Tak­ing Ac­tion to En­sure Clin­i­cal Tri­al Progress Dur­ing COVID-19

Why does it take so long to get new vac­cines and med­i­cines to mar­ket?

It is not a new ques­tion. But as gov­ern­ments, com­mu­ni­ties and med­ical pro­fes­sion­als around the world fo­cus their en­er­gy and re­sources on con­tain­ing the COVID-19 pan­dem­ic, it’s be­ing asked with in­creas­ing ur­gency. It de­serves – in fact, it re­quires – our col­lec­tive at­ten­tion and ef­fort.

The good news amidst so many trou­bling head­lines is that the tech­nolo­gies we need to im­prove pa­tient ac­cess and ex­pe­ri­ence are here now. The smart ap­pli­ca­tion of those tech­nolo­gies can over­come bar­ri­ers to tri­al ex­e­cu­tion and im­prove da­ta shar­ing and process ef­fi­cien­cy across or­ga­ni­za­tions. Most ur­gent­ly, those tech­nolo­gies can be used im­me­di­ate­ly to en­sure progress for thou­sands of clin­i­cal tri­als in an en­vi­ron­ment where pa­tients are ex­pect­ed to stay at home.

De­cen­tral­ized and hy­brid tri­als – the time has come

At a re­cent con­gres­sion­al hear­ing, NI­AID di­rec­tor An­tho­ny Fau­ci gave a frank as­sess­ment about the short­com­ings of the U.S. sys­tem for coro­n­avirus test­ing: It’s “not re­al­ly geared to what we need right now.”

The same can be said for our tra­di­tion­al clin­i­cal tri­al mod­el. Lim­it­ing tri­als to a hand­ful or two of phys­i­cal sites in­her­ent­ly lim­its pa­tient ac­cess. Re­strict­ing in­ter­ac­tion to in-per­son vis­its is not on­ly gross­ly in­ef­fi­cient in many cas­es, but it al­so lim­its da­ta fre­quen­cy and qual­i­ty. And dur­ing a cri­sis like the COVID-19 pan­dem­ic, it’s sim­ply in­fea­si­ble.

The tra­di­tion­al tri­al mod­el does not put pa­tient needs first.

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By con­trast, de­cen­tral­ized clin­i­cal tri­als look more com­pelling than ever. The Clin­i­cal Tri­als Trans­for­ma­tion Ini­tia­tive (CT­TI) de­fines de­cen­tral­ized tri­als as those tri­als ex­e­cut­ed through telemed­i­cine and mo­bile/lo­cal health­care providers, us­ing pro­ce­dures that vary from the tra­di­tion­al clin­i­cal tri­al mod­el. In layper­son terms, the tri­al is con­duct­ed re­mote­ly with the par­tic­i­pant re­main­ing at home.

The in­dus­try has been look­ing to de­cen­tral­ize tri­als for years. Now, as health au­thor­i­ties world­wide strug­gle to con­tain the COVID-19 out­break, there is a re­newed push to rapid­ly im­ple­ment re­mote health­care de­liv­ery ca­pa­bil­i­ties.

There are cur­rent­ly more than 55,000 in­ter­ven­tion­al clin­i­cal tri­als ac­tive­ly en­rolling and pro­vid­ing care for par­tic­i­pants world­wide. In light of the cur­rent out­break, it is crit­i­cal that we con­tin­ue to de­liv­er high-qual­i­ty health­care to re­search par­tic­i­pants, while al­so con­tin­u­ing to ad­vance clin­i­cal drug de­vel­op­ment pro­grams.

De­cen­tral­ized tri­als are large­ly “geared” for ex­act­ly this type of sit­u­a­tion. Of the 55,000 tri­als in flight, some are good can­di­dates for a ful­ly de­cen­tral­ized mod­el — while many oth­ers can be man­aged in a hy­brid mod­el. Pa­tients can be re­cruit­ed and con­sent­ed re­mote­ly. Physi­cian “vis­its” can be con­duct­ed re­mote­ly via telemed­i­cine. Da­ta can be cap­tured re­mote­ly (and fre­quent­ly) via med­ical de­vices and mo­bile tech­nol­o­gy.

The De­cen­tral­ized Tri­al mod­el pro­vides glob­al pa­tient ac­cess with in­creased da­ta fre­quen­cy and qual­i­ty.

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All of this ex­pands our abil­i­ty to con­duct re­search by “un­teth­er­ing” it from phys­i­cal sites — crit­i­cal when peo­ple around the world are be­ing told to “stay home” due to COVID-19. Go­ing dig­i­tal (where pos­si­ble) re­duces pa­tient risk of pathogen ex­po­sure, while po­ten­tial­ly ac­cel­er­at­ing drug and vac­cine de­vel­op­ment. That may re­quire some changes to study de­sign or reg­u­la­to­ry ap­provals, but we’re find­ing it’s a pri­or­i­ty for many clin­i­cal lead­ers right now — es­pe­cial­ly those that need to en­sure pro­duc­tive tri­al progress and avoid sig­nif­i­cant loss of pa­tient par­tic­i­pa­tion.

