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Biggest SCOPE Buzz: Two Dis­rup­tors in Clin­i­cal Re­search Are Re­defin­ing En­roll­ment Speed
top stories
1. Novo cites MFN as disappointing 2026 sales forecast triggers selloff
2. 'Turning around the Titanic': How the incoming PBM reforms will transform CMS
3. China startup AccurEdit raises $75M for gene editing therapies showing early promise
4. AstraZeneca gets CRL for self-injectable pen version of lupus drug Saphnelo
5. Ultragenyx unwraps data that may be central to its gene therapy resubmission
6. One cancer drug steps back, and obesity asset steps forward, as Pfizer reports earnings
7. Updated: Do Pfizer’s monthly GLP-1 data justify Metsera’s $10B price tag?
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Alexis Kramer
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The House passed a government spending package today that will reauthorize the rare pediatric PRV program until December 2029. The program previously expired in December 2024.

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Alexis Kramer
Editor, Endpoints News
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Biggest SCOPE Buzz: Two Dis­rup­tors in Clin­i­cal Re­search Are Re­defin­ing En­roll­ment Speed
by Clinical Enrollment

Tri­al en­roll­ment is an ever-press­ing is­sue, yet so many pa­tients search­ing for hope face a process where they wait days for phone calls, weeks to have their med­ical da­ta tracked down and sort­ed through, and weeks—or even months—for on-site vis­its. The im­pact of this can be dev­as­tat­ing: mil­lions of dol­lars in costs for Spon­sors each year, failed stud­ies, and worst of all, less­er care for pa­tients that de­serve bet­ter. While en­roll­ment de­lays are of­ten treat­ed as a num­bers prob­lem, the re­al­i­ty is they are ac­tu­al­ly a mo­men­tum prob­lem. The dis­con­nect oc­curs when pa­tients and their loved ones seek new care op­tions, but the clin­i­cal tri­al ecosys­tem sim­ply can’t move fast enough to get them screened and en­rolled in a suit­able time­frame. It’s clear the in­dus­try needs to move at a speed that puts pa­tients first, and da­ta sup­ports that when that hap­pens, en­roll­ment pe­ri­ods short­en by an av­er­age of 3.5 months!

For­tu­nate­ly Clin­i­cal En­roll­ment and Pre­doc—two of the fastest grow­ing com­pa­nies in clin­i­cal tri­al re­cruit­ment and pa­tient da­ta—have part­nered to cre­ate a sys­tem that pri­or­i­tizes the pa­tient ex­pe­ri­ence, match­es pa­tient in­ter­est, and moves qual­i­fied can­di­dates from ini­tial in­ter­est to en­roll­ment in a mat­ter of days. And the best part is, they’re so con­fi­dent in their mod­el that they take on the fi­nan­cial risk. Spon­sors on­ly pay when pa­tients en­roll. That’s right. Ze­ro cost un­less pa­tients en­roll and move the tri­al for­ward.

Across ther­a­peu­tic ar­eas, Clin­i­cal En­roll­ment dri­ves rough­ly 30% of to­tal tri­al en­roll­ment be­cause of its ded­i­ca­tion to the pa­tient ex­pe­ri­ence. With Pre­doc em­bed­ded in the Clin­i­cal En­roll­ment fun­nel from the be­gin­ning of a tri­al, on­site vis­its have in­creased by up to 45%.

Here’s how it hap­pens:

  • Pa­tient Screen­ing: Clin­i­cal En­roll­ment us­es al­go­rithms and be­hav­ioral tar­get­ing across dig­i­tal plat­forms to iden­ti­fy pa­tient pools. Pa­tients are con­tact­ed with­in five min­utes of ex­press­ing in­ter­est, kick­start­ing a dual screen­ing process to en­sure high­ly qual­i­fied can­di­dates, and hu­man touch­points through­out that serve as a trust­ed source to an­swer ques­tions and al­lay con­cerns. The pay­off: on-site to in­formed con­sent rate av­er­ages 89%, and screen-fail rates run ap­prox­i­mate­ly 18% be­low study av­er­ages.
  • Med­ical Records Re­trieval and Re­view: Pre­doc elec­tron­i­cal­ly re­trieves com­plete med­ical records in three to five days in­stead of five to six weeks. Then, Pre­doc us­es the da­ta with­in the record to an­swer study I/E cri­te­ria with clin­i­cian lev­el ac­cu­ra­cy so that when pa­tients are re­ferred to sites, they are re­ferred both hav­ing been more rig­or­ous­ly screened than any­where else in the in­dus­try, and al­ready with med­ical records in hand. Not on­ly does this lift the bur­den from the sites, but it al­so cares for the pa­tient and their time.
  • White Glove Clin­i­cal Site Re­la­tions: Clin­i­cal En­roll­ment part­ners with clin­i­cal sites every step of the way to make sure its process is op­ti­miz­ing for site band­width. One time sav­ings ef­fort: sites re­ceive a one-page clin­i­cal ref­er­ence and analy­sis of where the pa­tient sits with­in the can­di­date pool. The more con­text sites have on re­fer­rals, the more they can do to cre­ate a mean­ing­ful site ex­pe­ri­ence for pa­tients and their loved ones.
  • Suc­cess-Based Pric­ing: Spon­sors don’t pay for im­pres­sions, re­fer­rals, or ac­tiv­i­ty. They pay when pa­tients are ac­tu­al­ly en­rolled. When com­bined with Pre­doc’s rapid elec­tron­ic med­ical record re­trieval, the mod­el re­moves both op­er­a­tional drag and fi­nan­cial un­cer­tain­ty.

