Hot Topic: Clinical Operations

This hot topic was so big for the content at DIA 2017 that rather than highlighting Clinical Operations as a meeting track, it is its own Featured Topic. This topic boasts more than 50 sessions focused on the latest methods, regulations and best practices for clinical operations. Industry experts, health authorities and academic researchers will discuss topics ranging from implementation to monitoring to managing clinical trial efficiency.

Highlights

• Evaluation of Risk-Based Monitoring from the perspective of the sponsor’s GCP auditor
• Techniques for improving clinical trial retention
• Master protocols: benefits and challenges 
• Evolving clinical trial guidance and regulations

Questions

• How can clinical operations professionals effectively address considerations for multi-company collaborations?
• What is the impact of ICH GCP E6 (R2) revisions on clinical research competencies and workforce? 

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Sessions in Clinical Operations

The Future of Patient Engagement: Measuring What Matters
• Calling All Angels to the Valley of Death
• Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies

People Will Talk: Gathering Insights from Digital Listening
• Big Data: Regulatory Information
• Sharing the Burden
• Safety Evaluation: Transforming Information into Evidence
• Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol Development, and Operations Perspective
• Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development
• Outcomes Standardization: An Imperative to Value Assessments
• New Trial Design Approaches: Including New Endpoints
• If You See Something (About a Clinical Trial), Do You Say Something (to Your Doctor)?
• Regulatory Challenges with Next Generation Sequencing
• Integrating the Patient's Voice Across the Development Program of Rare Diseases: Translation into Meaningful Outcomes
• Post-Trial Access: Ensuring Patient Access Across the Development Spectrum
• Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2
• Novel Techniques for Improving Clinical Trial Subject Retention
• Next Generation Patient Recruitment: Part 1 of 2
• Integrating the Patient's Voice Across the Development Program of Rare Diseases: At the Table - Where to Sit?
• Challenges and Issues in Early-Phase Oncology Trials
• Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More
• What Question Are You Trying to Answer? The Use of Estimands, Potential Revisions to ICH E-9 and the Impact to Trial Design and Analysis
• Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In…
• Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2

Does Diversity Matter in Clinical Trials?
Progress in Pediatric Therapeutics
• Big Data: Combining Registries and Legacy Clinical Trial Databases
• New Site Paradigm: Just in Time Sites
• Next Generation Patient Recruitment: Part 2 of 2
• Quantitative Metrics to Capture the Value of Patient Engagement
• Evolution of Novel Registration Endpoints as Diseases Become Chronic
• Global Perspective on ICH Update: Part 1 of 2
• Engagement, Education, Networks, Media, and Societies in Rare Diseases: The MUST Haves
• Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation
• Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research From Sponsor, Vendor and National Health
• System Perspective: Case Studies
• Risk-Based Monitoring: Convergence of Technology, Processes, and People
• Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval
• Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric Indications
• What Do the Experts Believe?
• Translating Expert Knowledge and Judgment Into a Quantitative Belief Distribution
• Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision-Making
• Value-Based Conversations with Payers: Issues, Opportunities, and Barriers
• Biosimilars and Generics: Access Versus Innovation
• Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion
• Next Generation Predictive Analytics
• Are We Ready for Telemedicine-Powered Clinical Trials?
• How Is Digital Patient Engagement Impacting Trial Participation?
• Increasing Participation in Clinical Trials Among Under-Represented Populations
• Effective Portfolio Management and How to Ensure You Get the Value Out of the Decisions Made
• Maximizing Success in Partner Collaborations
• The Increasing Role for Big Data for Late Phase Drug and Postapproval Purpose

• Online Patient Networking
• How Do We Retain Patients in Studies? Using the Patients’ Words to Explore Treatment Acceptance and Patient Engagement
• Recruiting Rare Disease Patients: A Unique Set of Challenges
• Flexing Your Project Management Muscles Outside of Traditional Roles
• Of Course My Data Has Integrity…And I Can Prove It
• Evolving Clinical Trial Guidance and Regulations: Am I Ready?

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