mHealth in­no­va­tion: Iden­ti­fy­ing the best pa­tient-cen­tered tech­nol­o­gy for clin­i­cal tri­als

Sen­sor-based tech­nol­o­gy for clin­i­cal tri­al da­ta col­lec­tion rep­re­sents the lat­est med­ical par­a­digm shift. There are more than 700 clin­i­cal stud­ies in­volv­ing wear­able de­vices cur­rent­ly un­der­way in the Unit­ed States. A study from In­tel IT projects their in­clu­sion in clin­i­cal tri­als will surge to 70% by 2025.

Apps, biosen­sors and pa­tient-cen­tered tech­nolo­gies in­crease vis­i­bil­i­ty of com­pre­hen­sive pa­tient da­ta. Phar­ma lead­ers an­tic­i­pate the ben­e­fits of wear­ables to in­clude bet­ter da­ta (58%), faster re­sults (33%) and low­er tri­al costs (10%).

Plus, these tech­nolo­gies of­fer ad­di­tion­al ben­e­fits of im­prov­ing the over­all pa­tient ex­pe­ri­ence, re­sult­ing in high­er pa­tient re­cruit­ment, en­gage­ment, and re­ten­tion. Eighty-nine per­cent of spon­sors that use wear­able de­vices in clin­i­cal tri­als say that pa­tient feed­back has been pos­i­tive.

But pa­tient-cen­tered tech­nolo­gies are not cre­at­ed equal. What works for one pa­tient pop­u­la­tion may not be ap­pro­pri­ate for oth­ers. Thor­ough test­ing and care­ful eval­u­a­tion are es­sen­tial pre­req­ui­sites for iden­ti­fy­ing the best tech­nol­o­gy for a com­pa­ny’s tri­al needs.

I re­cent­ly mod­er­at­ed a we­bi­nar that took a clos­er look at the use of wear­able de­vices for clin­i­cal tri­als. The in­ter­ac­tive dis­cus­sion fea­tured my sen­sors and wear­ables col­leagues from Parex­el and Acti­graph, a provider of med­ical-grade bio­met­ric mon­i­tor­ing tech­nol­o­gy so­lu­tions.

We shared in­sights from mar­ket re­search on spon­sor us­age of wear­ables and sen­sors. The re­search study’s goal was to de­vel­op a deep­er un­der­stand­ing of the cur­rent trends and spon­sor adop­tion be­hav­ior for wear­able de­vices in clin­i­cal tri­als. All 140+ sur­vey par­tic­i­pants work for a bio­phar­ma­ceu­ti­cal com­pa­ny in some ca­pac­i­ty and are in­volved with de­ci­sion mak­ing for procur­ing and/or se­lect­ing an ex­ter­nal provider for clin­i­cal out­sourc­ing needs.

Bring­ing the fu­ture of clin­i­cal tri­als to the present

Six­ty-sev­en per­cent of the com­pa­nies rep­re­sent­ed in the sur­vey said they are cur­rent­ly us­ing wear­able de­vices in clin­i­cal re­search for re­mote da­ta col­lec­tion from pa­tients in their home en­vi­ron­ment, with on­col­o­gy and car­dio­vas­cu­lar dis­ease stud­ies rep­re­sent­ing the high­est adop­tion rates. One-quar­ter are con­sid­er­ing wear­able de­vices for fu­ture clin­i­cal tri­als.

The pan­dem­ic has rapid­ly ac­cel­er­at­ed the use of wear­ables in clin­i­cal tri­als. This has es­pe­cial­ly been the case for ful­ly de­cen­tral­ized clin­i­cal tri­als (DCTs) where the pa­tient par­tic­i­pates en­tire­ly from their home or lo­cal com­mu­ni­ty; as well as for hy­brid tri­als of­fer­ing a com­bi­na­tion of site and home-based par­tic­i­pa­tion.

At Parex­el, we guide spon­sors through sci­en­tif­ic con­sid­er­a­tions and op­er­a­tional re­quire­ments for the suc­cess­ful use of mHealth (mo­bile health) de­vices in clin­i­cal re­search. We have been at the fore­front of wear­able, mo­bile tech­nol­o­gy even pri­or to the pan­dem­ic. My col­league Rosamund Round, leader of Parex­el’s Pa­tient In­no­va­tion Cen­ter, re­cent­ly spoke about Parex­el’s work with DCTs.

