Da­ta re­veal that dif­fer­ent racial and eth­nic groups — by na­ture and/or nur­ture — can re­spond dif­fer­ent­ly in terms of phar­ma­co­ki­net­ics, ef­fi­ca­cy, or safe­ty to ther­a­peu­tics, but this dis­par­i­ty is not nec­es­sar­i­ly ac­count­ed for in clin­i­cal tri­als. A fresh analy­sis of the last decade of US can­cer drug ap­provals sug­gests the trend con­tin­ues, ce­ment­ing pre­vi­ous re­search that sug­gests on­col­o­gy tri­als are woe­ful­ly un­der-rep­re­sen­ta­tive of the racial make­up of the re­al world.

The study, pub­lished in the jour­nal JA­MA On­col­o­gy, eval­u­at­ed 230 tri­als to see whether spon­sors re­port­ed the racial com­po­si­tion of the pa­tients en­rolled in their stud­ies, and how mi­nori­ties were rep­re­sent­ed (ver­sus their ac­tu­al pop­u­la­tion preva­lence) in clin­i­cal tri­als that led to can­cer drug ap­provals from 2008 to 2018.

Re­searchers from the Uni­ver­si­ty of British Co­lum­bia, the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter, the Fred Hutchin­son Can­cer Cen­ter in Seat­tle and Bay­lor Uni­ver­si­ty found that 145 (63%) dis­closed at least one race — but a mea­ger 18 (7.8%) doc­u­ment­ed the four ma­jor races: White, Asian, Black and His­pan­ic.

Com­pared to the ac­tu­al make­up of US can­cer pa­tients — Blacks (22% of ex­pect­ed) and His­pan­ics (44% of ex­pect­ed) were un­der­rep­re­sent­ed com­pared with Whites (98% of ex­pect­ed) and Asians (438% of ex­pect­ed), the analy­sis found.

This pat­tern is con­sis­tent — even though the NIH re­quires that mi­nor­i­ty pop­u­la­tions be ap­pro­pri­ate­ly rep­re­sent­ed in clin­i­cal re­search. Cor­po­ra­tions, which car­ry the li­on’s share of drugs across the fin­ish line, are on­ly rec­om­mend­ed to shore up rep­re­sen­ta­tion by the FDA.

A study ex­plor­ing the rea­sons be­hind chron­ic un­der­rep­re­sen­ta­tion of mi­nori­ties in on­col­o­gy tri­als, pub­lished in 2016, cit­ed a sys­tem­at­ic re­view of late-stage can­cer tri­als from 1990 to 2000 and 2001 to 2010 showed that eth­nic mi­nori­ties, par­tic­u­lar­ly African-Amer­i­cans, were not ad­e­quate­ly rep­re­sent­ed.

In stud­ies con­duct­ed be­tween 2001 and 2010 that re­port­ed race/eth­nic­i­ty, re­view­ers found that 82.9% of par­tic­i­pants were White, 6.2% were African Amer­i­can, 3.3% were Asian, 2.2% were His­pan­ic, and 0.1% were Na­tive Amer­i­can. In tri­als con­duct­ed be­tween 1990 and 2000, 89% of par­tic­i­pants were White, 10.5% were African Amer­i­can, 0.4% were His­pan­ic, and 0.04% were Asian. Even though the pro­por­tion of White par­tic­i­pants de­creased across the two pe­ri­ods, Whites con­tin­ued to com­prise a large ma­jor­i­ty of par­tic­i­pants, and the pro­por­tion of African Amer­i­can par­tic­i­pants de­creased be­tween the pe­ri­ods 1990 to 2000 and 2001 to 2010, the re­searchers ex­trap­o­lat­ed. Low mi­nor­i­ty rep­re­sen­ta­tion re­sults from “pre­ventable and in­ter­linked poli­cies, prac­tices, and bar­ri­ers at the sys­tem, in­di­vid­ual, and in­ter­per­son­al lev­els,” they con­clud­ed.

The pat­tern of dis­pro­por­tion­ate en­roll­ment in tri­als test­ing treat­ments for can­cer — a dis­ease which there are pro­nounced racial and eth­nic dis­par­i­ties in in­ci­dence and mor­tal­i­ty — is es­pe­cial­ly con­cern­ing giv­en the new wave of check­point in­hibitors.

In a sep­a­rate study pub­lished this May, re­searchers found that Black pa­tients con­sti­tut­ed less than 4% of pa­tients re­cruit­ed across mul­ti­ple tri­als that sup­port­ed the ap­proval of im­mune check­point in­hibitors for lung can­cer. The dis­crep­an­cy was echoed in tri­als con­duct­ed in re­nal cell car­ci­no­ma and oth­er tu­mor types.

“The in­ad­e­quate rep­re­sen­ta­tion of mi­nor­i­ty pa­tients on im­munother­a­py clin­i­cal tri­als could per­pet­u­ate out­come dis­par­i­ty be­cause the unique bi­ol­o­gy of the host and the tu­mors from this sub­pop­u­la­tion is not ac­count­ed for as new treat­ment al­go­rithms to guide op­ti­mal use of im­munother­a­py are de­vel­oped for use in the re­al world,” the re­searchers sug­gest­ed.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.