The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As tech­nol­o­gy-en­abled clin­i­cal re­search be­comes the new nor­mal, an in­te­grat­ed de­cen­tral­ized clin­i­cal tri­al op­er­at­ing sys­tem can en­sure qual­i­ty, de­liv­er con­sis­ten­cy and im­prove the pa­tient ex­pe­ri­ence.

The in­creas­ing avail­abil­i­ty of COVID-19 vac­cines has many of us look­ing for­ward to a time when every­day things re­turn to a state of nor­mal. Schools and teach­ers are re­turn­ing to class­rooms, of­fices and small busi­ness­es are re­open­ing, and there’s a pal­pa­ble sense of op­ti­mism that the of­ten-awk­ward ad­just­ments we’ve all made per­son­al­ly and pro­fes­sion­al­ly in the last year are be­hind us, nev­er to re­turn. In the world of clin­i­cal re­search, how­ev­er, some pan­dem­ic-ne­ces­si­tat­ed ad­just­ments are prov­ing to be more than emer­gency stop­gap mea­sures to en­sure tri­al con­ti­nu­ity — and nu­mer­ous de­cen­tral­ized clin­i­cal tri­al (DCT) tools and method­olo­gies em­ployed with­in the last year are like­ly here to stay as part of bio­phar­ma’s new nor­mal.

The old nor­mal in clin­i­cal re­search wasn’t work­ing all that well any­way. We’re all fa­mil­iar with the age-old is­sues of tri­als tak­ing too long and cost­ing too much, and long over­due ef­forts to­ward pa­tient cen­tric­i­ty have on­ly helped to il­lu­mi­nate the tremen­dous bur­den of clin­i­cal tri­al par­tic­i­pa­tion on pa­tients and in­ves­ti­ga­tors. With on­ly 5% of physi­cians serv­ing as clin­i­cal tri­al in­ves­ti­ga­tors—and on­ly 8% of pa­tients par­tic­i­pat­ing in tri­als — the tra­di­tion­al, site-based mod­el was clear­ly flail­ing.

But the pan­dem­ic forced change, in a big way. As clin­i­cal re­search sites closed around the world, bio­phar­ma­ceu­ti­cal com­pa­nies and CROs quick­ly in­cor­po­rat­ed DCT tech­nolo­gies and meth­ods to ex­ist­ing tri­als. Study vis­its that had pre­vi­ous­ly been con­duct­ed face-to-face were han­dled via telemed­i­cine — a pa­tient-pre­ferred method — and sev­er­al oth­er tra­di­tion­al tri­al ac­tiv­i­ties were al­so con­vert­ed to dig­i­tal and/or re­mote plat­forms.

To get a bet­ter sense of the scale of these ad­just­ments, Sci­ence 37 com­mis­sioned a sur­vey of bio­phar­ma ex­ec­u­tives to gauge their ex­pe­ri­ence and per­cep­tions of de­cen­tral­ized clin­i­cal tri­als. Ac­cord­ing to our sur­vey — con­duct­ed by In­dus­try Stan­dard Re­search (ISR) —more than 60% of bio­phar­ma com­pa­nies con­duct­ed a clin­i­cal tri­al us­ing at least some DCT el­e­ments with­in the last year, in­clud­ing a hand­ful (4%) that were con­duct­ed ful­ly vir­tu­al­ly. What’s more, our find­ings al­so show that more than 80% of bio­phar­ma com­pa­nies ex­pect to con­duct a clin­i­cal tri­al us­ing at least some DCT el­e­ments this year, with close to one-in-six of these stud­ies ex­pect­ed to be ful­ly vir­tu­al [FIG­URE 1].

While these find­ings are cer­tain­ly en­cour­ag­ing, our study al­so shows that near­ly six-out-of-ten bio­phar­ma com­pa­nies do not have the in­ter­nal ca­pa­bil­i­ties to op­er­a­tional­ize any com­po­nents of a de­cen­tral­ized clin­i­cal tri­al [FIG­URE 2]. In lack­ing in­ter­nal DCT ca­pa­bil­i­ties but an­tic­i­pat­ing their in­creased adop­tion, bio­phar­ma de­vel­op­ers will soon be fac­ing a fa­mil­iar prob­lem — whether to build in­ter­nal in­fra­struc­ture to co­or­di­nate and in­te­grate DCT in­to clin­i­cal tri­al op­er­a­tions, or to out­source these ac­tiv­i­ties to any num­ber of ser­vice providers.

