A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

De­spite the promised de­cen­tral­ized tri­al rev­o­lu­tion, we haven’t yet moved the nee­dle in a sig­nif­i­cant way, al­though we are see­ing far bold­er com­mit­ments to this as we con­tin­ue to ex­pe­ri­ence the pan­dem­ic re­stric­tions for some time to come. The vi­sion of grandeur is one thing, but op­er­a­tional­iz­ing and ex­e­cu­tion are an­oth­er and recog­nis­ing that change, par­tic­u­lar­ly mid-flight on stud­ies, is wor­thy of thor­ough eval­u­a­tion and con­sid­er­a­tion in or­der to achieve suc­cess. Here we will dis­cuss one of the crit­i­cal build­ing blocks of a De­cen­tral­ized and Re­mote Tri­al strat­e­gy: Tele­Con­sent; more than pa­per un­der glass, it is a par­a­digm change and key dig­i­tal en­abler.

As de­cen­tral­ized clin­i­cal tri­als have gained sig­nif­i­cant adop­tion in re­sponse to the glob­al COVID-19 pan­dem­ic, there is a grow­ing need for plat­forms that al­low for Tele­Con­sent to con­nect pa­tients world­wide vir­tu­al­ly with clin­i­cal sites. This al­lows clin­i­cal tri­al spon­sors to screen, en­roll, and con­sent par­tic­i­pants in an en­vi­ron­ment where many pa­tients are be­ing told to shel­ter in place.

Tra­di­tion­al­ly, con­sent has been ob­tained us­ing a pa­per process where the clin­i­cian and the pa­tient are lo­cat­ed in the same fa­cil­i­ty. Both par­ties sign the pa­per doc­u­ment to con­firm it has been re­viewed and un­der­stood. eCon­sent al­lows this process to be dig­i­tized and en­ables elec­tron­ic sig­na­tures to be ob­tained at the site with both pa­tient and clin­i­cian. This new process re­moves man­u­al pa­per work­flows and en­ables in­creased qual­i­ty and com­pli­ance while check­ing re­al-time pa­tient com­pre­hen­sion through­out the process.

Tele­Con­sent, on the oth­er hand, means that a pa­tient can be lo­cat­ed ge­o­graph­i­cal­ly any­where, dis­tant from the site, and fol­low the eCon­sent process. Pa­tients can be in their own homes and con­nect vir­tu­al­ly to the site by Tele­Vis­it. This process can al­so be used in a “re-con­sent” for any fu­ture changes in a clin­i­cal tri­al. Like eCon­sent, it is cru­cial with Tele­Con­sent that the sys­tem is in line with the pa­ra­me­ters out­lined by the FDA in their De­cem­ber 2016 guid­ance and 21 CFR Part 11, and ICH GCP E6 R2. In terms of se­cu­ri­ty and pri­va­cy, the eCon­sent sys­tem should be aligned to HIPAA and GDPR.

Re­cent­ly, we an­nounced gen­er­al avail­abil­i­ty of Med­able Tele­Con­sent™, a new prod­uct that en­ables ful­ly re­mote in­formed con­sent and re-con­sent for clin­i­cal tri­als. Un­like tra­di­tion­al eCon­sent prod­ucts that re­quire both pa­tient and in­ves­ti­ga­tor to be phys­i­cal­ly present to­geth­er in the clin­ic, Med­able Tele­Con­sent al­lows pa­tients, doc­tors, nurs­es, and clin­i­cal tri­al staff all to con­nect and sign re­mote­ly from any lo­ca­tion.

Med­able Tele­Con­sent solves one of the most com­plex as­pects of clin­i­cal tri­als for pa­tients, sites and spon­sors and de­fines the first ex­pe­ri­ence for pa­tients of tri­al par­tic­i­pa­tion. By elim­i­nat­ing the need for mul­ti­ple round-trip vis­its to clin­i­cal sites, Tele­Con­sent dra­mat­i­cal­ly im­proves pa­tient ac­ces­si­bil­i­ty to stud­ies from their home lo­ca­tion con­nect­ing them di­rect­ly with their PI’s and site teams re­sult­ing in faster en­roll­ment and greater par­tic­i­pant di­ver­si­ty for tri­al spon­sors—and bet­ter re­ten­tion over the course of a study as pa­tients have more op­tions to en­hance un­der­stand­ing of tri­al ex­pec­ta­tions. Tele­Con­sent al­so im­proves pa­tient knowl­edge and com­pre­hen­sion by pro­vid­ing med­ical in­for­ma­tion in vi­su­al and mul­ti­me­dia for­mats, which pa­tients can re­view in depth to­geth­er with fam­i­ly mem­bers and care­givers—and then en­gage vi­su­al­ly with their physi­cian to sign con­sent forms dig­i­tal­ly from the com­fort of their home or lo­cal clin­ic.

It’s im­por­tant to note that eCon­sent op­er­ates on a con­tin­u­um. With Med­able Tele­Con­sent, you can choose whether to uti­lize eCon­sent at the site, whether to com­plete the eCon­sent re­mote­ly, or whether to com­mit to a ful­ly de­cen­tral­ized clin­i­cal tri­al where con­sent is not on­ly re­mote, but so too is screen­ing, en­roll­ment, ran­dom­iza­tion, and sup­ply. Fig­ure 1 shows the jour­ney to­ward full De­cen­tral­ized Clin­i­cal Tri­al In­formed Con­sents.

Tiered Re­mote In­formed Con­sent Op­tions

Click on the im­age to see the full-sized ver­sion

Med­able Tele­Con­sent is es­pe­cial­ly crit­i­cal in the COVID-19 en­vi­ron­ment, where many pa­tients are stay­ing home to avoid so­cial in­ter­ac­tion and min­imise ex­po­sure. Sites and spon­sors can now screen, en­roll and con­sent study par­tic­i­pants with­out meet­ing in per­son, tak­ing ad­van­tage of Med­able’s Tele­Vis­it ap­pli­ca­tion to con­duct per­son­al­ized in­ter­ac­tions that im­prove pa­tient un­der­stand­ing. Sites and spon­sors ben­e­fit from stream­lined work­flows and en­hanced da­ta qual­i­ty and com­pli­ance. Spon­sors al­so get in­creased trans­paren­cy with re­al-time re­port­ing and in­sight in­to study progress. Tele­Con­sent can al­so be used for re-con­sent­ing pa­tients for any fu­ture changes that may hap­pen in a clin­i­cal tri­al.

“Med­able Tele­Con­sent is a crit­i­cal step in the evo­lu­tion of de­cen­tral­ized re­search, as con­sent is the gate­way to tri­al par­tic­i­pa­tion,” said Dr. Michelle Long­mire, CEO and co-founder of Med­able. “This has the po­ten­tial to en­able glob­al pa­tient ac­cess and im­proved knowl­edge, lead­ing to greater par­tic­i­pant di­ver­si­ty, re­ten­tion, and ul­ti­mate­ly re­search qual­i­ty and speed. We’re ex­cit­ed to break down these bar­ri­ers to ben­e­fit pa­tients, sites and spon­sors alike.”

To learn more about our Tele­Con­sent, we in­vite you to sched­ule a TeleLunch and Learn where we’ll pro­vide a live de­mo of our Tele­Vis­it and Tele­Con­sent ca­pa­bil­i­ties.

AUTHOR

Alison Holland

Head of Decentralized and Remote trials