|Articles|February 17, 2014

Applied Clinical Trials-02-01-2014
Volume 23
Issue 2

Applied Clinical Trials Digital Edition - February/March 2014

CRO/Sponsor: Integrating Managed Access Programs: Global Considerations Trial Design: How to Improve Clinical Research in Children Also in this issue: Global Experience with Informed Consent Central Statistical Monitoring Sponsor/CRO Interaction

External Link - 2014-02ACT.pdf

Articles in this issue

over 12 years ago

Article

How to Improve Clinical Research in Children

over 12 years ago

Article

A New Look at Global Study Volunteer Experiences with Informed Consent

over 12 years ago

Article

Integrating Managed Access Programs: Global Considerations

over 12 years ago

Article

Fine-Tuning CRO/Sponsor Interaction

over 12 years ago

Article

BRIC Expenditures Increasing at a Much Faster Pace than US

over 12 years ago

Article

New Horizons in Research Funding for EU

over 12 years ago

Article

FDA, Sponsors Continue Quest for More Efficient Trials

over 12 years ago

Article

ACT Cover

over 12 years ago

Article

How to Improve the Quality of Research Reporting

over 12 years ago

Article

EMA Guidance Points to Central Statistical Monitoring

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

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October 8th, 2026

Real-Time Data, Right-Time Decisions: Rethinking Analysis Frequency in RBQM

Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue and operational noise that obscures meaningful deterioration.

October 8th, 2026

What It Takes to Harmonize AI Across Fragmented Oncology Health Systems

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, explain how building trust into the data foundation—through source lineage, standardization, and reconciliation—is what makes reliable real-world evidence generation in oncology possible.

October 8th, 2026

ACT Brief: AI and Protocol Design, Site Training Readiness, and GLP-1 Unmet Needs

In today's ACT Brief, we examine how AI surfaces design flaws before enrollment, why site training readiness depends on learning science, and the priorities defining next-generation weight-loss therapies.

October 7th, 2026

Better Site Training Starts With Five Simple Questions

Site training effectiveness depends on readiness at first-patient-in, requiring learning-science design principles around performance focus, cognitive load reduction, progressive sequencing, and spaced retrieval practice rather than training completion metrics or content volume.

October 7th, 2026

Using AI to Design Better Trials Before the First Patient Enrolls: Q&A with Claire Riches, Citeline

In this Q&A, Claire Riches, VP of clinical solutions at Citeline, discusses how AI is transforming endpoint selection and protocol pressure-testing, what data inputs matter most for realistic enrollment planning, and why the tools are more accessible than most sponsors assume.

October 7th, 2026

ACT Brief: FDA Transparency Roadmap, Radiopharmaceutical Trial Operations, and AI-Powered Enrollment Prediction

In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.

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October 6th, 2026

Beyond the Molecule: Why Radiopharmaceutical Trials Require a New Operating Model

Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only as fast as the infrastructure, data, and cross-functional decisions required to deliver it.

October 6th, 2026

FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review

A new FDA Voices post from the agency's acting chief of staff details completed milestones and upcoming priorities across complete response letter disclosure, application lifecycle transparency, new approach methodologies, labeling, and inspectional records.

Applied Clinical Trials Digital Edition - February/March 2014

Articles in this issue

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Using AI to Design Better Trials Before the First Patient Enrolls: Q&A with Claire Riches, Citeline

FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review

ACT Brief: FDA Transparency Roadmap, Radiopharmaceutical Trial Operations, and AI-Powered Enrollment Prediction

FDA Seeks Public Input on Early-Phase Clinical Trial Design for Ibogaine

ACT Brief: AI and Protocol Design, Site Training Readiness, and GLP-1 Unmet Needs