ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

September 24, 2021

Statistics in the Changing Product-Development Environment Accelerated by the Pandemic 

Marc Buyse, ScD speaker at the plenary session: Statistics in the Changing Product-Development Environment Accelerated by the Pandemic : Sept. 24 – 10:30-11:45am EDT 

The theme of this year’s workshop is “Statistical Innovation in Healthcare: Celebrating the Past 40 Years and looking Toward the Future”. In keeping with the theme, we envision that the panelists could describe their vision of the future of clinical trials, in particular, the revolutionary transformations anticipated to take place and how these changes are expected to affect the roles of regulatory, industry, and academic biostatisticians. For example, potential topics to discuss at the panel might include:

– For FDA Statisticians: better simulation tools; combining diverse data sources to make regulatory decisions; how FDA can move at the speed of science; how it can accelerate the availability of safe and effective medical products; how to best achieve progress in its 2021 Focus Areas of Regulatory Science; how to encourage broader use of innovative statistical methods in clinical protocols as proposed in the 21st Century Cures Act.

– For Industry Statisticians: decentralized trials; telehealth to increase compliance; use of artificial intelligence / machine learning (AI/ML) for clinical trial tasks such as identifying trial participants, data queries, and data cleaning, and for diagnostic device development; expanding eligibility and diversity in clinical trials; augmenting control information using external information (clinical trial and real-world data)

– Initiatives / Collaborations: data sharing; public-private partnerships; working interactively on submissions; software for complex innovative designs (CID); digital health; novel endpoints; FDA/CMS joint efforts; centralized IRB; transforming the clinical trial enterprise with disruptive innovation (NAP Agenda for 2020; Transformation of the Clinical Trial Enterprise; NAP Agenda for 2030).

– Impact of COVID-19 on Clinical Trials: on meeting trial objectives for clinical trials conducted during the pandemic; on trials of medical products intended for use in the diagnosis of the SARS-CoV-2 or related conditions, or in the cure, mitigation, treatment, or prevention of the COVID-19.

– Innovations in Statistical Science: e.g., quantifying benefit-risk trade-offs; quantifying strength of evidence; data science.

Join us on Friday September 24th!