Why the pre­mier re­cruit­ment agency in the world is giv­ing up re­cruit­ing, and spon­sors should, too

KEY TAKE­AWAYS:

• 70% of Spon­sors miss their mile­stones by an av­er­age of eight months, sug­gest­ing the clin­i­cal tri­al re­cruit­ment mod­el is bro­ken, but there is an op­ti­mized method be­ing uti­lized that most are un­aware of
• Clin­i­cal En­roll­ment (CE), cur­rent­ly the on­ly pa­tient qual­i­ty firm op­er­at­ing in the U.S., is able to boast 32% un­der­rep­re­sent­ed pa­tient pop­u­la­tions and a 22% re­duc­tion in screen fail rate by es­chew­ing stan­dard re­cruit­ment prac­tices
• The pa­tient qual­i­ty firm mod­el al­so means CE earns an 88% on-site-to-In­formed-Con­sent-sig­na­ture rate
• CE’s Founder says that com­pa­nies who have yet to em­ploy pa­tient qual­i­ty firm tac­tics have ei­ther yet to dis­cov­er this oth­er mod­el ex­ists, or haven’t ful­ly ap­pre­ci­at­ed the dis­tinc­tion, but an in­dus­try shift is com­ing

For any­one in the biotech in­dus­try, it’s hard­ly a se­cret that when it comes to clin­i­cal tri­als, “re­cruit­ment” is a dirty word. The once tried-and-true method that in­volved a trust­ed doc­tor call­ing pa­tients on the phone to tell them about a po­ten­tial in­ves­ti­ga­tion­al op­por­tu­ni­ty has evolved in­to the data­base-dri­ven, al­go­rithm-based mod­el of to­day, and with it has gone the hu­man­i­ty of the process. That may be the rea­son why less than 5% of the U.S. pop­u­la­tion par­tic­i­pate in clin­i­cal tri­al work, and it’s def­i­nite­ly the rea­son why in­dus­try leader Clin­i­cal En­roll­ment (CE) has de­cid­ed that “re­cruit­ment” as a busi­ness mod­el just wasn’t right for them.

Bryan Man­ning, CE’s Founder and CEO, has been vo­cal about the fact that what re­cruit­ment is de­fined by to­day is the an­tithe­sis of what the in­dus­try should be do­ing, so much so that he’s bet­ting the suc­cess of his com­pa­ny on it. “When 70% of Spon­sors are miss­ing mile­stones by an av­er­age of eight months, every­one in this in­dus­try should be ask­ing ‘why?’”, says Man­ning, who cur­rent­ly runs the on­ly pa­tient qual­i­ty firm op­er­at­ing in the U.S., head­quar­tered in Char­lottesville, VA. So how does a com­pa­ny lo­cat­ed out­side of the known biotech hotbeds end up be­ing trust­ed by the most sought-af­ter ros­ter in the in­dus­try? By set­ting the bar.

If you’ve nev­er heard the term “pa­tient qual­i­ty firm” be­fore, it’s be­cause it’s a rel­a­tive­ly re­cent trend and strate­gic mod­el, and it is born from an at­tempt to course cor­rect mis­guid­ed think­ing, says Man­ning, whose firm main­tains an ar­se­nal of on-staff pa­tient ad­vo­cates to pro­vide guid­ance and hand­hold pa­tients through the tri­al process. The prob­lem? “[Spon­sors] are view­ing the process as re­cruit­ment, and not as pa­tient qual­i­ty and over­all qual­i­ty of the tri­al,” he ex­plains, how­ev­er one need on­ly look at Clin­i­cal En­roll­ment’s me­te­oric rise for ev­i­dence of its suc­cess. In the short years since its in­cep­tion, CE has be­come one of the most high­ly lo­go’d agen­cies in the in­dus­try, and they owe their clout in no small part to rec­og­niz­ing that re­cruit­ment may very well be a dirty word, and it’s one whose time has passed. “We nev­er felt like ‘re­cruit­ment’ fit what we were do­ing, but it’s the man­tle every­one us­es, for good or bad,” Man­ning says. “Be­ing a pa­tient qual­i­ty firm means view­ing our re­spon­si­bil­i­ty to pa­tients on the same lev­el as our re­spon­si­bil­i­ty to the Spon­sors who hire us. A sub-5% rate of par­tic­i­pa­tion in clin­i­cal tri­al work is a dis­par­i­ty we found not on­ly un­ac­cept­able, but rife for trans­for­ma­tion.”

