The goal of clin­i­cal de­vel­op­ment is to de­liv­er new ther­a­pies to the peo­ple who need them. Un­for­tu­nate­ly, the way we de­sign and op­er­a­tional­ize clin­i­cal tri­als of­ten cre­ates bur­dens for the clin­i­cal tri­al par­tic­i­pants.

For ex­am­ple, 17.8% of to­tal phase 2 and 16.2% of to­tal phase 3 pro­ce­dures were non-core pro­ce­dures, ac­cord­ing to a study in Ther­a­peu­tic In­no­va­tion & Reg­u­la­to­ry Sci­ence. Fur­ther, as much as 30% of par­tic­i­pant and site bur­den is as­so­ci­at­ed with pro­ce­dures that are ei­ther non-core or are non-es­sen­tial pro­ce­dures that sup­port core end­points.¹ This rep­re­sents an enor­mous strain on pa­tients and it’s up to spon­sors and CROs to change that. But to al­le­vi­ate the bur­den, we need to first un­der­stand it from the per­spec­tive of a clin­i­cal tri­al par­tic­i­pant. And we do that by invit­ing pa­tients in­to the de­vel­op­ment process.

As Parex­el’s Chief Pa­tient Of­fi­cer, one of my most im­por­tant re­spon­si­bil­i­ties is en­sur­ing that pa­tients and their care part­ners have a voice in every study we plan and con­duct. It’s the on­ly way we can ful­ly ap­pre­ci­ate the hu­man im­pact of our clin­i­cal tri­al de­signs. In­clud­ing pa­tients more ful­ly in our de­ci­sion mak­ing will re­quire struc­tur­al change with­in an or­ga­ni­za­tion — for ex­am­ple, putting a pa­tient ad­vo­cate in a lead­er­ship role like Parex­el has done. Through this kind of change, we can make clin­i­cal re­search more ac­ces­si­ble. We can al­so make tri­als more fea­si­ble to ex­e­cute, faster to re­cruit for and eas­i­er for par­tic­i­pants to re­main en­rolled in.

Clin­i­cal re­search can’t hap­pen with­out pa­tients, so it’s crit­i­cal that we con­sid­er them our part­ners and pri­or­i­tize their needs. This might in­clude:

• Seek­ing pa­tient in­put on pro­posed pro­to­cols and ad­just­ing the plan as need­ed.
• Se­lect­ing end­points that are mean­ing­ful to pa­tients.
• De­vel­op­ing easy-to-un­der­stand in­formed con­sent doc­u­ments and ed­u­ca­tion­al ma­te­ri­als.
• Lever­ag­ing pa­tient feed­back to guide site se­lec­tion, then train­ing staff in pa­tient-first meth­ods.
• Be­ing trans­par­ent about how pa­tient da­ta will be used.
• Col­lect­ing da­ta on pa­tient-re­port­ed out­comes (PROs) so par­tic­i­pants can ex­plain their ex­pe­ri­ences in their own words.
• Com­mu­ni­cat­ing with pa­tients fre­quent­ly so they know the val­ue of their con­tri­bu­tions.

As we meet these oblig­a­tions to pa­tients, it be­comes eas­i­er for them to par­tic­i­pate in re­search. At the same time, we im­prove the op­er­a­tional ef­fi­cien­cy of our de­vel­op­ment work.

That’s in part be­cause pa­tient-first stud­ies re­quire few­er amend­ments. Re­searchers have found that a sub­stan­tial amend­ment has a me­di­an cost of $141,000 in phase 2 and $535,000 in phase 3. ² In ad­di­tion, amend­ments cost time: the av­er­age amend­ment im­ple­men­ta­tion takes 260 days.³ By ask­ing pa­tients ear­ly in the process for in­put on a pro­posed pro­to­col, we can mit­i­gate risks be­fore they be­come part of the clin­i­cal tri­al.

Pa­tient-first clin­i­cal de­vel­op­ment al­so helps ac­cel­er­ate re­cruit­ment and im­prove re­ten­tion. Re­cruit­ment for pa­tient-first study de­signs is in­her­ent­ly eas­i­er be­cause the pro­to­col has been in­formed by the per­spec­tives of the peo­ple who will par­tic­i­pate in it. In prac­tice, this might mean short­er or few­er vis­its, few­er pro­ce­dures, op­tions for de­cen­tral­ized par­tic­i­pa­tion, re­duced lo­gis­ti­cal bur­den, or trav­el as­sis­tance —ac­com­mo­da­tions that al­so make it eas­i­er for pa­tients to re­main en­rolled in stud­ies. Drug de­vel­op­er Boehringer In­gel­heim re­ports that, on av­er­age, their pa­tient-in­formed study de­signs re­cruit­ed par­tic­i­pants 31% faster than de­signs that did not use pa­tient in­put — re­duc­ing the re­cruit­ment pe­ri­od by more than 200 days.⁴ For stud­ies with pa­tient in­put, dropout rates were re­duced by 46% com­pared to stud­ies with­out in­put.⁵

