Clin­i­cal tri­al adap­ta­tions made dur­ing the pan­dem­ic re­veal an in­dus­try em­brac­ing change

For years, pa­per-based process­es and in­di­vid­ual point so­lu­tions dom­i­nat­ed the clin­i­cal re­search land­scape, and pa­tient par­tic­i­pa­tion in clin­i­cal tri­als was large­ly an in-per­son en­gage­ment. But when the COVID-19 pan­dem­ic took a strong­hold, tra­di­tion­al clin­i­cal tri­al meth­ods emerged as in­ad­e­quate, putting clin­i­cal tri­als and the life sci­ences in­dus­try at a cross­roads. Prac­ti­cal­ly overnight, the in­dus­try had to rapid­ly shift to de­cen­tral­ized clin­i­cal tri­al meth­ods, while main­tain­ing da­ta qual­i­ty and reg­u­la­to­ry com­pli­ance.

Now it is ev­i­dent that the meth­ods uti­lized dur­ing the pan­dem­ic are like­ly to have a last­ing im­pact on the fu­ture of clin­i­cal tri­als, ac­cord­ing to a new re­search study con­duct­ed by In­for­ma Phar­ma In­tel­li­gence and Or­a­cle. In­deed, an over­whelm­ing ma­jor­i­ty of sur­vey re­spon­dents be­lieve that new clin­i­cal tri­al meth­ods are here to stay.

Out of a sur­vey of 251 pro­fes­sion­als from bio­phar­ma­ceu­ti­cal com­pa­nies (76%), with the bal­ance rep­re­sent­ing med­ical de­vice com­pa­nies and CROs, 97% of re­spon­dents who adopt­ed new clin­i­cal tri­al meth­ods dur­ing the pan­dem­ic re­vealed that their or­ga­ni­za­tion plans to con­tin­ue us­ing at least one of the new meth­ods go­ing for­ward.

“The in­dus­try had to move quick­ly to keep clin­i­cal tri­als afloat and this forced change has helped the in­dus­try un­der­stand when and how to im­ple­ment these ap­proach­es to im­prove clin­i­cal re­search,” said Hen­ry Mc­Na­ma­ra, se­nior vice pres­i­dent and gen­er­al man­ag­er of Or­a­cle Health Sci­ences. “Meth­ods and tech­nol­o­gy that were be­ing ex­plored pre-pan­dem­ic have come front and cen­ter dur­ing the past 18 months.”

In last year’s in­dus­try sur­vey con­duct­ed by In­for­ma Phar­ma In­tel­li­gence and Or­a­cle, 76% of re­spon­dents in­di­cat­ed that the COVID-19 pan­dem­ic had ac­cel­er­at­ed their adop­tion of de­cen­tral­ized clin­i­cal tri­al meth­ods.

De­cen­tral­iza­tion lever­ages re­mote tech­nol­o­gy—such as wear­able de­vices, sen­sors, mo­bile ap­pli­ca­tions, and tele­health—to con­duct clin­i­cal tri­al ac­tiv­i­ties and da­ta col­lec­tion as close to the pa­tient as pos­si­ble, rather than at a study site. Pa­tient da­ta is en­tered in­to clin­i­cal tri­al man­age­ment plat­forms, such as Or­a­cle Health Sci­ences Clin­i­cal One. This flex­i­bil­i­ty not on­ly de­liv­ers bet­ter re­sults for the clin­i­cal tri­al, but it al­so makes par­tic­i­pa­tion eas­i­er for the pa­tient. The sur­vey re­vealed that 58% of re­spon­dents’ or­ga­ni­za­tions plan to give pa­tients the abil­i­ty to choose how they par­tic­i­pate in clin­i­cal tri­als go­ing for­ward, which may lead to faster and larg­er tri­als, and ul­ti­mate­ly, faster drugs to mar­ket.

