Over the last sev­er­al months, the pan­dem­ic has am­pli­fied calls for more di­verse clin­i­cal tri­als.

While mi­nor­i­ty pop­u­la­tions are con­tract­ing Covid-19 at high­er rates than white Amer­i­cans, they are no­tably un­der­rep­re­sent­ed in clin­i­cal tri­als. Black Amer­i­cans make up 13% of the US pop­u­la­tion, but on­ly 7% of par­tic­i­pants in clin­i­cal tri­als, ac­cord­ing to the FDA. And they’re be­ing in­fect­ed with Covid-19 at a 2.6 times high­er rate than white Amer­i­cans.

“The im­por­tance of di­ver­si­ty in the clin­i­cal tri­als for the vac­cines is just an­oth­er spot­light on an is­sue that’s been go­ing on for decades,” John Da­mon­ti, pres­i­dent of the Bris­tol My­ers Squibb Foun­da­tion, told End­points News. 

On Tues­day, the foun­da­tion launched a new pro­gram with the non­prof­it or­ga­ni­za­tion Na­tion­al Med­ical Fel­low­ships and backed it with $100 mil­lion to help clin­i­cal tri­als reach un­der­served pop­u­la­tions. The pro­gram con­sists of three parts: a train­ing com­po­nent for 250 new clin­i­cal in­ves­ti­ga­tors, fel­low­ships for 250 mi­nor­i­ty med­ical stu­dents, and an in­fra­struc­ture fund to help in­ves­ti­ga­tors build new clin­i­cal tri­al sites.

The new sites, he said, would ide­al­ly go “in clin­i­cal tri­al deserts where … the dis­ease bur­den is high but clin­i­cal tri­als don’t ex­ist in those sites, or even look to build­ing out in ur­ban cen­ters through safe­ty net hos­pi­tals and oth­ers.”

Prin­ci­pal in­ves­ti­ga­tors will men­tor the new clin­i­cal in­ves­ti­ga­tors who will men­tor the med­ical stu­dents, who will work in fed­er­al­ly qual­i­fied health cen­ters, safe­ty net hos­pi­tals and oth­er med­ical cen­ters in their com­mu­ni­ties.

“At the end of the day, even if you have 250 di­verse clin­i­cal in­ves­ti­ga­tors, if they’re not ac­tive­ly work­ing in the com­mu­ni­ties to build those re­la­tion­ships and build that trust, the pro­gram will not be as suc­cess­ful as it po­ten­tial­ly could be,” Da­mon­ti said.

The mon­ey comes from a $300 mil­lion com­mit­ment that Bris­tol My­ers Squibb and its foun­da­tion made back in Au­gust for health eq­ui­ty, di­ver­si­ty and in­clu­sion ef­forts. Na­tion­al Med­ical Fel­low­ships will help with im­ple­men­ta­tion, such as man­ag­ing com­po­nents of the ap­pli­ca­tion process and an in­de­pen­dent ad­vi­so­ry board.

Ap­pli­ca­tions will open in Jan­u­ary for clin­i­cal in­ves­ti­ga­tors, and Da­mon­ti ex­pects the first class to be­gin some­time in Sep­tem­ber.

“While the pa­tient re­sponse to med­ical ther­a­pies may dif­fer across racial and eth­nic sub­groups, clin­i­cal tri­als of­ten fail to rep­re­sent the de­mo­graph­ic di­ver­si­ty of the pop­u­la­tions that these prod­ucts aim to serve,” said Robert Winn, di­rec­tor of the Vir­ginia Com­mon­wealth Uni­ver­si­ty Massey Can­cer Cen­ter and chair of the na­tion­al ad­vi­so­ry com­mit­tee of the Bris­tol My­ers Squibb Foun­da­tion’s new pro­gram.

Black Amer­i­cans made up 20% of par­tic­i­pants in the NI­AID-fund­ed ACTT-1 tri­al of remde­sivir, ac­cord­ing to a New Eng­land Jour­nal of Med­i­cine piece. And Lat­inx and Na­tive Amer­i­cans, who are at a 2.8 times high­er risk of in­fec­tion than white Amer­i­cans, made up 23% and 0.7% of the ACTT-1 par­tic­i­pants, re­spec­tive­ly.

The is­sue isn’t unique to the pan­dem­ic. Out of 230 tri­als lead­ing to FDA on­col­o­gy OKs in the last decade or so, Black and Lat­inx par­tic­i­pants were “un­der­rep­re­sent­ed… rel­a­tive to their pro­por­tion among the US can­cer pop­u­la­tion,” ac­cord­ing to a piece pub­lished in JA­MA last year.

“The re­al out­come, and the im­pact of this pro­gram is go­ing to be mea­sured by the role that these in­di­vid­u­als can play in terms of at­tract­ing di­verse pa­tient pop­u­la­tions in­to clin­i­cal tri­als. That’s what this pro­gram has been cre­at­ed to do,” Da­mon­ti said. “We just want to make sure that the end of the day it’s the pa­tient that gets in­to the tri­al.”

A pre­vi­ous ver­sion of this ar­ti­cle stat­ed that the Bris­tol My­ers Squibb Foun­da­tion made a $300 mil­lion com­mit­ment in Au­gust for health eq­ui­ty ef­forts. The piece has been up­dat­ed to clar­i­fy that the biotech al­so par­tic­i­pat­ed in the com­mit­ment.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.