New York-based part­ner­ship sets the stan­dard for ex­pand­ing clin­i­cal tri­al ac­cess for un­der­served and di­verse pop­u­la­tions

For decades, ground­break­ing med­ical re­search has re­mained out of reach for many who need it most, leav­ing un­der­served com­mu­ni­ties with lim­it­ed op­por­tu­ni­ties to par­tic­i­pate. While nu­mer­ous ef­forts have been made in re­cent years to ad­dress this is­sue, many have been frag­ment­ed and have failed to ad­dress the sys­temic bar­ri­ers that lim­it ac­cess to clin­i­cal tri­als. The sig­nif­i­cance of this is­sue is un­der­scored by the FDA’s June 2024 draft guid­ance, “Di­ver­si­ty Ac­tion Plans to Im­prove En­roll­ment of Par­tic­i­pants from Un­der­rep­re­sent­ed Pop­u­la­tions in Clin­i­cal Stud­ies.”¹ Set­ting aside re­cent con­tro­ver­sy sur­round­ing the doc­u­ment it­self ², the guid­ance high­lights that the prob­lem ex­ists, still in 2025.

A re­cent New York-based part­ner­ship be­tween Pra­tia, a glob­al leader in clin­i­cal re­search, and Es­sen Health Care, a trust­ed health­care provider in the Bronx, is tak­ing the lead in ad­dress­ing this is­sue by in­te­grat­ing clin­i­cal tri­als di­rect­ly in­to com­mu­ni­ty health­care.

There is a lot of work to be done in the Bronx

With a pop­u­la­tion of 1.4 mil­lion, the Bronx faces ex­cep­tion­al­ly high rates of pre­ventable con­di­tions. Di­a­betes-re­lat­ed hos­pi­tal­iza­tions are near­ly dou­ble the New York City av­er­age, while 39% of the Bronx res­i­dents have high blood pres­sure com­pared to 28% of all NYC res­i­dents—just two of many con­cern­ing ex­am­ples.

Ac­cess to med­ical in­no­va­tion should not be de­ter­mined by ge­og­ra­phy or so­cioe­co­nom­ic sta­tus. Yet, for many Bronx res­i­dents, par­tic­i­pa­tion in clin­i­cal tri­als—and with it, ac­cess to free health screen­ings and cut­ting-edge ther­a­pies—has been lim­it­ed by sev­er­al bar­ri­ers: (1) mis­trust, of­ten root­ed in past in­jus­tices in med­ical his­to­ry and fu­eled by a lack of in­for­ma­tion and dis­com­fort with the re­search process; (2) lo­gis­ti­cal chal­lenges, such as time and re­source con­straints; and (3) lim­it­ed un­der­stand­ing and aware­ness of avail­able clin­i­cal tri­al op­por­tu­ni­ties ³.

Pra­tia pow­ered by Es­sen – a case study

For the clin­i­cal tri­al op­er­at­ing mod­el to be suc­cess­ful, it needs to ad­dress all of the above bar­ri­ers si­mul­ta­ne­ous­ly. This means meet­ing pa­tients where they are—both phys­i­cal­ly and emo­tion­al­ly—build­ing trust and work­ing with­in the sys­tems they are fa­mil­iar with. It’s about min­i­miz­ing the steps a pa­tient un­der­takes to par­tic­i­pate in a clin­i­cal tri­al. This ap­proach is at the heart of Pra­tia’s vi­sion; to trans­form the clin­i­cal re­search land­scape by in­te­grat­ing in­no­v­a­tive treat­ments in­to every­day pa­tient care, mak­ing clin­i­cal tri­als a stan­dard of care op­tion. Rather than im­pos­ing a stan­dard­ized, one-size-fits-all clin­i­cal site mod­el, Pra­tia adapts its op­er­at­ing mod­els to fit lo­cal con­texts, en­sur­ing that clin­i­cal tri­als be­come a seam­less part of the health­care jour­ney.

This mod­el has al­ready proven suc­cess­ful in sev­en oth­er coun­tries where Pra­tia op­er­ates, uti­liz­ing both ded­i­cat­ed sites (e.g., Pra­tia Sir­ius in Spain) and in­te­grat­ed site mod­els (e.g., the ac­qui­si­tion of CRC in Czechia and Slo­va­kia).

