Statistical Innovation in Healthcare: Celebrating the Past 40 Years and Looking Toward the Future–Special Issue for the 2021 Regulatory-Industry Statistics Workshop

We are pleased to release a special issue devoted to the 2021 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop (RISW). We thank Statistics in Biopharmaceutical Statistics (SBR) for continuing to offer a special issue on the annual workshop. As co-chairs of RISW 2021, our last task was to curate this special issue. We are indebted to Freda Cooner (Lilly) and Dandan Xu (FDA), who graciously lent their talents as additional Guest Associate Editors for the special issue, and to the Editor-in-Chief of SBR, Toshimitsu Hamasaki.

The special issue includes 13 forward-looking and thought-provoking articles, covering a diverse range of contemporary topics related to biostatistics for the biopharmaceutical industry and regulatory science: from cutting-edge research on causal inference and artificial intelligence/machine learning, to recent methodologic advances in estimands, survival analysis, surrogate/composite endpoints, and adaptive designs; from new insights on statistical thinking and leadership, to pragmatic experience with advisory committee preparation and execution. We are confident that these articles will provide you with fresh perspectives that nurture future research work. We hope you enjoy reading these articles as much as we did.

The theme of RISW 2021 was Statistical Innovation in Healthcare: Celebrating the Past 40 Years and Looking Toward the Future (Figure 1). As the theme indicates, 2021 marked the 40th anniversary of the ASA BIOP Section. To commemorate the anniversary, the workshop included a special townhall session on “40 Years of the Biopharmaceutical Section: Celebrating our Past, Planning for our Future.” We are grateful to the organizers who worked hard to offer these special activities.

Figure 1: 2021 Logo for the 40th anniversary of the ASA Biopharmaceutical Section.

Three plenary sessions were offered, one more than usual. On opening day, Julia Beaver (FDA) delivered her keynote speech on “FDA Oncology Center of Excellence: Clinical Trial and Drug Development Innovations,” and Frank Bretz (Novartis) presented “The Role of ‘Statistical Thinking’ in the Pharmaceutical Sciences.” On Day 2, Thomas Fleming (University of Washington) presented “Best Practices in Design and Conduct of Clinical Trials: Experiences and Learnings During the COVID-19 Pandemic” and Rebecca Hubbard (University of Pennsylvania) presented “Principled Approaches to thePractical Challenges of Real-World Data.” On Day 3, an exemplary panel discussed “Statistics in the Changing Product-Development Environment Accelerated by the Pandemic.” Christy Chuang-Stein (Chuang-Stein Consulting) moderated the discussion by panelists Marc Buyse (CluePoints), Sylva Collins (FDA), Lisa LaVange (University of North Carolina-Chapel Hill), Kannan Natarajan (Pfizer), and John Scott(FDA).

The overall program included 10 short courses, 3 plenary sessions, 45 parallel sessions, 32 roundtable discussions, and 56 posters. Five parallel sessions were on COVID-19 drugs, vaccines or diagnostics. For the first time, two poster sessions were offered instead of one to afford more opportunities to participate in our ever-growing workshop. Late-breaking sessions were also offered on career development, COVID-19, and covariate adjustment.

Planning this virtual workshop was a challenging and unique experience. We are greatly indebted to the workshop’s Steering Committee (members and advisers), ASA meeting planner Kristin Mohebbi, the ASA Biopharmaceutical Section Executive Committee and 40th Anniversary Committee, the International Society on Bayesian Analysis, the ASA section on Medical Devices and Diagnostics, and all our sponsors.

We hope that this special issue will act as a catalyst for the promotion of groundbreaking statistical innovation as we navigate the thrilling future and ever-evolving role of biostatistics in medical product development. At the same time, we celebrate and reflect on 40 years of remarkable statistical achievements that have brought us to where we are today. With this special issue, we hope to propel the field of biostatistics evenfurther.

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Funding

The author(s) reported there is no funding associated with the work featured in this article.