Pharmaceutical Clinical Trials Transparency and Privacy
Are you prepared for the shift to increased clinical trial transparency and the drive for more access to data?
A flurry of new clinical trial transparency regulations from the 2007 FDA Amendments Act (FDAAA) Final Rule (2017), the European Medicines Agency (EMA) Policy 0070 (scheduled to resume in 2020) and Health Canada’s Public Release of Clinical Information (2019) are part of the impetus.
These are coupled with the increased need for access to clinical data due to COVID-19 spurring the acceleration of research and vaccine development. Not to mention the more general trends toward voluntary data-sharing initiatives that enable researcher access to structured individual patient data.
You need a broader and more robust toolkit of capabilities to stay compliant. For instance, how can you incorporate quantitative anonymization in order to ensure trial participant privacy?
Sarah Lyons, general manager of Privacy Analytics, and Vivien Fagan, director, medical writing and clinical trial disclosure for IQVIA will explain how to build brand trust through clinical trial transparency, navigate evolving transparency regulations and protect patient privacy when sharing clinical trial data.
- Explore current transparency requirements for study publication from the FDA, EMA and Health Canada
- Grasp the link between transparency, privacy and brand trust, and how privacy-preserving data-sharing methods can help sponsors earn trust with internal and external stakeholders, including patients themselves
- Understand new regulatory guidance, EMA Policy 0070 and Health Canada Public Release of Clinical Information, on how to anonymize clinical study reports
- Implement best practices for anonymization to enable trial transparency while protecting participant privacy, including quantitative re-identification risk measurement
- Preserve data utility and protect patients when sharing data voluntarily
Master emerging trends in clinical trial transparency to ensure participant privacy.
Meet Your Presenters
Sarah Lyons is general manager of Privacy Analytics, an IQVIA company, where she helps companies deliver insight-rich health data while protecting patient privacy. Ms. Lyons has led the development and implementation of innovative risk assessment methodologies for governments, large financial institutions and Fortune 500 companies. She previously led the establishment of new consulting markets and methodologies for Ernst & Young’s growing Government and Public Sector practice, where she also managed large-scale global projects. Ms. Lyons has provided privacy advisory services globally across jurisdictions, including in the health sector and for privacy regulators. She holds professional certifications in audit, risk management and information system control.
Vivien Fagan is director, medical writing and clinical trial disclosure for IQVIA. She has more than 20 years’ experience in the CRO industry, of which 17 have been in medical writing. Ms. Fagan has extensive experience in preparing clinical documents for clinical trials in a range of therapeutic indications. She is also a member of the cross-industry working group within the European and American Medical Writers Associations responsible for CORE Reference and is an EMWA workshop leader and DIA panellist.
Who Will Benefit
Professionals responsible for clinical trials transparency, including:
- Regulatory Affairs
- Medical Writing
- Clinical Trials Transparency
- Clinical Quality Assurance (CQA)
- Clinical IT (R&D)
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July 23, 2020