As an ad­di­tion­al ben­e­fit, we’ve found that Parex­el’s pa­tient-first cul­ture uni­fies our team. As we’ve fur­thered our com­mit­ment to el­e­vat­ing the pa­tient voice, we’ve seen a pos­i­tive im­pact on em­ploy­ee sat­is­fac­tion, which we think is re­flect­ed in our ex­cel­lent staff re­ten­tion rate: 90% in 2025.⁶

Pa­tient en­gage­ment isn’t a check­box ac­tiv­i­ty but a phi­los­o­phy that should un­der­pin every study strat­e­gy. Prac­ti­cal­ly speak­ing, what does this look like? At Parex­el, we em­bed the pa­tient per­spec­tive through­out the de­vel­op­ment life­cy­cle, lever­ag­ing re­la­tion­ships with more than 120 glob­al pa­tient ad­vo­ca­cy groups. We’ve al­so es­tab­lished in­ter­nal and ex­ter­nal Pa­tient Ad­vi­so­ry Coun­cils — an­oth­er way to learn di­rect­ly from pa­tients and their care part­ners, in­clud­ing our own col­leagues.

We’re com­mit­ted to fos­ter­ing a pa­tient-first cul­ture across our or­ga­ni­za­tion be­cause it re­minds us of the re­spon­si­bil­i­ty we have to the peo­ple who par­tic­i­pate in clin­i­cal tri­als. We start every com­pa­ny-wide town hall meet­ing with a pa­tient sto­ry that reaf­firms our mis­sion. I al­so reg­u­lar­ly host Pa­tients First Fri­days dis­cus­sions with Parex­el lead­ers and pa­tient ad­vo­cates who share how clin­i­cal de­vel­op­ment has im­pact­ed them per­son­al­ly.

When we bet­ter un­der­stand pa­tients’ ex­pe­ri­ences, our work can be ground­ed in hu­man­i­ty, not just process. A leader at a spon­sor or­ga­ni­za­tion re­cent­ly told me that we helped her see how pa­tient en­gage­ment and clin­i­cal tri­al per­for­mance are in­her­ent­ly con­nect­ed. And the ben­e­fits ex­tend be­yond study op­er­a­tions. So we have an eth­i­cal man­date to in­clude pa­tients in our clin­i­cal de­vel­op­ment process. But we al­so have a grow­ing busi­ness case for it. It’s greater em­pa­thy that re­sults in greater ef­fi­cien­cy so we can de­liv­er crit­i­cal ther­a­pies faster to the peo­ple who need them.

Learn more about Parex­el’s ap­proach to pa­tient-first clin­i­cal de­vel­op­ment.

Ref­er­ences:

¹Getz K, Bot­to E, Ar­ques AC, et al. In­sights In­form­ing Strate­gies for Op­ti­miz­ing the Col­lec­tion of Clin­i­cal Tri­al Da­ta. Ther In­nov Reg­ul Sci. 2026;60(2):563-574. doi:10.1007/s43441-025-00899-4

²Getz KA, Ster­giopou­los S, Short M, et al. The Im­pact of Pro­to­col Amend­ments on Clin­i­cal Tri­al Per­for­mance and Cost. Ther In­nov Reg­ul Sci. 2016;50(4):436-441. doi:10.1177/2168479016632271

³Getz K, Smith Z, Bot­to E, Mur­phy E, Dauchy A. New Bench­marks on Pro­to­col Amend­ment Prac­tices, Trends and their Im­pact on Clin­i­cal Tri­al Per­for­mance. Ther In­nov Reg­ul Sci. 2024;58(3):539-548. doi:10.1007/s43441-024-00622-9

⁴Kallsen K, Fal­cous J, Gilbert A. How Sys­tem­at­ic Ear­ly Pa­tient In­put De­liv­ers Mea­sur­able Val­ue in Clin­i­cal Tri­al De­sign and Ex­e­cu­tion. DIA Glob­al Fo­rum. Pub­lished Ju­ly 1, 2026. Ac­cessed Sep­tem­ber 3, 2026. https://glob­al­fo­rum.dia­glob­al.org/is­sue/june-ju­ly-2026/from-as­sump­tions-to-ev­i­dence-how-sys­tem­at­ic-ear­ly-pa­tient-in­put-de­liv­ers-mea­sur­able-val­ue-in-clin­i­cal-tri­al-de­sign-and-ex­e­cu­tion/

⁵ Ibid.

⁶2025 Sus­tain­abil­i­ty and Im­pact Re­port. Parex­el. Ac­cessed Sep­tem­ber 3, 2026. https://www.parex­el.com/ap­pli­ca­tion/files/3417/7809/3169/PXL_2025_Sus­tain­abil­i­ty_and_Im­pact_Re­port_050626_FI­NAL.pdf

Brent Saun­ders, one of bio­phar­ma’s most promi­nent deal­mak­ers and high­est-paid lead­ers, is out as CEO of Bausch + Lomb, fail­ing to add an­oth­er multi­bil­lion-dol­lar com­pa­ny...

Bris­tol My­ers Squibb re­port­ed two Phase 3 suc­cess­es on Mon­day morn­ing, in­clud­ing for an ex­per­i­men­tal drug that re­cent­ly ran in­to safe­ty is­sues.

A tri­al