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 Castellan
Add to Briefcase
John Castellan
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?

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 »
STRIKES DOWN NEW HAMPSHIRE BAN
Court: Selfies in Voting Booth Now OK
1 hours ago
WHY WE CARE
WILL LEAD U.S. DELEGATION
Obama to Travel to Israel for Peres’s Funeral
1 hours ago
THE DETAILS
FOUR-POINT LEAD IN FOUR-WAY RACE
Reuters/Ipsos Shows Clinton Ahead by 6
1 hours ago
THE LATEST

In one of the first polls released since Monday night's debate, a Reuters/Ipsos survey shows Hillary Clinton leading Donald Trump 44%-38%. When third-party candidates are thrown into the mix, Clinton's share of the vote drops to 42%, with Gary Johnson picking up 7% and Jill Stein at 2%.

Source:
NO SHUTDOWN
Senate Votes to Fund Government
2 hours ago
THE LATEST

The Senate voted on Wednesday 72-26 on a bill to fund the government through Dec. 9, averting a looming shutdown. The legislation will now go to the House, where it could be voted on as early as Wednesday. After this legislation is approved by the House, Congress will recess until the lame-duck session following elections.

FIRST OVERRIDE OF HIS PRESIDENCY
House Completes Override of Obama Veto
3 hours ago
THE LATEST

"Congress voted Wednesday to override President Obama for the first time in his eight-year tenure, as the House followed the Senate in rejecting a veto of legislation allowing families of terrorist victims to sue Saudi Arabia. The House easily cleared the two-thirds threshold to push back against the veto. The final tally was 348-77, with 18 Republicans and 59 Democrats voting no."

Source:
×