BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-con­sum­ing com­po­nents of clin­i­cal re­search cen­ter on gath­er­ing, an­a­lyz­ing, and re­port­ing da­ta. To im­prove ef­fi­cien­cy, many clin­i­cal tri­al spon­sors have shift­ed to elec­tron­ic clin­i­cal out­come as­sess­ments (eCOA), in­clud­ing elec­tron­ic pa­tient-re­port­ed out­come (ePRO) tools.

In most cas­es, pa­tients en­ter da­ta us­ing apps in­stalled on pro­vi­sioned de­vices. At a time when 81% of Amer­i­cans own a smart­phone, why not use the de­vice they re­ly on every day?

Us­ing pa­tients’ mo­bile de­vices, as ei­ther a stand-alone so­lu­tion to col­lect par­tic­i­pant da­ta or as part of a hy­brid op­tion that al­so in­cor­po­rates pro­vi­sioned de­vices, en­hances pa­tient cen­tric­i­ty. That’s the the­o­ry be­hind the bring your own de­vice (BY­OD) strat­e­gy — a vi­able op­tion for many clin­i­cal tri­als and a must for vir­tu­al or hy­brid clin­i­cal tri­als.

While de­cen­tral­ized tri­al mod­els and ePRO are both ac­cept­ed in the in­dus­try, some spon­sors have hes­i­tat­ed on BY­OD due to ques­tions over da­ta qual­i­ty, in­tegri­ty, and vari­abil­i­ty; reg­u­la­to­ry ac­cep­tance; and lo­gis­ti­cal is­sues. How­ev­er, COVID-19 has prompt­ed spon­sors and CROs to give BY­OD a longer look. Pa­tients are less will­ing to trav­el to phys­i­cal sites and more com­fort­able us­ing their mo­bile de­vices in the con­text of health­care. To en­cour­age en­roll­ment, spon­sors must meet pa­tients where they are: at home, on the go, or at the clin­ic.

With the FDA en­cour­ag­ing adop­tion of pa­tient-cen­tric ap­proach­es, clin­i­cal tri­al mod­els that al­low pa­tients to re­port out­comes from home are the way for­ward. BY­OD is a key com­po­nent of this ap­proach.

BY­OD Ben­e­fits for Pa­tients, Spon­sors, and CROs

An in­creas­ing num­ber of stud­ies are de­ploy­ing BY­OD mod­els with suc­cess, prov­ing reg­u­la­to­ry and da­ta qual­i­ty/con­sis­ten­cy hur­dles can be cleared. And the ben­e­fits to both pa­tients and spon­sors make BY­OD a clear choice for many clin­i­cal tri­als.

The biggest win? Pa­tients pre­fer it. The more seam­less­ly your clin­i­cal tri­al fits in­to pa­tients’ lives, the more like­ly they will stay en­gaged. Think about it: Most smart­phone users can’t part with their de­vices for five min­utes. But if they left a pro­vi­sioned de­vice at the of­fice, there it would stay un­til to­mor­row. “I’ll en­ter my symp­tom in­fo lat­er,” they’d think. Not good for da­ta ac­cu­ra­cy.

A 2018 study ex­plored pa­tients’ pref­er­ences for pa­per-based and dig­i­tal PROs. Pa­tients com­plet­ed a PRO us­ing pa­per, a pro­vi­sioned de­vice, and an app in­stalled on their mo­bile de­vice. Pa­tients lat­er filled out a ques­tion­naire about their at­ti­tudes to­ward each method.

Of the 155 par­tic­i­pants, 94% said they would “def­i­nite­ly” or “prob­a­bly” down­load an app on­to their mo­bile de­vice for a fu­ture clin­i­cal tri­al. A to­tal of 45% thought BY­OD would be more con­ve­nient. On­ly 15% pre­ferred a pro­vi­sioned de­vice.

BY­OD al­so paves the way for com­pli­ance. In an ear­ly Clin­i­cal Ink case study con­duct­ed on the Lunex­is™ plat­form, pa­tients lever­aged the BY­OD im­ple­men­ta­tion twice as of­ten and for twice as long (see be­low). This sug­gests pa­tients were us­ing the app as in­tend­ed, which leads to bet­ter da­ta and a smoother clin­i­cal tri­al.

Clin­i­cal tri­al spon­sors and CROs face enor­mous pres­sure to con­trol costs and short­en time­lines. BY­OD helps achieve both. In ad­di­tion to im­prov­ing ef­fi­cien­cy, BY­OD sig­nif­i­cant­ly lessens — and per­haps elim­i­nates in some tri­als — costs as­so­ci­at­ed with da­ta plans, ship­ping, lost or un­re­turned de­vices, and the over­all lo­gis­tics of in­ven­to­ry man­age­ment. For a large tri­al, these sav­ings are sig­nif­i­cant.

Reg­u­la­to­ry Ac­cep­tance of BY­OD Da­ta

Mul­ti­ple stud­ies have com­plet­ed reg­u­la­to­ry sub­mis­sions us­ing BY­OD-cap­tured pri­ma­ry end­point da­ta. Con­cern­ing PRO as­sess­ments, in its COVID-19 guid­ance doc­u­ment, the FDA rec­om­mends “tech­nolo­gies that can re­mind tri­al par­tic­i­pants to com­plete the ques­tion­naires and/or ver­bal ad­min­is­tra­tion at the time in­struct­ed.”

This state­ment in­di­cates FDA ac­cep­tance of mo­bile de­vices gen­er­al­ly. En­gage with the agency ear­ly in your pro­to­col to get feed­back re­gard­ing BY­OD or a hy­brid strat­e­gy.

Copy­right Is­sues

Any ap­proach for BY­OD should be re­viewed and ap­proved by the ePRO ques­tion­naire copy­right hold­ers be­fore ePRO de­vel­op­ment be­gins. If the copy­right hold­er has ex­pressed com­fort with BY­OD or if the ques­tion­naire was cre­at­ed by the spon­sor or CRO, you’ve got the green light for BY­OD.

As you plan ePRO de­vel­op­ment, raise any copy­right con­cerns with your ven­dor. They may have re­la­tion­ships that can help fa­cil­i­tate the process.

Da­ta Equiv­a­len­cy

Mul­ti­ple stud­ies and meta-analy­ses show high lev­els of agree­ment be­tween pa­per and elec­tron­ic for­mats, as well as be­tween pro­vi­sioned de­vices and pa­tient smart­phones. If you fol­low gen­er­al prin­ci­ples of ePRO de­sign good prac­tices, mea­sure­ment ca­pa­bil­i­ties be­tween pa­per-based da­ta col­lec­tion and mo­bile de­vices should be equiv­a­lent.

The BY­OD Bot­tom Line

BY­OD is an im­por­tant com­po­nent of pa­tient-cen­tric clin­i­cal tri­als. The ap­proach doesn’t suit every tri­al — some may re­quire a hy­brid ap­proach while oth­ers may re­quire pro­vi­sioned de­vices ex­clu­sive­ly. To de­ter­mine whether BY­OD is right for your or your client’s tri­al, con­sult with a BY­OD-ex­pe­ri­enced ven­dor to eval­u­ate risks and op­por­tu­ni­ties and de­ter­mine the best path for­ward.