The Underlying Condition: Increasing Diversity in Clinical Trials

Opinion: African-Americans, at 12 percent of the population, comprise only 5 percent of clinical-trial participants; the numbers for Hispanics are 16 percent and 1 percent. It’s time for that inequity to change, PhRMA’s CEO says.

National Journal
John Castellani
Feb. 20, 2014, 11:52 a.m.

When a pa­tient picks up her pre­scrip­tion for rheum­at­oid arth­rit­is, she knows it will en­able her to hold her grand­son with less pain. The heart-dis­ease sur­viv­or takes his stat­in to avoid by­pass sur­gery that could sig­ni­fic­antly im­pact his qual­ity of life. Med­ic­al in­nov­a­tions have the power to change lives, as these ex­amples demon­strate.

But these break­throughs don’t just hap­pen. De­vel­op­ing new medi­cines is a lengthy and com­plex pro­cess, re­ly­ing heav­ily on vo­lun­teer par­ti­cip­a­tion to eval­u­ate po­ten­tial ther­apies for safety and ef­fect­ive­ness in clin­ic­al tri­als. Without the pa­tients who vo­lun­teer to par­ti­cip­ate in clin­ic­al re­search, the de­vel­op­ment of new treat­ments would not be pos­sible.

Stud­ies have shown that ge­net­ic makeup can im­pact how in­di­vidu­als re­spond to medi­cines, so clin­ic­al test­ing of the ef­fect­ive­ness of po­ten­tial new treat­ments should ac­cur­ately re­flect the pa­tient pop­u­la­tion that will even­tu­ally take them if suc­cess­fully de­veloped. Cur­rently, this is not al­ways the case.

The FDA re­ports that even though Afric­an-Amer­ic­ans are 12 per­cent of the U.S. pop­u­la­tion, they make up only 5 per­cent of clin­ic­al-tri­al par­ti­cipants. His­pan­ics rep­res­ent 16 per­cent of the U.S. pop­u­la­tion, but only 1 per­cent of clin­ic­al-tri­al par­ti­cipants.

Bar­ri­ers to in­creas­ing di­versity in clin­ic­al tri­als are ex­tens­ive and var­ied, ran­ging from so­cioeco­nom­ic and wor­ries among pa­tients, to lim­ited phys­i­cian en­gage­ment. But des­pite these chal­lenges, there is a sig­ni­fic­ant op­por­tun­ity to reach un­der­rep­res­en­ted groups with in­form­a­tion about clin­ic­al tri­als. For ex­ample, a Ju­ly 2013 sur­vey by Re­search!Amer­ica found that Afric­an-Amer­ic­ans, Asi­an-Amer­ic­ans, and His­pan­ics ad­mire clin­ic­al tri­als vo­lun­teers more than Caucasi­ans do and are more likely to vo­lun­teer for a clin­ic­al tri­al to help im­prove the health of oth­ers.

John J. Cas­tel­lani is pres­id­ent and CEO of the Phar­ma­ceut­ic­al Re­search and Man­u­fac­tur­ers of Amer­ica, which rep­res­ents the coun­try’s lead­ing bio­phar­ma­ceut­ic­al re­search and bi­o­tech­no­logy com­pan­ies. (Cour­tesy photo)

In­clu­sion of par­ti­cipants with di­verse eth­nic and ra­cial back­grounds can fur­ther re­search and help find bet­ter ways to fight dis­eases that dis­pro­por­tion­ately im­pact these pop­u­la­tions. The bio­phar­ma­ceut­ic­al in­dustry has long made in­creas­ing di­versity in clin­ic­al tri­als a pri­or­ity, and in­di­vidu­al com­pan­ies have made sub­stan­tial in­vest­ments to im­prove clin­ic­al-tri­al par­ti­cip­a­tion. However, we re­cog­nize that an in­dustry-wide, col­lab­or­at­ive ef­fort is needed to in­crease par­ti­cip­a­tion in clin­ic­al tri­als in un­der­rep­res­en­ted pop­u­la­tions.

That’s why the Phar­ma­ceut­ic­al Re­search and Man­u­fac­tur­ers of Amer­ica, known as PhRMA, is col­lab­or­at­ing with the Na­tion­al Minor­ity Qual­ity For­um to launch a cam­paign to help in­crease aware­ness and par­ti­cip­a­tion in clin­ic­al tri­als among a di­verse pa­tient pop­u­la­tion. The ini­ti­at­ive, launch­ing in spring 2014, will in­clude joint out­reach ef­forts, as well as sup­port for the cre­ation of on­line tools to em­power in­di­vidu­als to learn more about clin­ic­al tri­als and the be­ne­fits to pa­tient—and their com­munit­ies—from par­ti­cip­at­ing in clin­ic­al re­search.

