DAY TWO - CET (Central European Time, GMT+01:00)
DAY TWO - CET (Central European Time, GMT+01:00)
- Behtash Bahador, MS - Director, Health Literacy, Center for Information & Study on Clinical Research Participation (CISCRP)
- Hear directly from the masterminds behind the most advanced artificial intelligence and machine learning solutions to the new EU CTR and CTIS
- Solutions to plain language summaries, anonymization (redactions), company confidential information, CTIS and more
- Simplify your processes, streamline your approach, and keep compliant
- Open conversation on the possibilities and challenges wit AI: How could ChatGPT be used and find innovative but safe solutions.
- Borislava Pavlova - Head, Clinical Trial Transparency, Takeda
- Woo Song - Co-founder, Xogene Services LLC
- Making transparency easy and the norm, earning people’s trust, and keeping the UK a great place to do clinical research.
- Upcoming changes in the regulatory requirements on registration, publication of results and communicating trial outcomes to participants.
- Where to register clinical trials.
- What does UK’s compliance with transparency expectations look like?
- Naho Yamazaki - Deputy Director, Policy and Partnerships, Health Research Authority (HRA)
Updates to ClinicalTrials.gov processes and resources will be discussed, including the availability of new documentation to support requests for Good Cause Extension and recently added FAQs. An introduction to the modernization of the ClinicalTrials.gov public website and the PRS database will also be provided. Sponsors and Investigators use the PRS to submit clinical trial information for posting on the ClinicalTrials.gov public website, where it is accessed not only by the research community but by patients and their families, health care professionals, and other interested parties. Both sites are undergoing modernization to improve their functionality and sustain their usability for years to come. These efforts have been informed input from users and continue to be guided by user-provided feedback.
- Stacey Arnold - Results Subject Matter Expert for ClinicalTrials.gov, National Library of Medicine, National Institutes of Health
The clinical trial transparency landscape is undergoing a profound shift accelerated by the EU clinical trial regulations. As regulators worldwide evolve disclosure requirements, sponsors face emerging complexities in managing compliance across borders and systems. But challenge brings opportunity. We can optimize transparency by harnessing technology, enacting mitigation strategies, and collaborating strategically. Discover ways to adapt using automation, analytics, and partnerships. You'll leave with practical actions for navigating the new era, maintaining competitiveness, and managing transparency globally.
- Thomas Wicks - Head of Transparency Operations, Citeline
- Catherine D'Arcy - Senior Program Manager, Vivli
Welcome to the cross-functional hub facilitating early and strategic integration of patient perspectives across clinical development and commercialisation. This platform represents the new era of patient centricity in which we can effectively collect, provide and disclosure data. Going into depth with patient advocacy, patient-reported outcomes and registries expertise enabling disclosure of protocol design, study endpoint identification, patient recruitment and more.
- Sudipta Chakraborty - Senior Manager, Clinical Trial Transparency Strategy Lead Clinical Trial Transparency & Data Sharing Global Clinical Operations, Biogen
With the new EU CTR directive, CTIS implementation and restart of policy 70, clinical trial disclosure, transparency and anonymization is no longer a choice but a necessity. Hear from industry representatives of varying sized pharma to get insight into the unique strategies each is implementing to ensure they are meeting these new needs. Larger pharma are tending towards having internal transparency teams while smaller pharma usually will outsource this responsibility to vendors. This panel discusses both sides and highlights the challenges and possibilities with varied approaches.
- Barbara Kress - Executive Director, Clinical Data Disclosure & Transparency, MSD
- Is data being properly disclosed?
- Is disclosed data accessible?
- How is this data being utilised and is it bringing value?
- Is the disclosure of data making good on its prospects?
- What is actually happening/ what is the uptake by patients? How do we discuss the metrics for who is viewing this stuff? Who are the users?
- EMA info on this?
- How is the data being distributed/disseminated and what tracking mechanisms are in place? Are we capturing impact measures?
- Case studies
- Is the process through the CTIS patient centric, take the example of plain language summaries?
- Protocol synopsis etc.
- Communications geared towards non-specialist users.
- Lay summary as required by CTR
- Lee Holland - Associate Director, Regulatory Services Management - Plain Language Summary, Certara Synchrogenix
- Alicia Berg - Clinical Trial Transparency Strategy Lead, Biogen
- Megan Niner - Manager, Clinical Transparency and Data Disclosure, Arcus Biosciences
- Behtash Bahador, MS - Director, Health Literacy, Center for Information & Study on Clinical Research Participation (CISCRP)
- Joan Chambers - Chief Executive Officer, Greater Gift
- Geoff Kieley - Data Transparency and Regulatory Disclosure Manager, Ipsen