In an in­ter­view with Con­tract Phar­ma mag­a­zine, Round said, “Parex­el now in­cludes DCT in 80% of phase II/III and 100% of phase IV pro­pos­als. We see DCT as the cen­ter­piece of a new op­er­at­ing mod­el and how we can best sup­port pa­tients in or near their home to im­prove tri­al ac­cess and ex­pe­ri­ences.”

Lever­ag­ing the right tech at the right time

Many com­pa­nies are lever­ag­ing wear­able de­vices be­cause of their po­ten­tial to re­duce study costs, abil­i­ty to track da­ta that could not be vi­ably ob­tained in a clin­i­cal set­ting oth­er­wise and to de­liv­er pa­tient-cen­tric re­search ap­proach­es. But mHealth in­fra­struc­ture and op­er­a­tional­iza­tion need to be right for this ap­proach to be ef­fec­tive.

Ease of use for the pa­tient and da­ta qual­i­ty are the two top at­trib­ut­es that sur­vey re­spon­dents con­sid­er when se­lect­ing a wear­able de­vice to use in a clin­i­cal tri­al. So­lu­tions ar­chi­tect and pro­gram di­rec­tor at Parex­el’s Sci­en­tif­ic Da­ta Or­ga­ni­za­tion Nathan Noakes ad­vised that start­ing with the right tech­nol­o­gy is crit­i­cal.

“You need to be sure that the type of de­vice that you are se­lect­ing is the right one for the pro­to­col, the right one for the pa­tient, and is go­ing to give you the end­points and the out­puts that you are ex­pect­ing,” said Noakes.

Parex­el main­tains a de­vice cat­a­log of wear­ables and con­nect­ed de­vices that have been as­sessed for de­ploy­ment in clin­i­cal tri­als. To date, this in­cludes more than 70 de­vices across ther­a­peu­tic ar­eas, 57 of which are med­ical-grade de­vices. All Parex­el ven­dors are au­dit­ed and qual­i­fied to en­sure they meet strict da­ta pro­tec­tion and pri­va­cy re­quire­ments and are fol­low­ing ro­bust process­es for man­u­fac­tur­ing and im­ple­men­ta­tion.

All da­ta from the wear­able de­vices are in­gest­ed in­to a plat­form. This is usu­al­ly via a da­ta hub placed in the pa­tient’s home or through an app on the pa­tient’s own or pro­vi­sioned smart­phone.

The col­lect­ed da­ta are vi­su­al­ized and re­port­ed through an on­line por­tal and re­viewed re­mote­ly. If more con­text is need­ed, es­pe­cial­ly for DCTs, oth­er pa­tient-re­port­ed tech­nolo­gies like eDi­aries, ePRO/eCOA and eCon­sent can be over­layed on­to the da­ta to pro­vide ad­di­tion­al in­sights.

En­abling greater vis­i­bil­i­ty in­to pa­tient well­ness

The mas­sive amounts of da­ta ob­tained through these tech­nol­o­gy plat­forms in­form clin­i­cal de­ci­sions on a pa­tient’s treat­ment such as dose re­quire­ments and ther­a­py changes. Ex­pand­ed da­ta sets pro­vide ad­di­tion­al learn­ings that guide the en­tire tri­al.

Je­re­my Wy­att, CEO of Acti­Graph, said that wear­able sen­sors of­fer “… a much more gran­u­lar view in­to the pa­tient and a bet­ter op­por­tu­ni­ty to un­der­stand what’s go­ing on in the pa­tient’s life, rather than just what some bio­mark­er tells us about a blood sam­ple.” That gran­u­lar view of the da­ta pro­vides high val­ue to spon­sors, in­ves­ti­ga­tors and reg­u­la­to­ry au­thor­i­ties. The abil­i­ty to cap­ture dig­i­tal end­points that can’t be col­lect­ed in oth­er ways are the pri­ma­ry dri­vers of us­ing wear­able de­vices in clin­i­cal tri­als.

