ASA Connect

Dear Colleagues and Friends,

Given the JSM is just a few days away, here is a gentle reminder:

The ASA SPAIG (Statistical Partnerships Among Academe, Industry, & Government) Committee is proud to organize/sponsor the following events at the 2021 Joint Statistical Meetings. Since the conference is less than 6 weeks away, we hope you consider to attend and add them to your calendar.

• • Title: The Stories of Effective Statistical Partnerships – An In-Depth Look at Educational Outreach, Knowledge, and Data Sharing
  • Time: Tuesday, 8/10/2021 at 10:00-11:50 AM EST
  • Panel members: David Williamson, Barry Nussbaum, Arnold J. Stromberg, Leslie McClure, Fanni Natanegara, William Brenneman
  • Chair: Scott Clark
  • Co-sponsor: CAR, Committee on Funded Research
    

    
    Abstract
    Collaboration is essential in our statistics profession and the American Statistical Association (ASA) seeks to encourage and recognize outstanding collaborations. The mission of the ASA Committee on Statistical Partnerships among Academe, Industry, and Government (SPAIG) is to identify, lead, and promote initiatives that foster statistical partnerships or collaborations between two or more entities across academic, industry, and/or government sectors. This invited session highlights stories of effective cross-sector partnerships to solve practical problems, advance research, drive innovation, and inform decisions. These partnerships are centered around statistical thinking, enabling knowledge and real-world data sharing as well as educational outreach efforts such as, technical trainings provided by universities, internship programs in the industry and government sectors, professional development for students, research work leading to dissertations, and funding and consulting opportunities.

    We expect these topics will have wide appeal, given the interdisciplinary nature of our profession and problems we solve. Our panel members are distinguished statisticians and researchers representing academic, industry, and government sectors. They will offer valuable insights and advice on how cross-sector statistical partnerships can help promote our practice, provide opportunities to cultivate future statisticians as leaders, as well as strengthen our statistical community, and discuss strategies to nurture a strong collaborative culture. Attendees will also benefit from hearing diverse perspectives along with examples of success stories and challenges on partnerships across various sectors so they can bring back best practices to their respective organizations.

          2. Lunchtime Speaker Session

• • Title: Master Protocols in a Pandemic – Lessons Learned from the ACTIV Experience
  • Time: Sunday, 8/8/2021 at 12:00-1:20 PM EST
  • Speaker : Lisa LaVange (UNC)
  • Chair: Ying Ding
  • Co-sponsors: ASA Biopharmaceutical Section, ASA Statistics in Epidemiology

Abstract
Master protocols are used to investigate multiple therapies, multiple biomarker-defined patient subgroups, and/or multiple diseases or disease subtypes under a single overarching protocol. Their use grew out of the precision medicine environment to address questions about what treatment works best for what type of patient. Master protocols are attractive to patients and patient advocates because they provide multiple treatment options under one protocol, thereby avoiding the need for patients to be separately screened for each trial, especially when treatments are linked to biomarker profiles. The FDA often advocates for their use as a collaborative tool that can enhance efficient and timely drug development in a competitive commercial landscape. Master protocols capitalize on similarities among elements of trial design and conduct and use of a shared trial infrastructure, which can increase efficiency relative to conducting separate trials for each therapy. Hurdles include the need for considerable up-front investment, regulatory buy-in, and sponsors that are willing to test drugs in collaboration with others.  The most common master protocol design is an adaptive platform design that allows promising agents to graduate for further study, agents with low probabilities of success to be terminated early, and new agents to enter the study in a perpetual manner. With the outbreak of Covid-19 in the US early in 2020, the NIH announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership coordinated by the Foundation for the NIH and consisting of representatives from the NIH, FDA, and other government agencies; the European Medicines Agency (EMA); academic and philanthropic organizations; and numerous pharmaceutical companies. The consortium selected master protocols as a key component of their coordinated research strategy to investigate Covid -19 treatments in both in- and out-patient populations. Three master protocols were launched within a matter of months, and as of this writing a 6^th is in the final planning stage. In this presentation, I will provide an overview of master protocols and a brief history of their evolution, and then discuss design considerations for using master protocols in a pandemic and some lessons learned from the ACTIV experience.

We hope to see you at the events!

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Ying Ding, PhD
Department of Biostatistics
University of Pittsburgh
Vice Chair, ASA SPAIG Committee
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