Shows / Applied Clinical Trials
Episodes
Applied Clinical TrialsACT Brief: Diversity Embedded as Standard Practice, Early Phase Statistician Collaboration, and First HDV Treatment Approved
In today's ACT Brief, we examine how Merck embeds diversity into trial execution from design through community engagement, a new statistician special interest…
- Applied Clinical Trials
ACT Brief: CNPV Program Operational Realities, Statistician Collaboration in Complex Trials, and GLP-1 Market Concentration
In today's ACT Brief, we examine what succeeding under compressed FDA review timelines requires, why statistician collaboration is essential as trial…
- Applied Clinical Trials
ACT Brief: RBQM and AI Integration, Statistician Role in Data Stewardship, and Oncology Regulatory Navigation
In today's ACT Brief, we examine operational RBQM enhanced by AI, how statisticians ensure responsible data use across development phases, and navigating…
- Applied Clinical Trials
ACT Brief: Clinical Development Orchestration, Career Insights in Trials, and FDA Communication Gaps
In today's ACT Brief, we examine how program-level orchestration is becoming critical to R&D success, reflections on meaningful work in clinical trials, and…
- Applied Clinical Trials
ACT Brief: Safety Monitoring Alignment, AI Performance Gap Emerging, and Real-Time Data Quality Challenges
In today's ACT Brief, we examine safety signal prioritization in RBQM, widening performance gaps between early AI adopters and the broader industry, and data…
- Applied Clinical Trials
ACT Brief: Trial Representation and Design, CRO Revenue Recognition Risks, and Real-Time FDA Data Review
In today's ACT Brief, we examine how improving representation changes trial design at Merck, revenue recognition challenges in CRO contracts, and FDA's pilot…
- Applied Clinical Trials
ACT Brief: Trust in Clinical Trial Engagement, Participant Readiness and Adherence, and AI in Regulatory Compliance
In today's ACT Brief, we explore how Let's Talk Trials addresses clinical trial awareness gaps, why participant readiness matters more than digital tools…
- Applied Clinical Trials
ACT Brief: Diversity Embedded in Trial Design, Unified Patient Outcome Data, and AI-Informed Protocol Development
In today's ACT Brief, we explore how diversity is embedded across trial planning at Merck, integration of patient-reported and wearable-derived outcome…
- Applied Clinical Trials
ACT Brief: Makary's Turbulent FDA Tenure, Pediatric Trial Experience Design, and Weight Loss Maintenance Data
In today's ACT Brief, we examine leadership instability and regulatory uncertainty during Makary's FDA tenure, how lived experience shapes pediatric trial…
- Applied Clinical Trials
ACT Brief: Cloud-Native Imaging Infrastructure, Community Relationships in Trial Design, and FDA Leadership Transition
In today's ACT Brief, we examine cost models for imaging infrastructure in clinical trials, how community relationships improve protocol design and site…
- Applied Clinical Trials
ACT Brief: Protocol Design as Business Strategy, Site Financial Pressures, and FDA Leadership Uncertainty
In today's ACT Brief, we examine how protocol design decisions have become strategic business choices with outsized consequences for smaller companies, what…
- Applied Clinical Trials
ACT Brief: eSource Data Integration, Direct-to-Patient Site Performance, and Pragmatic Trial Safety Framework
In today's ACT Brief, we examine CRIO and Medidata's partnership on seamless clinical trial data flow, Tufts CSDD findings on direct-to-patient site enrollment…
Applied Clinical TrialsCRIO and Medidata Partnership Targets Clinical Trial Data Friction
In this episode of the Applied Clinical Trials Podcast, Jonathan Andrus, co-CEO, CRIO, and Samir Jain, vice president of product management, healthcare data…
- Applied Clinical Trials
ACT Brief: AI Governance Lag, Site Payment Experience, and Schizophrenia Relapse Prevention
In today's ACT Brief, we examine governance inertia when AI accelerates protocol development, why payment experience is becoming a competitive differentiator…
- Applied Clinical Trials
ACT Brief: AI Impact Faces Reality Check, Supply Chain Risks Intensify, and RWE Shapes Global Strategy
In today’s ACT Brief, we highlight where AI is delivering real gains in protocol development, how geopolitical disruption is redefining supply chain…
- Applied Clinical Trials
ACT Brief: CRO Consolidation in Regulatory Services, Reimbursement in Development Planning, and Site Selection Misalignment
