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Wednesday, June 17 • 4:00pm - 5:00pm
#341 L: Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-709-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data Monitoring Committee (DMC) plays a vital role in determining the direction of an ongoing clinical trial. The DMC gets ongoing views of trial data and findings before submission to any regulatory agency. The results of the interim analysis can affect crucial trial design changes, such as sampling methodology, recalculation of sample size, or early stopping decisions due to futility, safety signals, or overwhelming efficacy. Therefore, the DMC might recommend altering the trial from its original design based on issues arising during the trial. Since the DMC has a unique opportunity for first view of the unblinded data, it can assist in monitoring the progress of the trial and oversee data quality issues to ensure the trial integrity. On the other hand, central data monitoring and proper statistical process control during the trial can mitigate issues caused by data anomalies and the impact of trial misconduct, before the submission is sent for regulatory review. Familiarity with available data monitoring tools will help in accomplishing these tasks. This session will provide a platform for trial designers and analysts from industry and regulatory agencies to discuss the proper role of the DMC, in particular, how it can be utilized to address issues of data quality and detect potential misconduct.

Learning Objectives

Discuss with trial designers and analysts from industry and regulatory agencies the proper implementation of the DMC; Describe how it can be utilized to address issues of data quality and detect potential misconduct.

Chair

Anna Kettermann, MA, MS

Speaker

The Role of DMCs in Ensuring Reliable Data
Janet Turk Wittes, PhD

How to Apply Statistical Process Control to Monitor Clinical Trials Aiming to Detect Performance and Data Quality Issues
Nechama Katan, MA, MS

Panelist
Sylva Collins, PhD

Panelist
Kenneth A. Getz, MBA



Speakers
avatar for Kenneth Getz

Kenneth Getz

Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Nechama Katan

Nechama Katan

Director Data Science, Data Management, Pfizer Inc, United States
Nechama Katan, is a “Data Wizard with Personality.” Nechama has been the technical lead for the RBM team at Pfizer and is working on understanding the best ways to upskill SMEs so that they can drive Data Science Discussions. She helps organizations access and use their data to... Read More →
avatar for Janet Wittes

Janet Wittes

President, Statistics Collaborative Inc.
Janet Wittes is President of Statistics Collaborative, a company that consults on design of clinical trials. She has participated in many Data Safety Monitoring Committees for government and for industry. Her research deals with statistical monitoring of randomized trials.
avatar for Anna Kettermann

Anna Kettermann

Mathematical Statistician, OB, OTS, CDER, FDA
Anna Kettermann has 15 years of experience as a biostatistician working on interdisciplinary projects hand-in-glove with teams of physicians, medical officers, pharmacologists, and other scientists, reaching 10 years in FDA last year and 5 in CDER. Anna came to FDA following 5 years... Read More →
avatar for Sylva Collins

Sylva Collins

Director, Office of Biostatistics, OTS, CDER, FDA
Dr. Collins is the Director of the Office of Biostatistics, OTS/CDER/FDA. Prior to joining the FDA in August 2019, she has spent more than 30 years leading large global biometrics organizations and has contributed to dozens of successful regulatory submissions in multiple jurisdictions... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session