By em­bed­ding clin­i­cal tri­als in­to the lo­cal health­care net­work, the part­ner­ship re­moves key bar­ri­ers and brings ad­vanced treat­ment op­tions to the his­tor­i­cal­ly un­der­served com­mu­ni­ty. The col­lab­o­ra­tion is built on five fun­da­men­tal pil­lars:

1. Be­ing where pa­tients are: Es­sen Health­care op­er­ates over 45 clin­ics across the Bronx, di­rect­ly with­in the com­mu­ni­ties that need ex­pand­ed health­care op­tions the most. Be­yond clin­ic-based care, Es­sen Health Care takes an ex­tra step by of­fer­ing Es­sen House Calls ser­vices, en­sur­ing that even home­bound Pa­tients can have ac­cess to clin­i­cal tri­als by elim­i­nat­ing trans­porta­tion and mo­bil­i­ty chal­lenges that of­ten pre­vent par­tic­i­pa­tion in re­search.
2. Ther­a­peu­tic ex­per­tise aligned with lo­cal needs: As men­tioned above, the Bronx has dis­pro­por­tion­ate­ly high rates of chron­ic con­di­tions across mul­ti­ple ther­a­peu­tic ar­eas, in­clud­ing meta­bol­ic dis­or­ders, car­di­ol­o­gy, pul­monolo­gy, and men­tal health—ar­eas that align di­rect­ly with Pra­tia’s re­search ex­per­tise. The part­ner­ship will in­clude tri­als that ad­dress these press­ing health con­cerns, en­sur­ing that the stud­ies con­duct­ed are both rel­e­vant and ben­e­fi­cial to the lo­cal pop­u­la­tion.
3. Com­mu­ni­ty out­reach and ed­u­ca­tion: Com­mu­ni­ty en­gage­ment is an in­te­gral part of re­cruit­ment and re­ten­tion of un­der­rep­re­sent­ed groups⁴. This part­ner­ship pri­or­i­tizes pa­tient ed­u­ca­tion, with Es­sen Health Care lever­ag­ing its deep roots in the Bronx to lead com­mu­ni­ty out­reach ef­forts. By pro­vid­ing clear, ac­ces­si­ble in­for­ma­tion about clin­i­cal re­search, the ini­tia­tive aims to fos­ter trust and em­pow­er pa­tients to make in­formed de­ci­sions about their health­care.
4. A net­work of trust­ed re­fer­ring physi­cians: Stud­ies show that physi­cians are the most trust­ed source of in­for­ma­tion for Pa­tients con­sid­er­ing clin­i­cal tri­als⁵. Es­sen Health Care clin­i­cians’, who have long-stand­ing re­la­tion­ships with their Pa­tients, play a crit­i­cal role in pro­vid­ing guid­ance for tri­al par­tic­i­pa­tion. With the right tools and -guid­ance from Pra­tia, they can in­tro­duce clin­i­cal tri­al op­por­tu­ni­ties as a nat­ur­al ex­ten­sion of care, re­in­forc­ing trust and en­cour­ag­ing more pa­tients—es­pe­cial­ly from mi­nor­i­ty pop­u­la­tions—to en­roll.
5. Ad­just­ing to the lo­cal health­care sys­tem: Rather than im­pos­ing a rigid, dis­con­nect­ed clin­i­cal tri­al mod­el, Pra­tia fol­lows its mis­sion to in­crease ac­cess to in­no­v­a­tive treat­ments across di­verse pa­tient pop­u­la­tions by seam­less­ly adapt­ing to lo­cal needs, mak­ing clin­i­cal tri­als a nat­ur­al ex­ten­sion of stan­dard med­ical care. This flex­i­bil­i­ty en­ables dif­fer­ent mod­els de­pend­ing on com­mu­ni­ty re­quire­ments—whether through stand­alone ded­i­cat­ed re­search clin­ics, em­bed­ded on­col­o­gy units with­in hos­pi­tals, or, as in the Bronx, es­tab­lish­ing strong part­ner­ships with lo­cal health­care providers to ex­pand re­search ac­ces­si­bil­i­ty and pa­tient en­gage­ment.