In today's ACT Brief, we examine Veristat's acquisition of Certara's regulatory business, why reimbursement probability should inform development planning…
- Applied Clinical Trials
ACT Brief: Organizational Shifts in Trial Design, Amyloid Antibody Evidence Review, and Compounding's Role in Care Continuity
In today's ACT Brief, we explore organizational factors behind CRL decisions, methodological concerns with pooling amyloid antibody trial data, and how…
- Applied Clinical Trials
ACT Brief: Community Engagement Framework for Enrollment, Plausible Mechanism Framework Essentials, and AI Scaling Foundations
In today's ACT Brief, we explore practical community engagement strategies that drive representative enrollment, how sponsors should structure development…
- Applied Clinical Trials
ACT Brief: Plausible Mechanism Pathway Implementation Steps, Behavioral Science in Trial Design, and Psychedelic Drug Accelerated Review
In today's ACT Brief, we explore practical steps sponsors can take to prepare for the plausible mechanism framework, how behavioral science addresses root…
- Applied Clinical Trials
ACT Brief: Natural History Data Matching Challenges, Execution Translation Gap in Trials, and Accelerated Approval Pathway Reforms
In today's ACT Brief, we explore how disease heterogeneity confounds natural history controls, the execution translation gap converting identified problems…
- Applied Clinical Trials
ACT Brief: Master Protocol Design Considerations, Early Predictive Data Integration, and Real-World Evidence as Regulatory Standard
In today's ACT Brief, we explore biological and dosing considerations for basket trial designs, how human-relevant data earlier in development reduces…
- Applied Clinical Trials
ACT Brief: Evaluating Evidence for Individualized Therapies, Clinical Trial Reporting Compliance, and TIL Therapy Merger
In today's ACT Brief, we explore how FDA evaluates effectiveness for ultra-rare individualized therapies, the agency's enforcement push for mandatory trial…
- Applied Clinical Trials
ACT Brief: Protocol Interpretation as Startup Bottleneck, Plausible Mechanism Framework, and Real-Time Trial Tracking Systems
In today's ACT Brief, we examine how protocol interpretation and source document preparation delay study startup, how the plausible mechanism framework…
- Applied Clinical Trials
ACT Brief: Real-World Data Access Expansion, eSource Implementation at Scale, and FDA Regulatory Setback for Oncolytic Therapy
In today's ACT Brief, we examine Thermo Fisher's expanded real-world data access through HealthVerity, how FHIR-based standards are finally enabling scalable…
- Applied Clinical Trials
ACT Brief: Clinical Trial Trends and 2026 Outlook, AI Agents and Workforce Transformation, and Degrader-Antibody Conjugate Partnership
In today's ACT Brief, we explore industry perspectives on operational and methodological shifts defining 2026, how agentic AI will augment clinical trial roles…
- Applied Clinical Trials
ACT Brief: Governance vs. Execution in Pharma Modernization, AI Workforce Augmentation Planning, and Adaptive Trial Regulatory Shifts
In today's ACT Brief, we examine why expanding governance layers slow digital modernization initiatives, how AI will augment clinical trial roles over the next…
- Applied Clinical Trials
ACT Brief: Diversity Built Into Trial Design, AI Impact Across Trial Lifecycle, and Companion Diagnostics Adoption
In today's ACT Brief, we explore why clinical trial diversity requires protocol redesign from the outset, the highest-impact opportunities for AI across the…
- Applied Clinical Trials
ACT Brief: Risk-Based Monitoring in Global Trials, Patient-Centered AI Design, and Generative AI in Healthcare
In today's ACT Brief, we examine the technical and operational challenges of implementing risk-based monitoring across global trials, how AI must address…
- Applied Clinical Trials
ACT Brief: AI Leadership and Organizational Adoption, Bayesian Methods in Drug Development, and NIH Budget Reductions
In today's ACT Brief, we explore the leadership priorities that enable meaningful AI gains in clinical research, how Bayesian methodologies are reshaping trial…
- Applied Clinical Trials
ACT Brief: Real-World Data Across Therapeutic Areas, AI-Driven Case Intake, and COVID-19 Vaccine Trial Enrollment Challenges
In today's ACT Brief, we examine how real-world data is being applied across oncology, ophthalmology, and other therapeutic areas to optimize trial design, how…
