eCOA Clin­i­cal Tri­als: A Sim­ple, Cost-Ef­fec­tive Ap­proach to Study Build

Ad­vanced tech­nol­o­gy is sup­posed to help spon­sors run clin­i­cal tri­als faster. So why are time­lines get­ting longer?

A re­port from the Tufts Cen­ter for the Study of Drug De­vel­op­ment (CS­DD) found that the clin­i­cal phase of new drugs and bi­o­log­ics ap­proved by the FDA be­tween 2008 and 2013 took 83.1 months on av­er­age. Be­tween 2014 and 2018, the clin­i­cal phase ex­tend­ed to an av­er­age of 89.8 months.

Ac­cord­ing to CS­DD di­rec­tor Ken­neth Getz, frag­ment­ed op­er­at­ing ac­tiv­i­ty is one of the pri­ma­ry fac­tors that con­tribute to grow­ing time­lines. What’s one way to lim­it frag­men­ta­tion? Bring more clin­i­cal tri­al func­tions in-house. By mak­ing the most of in­ter­nal re­sources, spon­sors not on­ly sim­pli­fy op­er­a­tions, they re­duce risk and op­er­a­tional costs.

Re­duced ven­dor re­liance doesn’t mean clin­i­cal tri­al spon­sors must take on all the ser­vices their tech­nol­o­gy ven­dors pro­vide. It means ven­dors must cus­tomize their ser­vices and so­lu­tions to suit their cus­tomers’ tri­als. They must al­so de­sign so­lu­tions that ac­com­mo­date all types of pa­tient da­ta and all types of plat­forms.

A DIY Ap­proach to Study Build

Due to in­di­vid­ual in-house ca­pa­bil­i­ties, not every clin­i­cal tri­al re­quires a full suite of so­lu­tions — di­rect da­ta cap­ture (DDC), eCOA, ePRO, and eCon­sent — to cap­ture da­ta dur­ing pa­tient vis­its. And not every clin­i­cal tri­al spon­sor or CRO needs full-ser­vice sup­port from their da­ta cap­ture ven­dor. As an al­ter­na­tive to a com­pre­hen­sive tech­nol­o­gy part­ner­ship, these or­ga­ni­za­tions can work with ven­dors us­ing a per­son­al­ized sub­scrip­tion-based mod­el to bring more func­tions in- house. By do­ing so, they not on­ly sim­pli­fy op­er­a­tions, they al­so de­crease costs, re­duce risk, and im­prove ef­fi­cien­cy.

Or­ga­ni­za­tions with ex­ist­ing in­ter­nal IT re­sources can take ad­van­tage of a sub­scrip­tion-based mod­el to build stud­ies them­selves. The spon­sor or CRO can li­cense on­ly the ser­vices they need, whether elec­tron­ic pa­tient-re­port­ed out­comes (ePRO), clin­i­cal out­come as­sess­ments (eCOA, Clin­RO), in­formed con­sent (eCon­sent), bring your own de­vice (BY­OD) strate­gies, or trans­la­tion sup­port. The spon­sor or CRO’s in­ter­nal team would then de­sign and build the study us­ing a com­bi­na­tion of their own ca­pa­bil­i­ties and li­censed tech­nol­o­gy.

By max­i­miz­ing in­ter­nal ca­pa­bil­i­ties, spon­sors and CROs can ben­e­fit in the fol­low­ing ways:

