NISS is announcing a new Ingram Olkin Forum Series Event!
Unplanned Clinical Trial Disruptions
COVID-19 has resulted in unprecedented disruptions to ongoing clinical trials. Clinical trials have been forced to break protocol by, for example, halting enrollment, altering the timing and type of data collection, conducting an unplanned interim analysis. Many data collection appointments were canceled, postponed, or substituted by "virtual" procedures. A large number of clinical trials now face failure due to irreversible losses of enrollment and follow-up, or due to the inability to analyze the data according to the preplanned protocol, potentially dealing a substantial setback to clinical research. This online forum will bring together statistical leaders from government agencies, clinical trial practitioners, and expert methodological statisticians to focus on these affected areas. Online meetings will be held to define the statistical characteristics of each aspect of trial disruption and bring statisticians with related areas of expertise together to focus on these challenges. Each meeting will include time for discussion and synthesis, where participants will have the opportunity to ask questions and present ideas relevant to the topic. The overall objective of these meetings is to suggest paths to novel statistical methodological solutions and call the community to action to address this need.
Forum Organizing Committee
Jonathan Bartlett, University of Bath
Adam Lane, University of Cincinnati
Nancy Flournoy, University of Missouri
Chris Jennison, University of Bath
Assaf Oron, Institute for Disease Modeling
Sergey Tarima, Medical College of Wisconsin
The first two days are free and open sessions, but registration is required, and donations are appreciated. These first two days will expose the statistical issues surrounding unplanned disruptions of clinical trials and lay the foundations for the issues to be addressed in days 3-6.
Watch this space for more details about these sessions as they become available!
Day One and Day Two
Day One: NIH Perspectives
July 21, 2020
10:00-10:10 ET - Welcome and Orientation: Session 1
10:10-10:30 Nancy L. Geller (Director of Biostatistics Research, NHLBI)
10:30-10:50 Dean Follmann (Chief, Biostatistics Research Branch, NIAID)
10:50-11:10 Lisa McShane (Associate Director, Division of Cancer Treatment & Diagnosis; Chief, Biometric Research Program NCI)
11:10-11:30 - Discussion
Day Two: CDC, FDA, and EMA Perspectives
July 28, 2020
10:00-10:10 ET - Welcome and Orientation: Session 2
10:10-10:30 Lilly Yue (Deputy Director, Division of Biostatistics, FDA)
10:30-10:50 G. David Williamson (Director, Office of Science, National Center for Environmental Health, CDC)
10:50-11:10 Speaker 6 (EMA - TBA)
11:10-11:30 - Discussion
Invited Working Group Sessions - Day Three through Day Six
Following the first two days, attendees will be presented with a survey that will ask if they are interested in participating in smaller active, working group sessions whose purpose is to tackle the technical and methodological issues as they emerge from the opening sessions and from the discussion that follows. Participants, chairs, moderators, and recorders will be selected from the survey responses. Each working group will be charged with producing a white paper or a manuscript for the purpose of sharing the findings that result.
More Information to Follow! Date and Participant Information TBD!