Re­spon­dents to the sur­vey cit­ed the top three ben­e­fits of in­clud­ing wear­able de­vices in clin­i­cal tri­als as im­proved da­ta qual­i­ty, ob­tain­ing da­ta that can’t be ob­tained from oth­er meth­ods and bet­ter pa­tient com­pli­ance. More than half of re­spon­dents re­port­ed that heart rate and blood pres­sure are the top mea­sure­ments cur­rent­ly cap­tured through wear­able de­vices. Heart rate and blood pres­sure were fol­lowed by mea­sure­ments of tem­per­a­ture, heart rhythm, ECG/EKG, blood glu­cose, steps and sleep. The da­ta for these types of out­comes tend to be more eas­i­ly cap­tured via wear­ables ver­sus non-wear­ables.

Re­duc­ing the pa­tient bur­den

The re­al­i­ty is that the suc­cess of a clin­i­cal tri­al us­ing wear­ables hinges on the pa­tient. The process must be as seam­less as pos­si­ble for them.

Our re­search find­ings sug­gest that sur­vey re­spon­dents be­lieve that pa­tients find wear­able and con­nect­ed de­vices ap­peal­ing. Most like the re­duc­tion in the num­ber of tri­al site vis­its that are re­quired by us­ing a DCT mod­el with tele­health op­tions. This en­gage­ment leads to both eas­i­er re­cruit­ment and in­creased re­ten­tion of pa­tients.

Feed­back from spon­sors is en­cour­ag­ing, as well. Eighty-nine per­cent re­port that pa­tient re­ac­tions have been pos­i­tive with Chi­na see­ing more fa­vor­able feed­back than the oth­er ge­o­gra­phies sur­veyed in­clud­ing North Amer­i­ca and Eu­rope.

Find­ings show that to dri­ve pa­tient re­ten­tion and com­pli­ance, the de­vice must be easy to use and fit in­to an ex­ist­ing lifestyle. Pa­tients have to see the val­ue in the de­vice and the da­ta col­lect­ed and how it fa­cil­i­tates their health. Cer­tain meth­ods can help dri­ve us­age, like:

  • In­clud­ing cus­tomiz­able de­vice at­tach­ments to en­sure pa­tient com­pat­i­bil­i­ty such as var­i­ous sizes for body types or op­tions for wrist, waist or hip.
  • En­sur­ing vari­able sen­sor con­trols cap­ture the ap­pro­pri­ate da­ta over the de­vice’s re­quired bat­tery life or be­tween recharges.
  • Pro­vid­ing avail­able sup­port in­clud­ing “hy­per­care” dur­ing the ini­tial en­roll­ment and on­go­ing 24/7 helpdesk staff.
  • Of­fer­ing ro­bust, easy-to-in­ter­pret train­ing ma­te­ri­als for use of the de­vice and col­lect­ing da­ta.

A promis­ing fu­ture for wear­ables

A work­group con­vened by two of the Na­tion­al In­sti­tutes of Health’s Big Da­ta to Knowl­edge (BD2K) Cen­ters of Ex­cel­lence eval­u­at­ed the clin­i­cal ap­pli­ca­tion of wear­ables. The re­sult­ing ar­ti­cle found that “… the fu­ture re­mains promis­ing for wear­ables in health­care.”

The group ex­pects the uti­liza­tion of wear­ables in health­care en­vi­ron­ments to in­crease as the tech­nol­o­gy ad­vances and in­ter­est ex­pands. They al­so an­tic­i­pate the in­te­gra­tion of wear­able sen­sors in­to cloth­ing and footwear will elim­i­nate com­pli­ance lim­i­ta­tions while im­prove­ments in sen­sor ac­cu­ra­cy will in­crease their use in the med­ical en­vi­ron­ment.

The eval­u­a­tion con­clud­ed, “Over­all, wear­ables her­ald a new era in health­care de­liv­ery with the po­ten­tial to trans­form many as­pects of clin­i­cal care.”

AUTHOR

Keith Wenzel

Senior Director, Scientific Data Organization, Parexel