De­cen­tral­ized Clin­i­cal Tri­als: The fu­ture of clin­i­cal tri­als is now

Chang­ing what’s pos­si­ble to­day for to­mor­row

What­ev­er chal­lenges the world may throw at us – now, and to­mor­row, Parex­el’s De­cen­tral­ized Clin­i­cal Tri­als rep­re­sent an op­por­tu­ni­ty to re­think and re­fresh how re­search stud­ies are con­duct­ed, while keep­ing the pa­tient at the heart of this emerg­ing par­a­digm. De­vel­oped with­in our Pa­tient In­no­va­tion Cen­ter, our flex­i­ble De­cen­tral­ized Clin­i­cal Tri­al so­lu­tions pro­vide both ful­ly vir­tu­al and hy­brid op­tions.

With more than 70 De­cen­tral­ized Clin­i­cal Tri­als al­ready un­der­way or com­plete and ex­pe­ri­ence in ex­cess of 200 re­mote pa­tient en­gage­ments strate­gies, Parex­el leads the way as a pre­pared part­ner to the in­dus­try. Our De­cen­tral­ized Clin­i­cal Tri­als com­bine in-house ex­per­tise and pa­tient/care­giv­er in­sights with the lat­est tech­nolo­gies to cre­ate be­spoke strate­gies that can help you meet your goals. From study de­sign through ex­e­cu­tion, we’ll help you iden­ti­fy and man­age all tech­nol­o­gy re­quire­ments. To­geth­er, we can help en­sure treat­ments get to the pa­tients who need them most by mak­ing it eas­i­er for di­verse pop­u­la­tions and ge­o­gra­phies to ac­cess re­search.

Lead­ing the in­dus­try by en­gag­ing pa­tients in De­cen­tral­ized Clin­i­cal Tri­als

Cen­tral to nav­i­gat­ing a dy­nam­ic re­search land­scape is the abil­i­ty to har­ness and ap­ply pa­tient in­sights. This ap­proach, along with glob­al ex­per­tise in un­der­stand­ing the ever­chang­ing reg­u­la­to­ry en­vi­ron­ment and the skills nec­es­sary to ac­cess and ap­ply fit-for-pur­pose da­ta, makes Parex­el a leader in De­cen­tral­ized Clin­i­cal Tri­als. All these el­e­ments, com­bined with the ex­per­tise of our Pa­tient In­no­va­tion Cen­ter and “best-in-breed” tech­nolo­gies, are es­sen­tial to cre­at­ing De­cen­tral­ized Clin­i­cal Tri­al de­signs that work for you and can be prac­ti­cal­ly de­ployed as part of your over­all clin­i­cal de­vel­op­ment and mar­ket ac­cess strat­e­gy.

By bring­ing the tri­al to the pa­tient’s home – with the help of home tri­al sup­port, telemed­i­cine ca­pa­bil­i­ties, di­rect-to-pa­tient drug ship­ments and more – we are min­i­miz­ing re­cruit­ment and re­ten­tion bar­ri­ers. Our ex­pe­ri­ence in­cludes more than 70 De­cen­tral­ized Clin­i­cal Tri­als (in­clu­sive of home nurs­ing vis­its) and and ex­pe­ri­ence in ex­cess of 200 re­mote pa­tient en­gage­ment strate­gies in­cor­po­rat­ed in­to tri­als (e.g., pa­tient re­cruit­ment and re­ten­tion plat­forms, e-vis­its/video dos­ing reg­i­mens and pa­tient in­sight projects).

This al­lows us to man­age and de­liv­er a wide range of ful­ly vir­tu­al and hy­brid ap­proach­es to De­cen­tral­ized Clin­i­cal Tri­als while al­so of­fer­ing im­por­tant sup­port­ing ca­pa­bil­i­ties:

• 250+ di­rect-to-pa­tient ship­ments
• 300+ pa­tient apps/eCOA plat­forms
• 3,000+ tech­nol­o­gy in­te­gra­tions

In­creas­ing the like­li­hood of launch with pa­tient-cen­tric tri­als

Drugs de­vel­oped us­ing pa­tient-cen­tric de­signs are 19% more like­ly to launch – 87% ver­sus 68% for drugs de­vel­oped with­out this ap­proach. And, they take less time to re­cruit the first 100 par­tic­i­pants, too – 4 months ver­sus the all-tri­als av­er­age of 7 months.

