Mi­nor­i­ty pa­tients un­der­rep­re­sent­ed in Covid-19 tri­als de­spite greater will­ing­ness to par­tic­i­pate, re­port finds

When Wan­da Mc­Clain was work­ing at Brigham and Women’s Hos­pi­tal last March and April, she and oth­er clin­i­cians no­ticed some­thing about the sick pa­tients oc­cu­py­ing beds.

“They were much more di­verse than, you know, our tra­di­tion­al pa­tients,” the for­mer VP of com­mu­ni­ty health and health eq­ui­ty said. “It showed very clear­ly the dis­pro­por­tion­ate im­pact that Covid is hav­ing on com­mu­ni­ties of col­or.”

What Mc­Clain ob­served in Boston is on par with num­bers col­lect­ed across the coun­try. Black Amer­i­cans are near­ly three times more like­ly than white Amer­i­cans to be hos­pi­tal­ized with Covid-19, and near­ly twice as like­ly to die, the CDC re­ports. His­pan­ic or Lat­inx Amer­i­cans are three times as like­ly to find them­selves in a hos­pi­tal bed, and more than twice as like­ly to die. And Amer­i­can In­di­an or Alas­ka Na­tive com­mu­ni­ty mem­bers are 3.5 times as like­ly to be hos­pi­tal­ized, and more than twice as like­ly to die.

Wan­da Mc­Clain

Yet Black par­tic­i­pants made up on­ly 9.7% and 9.8% of Mod­er­na and Pfiz­er/BioN­Tech’s Phase III vac­cine tri­als, re­spec­tive­ly — de­spite rep­re­sent­ing just over 13% of the US pop­u­la­tion. His­pan­ic or Lat­inx vol­un­teers made up 20% and 26.2%, which is ac­tu­al­ly over cen­sus lev­els. But Amer­i­can In­di­an and Alas­ka Na­tive vol­un­teers? Just 0.8% and 0.6% of the tri­als, re­spec­tive­ly.

“A lot has hap­pened I think in the last 12 to 18 months, and we thought it was re­al­ly ap­pro­pri­ate at this point in time to re­al­ly dig deeply in­to some of those chal­lenges that have sur­faced,” Clare Grace, Parex­el’s first chief pa­tient of­fi­cer, told End­points News. 

The New­ton, MA-based CRO con­duct­ed lis­ten­ing ses­sions with physi­cians, in­ter­views with the pub­lic, pa­tient ad­vi­so­ry coun­cil meet­ings, and a glob­al sur­vey to gauge per­spec­tives on clin­i­cal tri­al di­ver­si­ty. And on Thurs­day morn­ing, it pub­lished the re­sults.

Clare Grace

A key theme that emerged was trust, both Grace and Mc­Clain said — or rather, a lack there­of.

“This is be­fore the vac­cine was ac­tu­al­ly ap­proved for emer­gency use, and I think we were in the midst of ap­point­ing peo­ple to the vac­cine tri­als, so we were run­ning up against those is­sues of trust and mis­trust,” Mc­Clain said, who par­tic­i­pat­ed in a fo­cus group with oth­er physi­cians.

One in­ter­est­ing find­ing was that of 1,945 peo­ple sur­veyed in the US, Cana­da, UK, Aus­tralia, France, Hun­gary, Italy, Mex­i­co, Poland and Spain, more non-white re­spon­dents said they’d be both will­ing to par­tic­i­pate in a Covid-19 tri­al and take a vac­cine. Yet in the US, com­mu­ni­ties of col­or are now get­ting vac­ci­nat­ed at much slow­er rates.

“I think what’s re­al­ly im­por­tant to re­mem­ber is that, you know, dif­fer­ent coun­tries have dif­fer­ent ex­pe­ri­ences around the pan­dem­ic in par­tic­u­lar,” Grace said. “And so some of those coun­tries have had very, very dif­fi­cult times, where­as oth­ers have got more so­phis­ti­cat­ed health­care sys­tems and (are) gen­er­al­ly a lit­tle bit more in­clu­sive.”

When Brigham and Women’s set up Covid-19 test­ing, Mc­Clain no­ticed that peo­ple of col­or want­ed to get test­ed, but were lim­it­ed by a lack of in­for­ma­tion, or a lack of trust.

“It’s hard to have trust if peo­ple don’t know you,” she said.

So the hos­pi­tal dis­trib­uted in­for­ma­tion in mul­ti­ple lan­guages, and screened peo­ple for so­cial de­ter­mi­nants of health. They hand­ed out bags of gro­ceries at the test sites, and did things like screen for do­mes­tic vi­o­lence.

“Re­al­ly be­gin­ning to ad­dress those bar­ri­ers that might lim­it some­one’s abil­i­ty to par­tic­i­pate in the tri­al, that was a big piece of it — of earn­ing their trust and ed­u­cat­ing them at the same time,” she said.

Oth­er bar­ri­ers dis­cussed in the re­port in­clude how much time it takes to par­tic­i­pate in a clin­i­cal tri­al, or the trans­porta­tion re­quired to get to a tri­al site. Sur­vey par­tic­i­pants cit­ed the num­ber of re­quired study vis­its as the great­est bar­ri­er, fol­lowed by vis­it du­ra­tion, and pay­ment for trav­el or for par­tic­i­pa­tion.

“Clin­i­cal tri­als, es­pe­cial­ly those with­in mi­nori­ties and in cer­tain ar­eas, need to be ac­ces­si­ble for those with lim­i­ta­tions, both phys­i­cal­ly and fi­nan­cial­ly. Many for­get that even in this day and age not every­one has ac­cess to the in­ter­net or pub­lic forms of trans­porta­tion,” an un­named re­spon­dent said.

“Some women, some African Amer­i­can women, don’t have time to come to chemo be­cause they have chil­dren at home that have to be cared for,” said Yas­meem Wat­son, a pa­tient ad­vi­so­ry coun­cil mem­ber. “They don’t have time to come to med­ical ap­point­ments. They would love to be cured and love to be healed, but some­times it is be­yond their con­trol.”

Go­ing forth, Mc­Clain says she wants to see bio­phar­ma com­pa­nies hold them­selves ac­count­able, and de­vel­op ro­bust com­mu­ni­ty en­gage­ment strate­gies around “get­ting to know and in­vest­ing in — and I’m us­ing that word de­lib­er­ate­ly — mak­ing in­vest­ments in those com­mu­ni­ties.” That means lis­ten­ing to pa­tients, and cre­at­ing pro­grams for young peo­ple to build the next gen­er­a­tion of di­verse pro­fes­sion­als.

“None of this is go­ing to be done with a snap of the fin­ger,” she said.

So­cial: via Parex­el web­site

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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