Am­pli­fy the Pa­tient Voice in Clin­i­cal Re­search Tech­nol­o­gy De­vel­op­ment

For those of us who use so­phis­ti­cat­ed dig­i­tal tools every day, it’s easy to as­sume that tech­nol­o­gy al­ways makes life eas­i­er. It doesn’t.

For many peo­ple, tech­nol­o­gy can make life hard­er. Study eDi­aries are an ex­am­ple of a clin­i­cal re­search tech­nol­o­gy that can cre­ate ad­di­tion­al bur­dens. Yes, they have im­proved the ac­cu­ra­cy and ef­fi­cien­cy of da­ta col­lec­tion. How­ev­er, for some, they can be more dif­fi­cult to use than pa­per log­books. As re­searchers, we must ask for pa­tient feed­back to bet­ter un­der­stand the ease of use of such pa­tient tech­nolo­gies.

By har­ness­ing pa­tient in­sights on clin­i­cal re­search tech­nol­o­gy, da­ta ac­cu­ra­cy can be im­proved, the clin­i­cal tri­al process can be stream­lined, and the bur­den on par­tic­i­pants and sites can be re­duced. Re­searchers must seek in­sights from the peo­ple who are the end users of these tools.

Pro­vi­sioned De­vice vs. Bring Your Own De­vice (BY­OD)

De­spite all their ad­van­tages, eDi­aries can in­tro­duce new ob­sta­cles. When pro­vi­sioned de­vices are uti­lized to track elec­tron­ic pa­tient re­port­ed out­comes (ePRO), some par­tic­i­pants may have nev­er used a smart­phone. A life­long Ap­ple user may strug­gle with an An­droid-based plat­form. For some par­tic­i­pants, keep­ing track of yet an­oth­er de­vice can be frus­trat­ing.

Al­low­ing par­tic­i­pants to use their own de­vices may mit­i­gate some of these is­sues, but BY­OD on­ly ac­counts for about 30% of study par­tic­i­pants in a giv­en study (ex­clud­ing vac­cine stud­ies). And keep in mind that not every­one owns a suit­able de­vice.

Ad­di­tion­al­ly, par­tic­i­pants with cog­ni­tive lim­i­ta­tions may not be able to nav­i­gate the eDi­ary plat­form, and even peo­ple with­out cog­ni­tive is­sues may strug­gle with com­plex as­sess­ments.

All of this can re­sult in frus­trat­ed par­tic­i­pants and in­ac­cu­rate and/or in­com­plete da­ta.

In­cor­po­rat­ing the Par­tic­i­pant Voice

Pa­tients need to be in­volved in de­vel­op­ing ePRO as­sess­ments from the out­set, es­pe­cial­ly for end­points with­out ex­ist­ing stan­dards or scales. Ide­al­ly, spon­sors would so­lic­it pa­tient in­sight ear­ly in end­point de­vel­op­ment. Too of­ten, how­ev­er, study start­up time­lines take prece­dence over pa­tient in­put.

Par­tic­i­pants typ­i­cal­ly don’t get to of­fer their per­spec­tive un­til cog­ni­tive de­brief­ing and us­abil­i­ty test­ing, which in­volve in­ter­pret­ing and re­spond­ing to ques­tions about the func­tion­al­i­ty of the as­sess­ment. These steps are es­sen­tial, but they shouldn’t be the first-time pa­tients are in­volved. Bring­ing in the pa­tient voice too late re­sults in missed op­por­tu­ni­ties for cre­at­ing more rel­e­vant and ef­fec­tive tools.

One way to en­sure the pa­tient voice is be­ing cap­tured is to cul­ti­vate re­la­tion­ships with pa­tient ad­vo­ca­cy groups re­lat­ed to the ther­a­peu­tic in­di­ca­tion of the study. We’ve found that these in­di­vid­u­als are very en­thu­si­as­tic about par­tic­i­pat­ing. They can help tai­lor the end­points, as­sess­ments and tech­nol­o­gy to the needs of the rel­e­vant pa­tient pop­u­la­tion. En­gag­ing with ad­vo­ca­cy groups can al­so dri­ve pa­tient par­tic­i­pa­tion in tri­als.