Why in­clu­sion in clin­i­cal tri­als mat­ters

Clin­i­cal tri­als shape the fu­ture of med­i­cine, but their im­pact is di­rect­ly re­lat­ed to the di­ver­si­ty of the par­tic­i­pants in­volved. When re­search fails to in­clude all racial, eth­nic, and so­cioe­co­nom­ic groups, the re­sult­ing treat­ments may not work equal­ly well for every­one. The FDA has re­in­forced the ur­gency of ad­dress­ing these gaps, push­ing for more in­clu­sive study pop­u­la­tions. Pra­tia, through its part­ner­ship with Es­sen, is turn­ing this vi­sion in­to re­al­i­ty—em­bed­ding re­search in­to lo­cal health­care net­works, re­mov­ing bar­ri­ers to par­tic­i­pa­tion, and en­sur­ing that ground­break­ing ther­a­pies reach those who have his­tor­i­cal­ly been left be­hind. This is more than just ex­pand­ing ac­cess; it’s about build­ing a fu­ture where med­ical in­no­va­tion tru­ly serves every­one.

Pra­tia is part of the Hu­mane­va Group.

Fol­low Pra­tia on LinkedIn to stay up to date.

Ref­er­ences:

¹Of­fice of the Com­mis­sion­er. (2024, June 26). Di­ver­si­ty Ac­tion Plans to Im­prove En­roll­ment of Par­tic­i­pants from Un­der­rep­re­sent­ed Pop­u­la­tions in Clin­i­cal Stud­ies. U.S. Food And Drug Ad­min­is­tra­tion. https://www.fda.gov/reg­u­la­to­ry-in­for­ma­tion/search-fda-guid­ance-doc­u­ments/di­ver­si­ty-ac­tion-plans-im­prove-en­roll­ment-par­tic­i­pants-un­der­rep­re­sent­ed-pop­u­la­tions-clin­i­cal-stud­ies

²Grossi, G. (2025, Feb­ru­ary 6). FDA qui­et­ly re­moves draft guid­ance on di­ver­si­ty in clin­i­cal tri­als fol­low­ing ex­ec­u­tive or­der on DEI. AJMC. https://www.ajmc.com/view/fda-qui­et­ly-re­moves-draft-guid­ance-on-di­ver­si­ty-in-clin­i­cal-tri­als-fol­low­ing-ex­ec­u­tive-or­der-on-dei

³Clark, L. T., Watkins, L., Piña, I. L., Elmer, M., Ak­in­boboye, O., Gorham, M., Jamer­son, B., Mc­Cul­lough, C., Pierre, C., Po­lis, A. B., Puck­rein, G., & Reg­nante, J. M. (2019). In­creas­ing Di­ver­si­ty in Clin­i­cal Tri­als: Over­com­ing Crit­i­cal Bar­ri­ers. Cur­rent Prob­lems in Car­di­ol­o­gy, 44(5), 148-172. https://doi.org/10.1016/j.cp­car­di­ol.2018.11.002

⁴Kelsey, M. D., Patrick-Lake, B., Ab­du­lai, R., Broedl, U. C., Brown, A., Cohn, E., Cur­tis, L. H., Kome­lasky, C., Mbag­wu, M., Men­sah, G. A., Mentz, R. J., Nyaku, A., Omokaro, S. O., Se­wards, J., Whit­lock, K., Zhang, X., & Bloom­field, G. S. (2022). In­clu­sion and di­ver­si­ty in clin­i­cal tri­als: Ac­tion­able steps to dri­ve last­ing change. Con­tem­po­rary Clin­i­cal Tri­als, 116, 106740. https://doi.org/10.1016/j.cct.2022.106740

⁵Clark, L. T., Watkins, L., Piña, I. L., Elmer, M., Ak­in­boboye, O., Gorham, M., Jamer­son, B., Mc­Cul­lough, C., Pierre, C., Po­lis, A. B., Puck­rein, G., & Reg­nante, J. M. (2019). In­creas­ing Di­ver­si­ty in Clin­i­cal Tri­als: Over­com­ing Crit­i­cal Bar­ri­ers. Cur­rent Prob­lems in Car­di­ol­o­gy, 44(5), 148-172. https://doi.org/10.1016/j.cp­car­di­ol.2018.11.002

Con­tribut­ing au­thor:

Mona Alqam,
MD, Coun­try Head,
Pra­tia USA