{"id":17432,"date":"2025-09-30T16:28:50","date_gmt":"2025-09-30T16:28:50","guid":{"rendered":"https:\/\/ubc.com\/?post_type=insights&#038;p=17432"},"modified":"2025-09-30T16:33:44","modified_gmt":"2025-09-30T16:33:44","slug":"beyond-enrollment-woes-why-sponsors-seek-rescue-in-tumultuous-times","status":"publish","type":"insights","link":"https:\/\/ubc.com\/insights\/beyond-enrollment-woes-why-sponsors-seek-rescue-in-tumultuous-times\/","title":{"rendered":"Beyond Enrollment Woes: Why Sponsors Seek Rescue in Tumultuous Times"},"content":{"rendered":"\n<p>We all know the stats by now: over 80% of clinical trials fail to meet their projected timelines globally, and despite comprehensive efforts across the industry, that trend does not seem to be improving. It\u2019s a worrying, costly statistic, that drives down revenue and delays critical drugs finding their way to patients.<\/p>\n\n\n\n<p>In concert with that statistic, however, is the growing trend of rescue studies. The two are invariably intertwined\u2014disappointed sponsors look to tighten timelines when studies just can\u2019t get off the ground, which often means switching their service partners. Data is relatively scarce on specifics\u2014as what determines a \u201crescue study\u201d differs from company to company. Global Data\u2019s statistics for 2018 cites about 20% of trials that year being rescued, but there is no current standard for measurement, and no public up-to-date statistics. Either way, rescues are here to stay.<\/p>\n\n\n\n<p>Lagging enrollment is just part of the struggle for sponsors, and likely an easy scapegoat for a far more complex problem. In fact, in many cases, sponsors are looking for rescues due to factors dragging down or putting their trials at risk that have nothing to do with enrollment.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Lagging enrollment is just part of the struggle for sponsors, and likely an easy scapegoat for a far more complex problem.<\/p>\n<\/blockquote>\n\n\n\n<p>Rahul Malhotra, Project Director, Evidence Development Solutions at UBC, has observed a surprising shift. \u201cYou\u2019re seeing studies now with all sites activated and patients enrolling, but dissatisfaction and distrust on the sponsor side. Sometimes it\u2019s due to having too many vendors in the mix; other times it\u2019s a data quality issue. And often, it\u2019s full-scale lack of communication and coordination.\u201d<\/p>\n\n\n\n<p>Rahul further explains that some sponsors may feel as if they can\u2019t afford to rescue, given the perceived financial costs in developing such a transition. Adding another vendor into the mix is overwhelming, especially later in the game, because it doesn\u2019t just mean resetting the clock on an already delayed or at-risk program, but investing in a transition and rebuilding trust without data loss or change in momentum.<\/p>\n\n\n\n<p>However, in some cases, it\u2019s too risky and too expensive to remain in the same partnership, so sponsors gravitate toward solutions providers who can be flexible and strategic, experienced in the nuanced shift and lift needed to transition successfully.<\/p>\n\n\n\n<p>Although there are dozens of technical aspects of this handover, one thing that most often is overlooked\u2014and hardest to maintain\u2014is communication. Though the word has become more of a corporate buzzword these days, in rescue studies there is no room for compromise. New team staff must maintain consistent, clear, and direct communication during handoff, and sponsors need access and transparency throughout.<\/p>\n\n\n\n<p>\u201cFull program management requires a seamless experience, and communication is at the heart of that,\u201d Rahul says. \u201cIt\u2019s about partnering with a team who can pre-emptively anticipate what needs to happen, make those changes, and keep the program moving, so sponsors can get back to focusing on what matters&#8221;.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" src=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/rescue-studies-clinical-trials-checklist.png\" alt=\"CASE STUDY\nUBC completed a Phase III prostate cancer rescue study comprising 2,250 participants across 250 sites. \n \nChallenge\nGiven the quick startup time required, certain risks posed significant challenges to a successful study.\n\u2022 Site Contracting &amp; Activation: not gaining regulatory approvals, contracting with sites, training investigators, and activating sites quick enough threatened the patient recruitment schedule.\n\u2022 Patient Recruitment: recruitment of enough eligible and diverse patients within a short timeframe was in jeopardy\n\u2022 Patient Retention: once recruited, ensuring compliance with study protocol and follow-up visits required parallel planning during protocol design and site startup.\n\u2022 Data Collection and Monitoring: strong possibility for incomplete or inaccurate data \nSolution\nOur rescue team implemented a modernized approach to study design, and skilled patient and physician services team helped work around these issues and keep this study on time and, often, ahead of schedule.\n\u2022 Patient-Centric Trial Design: alleviated the burden on patient participation, and patient-centric elements like the use of PRO\u2019s helped efficiently collect data with patient engagement through the UBC Patient Service Center.