From Clin­i­cal Strat­e­gy to De­vel­op­ment: Nav­i­gat­ing COVID-19 to Sup­port the Next Gen­er­a­tion of Pa­tient-Fo­cused Treat­ments

Key Points

  • The COVID-19 pan­dem­ic has im­per­iled clin­i­cal tri­als in many ways, one of which is dis­rupt­ing a pa­tient’s abil­i­ty to have tra­di­tion­al in-per­son study vis­its, there­by po­ten­tial­ly jeop­ar­diz­ing pa­tient care and safe­ty and the long-term vi­a­bil­i­ty of the study.
  • De­cen­tral­ized clin­i­cal tri­als (DCTs) lever­age pa­tient-cen­tered tech­nol­o­gy and in­no­va­tions to re­think and sus­tain crit­i­cal re­search while boost­ing pa­tient en­gage­ment, re­cruit­ment and re­ten­tion, ex­pe­dit­ing time to mar­ket.
  • Parex­el Biotech is a pi­o­neer in part­ner­ing with the in­dus­try to de­liv­er de­cen­tral­ized tri­als and has the ex­pe­ri­ence and da­ta to guide emerg­ing com­pa­nies through the evolv­ing pan­dem­ic from pre-IND to Post-Ap­proval.

We in­ter­viewed Gra­ciela Rá­caro, Glob­al Head of Op­er­a­tions at Parex­el Biotech, an in­dus­try leader that spe­cial­izes in mak­ing the clin­i­cal de­vel­op­ment jour­ney more ef­fort­less for small and emerg­ing biotech com­pa­nies and keep­ing pa­tient en­gage­ment cen­tral to de­liv­ery. Ms. Rá­caro has more than 20 years of ex­pe­ri­ence in the phar­ma­ceu­ti­cal and CRO in­dus­tries and a high­ly suc­cess­ful track record of ex­e­cut­ing com­plex ini­tia­tives and lead­ing glob­al teams.

The COVID-19 pan­dem­ic has up­end­ed near­ly every in­dus­try across the globe, in­clud­ing bio­phar­ma. What has been the most sig­nif­i­cant im­pact to the pa­tient ex­pe­ri­ence in a clin­i­cal tri­al?

The COVID-19 pan­dem­ic has cer­tain­ly dis­rupt­ed—or has had the po­ten­tial to dis­rupt—busi­ness and project op­er­a­tions in a host of ways.

One of the ma­jor is­sues is site ac­cess. De­spite more sites now be­ing open, pa­tients may have lim­it­ed abil­i­ty and in­cli­na­tion to vis­it in per­son and re­ceive their treat­ments. This may put pa­tients at risk of treat­ment in­ter­rup­tion, and longer-term study im­pacts such as pro­to­col de­vi­a­tions or tri­al dis­con­tin­u­a­tions. Ad­di­tion­al­ly, clin­i­cal tri­al pa­tient re­cruit­ment and en­roll­ment have faced some dis­rup­tions.

These chal­lenges have re­quired strate­gic re­think­ing around every el­e­ment of the clin­i­cal tri­al ex­pe­ri­ence from a pa­tient per­spec­tive to en­sure that crit­i­cal and life-chang­ing re­search can con­tin­ue safe­ly and ef­fec­tive­ly.

What strate­gies and prac­ti­cal ap­proach­es are you us­ing to man­age these op­er­a­tional chal­lenges?

At Parex­el Biotech, we’ve im­ple­ment­ed a ded­i­cat­ed over­sight group fo­cused on as­sur­ing project con­ti­nu­ity by iden­ti­fy­ing train­ing and strate­gies to mit­i­gate the risks and chal­lenges as­so­ci­at­ed with in-per­son site vis­its. And we help our part­ners do the same, us­ing this piv­otal time as an op­por­tu­ni­ty to dri­ve to­ward a more pa­tient-fo­cused mod­el.

