Alterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).
- Breaking Through Tumor Defenses With Next-Generation Cell Therapy
- Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic
- Joe Dustin: Sites Are Driving Clinical Tech Evolution
- Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease
- The Problem With Excluding Children From GLP-1 Trials In The U.S.
- AI Trial Matching Comes Of Age At City Of Hope
- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
GUEST COLUMNISTS
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![Female nurse working at hospital-GettyImages-1333203074]( "4 Steps For Representative Enrollment In Rare Disease Trials")
4 Steps For Representative Enrollment In Rare Disease TrialsDiscover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.
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![Smart Chips, AI-GettyImages-1326193256]( "When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs")
When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROsLearn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).
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![FDA]( "FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now")
FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do NowOn December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.
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![AI, Holographic AI chip interface with European Union flag-GettyImages-2244741422]( "How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)")
How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.
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![European Union AI Act hologram-GettyImages-2244742120]( "How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)")
How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.
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![numbers, finance-GettyImages-2169186276]( "These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials")
These Four Things Are Helping Minovia Therapeutics' Rare Disease TrialsMinovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.
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![Return On Investment, growth-GettyImages-2224140598]( "Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment")
Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse EnrollmentTwice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
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![advertising on social media-GettyImages-2201068162]( "What ChatGPT Ads Will Really Mean For Clinical Trials")
What ChatGPT Ads Will Really Mean For Clinical TrialsAI health assistants may be used to surface clinical trials earlier in patient journeys, and advertising inside conversational AI is best understood as the next logical step in that same progression.
CLINICAL TRIAL WHITE PAPERS
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![trends-for-2025-GettyImages-2161094939]( "Completed Clinical Trials Continued To Climb In 2024")
Completed Clinical Trials Continued To Climb In 2024Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.
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Direct-To-Patient RTSM Solution6/17/2024
Explore modern decentralized trials that bring the supply chain into the patient experience. and including the pros and cons of direct-to-patient models.
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Unveiling The Critical Role of Sleep In Clinical Studies6/13/2024
Explore the critical role of sleep in clinical trials and its impact on health outcomes, emphasizing the need to address sleep disturbances for more effective and reliable research.
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Completed Clinical Trials, Terminations Both Rose In 20236/13/2024
This white paper highlights how the widespread growth in completed trials is coupled with higher success rates across multiple therapeutic areas, signaling the end of pandemic-related disruptions and infectious disease-related activity after three years of fluctuations.
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RWD, New Technologies Show Potential In Clinical Trial Recruitment7/10/2025
Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
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Conducting Early Phase Clinical Trials In Diverse Healthy Populations10/14/2025
Download our guide to learn proven strategies for designing early phase clinical trials that successfully enroll diverse populations and meet FDA diversity guidance.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
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How Syneos Health Tackles Protocol Complexities1/7/2025
Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase IIV clinical trials, particularly under a complex adaptive trial protocol.
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Partnership Driving Superior Enrollment And Speed In Phase III Trial1/31/2025
Examine the partnership between CRIO and Sitero, including how it underscores the significant impact of technology in optimizing trial performance and accelerating treatment development.
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Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments2/3/2025
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
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Digital Biomarkers Show Pathway To Reduced Study Sample Sizes, Shorter Durations7/8/2024
Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.
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Global Vaccine Trials Case Study5/22/2024
Explore targeted strategies for tackling the complexities of international payments and providing comprehensive participant support in global vaccine trials.
NEWSLETTER ARCHIVE
- 02.24.26 -- When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs
- 02.23.26 -- The U.S. Trial Advantage Is Eroding
- 02.21.26 -- The Case For Research-Naive PIs
- 02.20.26 -- Sponsors Collect Too Much "Non-Essential" Data, Say Tufts And TransCelerate
- 02.20.26 -- Partners To Elevate Your Clinical Trials
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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![Dietitian holding diet plan-GettyImages-1425188874]( "The Problem With Excluding Children From GLP-1 Trials In The U.S.")
In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
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![Woman using smartwatch-GettyImages-2248203064]( "How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows")
Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.
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![Female nurse working at hospital-GettyImages-1333203074]( "4 Steps For Representative Enrollment In Rare Disease Trials")
Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.
FOCUS ON PATIENTS
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![Father playing with child-GettyImages-1567083882]( "Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease")
The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
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![Dietitian holding diet plan-GettyImages-1425188874]( "The Problem With Excluding Children From GLP-1 Trials In The U.S.")
In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
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![Woman using smartwatch-GettyImages-2248203064]( "How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows")
Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.
