- Working Group Volunteers
Each of the SIG Working groups would like to provide opportunities to engage the broader SIG members in specific activities as listed.
Please feel free to email any specific question to the group leads.
If you would like to sign up, please return the attached excel via email to Joanne Wu, juan.wu3@pfizer.com, to volunteer by Jan 2n d!
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Emerging Public Health Topics Working Group
John Diaz-Decaro and Hu Li
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To identify and present opportunities and/or challenges of any new and emerging public health topics that impact RWD/RWE research including but not limited to issues related to emerging/reemerging infectious diseases, international environmental health concerns, new methodological approaches, important regulatory guidance, and novel application of ML/AI tools.
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ISPE Internal Collaborations Working Group
Cathy Ann Pinto and Lisa Weiss
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To promote mutual exchange of information between RWE Collaborative and the ISPE scientific community on SIG activities and opportunities for collaboration.
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Publications & Education Working Group
Mehmet Burcu and Marie Bradley
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To encourage and coordinate publications related to RWD/RWE, to help advance the field and increase awareness of the strengths and limitations of such research through education.
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Please email Joanne Wu ( Juan.Wu3@pfizer.com ) to volunteer by Jan 2nd!
If you have additional questions, please email Christina Mack.
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Duke-Margolis is launching a new 2024 workstream entitled "Operationalizing Electronic Health Record Data Relevance, Reliability, and Quality for RWE Policy Stakeholders" (described below). If you are interested in being the ISPE representative on this workstream, which involves monthly meetings and whitepaper reviews, please respond with your specific qualifications on this topic. As in years past, the ISPE board will review all applications and decide on the 2 representatives; FISPE status is required.
Description: RWE policy stakeholders, including regulators, sponsors, data curators, health systems, and patients, routinely consider electronic health records (EHRs) as data widely used in medical product safety studies and increasingly proposed for use or used in medical product effectiveness studies. This workstream will build on relevant literature, including the Duke-Margolis 2018 white paper entitled "Characterizing RWD Quality and Relevancy for Regulatory Purposes" covering data quality and relevancy dimensions, and consider reliability as an additional dimension within the scope of "fit-for-purpose data." The workstream will also review relevant and timely policy developments and efforts (e.g., FDA guidance for industry and EHR quality aims within the Advanced Research Projects Agency for Health, National Cancer Institute, and National Library of Medicine) to ultimately contemplate considerations and best practices within health systems and research that operationalize EHR data relevance, reliability, and quality (e.g., systematic EHR data collection and quality assurance, choice of study design using EHR data, types of statistical analysis involving EHR data, etc.).
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