In ei­ther case, these da­ta help il­lu­mi­nate the con­tours of a fu­ture, net­work-based clin­i­cal re­search ecosys­tem in which DCT com­po­nents are in­te­grat­ed in­to tri­al pro­to­cols from the on­set — eas­ing the bur­den on in­ves­ti­ga­tors and pa­tients while pro­vid­ing bio­phar­ma de­vel­op­ers the req­ui­site lev­el of qual­i­ty, ef­fi­cien­cy, and ex­per­tise. But with a seem­ing­ly end­less ar­ray of new DCT tech­nolo­gies and as­so­ci­at­ed ven­dors, it’s not hard to en­vi­sion a frus­trat­ing, Wild West-like sce­nario lit­tered with nu­mer­ous, dis­con­nect­ed plat­forms of un­proven re­li­a­bil­i­ty and in­ter­op­er­abil­i­ty.

Since its in­cep­tion, Sci­ence 37 has qui­et­ly led the de­vel­op­ment of de­cen­tral­ized clin­i­cal tri­al tech­nolo­gies and meth­ods, as­sem­bling net­works and man­ag­ing the vo­lu­mi­nous flow of vir­tu­al­ly col­lect­ed. This ex­pe­ri­ence has con­vinced us that ac­ti­vat­ing and op­er­a­tional­iz­ing DCT tech­nolo­gies in­to every­day clin­i­cal stud­ies seam­less­ly re­quires a com­mon op­er­at­ing sys­tem to or­ches­trate work­flow, col­lect ev­i­dence, and man­age streams of da­ta from sev­er­al dis­parate DCT sources. By con­sis­tent­ly or­ches­trat­ing each DCT touch-point— i.e., telemed­i­cine in­ves­ti­ga­tors, re­mote co­or­di­na­tors, mo­bile health­care providers, pa­tient com­mu­ni­ties, and con­nect­ed de­vices — the DCT OS plat­form pro­vides a seam­less ex­pe­ri­ence for tri­al co­or­di­na­tors, in­ves­ti­ga­tors, and pa­tients, while of­fer­ing clin­i­cal re­search pro­fes­sion­als da­ta of un­matched qual­i­ty.

As no sin­gle de­vel­op­ment mod­el will be suf­fi­cient for the clin­i­cal re­search ecosys­tem of the fu­ture, near­ly every study will be high­ly in­di­vid­u­al­ized, with each re­quir­ing a unique con­fig­u­ra­tion of tech­nolo­gies and net­works. Be­cause of its agili­ty, the DCT OS plat­form can be con­fig­ured to en­able a full de­cen­tral­ized clin­i­cal tri­al or one with just a few el­e­ments. It can be con­fig­ured to lever­age pa­tient re­cruit­ment net­works or mo­bile nurse net­works (or both). It can be con­fig­ured for ear­ly phase stud­ies, late phase stud­ies, non-in­ter­ven­tion­al stud­ies, and so on. The po­ten­tial ap­pli­ca­tions and com­bi­na­tions are lim­it­less, and all con­fig­u­ra­tions are guid­ed and man­aged by Sci­ence 37’s co­or­di­nat­ed ex­per­tise.

With a wide ma­jor­i­ty of bio­phar­ma com­pa­nies plan­ning to con­duct a tri­al with at least some DCT com­po­nents in the com­ing year, our study in­di­cates that the in­dus­try is in­creas­ing­ly un­der­stand­ing the po­ten­tial of DCT to ac­cel­er­ate time­lines and make tri­al par­tic­i­pa­tion less bur­den­some for pa­tients and in­ves­ti­ga­tors. But our study al­so finds that most of these com­pa­nies lack the in­ter­nal ca­pa­bil­i­ty and ex­per­tise to op­er­a­tional­ize any DCT el­e­ments at all. Clear­ly, they’ll need help. And in re­quir­ing qual­i­ty more than any­thing, bio­phar­ma com­pa­nies will al­so need co­or­di­nat­ed ex­per­tise and a tech­nol­o­gy-led op­er­at­ing sys­tem to im­ple­ment DTC tech­nolo­gies and meth­ods ef­fec­tive­ly in the con­nect­ed, pa­tient-cen­tered clin­i­cal re­search ecosys­tem of to­mor­row.