Will Com­mu­ni­cat­ing with Per­son­al HCPs Get the In­dus­try Clos­er to More Di­verse and Ful­ly En­rolled Clin­i­cal Tri­als?

In 2021, 50 nov­el med­ica­tions were ap­proved by the Fed­er­al Drug Ad­min­is­tra­tion (FDA), the third-high­est num­ber of ap­provals on record and one of many in­di­ca­tors of the ex­tra­or­di­nary ad­vance­ments the med­ical field has seen in re­cent decades. But progress with­in the in­dus­try is not equal­ly dis­trib­uted. When ac­knowl­edg­ing the con­tri­bu­tions of more than 38,000 pa­tients in its Drug Tri­als Snap­shot of the same year, the FDA not­ed that “there were many pro­grams where rep­re­sen­ta­tion from cer­tain racial and eth­nic groups was low.” This care­ful­ly word­ed ob­ser­va­tion de­scribes a long-stand­ing lim­i­ta­tion in the clin­i­cal tri­al sec­tor.

Peo­ple of col­or make up just one-fifth of clin­i­cal tri­al par­tic­i­pants in the US. That is far less than the non-white US pop­u­la­tion re­port­ed in the most re­cent cen­sus da­ta and does not ad­dress oth­er crit­i­cal vari­ables that can in­flu­ence health­care out­comes, such as age, gen­der and so­cio-eco­nom­ic fac­tors.

In April of 2022, the FDA is­sued its 9th guid­ance to com­bat the neg­a­tive im­pacts of de­mo­graph­i­cal­ly-bi­ased tri­als. But how can the in­dus­try en­sure that this lat­est guid­ance achieves the re­sults that all in­volved want and need? In short: what can we do that has not al­ready been done for more ful­ly en­rolled – and eq­ui­table – clin­i­cal tri­als?

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Lever­ag­ing the pa­tient jour­ney

To an­swer that ques­tion, we must pay at­ten­tion to the fac­tors at the core of every clin­i­cal tri­al: pa­tients and care­givers. A per­son’s de­ci­sion to par­tic­i­pate in a clin­i­cal tri­al is rarely bound to em­pir­i­cal da­ta. Rather, pa­tients re­spond most pos­i­tive­ly to per­son­al, in­di­vid­u­al­ized com­mu­ni­ca­tions to guide their choic­es, such as con­ver­sa­tions with their doc­tors. How­ev­er, these con­ver­sa­tions be­tween health­care pro­fes­sion­als (HCPs) and their pa­tients aren’t hap­pen­ing fre­quent­ly enough. 90% of pa­tients world­wide in­di­cate that their doc­tors have nev­er dis­cussed a clin­i­cal tri­al with them. Re­cent re­search pub­lished by the Cen­ter for In­fo & Study on Clin­i­cal Re­search Par­tic­i­pa­tion (CIS­CRP) re­vealed that on­ly 14% of po­ten­tial vol­un­teers learned about a study from their HCP.

This rais­es an im­por­tant ques­tion that chal­lenges the sta­tus-quo of clin­i­cal tri­al re­cruit­ment: could com­mu­ni­cat­ing with pa­tients’ per­son­al HCPs about rel­e­vant clin­i­cal tri­als tip the scales in fa­vor of more eq­ui­table, di­verse and ful­ly en­rolled tri­als? And if so, could they reach more di­verse pa­tient pop­u­la­tions and help bridge the gap be­tween pa­tients who mis­trust in the phar­ma in­dus­try and po­ten­tial­ly life-sav­ing clin­i­cal tri­als?

Yes, HCPs are will­ing to re­fer

To un­der­stand if per­son­al HCPs are will­ing to dis­cuss clin­i­cal tri­als with their pa­tients – and, if so, how best to reach out to them – Sy­neos Health queried 151 doc­tors across five dif­fer­ent spe­cial­ties and sizes of prac­tice on their view­points on clin­i­cal tri­als. The re­sults were em­phat­i­cal­ly pos­i­tive: 93% of doc­tors would re­fer pa­tients to clin­i­cal tri­als (Fig­ure 1).

Fig­ure 1: Sur­veyed HCPs were will­ing to re­fer pa­tients to clin­i­cal tri­als

Re­sults al­so sug­gest that most doc­tors who hadn’t ad­dressed clin­i­cal tri­als with their pa­tients did so due to a lack of in­for­ma­tion. 67% of them learned about tri­als on­ly every few or once every six months. In con­trast, a ma­jor­i­ty of those who had dis­cussed clin­i­cal tri­als with their pa­tients about tri­als (58%) learned about tri­als at least once a month.

Over­all, da­ta sug­gests that for var­i­ous rea­sons, sim­ply ed­u­cat­ing more HCPs out­side of stan­dard site re­fer­ral net­works about tri­als could be enough to in­crease tri­al en­roll­ment via re­fer­rals.

