A collaboration between Tufts CSDD, Tufts School of Medicine, and TransCelereate BioPharma revealed just how much extra data sponsors are collecting — and why that's a problem.
- Participant Recruitment In LMIC Clinical Trials
- Behavior Modeling Can Help Sponsors Better Understand Sites And Patients
- How The U.S. Can Beat China In Biotech
- Funding Diversity Where It Starts — At the Site
- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
- How AI Is Transforming Patient Stratification
- The Rise Of Specialist CROs In Clinical Outsourcing
GUEST COLUMNISTS
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How AI Is Rewriting The Future Of TMF And Clinical Quality
Discover how AI is transforming the TMF from a reactive repository into a proactive, intelligent co-pilot for clinical trials.
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Trends In Rare Disease Trials: Recommendations
In the third article of this series, analyst reveal their top 6 recommendations for designing selection criteria and selecting solution options to optimize rare disease research outcomes.
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The Hidden Power Of Specialized Community Research Sites In Accelerating Clinical Trials
Tyler Research Institute founder G. Aaron DuVall explores how community sites can offer access to diverse patient populations and build processes tailored for chronic disease care to accelerate timelines and improve outcomes.
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Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical Trials
Discover the most effective regulatory pathways used to support CGT development, including two real-life examples.
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Continuous Evidence Generation — Including RWE — Remains Critical To Vaccine Development
President of Takeda's Global Vaccine Business Unit Derek Wallace discusses the importance of continuous, real-world data collection in the context of vaccine development in low- and middle-income countries.
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How Redefining The Diagnostic Odyssey Can Lead To Better Patient Outcomes
Patient advocate Wendy Cogan calls for improved diagnostic pathways as a means to better clinical trial recruitment and design while telling the journey of her late husband's journey to a corticobasal degeneration(CBD)-frontal behavioral-spatial syndrome (FBS) diagnosis.
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Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development
Discover how partnerships — especially with capable CROs — as well as resilient supply chains, digital enablement, regulatory foresight, and specialized talent impact the success of targeted protein degradation therapies.
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What Can We Expect From The FDA In 2026?
Expert panelists at the 2025 RAPS Convergence discussed what lies ahead for the FDA in 2026.
CLINICAL TRIAL WHITE PAPERS
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Oesophageal Cancer: Global Clinical Trial Landscape (2024)
Oesophageal cancer is the 11th most common cancer and the 7th leading cause of cancer deaths, starting in the esophagus. Explore our report to discover the latest in treatments, clinical trials, and future innovations.
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Small Cell Lung Cancer- Global Clinical Trial Landscape (2025)5/9/2025
Historically dominated by chemotherapy and radiation, the treatment paradigm for small cell lung cancer (SCLC) is evolving in response to limited survival benefits and high relapse rates.
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IPF - Global Clinical Trial Landscape5/19/2025
This report provides a comprehensive overview of Idiopathic Pulmonary Fibrosis (IPF), a progressive and fatal interstitial lung disease.
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Long-Term Follow-Up For Gene Therapies — Innovative, Patient-Centered Approaches7/2/2024
Find out how long-term follow-up (LTFU) studies for gene therapies present unique challenges, and highlight important considerations for different kinds of sponsors, including biotech and emerging biopharma.
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Deriving Reliable Clinical Outcome Scores From Continuous DHT Data6/10/2025
DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.
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Key AI Trial Insights From Regulators And Consultants4/4/2025
AI’s transformative impact promises more efficient, cost-effective, and successful clinical trials across the pharmaceutical landscape.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Educating Globally Diverse Populations Through Branding & Visuals10/31/2024
See how this customized educational approach significantly enhanced recruitment and retention efforts, helping to ensure a more inclusive trial for Nonobstructive Hypertrophic Cardiomyopathy (nHCM).
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Patient Engagement: Early Cancer Detection Blood Draw4/17/2024
Discover how we aided a pharmaceutical company in enrolling participants for a Phase III trial, DETECT-ASCEND 2, focused on Plasma-Based CancerSEEK Testing for early cancer detection.
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Transforming Clinical Trial Sites With Research Study Rockstar2/10/2025
This innovative platform addresses prevalent pain points faced by trial coordinators by streamlining workflows, automating patient communication, and providing intuitive dashboards that simplify trial management.
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Advancing Oncology Innovation With Adaptive Trial Designs8/12/2025
When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.
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Muscular Dystrophy: Multi-National And Multi-Site Trials10/15/2024
Learn about the success ReveraGen found when expanding their partnership with Novotech to a larger phase 2b trial (VBP15-004) in Duchenne Muscular Dystrophy (DMD).
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Recruiting & Retaining More Patients Per Site:3/14/2025
Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
NEWSLETTER ARCHIVE
- 11.06.25 -- Regulatory Pathways For Successful CGT Clinical Trials
- 11.06.25 -- 2025: A Pivotal Year for Trial Tech Evolution
- 11.05.25 -- Trends In Rare Disease Trials
- 11.05.25 -- STREAM Edition: From Outreach To Engagement: Building Trust That Lasts
- 11.05.25 -- Is Fragmented Technology Holding Your Clinical Research Back?
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
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Due to the high burden of infectious diseases in low- and middle-income countries (LMICs), there is greater urgency for vaccine trials. Participant recruitment entails significant work with communities.
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Learn how behavioral modeling can identify patients at risk of dropout and sites that may need additional support, so you can build a more resilient research network.
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Discover how AI tools can help stratify or group patients into subtypes that respond differently to treatment.
FOCUS ON PATIENTS
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Learn how behavioral modeling can identify patients at risk of dropout and sites that may need additional support, so you can build a more resilient research network.
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Patient advocate Wendy Cogan calls for improved diagnostic pathways as a means to better clinical trial recruitment and design while telling the journey of her late husband's journey to a corticobasal degeneration(CBD)-frontal behavioral-spatial syndrome (FBS) diagnosis.
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When the federal government shuts down, clinical research suffers. Empactful Ventures' Denise N. Bronner, Ph.D., explains the wide-reaching ramifications.