Com­bin­ing ex­per­tise, and the lat­est tech­nol­o­gy, for re­al-time da­ta de­liv­ery and vi­tal pa­tient in­sights

Con­nect­ed de­vices, like wear­ables and sen­sors, can make it eas­i­er to col­lect re­al-time clin­i­cal da­ta read­ings while en­abling pa­tients to com­mu­ni­cate with study per­son­nel from home. Parex­el has fo­cused on in­te­grat­ing the lat­est tech­no­log­i­cal ad­vance­ments and es­tab­lish­ing key part­ner­ships with ex­pert providers to be able to iden­ti­fy the right de­vices and ap­pli­ca­tions for in­te­gra­tion in­to your study.

Work­ing with your team, Parex­el is ready to man­age the fol­low­ing:

• Iden­ti­fy­ing and rec­om­mend­ing the right con­nect­ed de­vices
• En­gag­ing and co­or­di­nat­ing ven­dor re­la­tion­ships
• Eval­u­at­ing tech­nol­o­gy for in­te­gra­tion to make sure clin­i­cal tri­al ob­jec­tives, end­points, and as­so­ci­at­ed mea­sure­ments or as­sess­ments can be done cor­rect­ly
• Val­i­dat­ing da­ta
• In­te­grat­ing da­ta
• Op­er­a­tional­iz­ing day-to-day ac­tiv­i­ty and over­sight
• De­com­mis­sion­ing up­on study com­ple­tion

Min­i­miz­ing the pa­tient bur­den while col­lect­ing ac­cu­rate, re­al-time da­ta

Case Study

A De­cen­tral­ized Clin­i­cal Tri­al to eval­u­ate the ef­fi­ca­cy of a drug in­tend­ed to im­prove night­time sleep in pe­di­atric and ado­les­cent pa­tients with a rare dis­or­der.

The chal­lenges:

• Min­i­miz­ing the bur­den of study par­tic­i­pa­tion for pa­tients and their fam­i­lies
• Long-term col­lec­tion of sleep da­ta in a man­ner that was not in­tru­sive for pa­tients and their fam­i­lies

The so­lu­tion:

• A hy­brid ap­proach, com­bin­ing:
• Just three in-clin­ic vis­its
• Vir­tu­al vis­its:
  – at-home nurs­ing
  – sen­sors: child-friend­ly actig­ra­phy watch­es to col­lect qual­i­ty sleep da­ta in a non-in­va­sive way
  – di­rect-to-pa­tient drug ship­ments
  – e-di­aries

Out­comes / find­ings:

• Suc­cess­ful re­cruit­ment, pre-screen­ing, and en­roll­ment of pa­tients from dif­fer­ent re­gions—some liv­ing >150 miles from the in­ves­tiga­tive site
• Im­ple­ment­ing pa­tient-cen­tric ap­proach­es re­sult­ing in im­proved par­tic­i­pa­tion, re­ten­tion,
  and com­pli­ance
• Feed­back from pa­tients and their fam­i­lies that they tru­ly en­joyed the hy­brid ap­proach; as the tri­al last­ed 2 years, they would not have been able to par­tic­i­pate if they had to trav­el to the clin­ic more fre­quent­ly
• Actig­ra­phy watch­es and e-di­aries gave the in­ves­ti­ga­tor re­al-time in­sight in­to pa­tients and
  the abil­i­ty to iden­ti­fy im­me­di­ate­ly if da­ta were missed or there were any is­sues
• Fam­i­lies en­joyed work­ing with the at-home nurs­ing ven­dor, who of­fered flex­i­ble vis­it dates and times so as not to in­ter­rupt the fam­i­lies’ dai­ly sched­ules
• Ef­fec­tive co­or­di­na­tion of mul­ti­ple site vis­its, at-home vis­its, ex­ter­nal ven­dors, and new tech­nol­o­gy so­lu­tions to pro­vide an in­no­v­a­tive ap­proach that was well-re­ceived by pa­tients and their fam­i­lies

Op­ti­miz­ing pro­to­cols around pa­tient in­sights

Our Pa­tient In­no­va­tion Cen­ter helps to put pa­tients first through the use of glob­al pa­tient ad­vi­so­ry boards and our Pa­tient In­sights method­ol­o­gy. We study the way pa­tients talk about their dis­ease and treat­ment op­tions, elic­it di­rect feed­back from pa­tients and care­givers, and con­sult with site staff to un­der­stand what is im­por­tant to them and the chal­lenges they face. This en­ables us to de­sign tar­get­ed de­cen­tral­ized tri­al strate­gies based on the needs and pref­er­ences of pa­tients that re­duce the bur­den of par­tic­i­pa­tion, there­by speed­ing up pa­tient en­roll­ment and sup­port­ing re­ten­tion.