En­sur­ing that un­der­rep­res­en­ted pop­u­la­tions are in­cluded in clin­ic­al tri­als starts with a con­ver­sa­tion. If we can en­cour­age pa­tients to vis­it the cam­paign web­site and use the in­form­a­tion to be­gin a dia­logue with their phys­i­cians about wheth­er a clin­ic­al tri­al is right for them, we’ve taken one ma­jor step for­ward.

In­creas­ing di­versity in clin­ic­al tri­als won’t make health dis­par­it­ies dis­ap­pear, but it can help make a pos­it­ive im­pact on the health of pa­tients today and in the fu­ture.

AN OPIN­ION ON THE IN­TER­SEC­TION OF DEMO­GRAPHY AND POLICY?

The Next Amer­ica wel­comes op-ed pieces that ex­plore the polit­ic­al, eco­nom­ic, and so­cial im­pacts of the pro­found ra­cial and cul­tur­al changes fa­cing our na­tion. Email us. Please fol­low us onTwit­ter and Face­book.

AN OPINION ON THE INTERSECTION OF DEMOGRAPHY AND POLICY?

The Next Amer­ica wel­comes op-ed pieces that ex­plore the polit­ic­al, eco­nom­ic, and so­cial im­pacts of the pro­found ra­cial and cul­tur­al changes fa­cing our na­tion. Email us. Please fol­low us onTwit­ter and Face­book.

What We're Following See More »
TAKING A LONG VIEW TO SOUTHERN STATES
In Dropout Speech, Santorum Endorses Rubio
2 days ago
THE DETAILS

As expected after earlier reports on Wednesday, Rick Santorum ended his presidential bid. But less expected: he threw his support to Marco Rubio. After noting he spoke with Rubio the day before for an hour, he said, “Someone who has a real understanding of the threat of ISIS, real understanding of the threat of fundamentalist Islam, and has experience, one of the things I wanted was someone who has experience in this area, and that’s why we decided to support Marco Rubio.” It doesn’t figure to help Rubio much in New Hampshire, but the Santorum nod could pay dividends down the road in southern states.

Source:
‘PITTING PEOPLE AGAINST EACH OTHER’
Rubio, Trump Question Obama’s Mosque Visit
2 days ago
WHY WE CARE

President Obama’s decision to visit a mosque in Baltimore today was never going to be completely uncontroversial. And Donald Trump and Marco Rubio proved it. “Maybe he feels comfortable there,” Trump told interviewer Greta van Susteren on Fox News. “There are a lot of places he can go, and he chose a mosque.” And in New Hampshire, Rubio said of Obama, “Always pitting people against each other. Always. Look at today – he gave a speech at a mosque. Oh, you know, basically implying that America is discriminating against Muslims.”

Source:
THE TIME IS NOW, TED
Cruz Must Max Out on Evangelical Support through Early March
2 days ago
WHY WE CARE

For Ted Cruz, a strong showing in New Hampshire would be nice, but not necessary. That’s because evangelical voters only make up 21% of the Granite State’s population. “But from the February 20 South Carolina primary through March 15, there are nine states (South Carolina, Alabama, Arkansas, Georgia, Oklahoma, Tennessee, Kentucky, Mississippi, and North Carolina) with an estimated white-Evangelical percentage of the GOP electorate over 60 percent, and another four (Texas, Kansas, Louisiana, and Missouri) that come in over 50 percent.” But after that, he better be in the catbird’s seat, because only four smaller states remain with evangelical voter majorities.

Source:
CHRISTIE, BUSH TRYING TO TAKE HIM DOWN
Rubio Now Winning the ‘Endorsement Primary’
2 days ago
WHY WE CARE

Since his strong third-place finish in Iowa, Marco Rubio has won endorsement by two sitting senators and two congressmen, putting him in the lead for the first time of FiveThirtyEight‘s Endorsement Tracker. “Some politicians had put early support behind Jeb Bush — he had led [their] list since August — but since January the only new endorsement he has received was from former presidential candidate Sen. Lindsey Graham.” Meanwhile, the New York Times reports that fueled by resentment, “members of the Bush and Christie campaigns have communicated about their mutual desire to halt … Rubio’s rise in the polls.”

Source:
7 REPUBLICANS ON STAGE
Carly Fiorina Will Not Be Allowed to Debate on Saturday
1 days ago
THE LATEST

ABC News has announced the criteria for Saturday’s Republican debate, and that means Carly Fiorina won’t be a part of it. The network is demanding candidates have “a top-three finish in Iowa, a top-six standing in an average of recent New Hampshire polls or a top-six placement in national polls in order for candidates to qualify.” And there will be no “happy hour” undercard debate this time. “So that means no Fiorina vs. Jim Gilmore showdown earlier in the evening for the most ardent of campaign 2016 junkies.

Source:
×