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2023 China Interchange Call for Abstracts

Abstracts Due: Friday, 2 June 2023

 

We welcome abstracts for the 2023 CDISC China Interchange on any of the topics listed below.

 

Novelty in Clinical Trials and CDISC Standards 

  • How modernization of clinical trials is impacting CDISC standards: experience from decentralized trials, master protocols, etc.
  • World-wide events impact on CDISC standards: e.g. how interim Covid guidelines have impacted and how they have been integrated/confirmed by CDISC and/or regulatory agencies
  • Social evolution can impact clinical trials conduct and standards: share experience or initiative related to this (e.g. diversity inclusion)

 

Real World Data / Evidence 

  • The life cycle of drug development is being modernized through the use of real-world data / evidence. 
    • The combination of RCT data (safety, efficacy) and RWD (effectiveness) for submission is becoming the 'new' standard
  • We are interested to receive experiences from the industry on the following related topics: 
    • Progress and barriers to the use of real-world data / evidence for regulatory evaluation
    • Best Practices of using CDISC Standards for RWD and Barriers
    • Pragmatic Clinical Trials
    • Use of CDISC and other life sciences/healthcare standards (OMOP data model, HL7 FHIR, etc.)
      • FHIR to CDISC Joint Mapping Implementation Guide v1.0
    • CDISC collaborations with other standards and initiatives
    • Move to decentralized clinical trials - usage of digital biomarkers / digital endpoints (collected as part of the clinical trial)

 

 CDISC in Academic Research 

  • Healthcare Data Systems
  • eSource/Direct Data Capture (DDC)
  • Meta Analysis / Data Integration
  • Computer Science and Data Science perspectives on CDISC standards

 

Unlocking the Power of Historic R&D Data and Opportunities in Clinical Data Sharing 

  • Big data / pooling of historic R&D data and harmonising it using common data standards e.g CDISC-SDTM standards
  • Opportunities across the life sciences data sharing (FAIRified) ecosystem post anonymization of critical GDPR data
  • Improve R&D returns by unlocking the power of RCT data to enhance and accelerate data driven decision-making across the value chain. Potentially connecting with Omics, RWD and Imaging

 

Conformance Rules and Validation, Including CDISC Open Rules Engine (CORE) 

  • Implementation of FDA / PMDA Business / Validation rules vs. CDISC conformance rules
  • Experience of various validation tools for SEND / SDTM / ADaM / Define-XML
  • Rules coming as part of a TAUG
  • Conformance rules integration into the standard governance
  • Experience in use of Open Source tools
  • Experience in the use of CORE, Rules Authoring Tool and generation of Rules

 

Global Regulatory Submissions 

  • Submission to FDA / PMDA / NMPA learnings
  • Submitting around the globe, submission experience with other Health Authorities e.g. EMA Clinical Trials Raw Data Pilot
  • Supporting FDA BIMO deliverables
  • Achieving quality and efficiency in data submission e.g.  
    • Proper documentation
    • How to correctly provide metadata in Define-XML
    • Automation
    • Process flow
  • Impact of new FDA guidance e.g.
    • Standard Safety Tables and Figures Guide
    • Experience and adherence to FDA division guidance e.g., CBER Vaccine, CDER NASH, etc.
    • Inclusion and diversity requirements and challenges from a standards point of view, e. g. gender, how to correctly provide metadata in Define-XML
    • RWE impacts decision making by regulators – opportunities and challenges from data standards / harmonization / review

 

Standards Governance, MDR and CDISC 360 - User Experiences 

  • How to handle CDISC versions before submission / across standards / regulatory agency requirements
  • How do you handle non-adherence in terms of submission to one or multiple regulatory agencies, how do you ensure adherence?
  • Metadata-driven governance. Collected element usage. How do you determine what data you aren’t using in the final CSR, in order to simplify collection?
  • Graph databases / linked data implementations
  • Automation experiences
  • Implementation of USDM / Transcelerate DDF

 

Artificial Intelligence (AI) and Impact of CDISC Standards on Business Optimization 

  • Applying AI in Life Sciences supporting Drug Development
  • Applications of AI to extract value from Real World Data
  • Experiences using AI with large data handling from devices / sensors, images, other(s)
  • Regulatory and CDISC positioning on usage of AI 
  • Meaningful realized benefits

 

CDISC Foundational Standards 

  • CDASHIG 2.3/3.0
    • Sexual Orientation & Gender Identity (SOGI)
  • SDTM/IG 2.1/4.0

    • SDTM/IG 1.7/3.3 Upversioning Experience

  • ADAM
    • ADaM Metadata Submission Guidelines 1.0
    • ADaM popPK Implementation Guide 1.0
    • Analysis Results Standard v1.0
    • Advanced use cases
  • SEND/IG 2.1/3.2
  • Define-XML v2.1
  • TAUG

 

OTHER TOPICS TOWARDS CDISC STANDARDS

You are welcome to submit an abstract on any CDISC model experience, its implementation and associated planning. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned.  CDISC is an open and multidisciplinary standard which interfaces with many areas and we are eager to hear about your experiences working with standards.

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Abstract Submission
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PLEASE NOTE: For successful oral presentation abstract applicants, one speaker per accepted abstract will receive access to the speaker registration rate. Successful poster abstract applicants can register the regular rate, with any applicable discounts, such as membership level and early bird.

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  1. All author(s) approve submitting this work for presentation.
  2. The author(s) agree(s) to materially confine their presentations to information in the abstract if accepted for presentation.
  3. The presenting author will be available to present the abstract in person in China if selected for the program. The presenting author will immediately notify CDISC if they are unable to present an abstract or if the presenting author changes.
  4. Submission of the contact details provided are those of the presenter of the abstract. The primary author will be notified about the status of the abstract and is responsible for informing the other authors about the status of the abstract.
  5. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations.
  6. Submission of the abstract constitutes consent of all authors that CDISC will make presentation(s) and paper(s) available online, whether in video or PDF format, to the conference attendees, and after six (6) months, to the CDISC member community.

WE LOOK FORWARD TO RECEIVING YOUR CONTRIBUTION!

Questions?

If you have any questions on the suitability of an abstract or about the submission process, please contact CDISC at events@cdisc.org.