Oth­er things to con­sid­er:

  • Is a par­tic­u­lar mea­sure over­ly bur­den­some on the par­tic­i­pant? Par­tic­i­pants can iden­ti­fy po­ten­tial dif­fi­cul­ties or bar­ri­ers that may hin­der the prop­er use of ePRO/eCOA tools.Based on the feed­back, you may de­cide to pri­or­i­tize must-have ver­sus nice-to-have end­points in your pro­to­col.
  • Do the ques­tions get to the core of what is mean­ing­ful to pa­tients? Pa­tient can tell you whether a ques­tion cap­tures what is tru­ly rel­e­vant to their ex­pe­ri­ences.
  • Does the tech­nol­o­gy ac­count for the needs of the pa­tients who will use it? You may need to ad­just for vi­su­al, hear­ing and cog­ni­tive is­sues, as well as for lit­er­a­cy and tech­nol­o­gy ex­pe­ri­ence.

Case Study: De­vel­op­ment of Pa­tient Seizure eDi­ary


In late-phase epilep­sy tri­als, spon­sors need to col­lect a large amount of da­ta di­rect­ly from par­tic­i­pants. Of­ten, tra­di­tion­al seizure di­aries, both pa­per-based and elec­tron­ic, fail to meet the needs of both spon­sors and par­tic­i­pants. They can be in­flex­i­ble, dif­fi­cult to use, and in­ad­e­quate for cap­tur­ing seizure ac­tiv­i­ty. In this case, this re­sult­ed in poor da­ta qual­i­ty and struc­ture. Ad­di­tion­al­ly, on the back end, the data­base didn’t al­low for prop­er analy­sis to sat­is­fy reg­u­la­tors.


The Epilep­sy Study Con­sor­tium col­lab­o­rat­ed with in­dus­try lead­ers, in­clud­ing WCG, study co­or­di­na­tors, da­ta man­agers, spon­sors, and par­tic­i­pants to cre­ate a bet­ter elec­tron­ic seizure di­ary. Dur­ing the course of di­ary de­vel­op­ment, WCG con­duct­ed mul­ti­ple pa­tient fo­cus groups to gath­er di­rect feed­back on di­ary fea­tures and lay­out.


A par­tic­i­pant-cen­tric Seizure eDi­ary was de­vel­oped that works across many pos­si­ble sce­nar­ios that are pre­sent­ed in tri­als that mea­sure seizure ac­tiv­i­ty.

  • Stan­dard­ized da­ta cod­ing: It al­lows for con­sis­tent da­ta in­put and cod­ing in the back­end data­base, en­abling the type of analy­sis pre­vi­ous­ly un­avail­able.
  • Im­proved da­ta ac­cu­ra­cy: Site-based work­flows fa­cil­i­tate the cre­ation of par­tic­i­pant-spe­cif­ic seizure de­scrip­tions, lead­ing to bet­ter da­ta ac­cu­ra­cy and sim­pli­fied re­view and clas­si­fi­ca­tion of po­ten­tial new seizure ac­tiv­i­ty.
  • Easy re­clas­si­fi­ca­tion and ad­ju­di­ca­tion: Sites can com­plete re­clas­si­fi­ca­tions with­out ven­dor sup­port, and seizure types can be ad­ju­di­cat­ed di­rect­ly with­in the di­ary, stream­lin­ing the ad­ju­di­ca­tion process.
  • En­hanced pa­tient ex­pe­ri­ence: The seizure eDi­ary en­ables pa­tients to record in­for­ma­tion more quick­ly and ac­cu­rate­ly than pa­per di­aries. It al­so al­lows them to log seizures, track med­ica­tions and ap­point­ments, and re­ceive cus­tomized con­tent on their con­di­tion.

A Mat­ter of Pri­or­i­ties

To be­come tru­ly par­tic­i­pant-cen­tric, we must, as an in­dus­try, pri­or­i­tize pa­tient needs in the de­vel­op­ment of pro­to­cols, end­points, as­sess­ment tools, and tech­nol­o­gy.


Mike Cioffi

Senior Vice President, Clinical Solutions and Strategic Development, WCG