Phase I

Healthy Volunteers

pain 1#76volume 9,136#2

Pain rank 76 of 76, volume rank 2 of 76 by industry trials. Trials here amend about 0.3x and fail enrollment about 0.3x 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 12 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 $5M at stake per 100 trials. Across the roughly 9,136 industry trials here, the floor is $478M.

If amendments fell by10%$48M30%$144M50%$239M

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 A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.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 sponsors1pain index
Eligibility amendments
12%vs map 40%proxyn = 43sampled
Enrollment failure
4%vs map 13%n = 8,410concluded
Startup lag
19 dvs map 45.5 dn = 4,108with dates
Median duration
3.0 mon = 8,891completed
All sponsors1pain index
Eligibility amendments
16%proxyn = 86sampled
Enrollment failure
5%n = 9,301concluded
Startup lag
21 dn = 4,580with dates
Median duration
3.0 mon = 9,913completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (131 of 367 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 decision131 (36%)
Safety or tolerability54 (15%)
Not reported53 (14%)
No enrollment recorded (inferred)inferred28 (8%)
Low accrual28 (8%)
Efficacy or futility22 (6%)
Other stated reason15 (4%)
Completed or objective met9 (2%)
Logistics or operations7 (2%)
Business or funding6 (2%)
External or regulatory5 (1%)
Never initiated4 (1%)
Feasibility or operational failure2 (1%)
Technical or device issue2 (1%)
Superseded by another study1 (0%)
n = 367terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell.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

TrialSponsorStatusStated reason
NCT07470866PfizerterminatedSafety or tolerability
NCT07250048Boehringer IngelheimterminatedSponsor decision
NCT07242781CelgeneterminatedSponsor decision
NCT07155980Acta PharmaceuticalswithdrawnLow accrual
NCT07086664PfizerterminatedSafety or tolerability
NCT07065617Boehringer IngelheimterminatedSponsor decision
NCT07039929Incyte CorporationterminatedSponsor decision
NCT07016464reMYNDterminatedSponsor decision
NCT07007520Dong-A ST Co., Ltd.withdrawnSponsor decision
NCT06910709AmgenterminatedSponsor decision
NCT06840769Helsinn Healthcare SAterminatedSponsor decision
NCT06821750PfizerterminatedLow accrual

Healthy Volunteers at other phases