Clin­i­cal En­roll­ment’s pa­tient qual­i­ty mod­el rec­og­nizes that par­tic­i­pants are mak­ing sub­stan­tial, life-al­ter­ing med­ical de­ci­sions by de­cid­ing to join a clin­i­cal re­search study, and that they need to feel con­fi­dent in the agency of their de­ci­sion, as well as be able to trust the ex­per­tise of whomev­er is guid­ing them. This man­i­fests in the form of CE’s emo­tion-dri­ven, en­gag­ing con­tent fo­cused on ed­u­ca­tion, and more im­por­tant­ly, on pa­tients’ lived ex­pe­ri­ences, and it ap­pears to be work­ing. Like, 22% re­duc­tion in screen fail rate, 88% on-site-to-ICF sig­nage work­ing.

Fur­ther ce­ment­ing pa­tient qual­i­ty’s dis­tinc­tion from that of tra­di­tion­al re­cruit­ing is its ad­her­ence to a north star of ac­cess, cal­iber of pa­tients, and ex­per­tise. The un­der­rep­re­sent­ed pa­tient pop­u­la­tion is less than 10% in an av­er­age tri­al, but for CE, who meets pa­tients where they are — on dig­i­tal and so­cial plat­forms — and in­ter­acts with them in a more op­ti­mized, hu­man-first way, it’s ac­tu­al­ly a soar­ing 32%. Clin­i­cal En­roll­ment al­so re­ceives 85% of their re­fer­rals from out­side the clin­ic.

“Our pur­pose is to gal­va­nize the pa­tients who can ben­e­fit the most, to in­fuse them with a sense of what is pos­si­ble and, more im­por­tant­ly, that these op­por­tu­ni­ties are with­in their reach,” says Man­ning, who al­so hap­pens to be a pa­tient with­an or­phan con­di­tion him­self. “As stew­ards of these ad­vanced pa­tient qual­i­ty re­cruit­ment ef­forts, we en­sure that our Spon­sor clients sit at the apex of clin­i­cal tri­al pro­fi­cien­cy and ex­pe­di­en­cy, and that these in­ves­ti­ga­tion­al treat­ments reach the right peo­ple —  who are mo­ti­vat­ed and well-in­formed — every time.”

Clin­i­cal En­roll­ment’s unique alche­my of suc­cess as a pa­tient qual­i­ty firm al­so re­lies heav­i­ly on three levers be­ing pulled: their abil­i­ty to gath­er elec­tron­ic health records from po­ten­tial par­tic­i­pants, hav­ing a ded­i­cat­ed (re­al live) site re­la­tions team that sees pa­tients and the study team all the way through the process at a time when oth­ers are au­tomat­ing the process, and dou­ble screen­ing all can­di­dates. This tri­ad has re­sult­ed in pro­duc­ing the high­est cal­iber of pa­tient qual­i­ty their Spon­sors say they have ever seen. Par­tic­i­pants en­rolled from CE’s ef­forts typ­i­cal­ly end up com­pris­ing more than one third (34%) of to­tal en­roll­ment in their tri­als, even when con­tact­ed more than mid­way through the process.

So then, the most head-scratch­ing ques­tion isn’t ‘Why did this com­pa­ny de­cide to stop re­cruit­ing?’ it more as­tute­ly should be ‘Why isn’t every­one em­ploy­ing the pa­tient qual­i­ty ap­proach to pop­u­late their tri­als?’ Man­ning thinks he knows the an­swer. “They ei­ther don’t know that there’s a bet­ter way, or they haven’t ful­ly ap­pre­ci­at­ed the dis­tinc­tion…yet.” Once the men­tal­i­ty shifts, he says, the land­scape of pa­tient en­roll­ment in the U.S. will en­joy a much-need­ed and long-over­due shift, too.

Learn more about the phi­los­o­phy of a pa­tient qual­i­ty firm, or make an in­quiry about work­ing with Clin­i­cal En­roll­ment here.