De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to di­ver­si­fy clin­i­cal tri­als have grown loud­er in re­cent years — gain­ing sup­port from fed­er­al agen­cies such as the FDA and NIH — progress has large­ly stalled, ac­cord­ing to a new re­port from the Na­tion­al Acad­e­mies of Sci­ences, En­gi­neer­ing and Med­i­cine.

Swaths of pa­tients in racial and eth­nic mi­nor­i­ty groups, as well as LGBTQIA+, preg­nant and old­er adult pop­u­la­tions con­tin­ue to be left out of clin­i­cal tri­als. While some ad­vances have been made in the last 30 years — women now ac­count for rough­ly half of clin­i­cal tri­al par­tic­i­pants — growth in oth­er ar­eas re­mains stag­nant, ac­cord­ing to the re­port, which was man­dat­ed by Con­gress and spon­sored by the NIH.

Just look at an FDA sum­ma­ry re­port of clin­i­cal tri­als con­duct­ed be­tween 2015 and 2019, the au­thors said. Non-His­pan­ic white pa­tients made up 78% of par­tic­i­pants, de­spite com­pris­ing on­ly 61% of the pop­u­la­tion.

Those num­bers are par for the course in bio­phar­ma. Of the 53 drugs ap­proved back in 2020, white par­tic­i­pants made up more than 80% of the tri­als reg­u­la­tors based their de­ci­sions on. Mean­while, Black pa­tients rep­re­sent­ed about 8% of par­tic­i­pants, de­spite rep­re­sent­ing about 13% of the US pop­u­la­tion. Asian pa­tients com­prised just over 6% of clin­i­cal tri­al par­tic­i­pants, while Na­tive Amer­i­can pa­tients rep­re­sent­ed less than 1%.

How­ev­er, it’s dif­fi­cult to com­pare da­ta, be­cause there are in­con­sis­ten­cies across agen­cies, ac­cord­ing to au­thor and Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co pro­fes­sor Kirsten Bib­bins-Domin­go.

“The qual­i­ty of da­ta in this area is re­al­ly poor,” she told End­points News. “So al­though we’ve had goals, we don’t know the progress to­wards goals be­cause the da­ta [are] not there.”

A lack of rep­re­sen­ta­tion on­ly com­pounds ex­ist­ing health dis­par­i­ties, the au­thors ar­gue. It pre­vents cer­tain pa­tients from get­ting ac­cess to ef­fec­tive treat­ments and hin­ders in­no­va­tion. That’s im­por­tant be­cause not all hu­mans are the same bi­o­log­i­cal­ly, and not every­one re­acts to drugs in the same way.

Take efavirenz, for ex­am­ple, the an­ti­retro­vi­ral med­ica­tion used to treat and pre­vent HIV/AIDS sold un­der the brand name Sus­ti­va. Re­search sug­gests that HIV pa­tients of African de­scent are pre­dis­posed to de­vel­op­ing neu­ropsy­chi­atric side ef­fects af­ter tak­ing efavirenz, due to spe­cif­ic CYP2B6 ge­net­ic vari­ants that cause im­paired me­tab­o­lism of the drug.

There’s al­so the blood thin­ner war­farin, the au­thors point­ed out. Giv­en cor­rect­ly, it helps pre­vent blood clots that can lead to strokes or pul­monary em­bolism. How­ev­er, too much war­farin can lead to ex­ces­sive bleed­ing. Pa­tients’ dose re­quire­ments vary wide­ly, de­pend­ing on the pres­ence of spe­cif­ic ge­net­ic vari­ants. For ex­am­ple, pop­u­la­tions with African an­ces­try are more like­ly to re­quire high­er av­er­age dai­ly dos­es, while pa­tients with Asian an­ces­try tend to re­quire low­er dos­es.

“Specif­i­cal­ly, re­search has demon­strat­ed that many groups un­der­rep­re­sent­ed and ex­clud­ed in clin­i­cal re­search can have dis­tinct dis­ease pre­sen­ta­tions or health cir­cum­stances that af­fect how they will re­spond to an in­ves­ti­ga­tion­al drug or ther­a­py,” the re­port states.

Poor rep­re­sen­ta­tion in clin­i­cal tri­als could even cost the coun­try hun­dreds of bil­lions of dol­lars, the au­thors added.

