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3 February, 2026 |
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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
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by Clinical Enrollment
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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. |
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Novo Nordisk CEO Mike Doustdar at Endpoints' #JPM26 event (Brian Benton Photography) |
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by Max Bayer
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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
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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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