How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

While the task can seem daunt­ing for small- or medi­um-sized biotechs that may not have the re­sources, it doesn’t have to be— there are mul­ti­ple op­por­tu­ni­ties for com­pa­nies to in­te­grate the pa­tient per­spec­tive. By mak­ing two to three de­fined changes for each new clin­i­cal tri­al, in­ves­ti­ga­tors can re­duce the risk of chas­ing a small pool of po­ten­tial pa­tients, re­duc­ing the study bur­den on the pa­tient and in­creas­ing a pa­tient’s con­sid­er­a­tion of a study, there­fore avoid­ing ad­di­tion­al costs and time to clin­i­cal tri­als.

Small and medi­um biotech com­pa­nies can take those steps in a cost ef­fec­tive and time sen­si­tive man­ner to de­sign more pa­tient-cen­tric ap­proach­es in on­col­o­gy clin­i­cal tri­als, in­clud­ing in­tro­duc­ing best prac­tices for con­nect­ing with can­cer pa­tients and us­ing their in­put to re­duce pa­tient bur­den in on­col­o­gy clin­i­cal tri­als.

De­sign­ing a tri­al to re­duce bur­den

The first step when de­sign­ing a pa­tient-cen­tric tri­al, biotechs should  con­sid­er the role of pa­tients in drug de­vel­op­ment. En­gag­ing with pa­tient sup­port groups at the be­gin­ning of tri­al de­sign al­lows spon­sors to in­cor­po­rate pa­tient feed­back as the pro­to­cols are be­ing writ­ten, in­stead of mak­ing amend­ments af­ter pro­to­cols are de­vel­oped, sav­ing time and costs. Ad­di­tion­al­ly, it is crit­i­cal to look at the larg­er pa­tient val­ue propo­si­tion as well as the bur­den. Ask­ing pa­tients spe­cif­ic ques­tions re­gard­ing their will­ing­ness to par­tic­i­pate can pro­vide in­sights in­to the po­ten­tial ben­e­fits and draw­backs of the pro­to­col.

Fur­ther, spon­sors should re­flect on ways to re­duce bur­den be­fore think­ing about how the treat­ment will af­fect the pa­tient. Some com­pa­nies may even con­sid­er hir­ing pa­tient ac­tors or hav­ing vol­un­teers do a “dry” or “dum­my” run of tri­al pro­ce­dures at the site. While this may seem like a large in­vest­ment in site and spon­sor time, prac­tice runs of pro­to­cols can re­solve any po­ten­tial is­sues be­fore they oc­cur in the cur­rent tri­al, and serve as a ref­er­ence to pre­vent prob­lems in fu­ture tri­als that have sim­i­lar pro­to­cols.

Un­der­stand­ing the pa­tient per­spec­tive

As spon­sors de­sign clin­i­cal tri­al pro­to­cols, they should al­so fac­tor in the pa­tient per­spec­tive on what ben­e­fit-risk trade­offs are ac­cept­able, which clin­i­cal out­comes are most im­por­tant to pa­tients and how to de­vel­op pa­tient-cen­tered end­points. To ful­ly grasp the pa­tient per­spec­tive, spon­sors should un­der­stand the pa­tient’s ed­u­ca­tion­al, emo­tion­al, phys­i­cal and fi­nan­cial well­be­ing, in ad­di­tion to trav­el lo­gis­tics and avail­abil­i­ty of care­givers.

The pa­tient per­spec­tive can be ac­quired through pa­tient ex­pe­ri­ence sur­veys, oth­er­wise known as pa­tient fea­si­bil­i­ty stud­ies, which can cap­ture a wider view of what pa­tients will and won’t be able to cope with dur­ing a study. This pa­tient feed­back, mar­ried with the in­for­ma­tion al­ready gath­ered from sites re­lat­ing to PI in­ter­est and the per­ceived sci­en­tif­ic val­ue of the study, gives a more ro­bust view of the over­all en­rol­ment po­ten­tial.

Im­prov­ing pa­tient con­sent and ed­u­ca­tion

A crit­i­cal part of pa­tient en­roll­ment in can­cer stud­ies is the con­sent process. Here, spon­sors have the op­por­tu­ni­ty to make pa­tient ed­u­ca­tion about the study more pa­tient-cen­tric. De­vel­op­ing ed­u­ca­tion­al ma­te­ri­als with easy-to-un­der­stand lan­guage in in­formed con­sent — along with oth­er re­sources to help pa­tients and their fam­i­lies un­der­stand the study and the im­pli­ca­tions of be­ing part of it — can in­crease ef­fi­cien­cy in pa­tient en­roll­ment and re­cruit­ment.

Af­ter com­plet­ing the stan­dard con­sent pa­per­work, pro­vid­ing on­go­ing ed­u­ca­tion is need­ed. Pa­tients may need to be re­mind­ed of, or spo­ken with, to en­sure they ful­ly un­der­stand the sched­ule of events, and any apps or web­sites they may need to use to ad­here to pro­to­cols, in­clud­ing ap­point­ments, tests, or whether or not they need to be in a fast­ed state for site vis­its. There­fore, spon­sors should con­sid­er adopt­ing a con­sent “plus” ap­proach which would in­clude con­tin­ued pa­tient-fo­cused ed­u­ca­tion and en­gage­ment through­out their par­tic­i­pa­tion.

Im­ple­ment­ing new strate­gies

Small and medi­um biotech com­pa­nies have an op­por­tu­ni­ty to change lives with a new drug or prod­uct and lead the way in chang­ing tri­al de­sign due to the lack of large phar­ma red tape and the de­sire to get it right the first time.

Biotechs con­tain a unique mix of sci­en­tists, in­dus­try per­son­nel and clin­i­cal in­ves­ti­ga­tors who are able to com­bine the knowl­edge and skills to dri­ve the sci­ence fast. CROs may be the first port of call for a biotech com­pa­ny to op­er­a­tionalise a study. When brought in at an ear­ly stage, CROs can com­bine their ex­pe­ri­ence and cus­tomer so­lu­tions to pre­pare a tai­lored pa­tient-cen­tric strat­e­gy.