Work­ing to­geth­er to ac­cel­er­ate COVID-19 re­search

In ad­di­tion to ac­cel­er­at­ing de­cen­tral­ized tri­al adop­tion, there’s an ur­gent need for cre­ative and col­lab­o­ra­tive so­lu­tions for COVID-19 re­search. To wit, sev­er­al com­pa­nies (in­clud­ing Med­able) re­cent­ly joined forces to stream­line the path for di­ag­nos­tics, health mon­i­tor­ing and clin­i­cal tri­als for COVID-19. The AC­CESS ini­tia­tive—short for Amer­i­can COVID-19 Col­lab­o­ra­tive En­abling Seam­less Sci­ence—pro­vides a mo­bile con­sumer ap­pli­ca­tion and se­cure in­fra­struc­ture to quick­ly con­nect health re­searchers and clin­i­cal tri­al teams se­cure­ly with up to mil­lions of home-bound in­di­vid­u­als in the Unit­ed States.

AC­CESS makes it easy for in­di­vid­u­als to con­tribute spe­cif­ic in­for­ma­tion about their COVID-19 ex­pe­ri­ence, com­bine it with health records and da­ta from wear­able de­vices, and opt in to par­tic­i­pate in cur­rent and fu­ture stud­ies for di­ag­nos­tics, treat­ments and vac­cines. The da­ta that peo­ple share can be quick­ly and anony­mous­ly matched to re­search stud­ies, pro­vid­ing re­searchers with a foun­da­tion­al frame­work for dy­nam­ic re­search at scale.

The mo­bile app makes it easy for in­di­vid­u­als to pro­vide health da­ta and be iden­ti­fied for ap­plic­a­ble stud­ies.

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AC­CESS is a col­lab­o­ra­tive ef­fort led by Med­able, to­geth­er with tech­nol­o­gy, health­care and life sci­ences com­pa­nies in­clud­ing BioIn­tel­liSense, Data­vant, Parex­el, PWN­Health and the Amer­i­can Heart As­so­ci­a­tion’s Cen­ter for Health Tech­nol­o­gy and In­no­va­tion. AC­CESS takes full ad­van­tage of mo­bile and dig­i­tal health tech­nolo­gies to fa­cil­i­tate at-home re­search, clin­i­cal tri­al ac­cess, and pop­u­la­tion-based long-term out­come stud­ies. The in­fra­struc­ture com­bines med­ical-grade wear­able sen­sors, pa­tient-re­port­ed da­ta and out­comes, his­tor­i­cal health da­ta and health record ag­gre­ga­tion. Par­tic­i­pants opt in at every stage, so they main­tain con­trol over their per­son­al health da­ta—and de­cide how they want to en­gage in po­ten­tial stud­ies.

We be­lieve AC­CESS will en­able us all to ac­cel­er­ate di­ag­nos­tic test­ing and clin­i­cal tri­als—and ad­vance im­por­tant mon­i­tor­ing and im­mu­ni­ty re­search—so that we can con­quer COVID-19 with ef­fec­tive pre­ven­tion and in­ter­ven­tion strate­gies. For more in­for­ma­tion on AC­CESS, go to https://ac­cess.med­able.com/.

Let’s mo­bi­lize

With all of this in mind, there is an im­me­di­ate op­por­tu­ni­ty for de­cen­tral­ized tri­als and cre­ative dig­i­tal so­lu­tions to im­prove pa­tient ac­cess, ex­pe­ri­ence and out­comes. Let’s work to­geth­er as a com­mu­ni­ty to dri­ve for­ward faster, whether it’s stream­lin­ing tri­als for COVID-19 vac­cines, re­duc­ing time­lines for oth­er ther­a­pies, or ini­ti­at­ing new tri­als to ad­dress the 7,000 rare dis­eases that have no ther­a­pies on the mar­ket.

The COVID-19 out­break has made it crys­tal clear: De­cen­tral­ized tri­als are no longer a nice-to-have. Re­duc­ing tri­al time­lines has to be a long-term in­dus­try im­per­a­tive, and dig­i­tal tech­nol­o­gy can help valu­able re­search con­tin­ue to move for­ward while keep­ing par­tic­i­pants safe. Let’s start now, and let’s move faster to­geth­er.


Al­i­son Hol­land is the head of de­cen­tral­ized and re­mote tri­als at Med­able. Ali has more than 30 years of clin­i­cal tri­al ex­pe­ri­ence, most re­cent­ly as Glob­al VP & Gen­er­al Man­ag­er for Gen­er­al Med­i­cine at Co­v­ance, a lead­ing glob­al clin­i­cal re­search or­ga­ni­za­tion. Ali has man­aged more than 300 clin­i­cal tri­als, work­ing suc­cess­ful­ly with biotech or­ga­ni­za­tions as well as glob­al phar­ma on some of their most crit­i­cal ini­tia­tives.

AUTHOR

Alison Holland

Head of Decentralized and Remote trials