\n\u2022 Comprehensive Patient Recruitment: UBC employed multiple recruitment strategies, including collaborations with diverse clinical trial sites, patient advocacy groups, UBC patient access services, call center and oncology database, and community outreach programs.\n\u2022 Real-Time Communication: the rescue team established a secure and centralized platform to facilitate real-time information sharing among stakeholders, including investigators, site coordinators, sponsors, and regulatory authorities.\n\u2022 Remote Monitoring &amp; Oversight: leveraged remote monitoring &amp; oversight minimized the need for on-site visits and reduced time delays and costs. \n\" class=\"wp-image-17428\" style=\"width:662px;height:auto\"\/><\/figure>\n\n\n\n<p>These solutions allowed timely approval from regulatory authorities and study start-up. Our rescue team achieved a first site initiation visit only three months after CRO handover, and the first subject identified was dosed one month later.<\/p>\n\n\n\n<p><strong>Patient screening and enrollment was four months ahead of schedule in the first year.<\/strong> The six-month goal of screened patients was 41, and the trial was able to screen over 200 patients during that time. The trial\u2019s focus on diverse recruitment led to a more comprehensive understanding of the treatment\u2019s potential benefits and risks across various populations.<\/p>\n\n\n\n<p>Comprehensive trial design and planning resulted in zero inclusion\/exclusion protocol amendments. This was a key factor in minimizing disruptions to trial progress, proving study and data integrity to patients and investigators, and allowing enrollment to stay ahead of schedule.<\/p>\n\n\n\n<p>Implementation of modernized study design kept the rescue in lock step with established startup, recruitment, treatment, and follow-up timelines. At the time of publication, the trial was trending for an early completion, which reduces costs without compromising research effectiveness and integrity.<\/p>\n\n\n\n<p><strong>About UBC<\/strong><br>United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.<\/p>\n\n\n\n<figure class=\"wp-block-image alignleft size-thumbnail is-resized\"><img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Headshot-2-150x150.png\" alt=\"\" class=\"wp-image-17417\" style=\"width:128px;height:auto\"\/><\/figure>\n\n\n\n<p><strong>About the Author<\/strong><\/p>\n\n\n\n<p><em>JB Flinders<\/em>, <em>Executive Director, Strategic Client Engagement<\/em><\/p>\n\n\n\n<p>With over 16 years of clinical and academic research experience, JB Flinders has an extensive track record of driving successful operational, feasibility, and analytic strategy across the full scope of therapeutic areas and trials including multiple rescue studies.<\/p>\n\n\n\n<figure class=\"wp-block-image alignleft size-thumbnail is-resized\"><img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Rahul-Headshot-150x150.jpg\" alt=\"\" class=\"wp-image-17418\" style=\"width:128px;height:auto\"\/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p><em>Rahul Malhotra<\/em>, <em>Project Director,&nbsp;Global Project Delivery<\/em><\/p>\n\n\n\n<p>Rahul Malhotra is an experienced clinical research Director with more than 17 years in global project delivery. He is recognized for his strategic oversight, strong client partnerships, and successful delivery of studies Globally, spanning Real-World Evidence and interventional research across a wide range of therapeutic areas.<\/p>\n\n\n\n<figure class=\"wp-block-image alignleft size-thumbnail is-resized\"><img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-150x150.png\" alt=\"\" class=\"wp-image-17416\" style=\"width:128px;height:auto\" srcset=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-150x150.png 150w, https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-300x300.png 300w, https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-768x768.png 768w, https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot.png 960w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p><em>Natania Barron<\/em>, <em>Sr. Director, Marketing<\/em><\/p>\n\n\n\n<p>Natania Barron is a life sciences marketing professional with over 20 years of experience. Her passion is storytelling at the intersection of data and narrative.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Rescue studies are a challenge, and often enrollment is a top reason for switching. But mismatched partnerships go beyond enrollment.<\/p>\n","protected":false},"featured_media":17405,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"insights_category":[33],"insights_tags":[],"class_list":["post-17432","insights","type-insights","status-publish","format-standard","has-post-thumbnail","hentry","insights_category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v26.1.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Beyond Enrollment Woes: Why Sponsors Seek Rescue in Tumultuous Times - UBC<\/title>\n<meta name=\"description\" content=\"Rescue studies are a challenge, and often enrollment is a top reason for switching. 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