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
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.

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