- Applied Clinical Trials
ACT Brief: Digital Twins for Virtual Control Arms, Clinical Tech Stack Evolution, and Universal Flu Vaccine Advances
In today's ACT Brief, we explore how digital twin technology creates reliable virtual control arms from historical data, what defines an effective clinical…
- Applied Clinical Trials
ACT Brief: Platform vs. Bespoke Technology, Patient and Site Experience Design, and AI-Driven ADC Development
In today's ACT Brief, we explore how to decide which trial complexities warrant core technology platforms versus custom configurations, how measuring patient…
- Applied Clinical Trials
ACT Brief: Intuitive Technology Design and Site Compliance, Vaccine Follow-Up Strategy Optimization, and AI-Driven Antibody Discovery
In today's ACT Brief, we explore how user-friendly technology reduces errors and site workarounds, strategic approaches to combining traditional and real-world…
- Applied Clinical Trials
ACT Brief: Clinical Technology Implementation Priorities, Digital Supply Chain Integration, and AI Drug Discovery Scale
In today's ACT Brief, we examine the three converging technology priorities reshaping trial execution in 2026, why sponsors must integrate digital and physical…
- Applied Clinical Trials
ACT Brief: Clinical Workflow User Experience, Sample Integrity and Logistics, and FDA's Unified Adverse Event System
In today's ACT Brief, we examine why eClinical platforms must prioritize user workflows over data flow, how digitizing sample tracking prevents integrity…
- Applied Clinical Trials
ACT Brief: CRO Selection as Incentive Design, Integrated Tech Stack Strategy, and Pricing Disruption in Pharma
In today's ACT Brief, we examine how game theory principles can improve CRO and vendor selection through ecosystem alignment, why clinical technology platforms…
- Applied Clinical Trials
ACT Brief: Behavioral Science and Recruitment Design, Community Engagement in Trials, and Big Pharma's Rare Disease Interest
: In today's ACT Brief, we examine how behavioral science applied during trial design and startup can identify recruitment barriers early, the importance of…
- Applied Clinical Trials
ACT Brief: Thermo Fisher Acquires Clario, Wearables and AI Integration, and Somatic Genomics for IBD
In today's ACT Brief, we examine Thermo Fisher's acquisition of Clario to expand clinical trial data infrastructure, how wearable devices and AI are reshaping…
- Applied Clinical Trials
ACT Brief: AI and Wearables for Patient Monitoring, FDA Modernizes Evidence Standards, and Regulatory Alignment in Rare Disease
In today's ACT Brief, we explore how AI can parse wearable data streams to identify subtle clinical patterns, FDA's four major policy shifts modernizing drug…
- Applied Clinical Trials
ACT Brief: FDA Clearance and Reimbursement for Wearables, Data Validation Across Complex Trials, and Wegovy HD Approval
In today's ACT Brief, we explore how FDA clearance and reimbursement models support wearable adoption in clinical care, the importance of end-to-end data…
- Applied Clinical Trials
ACT Brief: Wearable Data Integration Challenges, Human Performance Science, and Rare Disease Regulatory Flexibility
In today's ACT Brief, we explore the data overload and alert fatigue challenges in integrating wearable data into clinical workflows, how cognitive and…
- Applied Clinical Trials
ACT Brief: Remote Monitoring and Early Intervention, NAMs Replace Animal Testing, and Glass Box Clinical Intelligence
In today's ACT Brief, we explore how continuous remote monitoring enables early clinical interventions, FDA guidance on validating new approach methodologies…
- Applied Clinical Trials
ACT Brief: Wearable Data in Clinical Care, Generalized Pairwise Comparisons, and Vaccine Policy Litigation
In today's ACT Brief, we explore how wearable data is informing real-world clinical decision-making, a statistical method that analyzes multiple patient…
- Applied Clinical Trials
ACT Brief: Academic Trial Infrastructure, Vaccine Engagement Strategies, Workflow Orchestration
In today's ACT Brief, we examine the technology infrastructure gap facing investigator-initiated trials, how transparency and community engagement drive…
- Applied Clinical Trials
ACT Brief: Trial Transparency and Synthetic Controls, Readiness as Leading Risk Indicator, FDA Streamlines Biosimilar Pathway