Clin­i­cal En­roll­ment and Pre­doc’s mod­el means that, on av­er­age, pro­grams are able to fin­ish en­roll­ment rough­ly three and a half months ear­li­er than planned, and with av­er­age re­cruit­ment cy­cle cost sav­ings of $19+ mil­lion. Mean­ing med­ical break­throughs that change lives can hap­pen even faster.

Clin­i­cal tri­al re­cruit­ment will al­ways in­volve un­cer­tain­ty. But mo­men­tum and the pa­tient ex­pe­ri­ence is the dif­fer­ence be­tween stalled tri­als and suc­cess­ful ones, and that’s ex­act­ly what Clin­i­cal En­roll­ment and Pre­doc de­liv­er.

Both lead­er­ship teams are at SCOPE. If you’d like to learn more, click here.

Con­tribut­ing Au­thors: 

About Clin­i­cal En­roll­ment: Start­ed by a pa­tient for pa­tients, Clin­i­cal En­roll­ment ex­ists to make sure that no clin­i­cal tri­al fails be­cause it couldn’t meet en­roll­ment goals. Clin­i­cal En­roll­ment op­er­ates with a dig­i­tal-first hu­man­i­ty meets an­a­lyt­ics method­ol­o­gy de­signed to gen­er­ate at­ten­tion with­in rel­e­vant and hard-to-reach pa­tient pop­u­la­tions, and de­liv­ers un­prece­dent­ed re­sults to sites and spon­sors. 

About Pre­doc: 2026 SCOPE Site In­no­va­tion Award Nom­i­nee, Pre­doc works to im­prove hu­man health by con­nect­ing and or­ga­niz­ing the na­tion’s health­care da­ta so that health­care teams have ac­cess to the right da­ta at the right time. All in pur­suit of im­prov­ing hu­man health.

Novo Nordisk CEO Mike Doustdar at Endpoints' #JPM26 event (Brian Benton Photography)
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by Max Bayer

No­vo Nordisk ex­pects its sales to shrink by at least 5% this year, cit­ing neg­a­tive pric­ing dy­nam­ics, in­clud­ing its deal with the US gov­ern­ment.

The Dan­ish phar­ma said in its fourth-quar­ter earn­ings re­port that it ex­pects 2026 ad­just­ed sales to fall 5% to 13% at con­stant ex­change rates, a big­ger-than-ex­pect­ed de­cline that sank the com­pa­ny’s shares by more than 14% in Tues­day trad­ing.

It's the obe­si­ty mar­ket prospects that have been a main dri­ver for No­vo shares NVO in re­cent months. With the lat­est out­look, the stock has now ful­ly erased gains made ear­li­er this year aid­ed by the launch of oral We­govy. The share price had been up 22% from the be­gin­ning of the year through Jan. 26.

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by Zachary Brennan

The Cen­ters for Medicare and Med­ic­aid Ser­vices has nev­er played a sig­nif­i­cant role in reg­u­lat­ing phar­ma­cy ben­e­fit man­agers, the mid­dle­men that have his­tor­i­cal­ly re­lied on high drug prices for prof­its. But the gov­ern­ment spend­ing pack­age that's near­ing the fin­ish line this week is poised to change that.

The sweep­ing, bi­par­ti­san re­forms would be­gin to take ef­fect in 2028 and are seen by many as a win for the phar­ma in­dus­try. The changes, which have been float­ed in var­i­ous forms in Con­gress for at least three years, will re­de­fine how PBMs can be com­pen­sat­ed and make CMS the new stan­dard-set­ter for how they op­er­ate.

The Sen­ate passed the spend­ing bill last week, and the House nar­row­ly passed the bill on Tues­day, paving the way for Pres­i­dent Don­ald Trump's sig­na­ture.

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Yongzhong Wang, AccurEdit Therapeutics CEO
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