The pan­dem­ic has re­in­forced the need for flex­i­ble, pa­tient-cen­tric in­no­va­tions not on­ly to im­prove the pa­tient ex­pe­ri­ence, but al­so to deal with the un­fore­seen. Where site ac­cess is re­strict­ed, da­ta-dri­ven re­mote pa­tient mon­i­tor­ing strate­gies can be im­ple­ment­ed to af­ford busi­ness con­ti­nu­ity, sub­ject safe­ty, da­ta in­tegri­ty and study qual­i­ty.

Where sites are open for pa­tient vis­its, trav­el re­stric­tions can im­pact pa­tients’ abil­i­ty or will­ing­ness to phys­i­cal­ly vis­it a site, ne­ces­si­tat­ing a shift to­ward e-vis­its and video dos­ing reg­i­mens. The in­creas­ing fre­quen­cy of such sit­u­a­tions has ac­cel­er­at­ed the con­sid­er­a­tion and adop­tion of de­cen­tral­ized clin­i­cal tri­al ap­proach­es.

We’ve been a pi­o­neer in de­cen­tral­ized tri­als and have im­ple­ment­ed a range of tech­nolo­gies and pa­tient-cen­tric in­no­va­tions that en­able us to con­tin­ue fa­cil­i­tat­ing stud­ies amidst chang­ing con­di­tions. For ex­am­ple, eCon­sent, wear­ables, tele­health and telemed­i­cine are so­lu­tions that re­duce the num­ber of pa­tient vis­its re­quired to par­tic­i­pate. Tech­nol­o­gy and tools such as video calls, pa­tient mo­bile apps and dig­i­tal health mon­i­tors are al­so in­creas­ing­ly in­te­gral.

We al­so work with study teams to con­sid­er each study and its spe­cif­ic chal­lenges. DCTs re­quire ex­tra mea­sures in sup­ply chain man­age­ment, for ex­am­ple.

Our sup­ply chain op­ti­miza­tion team helps cus­tomers that are con­duct­ing stud­ies im­pact­ed by COVID-19, work­ing along­side them every step of the way to en­sure con­ti­nu­ity of the sup­ply chain, ad­just re­cruit­ment ex­pec­ta­tions if re­cruit­ment is still open and de­ter­mine the fre­quen­cy of pa­tient vis­its and site stor­age ca­pac­i­ty. An in­ter­ac­tive re­sponse tech­nol­o­gy sys­tem can help man­age sup­ply chain lo­gis­tics, sup­port­ing site-to-site med­ica­tion trans­fer, di­rect-to-pa­tient ship­ments from sup­ply de­pots, and more.

De­cen­tral­ized clin­i­cal tri­als haven’t al­ways been a pre­ferred ap­proach. Will we see more of them in the fu­ture?

Ab­solute­ly. One of the pan­dem­ic’s sil­ver lin­ings has been the in­dus­try’s in­creas­ing open­ness to new ap­proach­es, in­clud­ing de­cen­tral­ized tri­als. Through this mod­el, we’ve been able to keep clin­i­cal re­search mov­ing over the past year.

Parex­el has con­duct­ed more than 110 DCTs, and we have ex­pe­ri­ence in more than 200 stud­ies with re­mote pa­tient en­gage­ment strate­gies, such as pa­tient re­cruit­ment and re­ten­tion plat­forms, e-vis­its, video dos­ing reg­i­mens and pa­tient in­sight projects. We’ve worked with over 300 pa­tient apps. And most im­por­tant of all, we keep talk­ing with pa­tients and have a Pa­tient Ad­vi­so­ry Coun­cil that helps add pa­tient in­sight to clin­i­cal ex­cel­lence.

We dis­cov­ered there were some as­pects of DCTs that pa­tients were hes­i­tant to em­brace. For in­stance, some pa­tients didn’t want any­one com­ing in­to their home and pre­ferred to vis­it a near­by clin­ic or al­ter­na­tive site. This in­sight en­abled us to build this op­tion in­to the clin­i­cal tri­al, which re­al­ly res­onat­ed with pa­tients.

