dvs map 45.5 dn = 1,232with dates
Median duration
7.8 mon = 2,151completed
All sponsors20pain index
Eligibility amendments
31%proxyn = 87sampled
Enrollment failure
10%n = 3,926concluded
Startup lag
49 dn = 2,483with dates
Median duration
11.3 mon = 4,186completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (51 of 192 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 decision51 (27%)
Low accrual47 (24%)
Safety or tolerability24 (13%)
Not reported16 (8%)
Efficacy or futility11 (6%)
External or regulatory6 (3%)
Business or funding6 (3%)
No enrollment recorded (inferred)inferred6 (3%)
Superseded by another study6 (3%)
Logistics or operations5 (3%)
Technical or device issue5 (3%)
Other stated reason3 (2%)
Completed or objective met2 (1%)
Change in standard of care2 (1%)
Never initiated1 (1%)
Investigator decision or departure1 (1%)
n = 192terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT07115368Gilead SciencesterminatedSponsor decision
NCT07052682TakedaterminatedSponsor decision
NCT06888518Institut AllergoSan Pharma GmbHterminatedLow accrual
NCT06666179Clover Biopharmaceuticals AUS PtywithdrawnLow accrual
NCT06533280ViiV HealthcarewithdrawnSponsor decision
NCT06430905Hookipa Biotech GmbHterminatedSponsor decision
NCT06162299Yisheng Biopharma (Singapore) Pte. Ltd.terminatedSponsor decision
NCT06159062Yangshengtang Co., LtdterminatedLow accrual
NCT06102174PfizerterminatedLow accrual
NCT06055777Suzhou Erye Pharmaceutical Co., Ltd.terminatedCompleted or objective met
NCT05942820Bugworks Research Inc.terminatedTechnical or device issue
NCT05867056Immunocore LtdwithdrawnLow accrual

Infectious Disease at other phases