Oncology eCOA – What the New FDA Draft Guidelines Tell Us

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Drug Discovery & Development,
  • Tuesday, November 02, 2021 | 10am EDT (NA) / 2pm GMT (UK) / 3pm CET (EU-Central)
  • 60 min

In June 2021, the US FDA issued draft guidance entitled, “Core Patient-Reported Outcomes in Cancer Trials,” to provide clinical research sponsors with recommendations for the collection of patient-reported outcomes (PROs) in oncology trials. The draft guidance, which also covers instrument selection and trial design considerations, coincides with increased emphasis throughout the industry on the incorporation of patient-reported outcome measure (PROM) data in regulatory decision making and drug labelling.

In this webinar, Signant’s clinical experts provide a summary, as well as interpretation and analysis, of the draft guidance with a view to establish foundations for future study design and planning.

Register for this important virtual event to learn about these key elements of the guidance through the lens of Signant’s electronic clinical outcome assessment (eCOA) scientific experts, with featured topics including:

  • Measure selection – evaluation of commonly-used instruments to measure the core concepts outlined in the guidance
  • Frequency of PROM administration – study design considerations accounting for FDA’s thinking on the timing and frequency of assessments, how this challenges current measurement approaches, and implications for data collection.
  • Implementation considerations – the use of electronic solutions for PROM administration, patient acceptance considerations, PROM selection/adaptation, and data integrity strategies for future oncology trial designs that meet the new guidance

Don’t miss this opportunity to hear from industry experts with experience in over 350 oncology trials how they expect this draft guidance to impact future research in this therapeutic area.

Speakers

Dr. Bill Byrom, Principal, eCOA Science, Signant Health

Dr. Byrom serves as Principal, eCOA Science at Signant Health. He has worked in the pharmaceutical industry for 30 years and authored over 70 publications as well as two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work focuses on the use of wearable technology and bring-your-own-device (BYOD) in eCOA in clinical trials. He currently serves on two ISPOR task forces related to clinical outcome assessments and leads a cross-industry team on leveraging wearable technology for clinical trial endpoints with the DIA Study Endpoints Community.

Message Presenter

Dr. Jill Platko, Senior Scientific Advisor, Signant Health

Overseeing Signant’s Scientific Advisor team, Dr. Platko provides guidance on electronic data collection for Clinical Outcome Assessments (eCOA) and its associated diaries and questionnaires. Well-versed in best practices and regulatory requirements, Jill also develops training programs and resources for project delivery teams that cater to their specific needs. She’s authored countless scientific articles and regularly serves as a panelist for industry webinars.

Message Presenter

Who Should Attend?

This webinar will benefit those working the in following job areas:

  • Clinical Operations
  • Clinical Innovation
  • Clinical Technology
  • Data Management
  • Medical Director/Clinical Sciences
  • Patient Recruitment
  • Academic Research
  • Clinical Site Management
  • Executive Leadership
  • Health Economics
  • Outcomes Research
  • Regulatory/Risk Management
  • Quality Assurance
  • Outsourcing/Vendor Relations/Procurement
  • Adherence and Compliance

What You Will Learn

  • Regulatory context behind the new draft guidance and how it differs from previous policy
  • The impact of the draft guidance on the selection and implementation of PROMs in oncology trials
  • Examination of standard instruments used to measure the core concepts
  • Comparison of past and new recommendations for frequency of administration
  • Recommendations for meeting the guidance in four key areas of trial design

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Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.

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