• Flex­i­bil­i­ty and con­trol. Al­low in­ter­nal SMEs to weigh in on study build, giv­ing them more con­trol over the process. Re­al-time da­ta ac­cess (us­ing an eS­ource plat­form) gives spon­sors more con­trol of their da­ta.
• Ef­fi­cien­cy and speed. A build-it-your­self ap­proach de­creas­es study start­up time. Or­ga­ni­za­tions gain more con­trol over their own study build, which al­lows them to move through the process faster.
• Cost sav­ings. By sub­scrib­ing to on­ly the ser­vices and tech­nol­o­gy need­ed, or­ga­ni­za­tions save on the cost typ­i­cal­ly re­quired to pur­chase or li­cense a full da­ta cap­ture plat­form tech­nol­o­gy suite. By us­ing in­ter­nal re­sources for the study build and de­ploy­ment, they save even more.
• Dri­ve ad­di­tion­al rev­enue. CROs can cre­ate new rev­enue streams by ini­ti­at­ing ePRO, eCOA, DDC, and/or a bring your own de­vice (BY­OD) strat­e­gy. They can bid on and win pro­pos­als pre­vi­ous­ly lost to larg­er en­ti­ties or com­pa­nies that have ac­quired tech­nol­o­gy com­pa­nies.
• Da­ta vis­i­bil­i­ty and in­ter­op­er­abil­i­ty. Study teams can ac­cess and re­view clin­i­cal da­ta im­me­di­ate­ly. When spon­sors can ac­cess da­ta di­rect­ly, they can run their own re­ports and dri­ve their own in­sights.

Pa­tient Da­ta in To­tal­i­ty

To play a role in re­duc­ing op­er­a­tional com­plex­i­ty, da­ta cap­ture plat­forms must have a sim­ple, in­tu­itive in­ter­face that less tech-savvy in­di­vid­u­als can use. They must al­so have the abil­i­ty to in­te­grate all the dis­parate tech­nolo­gies and de­vices that com­prise to­day’s clin­i­cal tri­als.

Most da­ta cap­ture plat­forms aren’t equipped to ef­fec­tive­ly man­age all the third-par­ty tech­nolo­gies and de­vices used in DCTs. They aren’t holis­tic; they are mere­ly ag­gre­ga­tions of point so­lu­tions that evolved over time. They can’t seam­less­ly in­te­grate and val­i­date struc­tured and un­struc­tured da­ta — from vi­tals to video — in an or­ga­nized fash­ion. They can’t in­te­grate the myr­i­ad tele­health plat­forms, re­mote pa­tient mon­i­tor­ing tools, wear­ables, and oth­er tech­nolo­gies in­volved in DCTs. To ac­com­plish this re­quires a dif­fer­ent plat­form ar­chi­tec­ture and da­ta mod­el.

To make DCTs seam­less, da­ta cap­ture plat­forms must fo­cus on pa­tient da­ta in to­tal­i­ty. They must elim­i­nate the dis­tinc­tions be­tween elec­tron­ic da­ta cap­ture (EDC), elec­tron­ic out­come as­sess­ments (ePRO, eCOA, Clin­RO), and the EMR. They must al­so cap­ture da­ta de­pend­ing on how pa­tients choose to par­tic­i­pate.

The da­ta cap­ture plat­form de­signed for DCTs must have in­her­ent flex­i­bil­i­ty to al­low spon­sors to de­sign tri­als in a man­ner that best suits the re­search, the pa­tients, and the sites. To re­duce the cost and com­plex­i­ty as­so­ci­at­ed with new tech­nol­o­gy, ven­dors can em­pow­er spon­sors and CROs to de­sign and build stud­ies them­selves.

Ser­vices and Sup­port Avail­able by Sub­scrip­tion

Tiered sub­scrip­tion-based mod­els ex­ist in many oth­er in­dus­tries. In many cas­es, they al­low small busi­ness­es to use pow­er­ful soft­ware for a frac­tion of the For­tune 500-lev­el price. A sub­scrip­tion-based da­ta cap­ture ser­vice mod­el al­lows spon­sors and CROs to ac­cess eCOA, ques­tion­naire li­braries, and many oth­er ser­vices, plus sup­port, at pre­cise­ly the lev­el they need. This mod­el, com­bined with in­te­gra­tion, re­moves op­er­a­tional com­plex­i­ty while bring­ing ef­fi­cien­cy and rev­enue gains.