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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![India Flag]( "Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection")
Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data CollectionExplore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.
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Patient-Focused Data Capture For Cancer Research8/21/2025
In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
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Writing An IND Module 3 For Cell And Gene Therapy Products9/1/2025
This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.
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Best Practices For Internal Quality Audits In Life Sciences3/14/2025
Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.
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The Future Of Regulatory Operations6/3/2024
The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.
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A New Blueprint For Transforming Feasibility And Recruitment9/22/2025
Discover how a connected approach links feasibility and recruitment, using real-world data to design realistic protocols, reach the right patients, and accelerate enrollment with confidence.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Preparing The Next Generation Of Clinical Research Professionals9/4/2025
Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.
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Drug-Drug Interaction Study On A Novel Cardiovascular Medication9/17/2024
Learn how Altasciences leveraged its expertise to design, recruit, and conduct complex DDI studies, assessing pharmacokinetic and pharmacodynamic impacts of co-administered drugs.
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Overcoming Participant Compliance Challenges In A Medical Device Study9/9/2024
Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.
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Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology5/2/2025
Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.
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Streamlining Global Respiratory Trial Complexities With Robust Data Capture Strategy9/23/2025
Want to see how eCOA solutions can simplify patient-reported data capture and accelerate global trials? Explore implementation strategies, lessons learned, and measurable results.
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Meeting 100% Recruitment 7 Months Ahead Of Schedule7/23/2024
Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.
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.
