A new national survey from UPMC’s Center for Connected Medicine examines why women remain underrepresented in clinical trials. The research highlights key barriers such as fear of side effects, time and travel burdens, and limited awareness about how trials work. In a conversation with UPMC’s Nicole Ansani, we explore what sites and sponsors can do to make trials more accessible and appealing to women.
- FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know
- How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment
- Patient-Powered Drug Trials Are Getting The FDA Greenlight
- Do We Still Need To "Save" Our Sites?
- When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down
- How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026
- The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development
GUEST COLUMNISTS
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![World AIDS Day-GettyImages-1467238981]( "The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development")
The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug DevelopmentDiscover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.
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![network connection-GettyImages-920720422]( "Avoid Clinical Alignment Breakdowns With \"Lateral Agility\"")
Avoid Clinical Alignment Breakdowns With "Lateral Agility"Internal misalignment can stall the clinical timeline, erode the window of patent protection, and jeopardize funding. Learn why leadership can no longer be and instead must exhibit "lateral agility" across the enterprise.
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![business, teamwork,collaboration-GettyImages-922937404]( "Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes")
Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything ChangesThe outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
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![Risk protection, business and life-GettyImages-1872872331]( "The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board")
The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On BoardTufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring.
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![bayesian stats image-GettyImages-1205583077]( "FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs")
FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small BiotechsThe FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.
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![Climate Change-GettyImages-2151025853]( "Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial")
Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology TrialDiscover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.
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![AI-Artificial Intelligence in Healthcare-GettyImages-1365534802]( "The Uncomfortable Conversation: AI And Data Use In Clinical Trials")
The Uncomfortable Conversation: AI And Data Use In Clinical TrialsAI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.
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![Chat bot service, future marketing-GettyImages-1468141962]( "When A Clinical Trial Surfaces In An AI Chat, What Happens Next?")
When A Clinical Trial Surfaces In An AI Chat, What Happens Next?AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1370928101 regulatory compliance]( "How Sponsors Can Drive Success With Central eSource At Investigator Sites")
How Sponsors Can Drive Success With Central eSource At Investigator SitesCentralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
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eSource Purpose Is Not Just To Complete The EDC7/7/2025
Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.
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Breaking Through Barriers With Integrated Trial Optimization5/9/2025
In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.
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Rewriting The Future Of Clinical Trials8/8/2025
In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development
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Merits Of A Multifaceted Approach To Clinical Trial Recruitment1/27/2025
The best way to address clinical trial recruitment challenges is with a multifaceted approach that goes beyond traditional channels and ways of thinking.
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Powering More Efficient Clinical Development With AI And ML7/7/2025
Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
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Using eConsent Data To Populate Site And Sponsor Data Systems10/7/2024
A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.
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Reframing Clinical Vendor Selection7/2/2025
Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.
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Enhancing Investigator Training And Communication During COVID-196/26/2024
Centralizing all trial-related information, enabling seamless interaction and global team coordination through Scout Academy.
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Cracking The Code: Strategies For Success In Complex Trials8/27/2024
Navigating the complexities of modern clinical trials requires advanced technology and strategic planning. Learn what goes into managing a challenging, decentralized rare disease trial.
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Enhancing ER Patient Recruitment6/26/2024
Scout's custom information delivery mechanism for clear, accessible patient education facilitated trial enrollment in a high-pressure emergency room setting.
NEWSLETTER ARCHIVE
- 03.14.26 -- Clinical Leader Best Of February
- 03.13.26 -- The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board
- 03.12.26 -- Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
- 03.11.26 -- Mobile Health Exhibit Bringing Clinical Trial Education To Communities
- 03.11.26 -- STREAM Edition: Policy By Press Release Is Now A Real Problem
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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![Doctor and patient in nursing home-GettyImages-1345138968]( "PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients")
Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
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![Affordable care act-GettyImages-1148533483]( "How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment")
The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.
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![Chat bot service, future marketing-GettyImages-1468141962]( "When A Clinical Trial Surfaces In An AI Chat, What Happens Next?")
AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
FOCUS ON PATIENTS
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![Doctor and patient in nursing home-GettyImages-1345138968]( "PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients")
Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
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![Traffic light over urban intersection-GettyImages-1168877430]( "Patient-Powered Drug Trials Are Getting The FDA Greenlight")
Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.
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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.