Chal­leng­ing tra­di­tion­al site out­reach mod­els

In­form­ing HCPs of clin­i­cal tri­als is not new, but its con­ven­tion­al ap­pli­ca­tion means it falls short of its po­ten­tial. Tra­di­tion­al re­cruit­ment out­reach iden­ti­fies HCPs with­in a site’s re­fer­ral net­work and/or by spe­cial­ty. Im­por­tant fac­tors such as pa­tient vol­ume or whether an HCP is treat­ing tri­al-rel­e­vant pa­tients are ei­ther not con­sid­ered con­sis­tent­ly across the full co­hort of po­ten­tial re­fer­rers. As a re­sult, sig­nif­i­cant po­ten­tial re­fer­rers nev­er learn about tri­als that might ben­e­fit their pa­tients. Sta­t­ic re­fer­ral net­works may even com­pound un­in­ten­tion­al bias in fa­vor of the pre­vail­ing de­mo­graph­ic of a site’s pa­tient co­hort, omit­ting en­tire groups cru­cial to di­verse en­roll­ment (Fig­ure 2). But we don’t of­ten con­sid­er these vari­ables when strate­giz­ing site se­lec­tion or site out­reach method­ol­o­gy.

Fig­ure 2: HCP out­reach mod­els

These his­toric lim­i­ta­tions do not sug­gest any fail­ure on the part of study sites. Nor do they un­cov­er a lapse of at­ten­tive­ness on the part of re­cruit­ment teams. Un­til now, there has not been a con­sis­tent, work­able means to iden­ti­fy and lo­cate HCPs who prac­tice out­side a site’s re­fer­ral net­work. Tra­di­tion­al out­reach is de­pen­dent on some lev­el of ac­tive and time-con­sum­ing par­tic­i­pa­tion on the part of an HCP. This need for proac­tive ac­tion is a sig­nif­i­cant draw­back for of­ten over­bur­dened providers and clin­ic staff.

Ar­ti­fi­cial in­tel­li­gence (AI)-pow­ered and da­ta-dri­ven tech­nolo­gies can help over­come these lim­i­ta­tions. Dig­i­tal mes­sag­ing cam­paigns pow­ered by these ad­vances and tar­get­ed at pre­cise HCPs can en­cour­age clin­i­cal tri­al re­fer­ral. Lever­ag­ing the vi­tal pa­tient/provider re­la­tion­ship that we know in­flu­ences a pa­tient’s clin­i­cal tri­al par­tic­i­pa­tion de­ci­sion-mak­ing process in the ser­vice of more full clin­i­cal tri­al en­roll­ment, these cam­paigns can al­so em­pow­er more eq­ui­table en­roll­ment.

These tech­nolo­gies en­able clin­i­cal tri­al teams to iden­ti­fy and en­gage HCPs out­side a site’s re­fer­ral net­work. These providers are most like­ly to be help­ing pa­tients nav­i­gate crit­i­cal de­ci­sions in their health­care jour­neys rel­e­vant to a spe­cif­ic tri­al and the HCPs who treat pa­tients with di­verse back­grounds. An in-depth, hy­per-tar­get­ed, per­son­al­ized out­reach can em­pow­er un­der­rep­re­sent­ed de­mo­graph­ics to con­sid­er tri­als through en­gag­ing their HCPs. This pur­pose­ful at­ten­tion to pa­tient ac­cess and de­mo­graph­ics sup­ports more in­clu­sive and eq­ui­table clin­i­cal tri­al en­roll­ment.

Con­tri­bu­tions by Sy­neos Health

Our in­dus­try needs new chan­nels to ad­vance the re­cruit­ment of di­verse and epi­demi­o­log­i­cal­ly rel­e­vant pa­tient pop­u­la­tions, while bal­anc­ing da­ta pri­va­cy. Sy­neos Health in­no­va­tions in tech­nol­o­gy, da­ta and be­hav­ioral sci­ence pro­vide im­me­di­ate­ly ac­tion­able so­lu­tions for this long-stand­ing in­dus­try chal­lenge.  Our team has the abil­i­ty to con­nect the da­ta, con­trol its ac­cess, and stay in strict com­pli­ance with pri­va­cy reg­u­la­tions. We are car­ry­ing for­ward the mo­men­tum for change, of­fer­ing a suite of tech-en­abled di­ver­si­ty so­lu­tions en­abling you to take ac­tion on FDA guide­lines, in­dus­try com­mit­ments and the eth­i­cal re­spon­si­bil­i­ty to com­mu­ni­ties for di­verse and eq­ui­table clin­i­cal tri­als.

Sy­neos Health Au­thors:

Moni­ka Hirschbich­ler
Vice Pres­i­dent,
Pro­gram Strat­e­gy
Brooke Belk
Vice Pres­i­dent,
Pro­gram Strat­e­gy
Melis­sa Lep­ore
As­so­ciate Di­rec­tor,
Pro­gram Strat­e­gy