Sur­vey re­spon­dents said the de­cen­tral­ized, tech­nol­o­gy-based meth­ods re­sult­ed in more time­ly da­ta, im­proved flex­i­bil­i­ty for pa­tients, in­creased speed, and high­er pa­tient par­tic­i­pa­tion and re­ten­tion—all cru­cial com­po­nents of a suc­cess­ful clin­i­cal tri­al. And the sur­vey num­bers bear this out: 82% of re­spon­dents who im­ple­ment­ed new clin­i­cal tri­al meth­ods dur­ing the pan­dem­ic re­port­ed see­ing a pos­i­tive im­pact on clin­i­cal tri­als over­all, with 26% re­port­ing a sig­nif­i­cant­ly pos­i­tive im­pact.

De­cen­tral­ized clin­i­cal tri­als re­sult in mas­sive amounts of da­ta, both in vol­ume and va­ri­ety. As such, it is not sur­pris­ing that many of the pos­i­tive im­pacts of clin­i­cal tri­al ap­proach­es new­ly im­ple­ment­ed dur­ing the pan­dem­ic are re­lat­ed to da­ta. Ac­cord­ing to the study, 92% of re­spon­dents who adopt­ed new clin­i­cal tri­al meth­ods re­port­ed that they were equal­ly or more con­fi­dent in the da­ta col­lect­ed from these meth­ods, com­pared to da­ta from tra­di­tion­al meth­ods used be­fore the pan­dem­ic.

Ac­cu­rate and re­li­able da­ta is es­sen­tial in a clin­i­cal tri­al, as is the man­age­ment of and ac­cess to con­fi­den­tial pa­tient and op­er­a­tional da­ta. Or­a­cle’s Clin­i­cal One was de­signed to col­lect da­ta from any source and al­low faster adop­tion of new re­mote tech­nolo­gies. It lets a study team op­er­a­tional­ize de­cen­tral­ized pa­tient da­ta cap­ture and get a com­plete pic­ture of a pa­tient’s ex­pe­ri­ence in a sin­gle place. Study teams can al­so col­lect and con­sid­er da­ta from elec­tron­ic health record sys­tems and ge­nomics da­ta.

Most op­tions on the mar­ket for col­lect­ing and stor­ing clin­i­cal tri­al da­ta are in­te­grat­ed sys­tems, where­as Clin­i­cal One is a uni­fied plat­form that brings to­geth­er da­ta from dis­parate sources and makes it avail­able through a sin­gle ac­cess point. The idea is to pro­vide clin­i­cal tri­al teams and sites with the abil­i­ty to man­age more pa­tient da­ta with greater clin­i­cal in­sight and less sys­tem com­plex­i­ty.

While the forced adop­tion of fit-for-pur­pose, hy­brid, and de­cen­tral­ized mod­els dur­ing the pan­dem­ic was un­prece­dent­ed, it helped the in­dus­try un­der­stand when and how to im­ple­ment these ap­proach­es and al­so high­light­ed the im­pact that tech­nol­o­gy and soft­ware can have on the on­go­ing ad­vance­ment of clin­i­cal tri­als and drug de­vel­op­ment. This is re­flect­ed in re­sults of this sur­vey, with re­spon­dents ex­pect­ing the con­tin­ued use of these mod­els in the post-pan­dem­ic world and giv­ing pa­tients the op­tion to choose how they par­tic­i­pate in clin­i­cal tri­als.

“As com­pa­nies have adopt­ed in­no­v­a­tive ap­proach­es to clin­i­cal tri­als through the pan­dem­ic, we’ve proven the tech­nol­o­gy and soft­ware to sup­port these changes in clin­i­cal tri­al re­search ex­ists and will car­ry the in­dus­try for­ward,” said Mc­Na­ma­ra. “As clin­i­cal tri­als con­tin­ue to evolve, study teams can rest as­sured that tech­nol­o­gy will not slow them down.”

To learn more about the study, you can read the full re­port here.  Learn more about Or­a­cle Health Sci­ences Clin­i­cal One here.