Five Steps to Guide Suc­cess­ful Risk-Based De­cen­tral­ized Clin­i­cal Tri­als

DCTs are not a brand new idea. For more than a decade, the drug and med­ical de­vice de­vel­op­ment in­dus­try has been try­ing to an­swer the ques­tion: How do we bring the study to the pa­tient? DCTs of­fered a po­ten­tial an­swer, yet com­pa­nies had been wary to adopt this pre­vi­ous­ly rel­a­tive­ly un­tried mod­el.

Now, bring­ing tri­als to pa­tients is no longer a nice-to-have, as more than half of the top 50 phar­ma­ceu­ti­cal com­pa­nies have had to make pro­to­col changes in their on­go­ing tri­als since the pan­dem­ic be­gan and oth­ers have paused tri­als com­plete­ly. As of May 20, one-third of spon­sors were switch­ing to vir­tu­al or de­cen­tral­ized mod­els, ac­cord­ing to the Tufts Cen­ter for the Study of Drug De­vel­op­ment (CS­DD).{1} And on Sep­tem­ber 2nd, Fierce­Biotech re­port­ed a new sur­vey show­ing that two-third of health­care ex­perts plan to use vir­tu­al tri­als as a re­sult of Covid-19 (Fierce Biotech). {2}

Long af­ter the pan­dem­ic sub­sides, com­pa­nies will re­call these dark days and want to be pre­pared to min­i­mize the risk of tri­als be­ing dis­rupt­ed again as well as pro­vide more choic­es for en­gage­ment to sites and pa­tients. Here are five key steps to help spon­sors suc­cess­ful­ly de­cen­tral­ize in-flight tri­als and start new DCTs with­in a risk-based frame­work.

1. Doc­u­ment a spe­cif­ic de­cen­tral­ized study de­sign and im­ple­men­ta­tion plan, in­clud­ing all pa­tient safe­ty, da­ta in­tegri­ty, and reg­u­la­to­ry con­sid­er­a­tions (see Fig­ure 1).
2. De­ter­mine the wear­ables and de­vices that are need­ed, what tools are al­ready be­ing used in the study ecosys­tem (i.e., in­ter­ac­tive re­sponse tech­nol­o­gy, elec­tron­ic da­ta cap­ture, cen­tral labs, etc.), and oth­er types of sup­port that would be need­ed (i.e., home health nurs­ing, lo­cal labs, etc.).
3. Eval­u­ate how de­cen­tral­ized da­ta will be re­viewed and mon­i­tored to en­sure qual­i­ty and in­tegri­ty. For ex­am­ple, de­fine which da­ta are col­lect­ed for re­mote pa­tient safe­ty over­sight mon­i­tor­ing and which for study end­point analy­sis.
4. Equip all sites for suc­cess in a de­cen­tral­ized mod­el, con­sid­er­ing how it will im­pact ef­fi­cien­cy and dai­ly op­er­a­tions. Map out the op­tions that would be avail­able for each site, in­clud­ing those that are ac­cept­able with­in a site’s in­fra­struc­ture al­ready, to lever­age dif­fer­ent tech­nolo­gies or re­mote sup­port teams. Ad­di­tion­al­ly, con­sid­er what sup­port and train­ing will be need­ed to en­able the sites to en­gage ef­fec­tive­ly in DCTs.
5. En­hance the pa­tient/physi­cian re­la­tion­ship in a vir­tu­al world by pro­vid­ing op­tions such that study teams, in­ves­ti­ga­tors, and pa­tients have choic­es about how they can par­tic­i­pate in a study. It’s im­por­tant to rec­og­nize that one size does not fit all, so flex­i­bil­i­ty is cru­cial to al­low for physi­cian and pa­tient choice in or­der for DCTs to be ef­fi­cient and ef­fec­tive for both par­ties.

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DCTs are Prov­ing Them­selves as a Suc­cess­ful In­ven­tion That’s Here to Stay

From the largest to the emerg­ing, life sci­ences com­pa­nies are em­brac­ing DCTs, and so are their part­ners and pa­tients. A re­cent Site Land­scape Sur­vey by the So­ci­ety for Clin­i­cal Re­search Sites re­vealed that more than half of sites re­port­ed they would do “what­ev­er is re­quired” to con­duct a vir­tu­al or de­cen­tral­ized tri­al, while 75% of pa­tients say that col­lect­ing all study da­ta from their own home is ap­peal­ing.{3}

Clin­i­cal re­search, wher­ev­er it oc­curs, will al­ways re­quire the ex­per­tise and ex­pe­ri­ence of qual­i­fied teams that em­brace a risk-based ap­proach. By im­ple­ment­ing a “pa­tient first” DCT, or­ga­ni­za­tions can shat­ter the tra­di­tion­al study par­a­digm and fi­nal­ly achieve sought-af­ter im­prove­ments in pa­tient ac­ces­si­bil­i­ty, uni­fi­ca­tion of da­ta, and da­ta avail­abil­i­ty, cul­mi­nat­ing in faster, more ef­fec­tive tri­als.
We have the abil­i­ty to en­gage with our pa­tients, learn about their lives and pri­or­i­ties, and ap­ply these in­sights to op­ti­mize the study de­sign and mit­i­gate up­front risks. For ex­am­ple, by em­ploy­ing tech­nol­o­gy to con­duct pre-re­cruit­ment as­sess­ment da­ta col­lec­tion, com­pa­nies can un­der­stand how peo­ple live so that pro­to­cols can be cus­tomized—bring­ing a pa­tient-fo­cused ex­pe­ri­ence to clin­i­cal re­search.

While the COVID-19 pan­dem­ic has been a cat­a­lyst in forc­ing new clin­i­cal tri­al ex­e­cu­tion mod­els to go main­stream, they will be part of a mix of op­tions in the long term. The ad­van­tages are pow­er­ful and the re­sults are the proof—DCTs are here to stay.

(1) Cen­ter­Watch. 2020. Pan­dem­ic Un­leash­es Mo­men­tous Change in Clin­i­cal Re­search. See full re­source here.

(2) Fierce Biotech. 2020. Two Thirds of Health­care Ex­perts plot vir­tu­al tri­al use as a re­sult of Covid-19: Re­port. See full re­source here.

(3) Cen­ter for In­for­ma­tion and Study on Clin­i­cal Re­search Par­tic­i­pa­tion (CIS­CRP). 2019. 2019 Per­cep­tions and In­sights Study: Pa­tient Ex­pe­ri­ence Re­port. See full re­source here.