Call for Session, Presentation, and Short Course Abstracts
Read Submission Guidelines| Submit
Abstract Submission Deadline: Friday, May 10
Notification: Week of May 20
Final PowerPoint Presentations Due: September 13
Meeting Dates: September 23-24
Location: Arlington, VA
Questions: Contact Damisha White@DIAglobal.org
Are you a professional involved in Clinical Trial Disclosure, Data Transparency? If so, DIA wants to hear from you! The DIA Global Clinical Trial Disclosure and Data Transparency Conference, to be held September 23-24 in Arlington, VA, will feature informative sessions relating to global clinical trial disclosure and data transparency from industry experts.
The Clinical Trial Disclosure and Data Transparency Conference Program Committee is seeking proposals for Presentations related to the topics listed below. As this conference is attended by industry, academia, and regulatory authority professionals, topics in addition to those listed below that you feel are relevant may be submitted for evaluation and possible selection. Please keep in mind, specific use cases (both successful and unsuccessful) and lessons learned are encouraged in all topic areas.
Regulatory Compliance:
• Best practices in implementing transparency policies
• Challenges in overseeing and meeting global disclosure obligations
• EU big data initiative
• Recent US proposals on data sharing
• Guidance document with global implications
International Regulatory Impact on Data Transparency:
• Challenges / opportunities in regulatory landscape for data sharing
• How global clinical trial registries can help enhance transparency
• EMA Policy 70 -- implications for global workflow
Registering Complex Clinical Trials:
• Enhancing end user experience & modernizing ClinicalTrials.gov site
• Modernization of ClinicalTrials.gov site
• Ensuring compliance & enforcing ClinicalTrials.gov reporting requirements
Patient-Centric Approaches to CTD:
• Implications of patient-focused drug development programs on disclosure
• Informed consent in data sharing practices
• Transparency in rare disease and orphan drug development
• Individual participant data return
Plain Language Summaries/Protocol Synopses/Publications:
• Global application of AI in protocol development & result reporting
• Preparing plain language summaries and lay protocol synopses
• Impact of transparency rules on scientific publications and acceptance by journal editors
Data Transparency & Impact on Drug Development and Approval Processes:
• Open access initiatives and future of clinical trial data sharing
• Trust/public perception in clinical trial transparency efforts
• Transparency in clinical research regulations: global harmonization efforts
• Transparency in health technology assessment and market access decision-making
Miscellaneous:
• Effective communication with regulators
• Ethical considerations in CTD
• Impact of data transparency on clinical trial design & conduct
• RWE role in enhancing transparency and decision-making
• Data quality assurance in CTD
• Post-Market surveillance transparency & reporting of AE
• Transparency in investigator-initiated trials
• Challenges of registering complex clinical trials
EU Clinical Trials Information System (CTIS):
• Transition trial
• Revised transparency rules for protecting Commercially Confidential
Information (CCI) in clinical trial applications and documents
• EU CTR results requirements – how are sponsors meeting?
• Ensuring Member State alignment to EU CTR requirements
• Experience using automation for CTIS redactions
• Trends and best practices in EU Protocol Synopsis
• Challenges / best practices in protecting CCI in clinical trial documents for public disclosure
Clinical Document Disclosure:
• Addressing backlog post-restart of Policy 0070
• Health Canada PRCI: harmonizing with EMA (joint submissions, anonymization report, feedback structure, EMA acceptance of Health Canada submissions.)
• Redaction and anonymization techniques
Abstract Details and Guidelines