In today's ACT Brief, we explore the transparency demands of complex trial designs and synthetic controls, how measuring site readiness during training…
- Applied Clinical Trials
ACT Brief: Trial Data Transparency, Protocol Design Drives Enrollment, FDA Shifts Approval Standards
In today's ACT Brief, we examine why transparency in complex trial designs is essential for data confidence, how protocol structure—not operational…
- Applied Clinical Trials
ACT Brief: Bayesian Shifts Regulatory Culture, Quality Tolerance Limits Drive Risk Management, CBER Leadership Changes
In today's ACT Brief, we explore how Bayesian methods are reshaping FDA interactions and trial design, quality tolerance limits are becoming operational…
- Applied Clinical Trials
ACT Brief: Bayesian Implementation, Women in Statistics, and FDA Tightens Gene Therapy Standards
In today's ACT Brief, we explore the operational capabilities clinical teams need to implement Bayesian trial designs, why gender diversity strengthens data…
- Applied Clinical Trials
ACT Brief: Bayesian Methods Drive Adaptive Trials, Digital Endpoints Gain Regulatory Footing, and FDA Cracks Down on Compounded GLP-1 Marketing
In today's ACT Brief, we explore how Bayesian approaches are powering studies in rare disease and pediatrics, a major public-private initiative is…
- Applied Clinical Trials
ACT Brief: Bayesian Trials Advance, eSource Integration Scales, and FDA Standards Shift
In today’s ACT Brief, we highlight how Bayesian methods are reshaping adaptive trial design, a major eSource partnership is improving data flow and accuracy…
- Applied Clinical Trials
ACT Brief: Bayesian Approaches Expand, Patient Foundations Merge, and AI Transforms Clinical Trials
In today’s ACT Brief, we highlight how Bayesian methods are gaining operational traction, a major patient advocacy merger is streamlining clinical trial…
- Applied Clinical Trials
ACT Brief: RWD Integration Accelerates, FDA Advances Ultra-Rare Therapies, and Collaboration Shapes the Next Decade
In today’s ACT Brief, we examine how the Verana Health-COTA merger is evolving real-world data use, the FDA’s new framework for individualized ultra-rare…
Applied Clinical TrialsRWD at Scale: How Verana Health and COTA Are Shaping the Future of Clinical Development
In this episode of the Applied Clinical Trials Podcast, C.K. Wang, MD, chief medical officer at COTA; and Sujay Jadhav, CEO of Verana Health, discuss how their…
- Applied Clinical Trials
ACT Brief: Bayesian Designs Gain Ground, Data Priorities Take Shape, and Rare Disease Strategy Expands
In today’s ACT Brief, we explore how Bayesian trial designs are gaining traction in rare disease research, what priorities clinical operations leaders should…
- Applied Clinical Trials
ACT Brief: Sites Advance AI Adoption, Cross-Functional Alignment Moves Earlier, and Phase I Strategy Evolves
In today’s ACT Brief, we explore how sites are taking the lead on AI adoption to strengthen feasibility and enrollment, why earlier cross-functional alignment…
- Applied Clinical Trials
ACT Brief: Data Fragmentation Risks Rise, Outsourcing Models Evolve, and FDA Pathways Face Pressure
In today’s ACT Brief, we examine how fragmented data collection continues to challenge trial quality, how hybrid outsourcing and AI are reshaping execution…
- Applied Clinical Trials
ACT Brief: eSource Standardization Advances, Digital Protocols Gain Momentum, and Rare Disease Trial Risks Intensify
In today’s ACT Brief, we examine how protocol-driven eSource is reshaping data capture at sites, how digital protocols and data sharing are redefining trial…
- Applied Clinical Trials
ACT Brief: Site Data Quality Takes Priority, Merck Expands AI Discovery Efforts, and Gilead Advances Cell Therapy Strategy
In today’s ACT Brief, we examine how site-level data capture is becoming central to trial execution, how Merck and Mayo Clinic are scaling AI-driven discovery…
- Applied Clinical Trials
ACT Brief: Evinova Expands AI Partnerships, CTPM Role Evolves, and FDA Pressure Builds on GLP-1 Market
In today’s ACT Brief, we examine how Evinova is scaling AI-driven clinical development through industry collaboration, how the clinical trial project manager…
- Applied Clinical Trials
ACT Brief: SCOPE Highlights Operational Discipline, AI Adoption Accelerates Execution, and FDA Rethinks Evidence Standards
In today’s ACT Brief, we examine how SCOPE 2026 reinforced the link between speed and strategy, how AI adoption is driving real-world efficiency gains, and how…