Re­duc­ing the pa­tient bur­den can dri­ve more en­gaged pa­tients and high­er study re­ten­tion

Parex­el’s De­cen­tral­ized Clin­i­cal Tri­als take all or part of the tri­al to pa­tients in their home, while work­ing in part­ner­ship with in­ves­tiga­tive sites. By do­ing this, we re­duce the ge­o­graph­i­cal, prac­ti­cal, and fi­nan­cial bar­ri­ers that can pre­vent pa­tients from par­tic­i­pat­ing or stay­ing in a study. This leads to more en­gaged study par­tic­i­pants and high­er re­ten­tion rates.

Ge­o­graph­i­cal: bring­ing more of the tri­al to the pa­tient through at-home nurs­ing and tech­nolo­gies

Prac­ti­cal: re­duc­ing the de­mands on pa­tients’/fam­i­lies’ time that can pre­vent study par­tic­i­pa­tion

Fi­nan­cial: min­i­miz­ing trav­el, ac­com­mo­da­tion and sub­sis­tence re­quire­ments

Mov­ing to an­oth­er lev­el of site col­lab­o­ra­tion

Parex­el was re­cent­ly rec­og­nized for its high­qual­i­ty ser­vice by Cen­ter­Watch in its Glob­al Clin­i­cal Tri­al Site Re­la­tion­ship Bench­mark Sur­vey. Parex­el ranked one of the top three CROs among at­trib­ut­es most val­ued by sites and re­ceived “Ex­cel­lent” rat­ings on many key per­for­mance at­trib­ut­es, in­clud­ing:

• Well-trained mon­i­tors/clin­i­cal re­search as­so­ciates (CRAs)
• Or­ga­ni­za­tion and pre­pared­ness
• Eas­i­ly ac­ces­si­ble staff main­tain­ing open com­mu­ni­ca­tion

As spon­sors con­tin­ue bring­ing many com­po­nents of stud­ies di­rect­ly to pa­tients in their homes and in their com­mu­ni­ties, Parex­el seam­less­ly col­lab­o­rates with sites to make the process as ef­fi­cient as pos­si­ble. As the pi­o­neer in de­sign­ing and de­liv­er­ing De­cen­tral­ized Clin­i­cal Tri­als, Parex­el may of­fer sites more study op­por­tu­ni­ties, wider ac­cess to di­verse pa­tient pop­u­la­tions in their re­gion and re­duced dropout rates due to re­mote pa­tient en­gage­ment op­tions. In turn, Parex­el can de­sign more ef­fec­tive pro­to­cols based on valu­able site in­put about their pa­tients. And, to­geth­er, Parex­el and its site part­ners are even bet­ter poised to im­prove the over­all study ex­pe­ri­ence for pa­tients and spon­sors.

We ask:

• Which el­e­ments of par­tic­i­pa­tion may pa­tients/fam­i­lies find chal­leng­ing?
• Does the pa­tient need to at­tend a site vis­it for this part of the tri­al?
• Can we re­duce the length of time site vis­its last?
• How can we best com­mu­ni­cate with pa­tients/fam­i­lies?
• Which el­e­ments of the tri­al could work at home?

Case study

A De­cen­tral­ized Clin­i­cal Tri­al geared to col­lect­ing and trans­mit­ting clin­i­cal tri­al da­ta with mo­bile tech­nolo­gies – an ex­plo­ration of six sens­ing de­vices (for mon­i­tor­ing blood pres­sure, ac­tiv­i­ty lev­els, asth­ma, oxy­gen, blood glu­cose, and weight) as study end­points.

The chal­lenge:

• The need to
  – com­pare re­mote sen­sor de­vice da­ta with stan­dard clin­i­cal as­sess­ments
  – test med­ical de­vices si­mul­ta­ne­ous­ly
  – have an end-to-end so­lu­tion to col­lect, trans­mit and vi­su­al­ize da­ta

Re­sults:

• Trans­mis­sion with min­i­mal/no da­ta loss
• Lessons learned con­vert­ed in­to stan­dard prac­tice
• De­vices used in-clin­ic with min­i­mal help
• Some de­vices can be ap­plied be­yond ex­plorato­ry phase

The fu­ture of clin­i­cal tri­als is now

By chang­ing what’s pos­si­ble to­day, Parex­el’s De­cen­tral­ized Clin­i­cal Tri­als are pro­vid­ing a fu­ture for pa­tients to­mor­row.