Call for Session, Presentation, and Short Course Abstracts
Read Submission Guidelines| Submit
Abstract Submission Deadline: Friday, April 18
Notification: Week of June 9
Final PowerPoint Presentations Due: September 25
Meeting Dates: October 16-17
Location: San Diego, CA
Questions: Contact Damisha.White@DIAglobal.org
Are you a professional involved in real-world data (RWD) sourcing or real-world evidence (RWE) generation and integration into decision-making? If so, DIA wants to hear from you! The DIA Real-World Evidence Conference, to be held October 16-17 in San Diego, CA, will explore innovative applications of RWE and deliver cutting-edge insights from organizations leveraging this knowledge to advance healthcare decision-making.
The Real-World Evidence Conference Program Committee is seeking proposals for Presentations, Sessions, and Short Courses on the following topics listed below. As this conference is attended byAs this conference is attended by academics, payers, regulatory professionals, professionals in the biopharma and medical device industries, regulatory health authorities, and service providers, topics in addition to those listed below that you feel are relevant may be submitted for evaluation and possible selection. Please keep in mind, business use cases and lessons learned are encouraged in all topic areas.
Decision-making Use Cases Including Regulatory Agency, Health Technology Assessment Payer, Service Provider, or Drug/Device/Biologics Industry Perspectives
Target Identification and RWD/E, including the intersection of omics studies and observational research
Regulatory and Market Access Applications:
- Supporting drug/vaccine approval, reimbursement, and label expansion or modification
- Post-market commitments (PMR/PMC/PASS/PAES) and benefit-risk assessment
- Enhancing efficiency in subsequent authorizations
- RWE-driven clinical recommendations and market access strategies
Regulatory and Payment Pathways:
- Optimizing RWE for clinical recommendations and market access
- Enhancing efficiency in subsequent authorizations
Innovations in Technology, Methodology, and Operational Excellence to Support RWD and RWE, such as:
- Artificial intelligence
- Machine learning
- Digital health technologies
- Tokenization
- Synthetic data
- Data curation and quality improvement
RWD Data Standards, Quality, and Use in Practice:
- Retrospective data and prospective data quality considerations
- Practical implementation of RWD/E guidance
- Data Interoperability Standards
Emerging RWD Sources and Systems (North America, Europe, and Asia):
- Expanding geographic coverage
- Government, private sector, academic
- Therapeutic area-specific RWD resources
Governance, Access, and Harmonization:
- Data privacy, security, and governance challenges
- International convergence initiatives for RWD and RWE
Patient, Patient Advocate, and Special Population Perspectives on RWD and RWE
RWD and RWE in Study Designs Supporting Clinical Development and Post-Marketing Needs:
- De-risking pivotal trial designs
- Establishing a stage-gate framework for clinical programs
- Decentralized trials
- Traditional RCTs integrating RWD
- Trials in clinical practice settings, with pragmatic elements
- External controlled trials
- Observational studies to support pivotal study design
Health Equity and RWD/RWE:
- RWE as a strategy to support diversity in clinical development
- Incorporating social determinants of health into RWD/E analyses to enhance understanding of health outcomes and interventions
Therapeutic Area and/or Modality Considerations for RWE
Shared Learnings Among Public-Private and Cross-Industry Consortia and Initiatives Addressing RWD and RWE
Abstract Details and Guidelines
