2021 Europe Interchange: Call for Abstracts

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Call for Abstracts

Abstracts Due: Friday, 8 January 2021

Theme: Powering Next Generation Technology

We welcome abstracts for the Virtual 2021 CDISC Europe Interchange on any of the topics listed below, including on COVID-19. For any of the topics listed, if you have an interesting perspective based upon your experience during the time of COVID-19, this would be of great interest.

 

COVID-19 Impact 

• Implementation of FDA regulatory guidance
  • Handling missing data, and analysis – how do standards help with this
  • Protocol deviations, drug accountability, remote visits, adverse events, etc.
• CDISC COVID-19 Resources Home – CDISC & External
  • Specificity of Vaccines Trials and CDISC gaps
• Collaboration between organizations (on user guide and external)
• Streamlining the standards development process (CDISC & external)
• Impact on systems, processes, existing studies – creativity during this time (change management)
• Importance of standards in pulling things back from paper (QRS)
• Compassionate use data; expanded access
• The future of clinical research in relationship to infectious disease, how has COVID-19 changed how you work?
• Addressing industry disruptions in Clinical Trials with Real World Data in lieu of COVID19
• Accelerated move to Decentralized clinical trials incl. Digital Biomarkers and Endpoints
• Acceleration of Data Sharing and Collaboration
• Impact on Future regulations 
• COVID-19 PHUSE guidance documents

Global Regulatory Submissions 

• Submission to FDA/PMDA learnings
• Submitting CDISC to NMPA (China Authority)
• Submitting around the Globe, submission experience with other Health Authorities e.g. Korea, EMA
• eData consultation and Appendix 8 preparation experience from PMDA submission
• SDSP vs PMDA Appendix 8 and how to align it with cSDRG/ADRG
• Supporting FDA BIMO Deliverables
• Specificity and special requests from different FDA divisions when submitting data packages e.g. CDER vs CBER, specificity of Vaccine submission, etc.
• Achieving quality in data submission e.g.  
  • Proper documentation,
  • How to correctly provide metadata in define-xml

MDR and CDISC 360 - user experiences 

• Implementation Challenges
• Experiences in operational use
• Graph databases/Linked data implementations
• Automation experiences
• KPIs available
• How does an MDR affect governance compared to governance without an MDR
• How MDR support upversioning of SDTM/CT/ADaM

Implementation Use Cases

• Handling of USUBJID creation (update)
• Handling of Screen Failures (update)
• Extension studies
• Different implementations of RACE (add. RACE categories)
• Handling of Protocol Versions and Protocol Deviations in SDTM and ADaM
• How and what to annotate on aCRF
• Data Integration 
• Findings About usage
• Associated Person
• Experiences usage of CDISC in other domains (Medical Devices)
• Experience using the CDISC Library

Conformance rules and validation experience 

• Implementation of FDA/PMDA Business/Validation rules vs CDISC conformance rules
• Experience of various validation tools for SEND/SDTM/ADaM
• FDA's technical rejection criteria, PMDA reject severity rules
• Rules coming as part of a TAUG
• Conformance rules integration into the standard governance

Standards governance 

• How to handle CDISC versions before submission/across standards
• How do you handle non-adherence in terms of submission
• 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? 

Experience with TAUGs 

• Implementation of TAUG recommendations
• Differences (Variations) between TAUGs
• Major current TAUG gaps and recommendation for future development

Impact of CDISC standards on business optimization 

• Timelines in operational use and downstream processes
• Pre- and post trial processes
• Submission preparation and readiness
• Partner collaborations and cross-pharma initiatives, e.g. adoption of TransCelerate frameworks
• Management, resourcing and new opportunities
• What are meaningful KPIs and realized benefits?

Real World Data / Evidence 

• The Life cycle of drug development is being modernized through the use of real-world data / evidence. 
• 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
  • Adaptive Pathways experiences (gathering evidence through real-life use to supplement clinical trial data)
  • Pragmatic Clinical Trials (or large simple trials)
  • Synthetic Control Arms
  • Use of the CDISC and other life sciences/healthcare standards (OMOP data model, HL7 FHIR, etc.)
  • Collaborations between academia, CROs and pharma
  • Move to Decentralized Clinical Trials and usage of digital biomarkers / digital endpoints
    • Do you use all data or you filter at the sensor/device side only relevant data for regulatory evaluation ? 

Artificial Intelligence (AI) 

• Applying AI in Life Sciences supporting Drug Development: How do we benefit from using Data Standards ?
  • Machine learning, Natural Language Processing, Computer Vision, Optimization examples. 
• Experiences using AI with massive data handling sourced from devices, images, other(s) (deliver standards perspective)
• Regulatory and CDISC positioning on usage of AI e.g. US FDA discussion paper (SaMD)

CDASH 

• CDASH 1.2 and IG 2.2
• CDASH CRF Metadata
• CDASH Variable Naming Conventions e.g. LBRES/Collected Laboratory Results
• CDASH Projects:
  • SAE 2.0
  • CRF Library
  • FHIR-CDISC Mappings (including CDASH)

CDISC Core 

• SDTM IG 3.3/3.4
• DefineXML v2.1
• Medical devices
• SEND
• ADAM
  • Use of ADaM for data integration / pooling
  • Application of Imputation Methods in ADaM
  • How to achieve traceability in ADaM
  • Example of TA-specific endpoints application in ADaM
• Updates on LOINC and UCUM
• Code list changes
• Foundational Standards tips and tricks
• Current Gaps

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 interface with many areas and we are eager to hear about your experiences working with standards.

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