“Giv­en the as­sump­tion that bet­ter rep­re­sen­ta­tion in clin­i­cal tri­als would re­duce health dis­par­i­ties by even a mod­est amount, the analy­sis found that achiev­ing di­verse rep­re­sen­ta­tion in re­search would be worth bil­lions of dol­lars in sav­ings to the Unit­ed States,” they said.

Clin­i­cal tri­al di­ver­si­ty has be­come a pol­i­cy pri­or­i­ty in re­cent years — the FDA re­leased new draft guid­ance on the top­ic just a cou­ple months ago — which is an im­por­tant first step, the au­thors ac­knowl­edge. But ef­forts can’t end there.

The au­thors high­light­ed suc­cess­ful tac­tics for im­prove­ment, in­clud­ing es­tab­lish­ing trust with the com­mu­ni­ty, adopt­ing more flex­i­ble ap­proach­es to re­cruit­ment and da­ta col­lec­tion, and en­sur­ing di­verse lead­er­ship ex­ists at all en­ti­ties in­volved with clin­i­cal tri­als, from aca­d­e­m­ic cen­ters to reg­u­la­to­ry agen­cies.

The cur­rent lack of rep­re­sen­ta­tion is not be­cause pa­tients don’t want to par­tic­i­pate, Bib­bins-Domin­go said.

“There’s no ev­i­dence that the com­mu­ni­ties that are un­der­rep­re­sent­ed sys­tem­at­i­cal­ly don’t want to par­tic­i­pate,” she said. “There are some won­der­ful, beau­ti­ful, bril­liant ex­am­ples of in­ves­tiga­tive teams work­ing to­geth­er with com­mu­ni­ty part­ners to achieve very high rates of par­tic­i­pa­tion and in stud­ies.”

But it will al­so take time and mon­ey, the au­thors said.

“This in­cludes ex­pand­ed bud­gets for teams re­cruit­ing and re­tain­ing di­verse par­tic­i­pants, sup­port to ex­pand in­fra­struc­ture for com­mu­ni­ty or­ga­ni­za­tions, and in­vest­ments in com­mu­ni­ty-based part­ner­ships to re­duce pow­er dif­fer­en­tials be­tween re­searchers and par­tic­i­pants,” they wrote.

They al­so rec­om­mend­ed that the De­part­ment of Health and Hu­man Ser­vices es­tab­lish a task force fo­cused on re­search eq­ui­ty, that would be charged with co­or­di­nat­ing da­ta col­lec­tion and de­vel­op­ing bet­ter track­ing sys­tems across fed­er­al agen­cies.

“Gain­ing a ful­ly ac­cu­rate sta­tus of the cur­rent par­tic­i­pa­tion of un­der­rep­re­sent­ed pop­u­la­tions in clin­i­cal tri­als and clin­i­cal re­search, and trends in par­tic­i­pa­tion over time, is very chal­leng­ing due to in­suf­fi­cient da­ta-re­port­ing prac­tices at a na­tion­al lev­el,” the re­port states.

The au­thors al­so rec­om­mend that the FDA re­quire study spon­sors to sub­mit a re­cruit­ment plan de­tail­ing how they’ll en­sure tri­al di­ver­si­ty no lat­er than their IND or IDE sub­mis­sion.

Last month, in its draft guid­ance, the FDA called for drug­mak­ers to sub­mit such plans to the rel­e­vant IND ap­pli­ca­tion “as soon as prac­ti­ca­ble,” though def­i­nite­ly be­fore they seek feed­back on piv­otal tri­als.

“There are many peo­ple who are do­ing re­al­ly great work in this area and there are many peo­ple who have fig­ured out strate­gies that work, who are com­mit­ted to these types of is­sues,” Bib­bins-Domin­go said.

She added: “I think that what we would like to be able to do, and I think what the re­port speaks to, is to cre­ate a more en­abling en­vi­ron­ment that al­lows re­searchers and par­tic­i­pants and com­mu­ni­ties that are most af­fect­ed to ac­tu­al­ly work in part­ner­ship, so that the sci­ence that we in­vest in in this coun­try re­al­ly has the po­ten­tial to im­prove lives for all Amer­i­cans.”

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

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One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

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