Industry Special Interest Group (I-SIG)
[Formerly the Industry Advisory Committee (IAC)]
Who is the I-SIG?
The Industry Special Interest Group (I-SIG) members are a diverse group of researchers from the pharmaceutical and device industry, academia and consulting, who share a common interest in the application of patient-centered outcomes, including health-related quality of life (HRQOL), in research important to industry.
We are interested in innovative methods and research in patient-centered outcomes measurement for use in research important to industry.
What are our aims?
The purpose of the I-SIG is to synthesize, share, promote and educate on industry-related patient-centered outcomes research by bringing individuals together who are interested in topics of joint interest to industry and ISOQOL.
Our specific goals are to:
- Learn, develop and promote best practice in the field of patient-centered outcomes research and implementation in industry-related research
- Provide support to I-SIG members and stimulate research in this field
- Encourage I-SIG members to meet and share relevant research and experiences through ISOQOL and at other professional meetings
- Increase awareness among the general ISOQOL members of issues important to industry
Our research includes, among others topics:
- Methods for selecting, developing or adapting patient-centered outcomes instruments for use in industry-related research
- Testing the feasibility and usability of patient-centered outcomes instruments
- Implementation of patient-centered outcomes instruments in industry-related research
- Design of studies involving patient-centered outcomes instruments
- Analysis and interpretation of patient-centered outcomes data
- See links below to our online education webinars related to these research topics
Current I-SIG Initiatives:
2018 Annual Report
Annual Conference Activities:
2019 Annual Symposium: topic to be determined
Past Symposium Topics:
- 2018: Meaning in movement: Defining valid endpoints using data collected with mobile technology tools
- 2017: Real-world evidence to support approval and reimbursement: new frontier?
- 2016: Incorporating the patient voice in benefit risk assessment and regulatory/HTA decision making
- 2015: Bring Your Own Device (BYOD): trends, best practices, challenges….where do PRO measures go from here?
- 2014: Advancing Measurement Science Beyond PROs: Patient-Centeredness and Validity Across All Clinical Outcome Assessments
- 2013: Innovations for Patient Engagement in Health Outcomes Development, Selection and Measurement: Opportunities and Limitations
- 2012: Perspectives on Mixed Methods to Assess Content Validity of a Patient Reported Outcome
- 2011: To Qualify or Not to Qualify: Benefits and Challenges of PRO Instrument Qualification from Industry, Academic, and Regulatory Perspectives
Communication and Information Sharing
We encourage active communication between members.
- Connect with other I-SIG researchers using the ISOQOL Membership Directory.
- Review the Quality of Life Quarterly, ISOQOL's quarterly newsletter, to keep up to date.
- Consider the I-SIG Teamwork and ISOQOL LinkedIn as a way to connect with fellow I-SIG members.
- Contact one of the I-SIG leaders listed below for more information.
- Visit the Education page for announcements of upcoming webinars.
- View archived webinars available on ISOQOL website:
Co-Chair: Paivi Miskala, MSPH, PhD
Paivi Miskala is a Director of Global Regulatory Policy at Merck Sharp and Dohme Corp. In this role, Paivi has various responsibilities supporting vaccine development and patient focused drug development. Prior to Merck, Paivi has extensive experience working in various aspects of clinical trials and outcomes research across therapeutic areas in academics, industry, and U.S. federal government, including the National Institutes of Health and Food and Drug Administration. Paivi has a Ph.D. degree in epidemiology from the Johns Hopkins Bloomberg School of Public Health.
Co-Chair: Linda Nelsen, MHS
Linda Nelsen is Senior Director and Head, Patient Centered Outcomes at GlaxoSmithKline, leading a team with responsibility to develop and implement PRO measures, and define and support COA endpoint asset strategies. Prior to GSK, Linda was Director of Epidemiology at Merck, Sharp & Dohme. She has extensive experience in the development and implementation of PROs for use in clinical research, and has developed measures across a range of therapeutic areas. Linda is active in industry‐wide initiatives in PRO Development, including the Critical Path Institute PRO Consortium and ISOQOL. Linda received a master's degree in Epidemiology from the Johns Hopkins Bloomberg School of Public Health.
Josephine Norquist, MS