Patient Recruitment Applications & Studies
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Quality Trial Study Design For Phase II For Primary Biliary Cholangitis Improves Enrollment
7/12/2021
The only widely accepted treatment fro Primary biliary cholangitis (PBC) is Ursodeoxycholic Acid (UDCA), which can delay disease progression and improve long-term survival but does not address the underlying disease. A solution provider drew on their expertise to contribute to the study design and selection of appropriate endpoints for a Phase II trial with a European Pharmaceutical company. Operational teams were then able to focus on data capture and cleaning, leading to safety review assessments, as well as a key Interim analysis, final analysis and clinical study report – all delivered on budget and within required timelines.
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Global Pharma Saves 4 Months Recruitment Efforts With Digital Campaigning
7/1/2021
A large global pharma initiated a phase III study testing the efficacy of combining two existing drugs in overactive bladder patients. The study planned to enroll 3,500 patients worldwide a 10-month period across and included sites in multiple countries in the Nordic region. Read how engaging Trialbee from study start to ensured enrollment deadlines were met as planned.
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Ulcerative Colitis Study Gets Back On Track With Recruitment Support In Four Countries
6/30/2021
A global biotech initiated a phase IIb orphan drug study for the treatment of chronic ulcerative colitis. After deploying traditional recruitment methods, the sponsor met only 60% of its patient enrollment target, and extended the recruitment window an additional six months. Finding the right partner allowed them to successfully close the enrollment gap and move the study forward as planned.
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Retention And Compliance In A Multicenter, Open-Label Clinical Trial
6/18/2021
Missing outcome data caused by patient dropout and poor compliance not only jeopardize the scientific validity of a study, but also come at a significant financial cost to study sponsors. Technology and behavioral science offer potential solutions that together can address these challenges through patient-centric design of tools. This case study examines retention and compliance in a multicenter, open-label clinical trial (N=36) with the use of the Linkt mobile application.
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Overcoming EU Recruitment Challenges
6/14/2021
A biotech client needed to conduct a challenging Phase III study, requiring fast recruitment from multiples sites across Europe. This case study outlines how we achieved the Pan-European recruitment target on time to deliver the study successfully.
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The Case For Patient Diversity In Clinical Trials
2/25/2021
Uncover how a global pharmaceutical company met the FDA's challenge to increase patient diversity with a multi-tiered approach combining key tactics and technology.
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Groundbreaking Work Leads To First Gene Therapy Ever Approved In Europe
1/14/2021
Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters – our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts wrote the map on patient recruitment, regulatory and health agency engagement, natural history studies and the Central Site Model.
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Rho's Approach To Overcoming Enrollment Challenges In A CNS Trial
1/7/2021
A mid-sized biotech company running a randomized, doubleblind, placebo controlled (1:1) Phase 3 CNS pain study, with a single treatment administration, had achieved ex-US approval yet faced significant enrollment challenges when a modified version of the study was implemented in the US. With a goal of 300 participants, the rate of enrollment sat at a mere 0.5 subjects a month. The best laid plans weren’t cutting it.
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How Ramping Up Communications Helped Overcome A Next-To-Impossible Recruitment Challenge
4/21/2020
We knew going in that it could be the perfect recruiting nightmare with extremely complex inclusion/exclusion criteria. By letting sites set their own goals and commit to them along with assigning project coordinators that stayed close to those sites the study is off to a good start.
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From KOLs To Patient Advocates, Using Every Tool To Fight A Rare Disease
3/11/2020
With a recruiting target of 18 patients for a condition that afflicts just one in 31,000 people this CRO had to make full use of what few resources were avaiable. By working with KOLs and a patient advocacy group they located their 18 patients ahead of schedule and completed the 26-week trial early.