What are the ad­van­tages of ex­pand­ing the use of DCTs? What are you do­ing to pro­mote them?

DCTs rep­re­sent an op­por­tu­ni­ty to re­think and re­fresh how re­search stud­ies are de­signed and con­duct­ed, while keep­ing the pa­tient at the heart of this emerg­ing par­a­digm.

When you tru­ly put a pa­tient-cen­tric de­sign in­to a clin­i­cal tri­al, you have a study that’s com­pelling for pa­tients and in­ves­ti­ga­tors alike. It’s one of the rea­sons we al­ways rec­om­mend our part­ners start with the pa­tient and keep them at the heart of every­thing they do, every step of the way. Im­proved pa­tient re­cruit­ment—one of the chal­lenges for clin­i­cal re­search—is prob­a­bly the most sig­nif­i­cant ROI as­so­ci­at­ed with this view. But pa­tient re­ten­tion and ad­her­ence are al­so strength­ened by pa­tient-cen­tric in­no­va­tions. And bet­ter re­ten­tion re­sults in a short­er time to mar­ket, bring­ing the ther­a­py to more pa­tients, faster. And that’s bet­ter for every­one, pan­dem­ic or not.

These ben­e­fits are why we’re in­volved in var­i­ous ef­forts to ex­pand ac­cess to clin­i­cal tri­als through DCTs. Parex­el is a found­ing mem­ber of the De­cen­tral­ized Tri­als & Re­search Al­liance, a new part­ner­ship of 50 life sci­ences and health­care or­ga­ni­za­tions that will be look­ing at poli­cies, re­search prac­tices and dig­i­tal health tech­nolo­gies in DCTs. We al­so have ini­tia­tives to of­fer ful­ly vir­tu­al and hy­brid tri­al de­signs, boost clin­i­cal tri­al di­ver­si­ty and ed­u­cate pa­tients and care­givers to pro­mote aware­ness about clin­i­cal tri­als and build trust at the com­mu­ni­ty lev­el.

What does the fu­ture hold for clin­i­cal de­vel­op­ment op­er­a­tions? How long will the ef­fects of COVID linger?

As a re­sult of the pan­dem­ic, we ex­pect to ac­cel­er­ate our cur­rent da­ta-dri­ven mon­i­tor­ing ap­proach to a broad­er, end-to-end risk-based ap­proach to tri­al plan­ning and ex­e­cu­tion. This in­cludes up­front plan­ning for risks, lever­ag­ing in­no­v­a­tive tech­nolo­gies to per­form cen­tral­ized mon­i­tor­ing with da­ta sur­veil­lance, and im­ple­ment­ing risk-based ap­proach­es to SDV and mon­i­tor­ing of sites.

I be­lieve the changes over the past year will be last­ing ones. Our re­spon­si­bil­i­ty to pa­tients is not to take for grant­ed these in­no­va­tions we see in the pan­dem­ic re­sponse. Be­fore COVID, many in­sur­ers, in­clud­ing Medicare, did not re­im­burse for telemed­i­cine. Now they do, and they will like­ly con­tin­ue to do so, spurring both in­creas­ing tech­no­log­i­cal in­no­va­tion and high­er rates of adop­tion.

Mov­ing for­ward, we want to see more con­sis­tent and mean­ing­ful pa­tient in­volve­ment in every study, with the pa­tient be­ing a key stake­hold­er in plan­ning and de­ci­sion-mak­ing. We have a du­ty to pa­tients to learn from this ex­pe­ri­ence, con­tin­ue to in­no­vate, and ul­ti­mate­ly de­liv­er bet­ter health­care in a chang­ing world.

For more in­for­ma­tion, vis­it Parex­el Biotech.


Graciela Rácaro

Global Head of Operations at Parexel Biotech