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Promoting the Use of Complex Innovative Designs in Clinical Trials

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Promoting the Use of Complex Innovative Designs in Clinical Trials Meeting March 20, 2018 Page 1 1 2 U.S. FOOD AND DRUG ADMINISTRATION 3 CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) 4 CENTER FOR BIOLOGIC EVALUATION AND RESEARCH (CBER) 5 6 7 Public Meeting: 8 Promoting the Use of Complex Innovative Designs 9 in Clinical Trials 10 11 Tuesday, March 20, 2018 12 8:35 a.m. 13 14 FDA White Oak Campus 15 10903 New Hampshire Avenue 16 Silver Spring, Maryland 20903 17 18 19 20 Reported by: KeVon Congo, 21 Capital Reporting Company 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 2 1 A P P E A R A N C E S 2 Deborah Ashby, PhD 3 Imperial College London 4 Julie Beitz, MD 5 Office of Drug Evaluation III, CDER, FDA 6 Robyn Bent 7 Office of Biostatistics, CDER, FDA 8 Scott Berry, PhD 9 Berry Consultants, LLC 10 Frank Bretz, PhD 11 Novartis 12 Aloka Chakravarty, PhD 13 Office of Biostatistics, CDER, FDA 14 Shein-Chung Chow, PhD 15 Office of Biostatistics, CDER, FDA 16 Ivan Chan, PhD 17 AbbVie Inc. 18 Scott Emerson, MD, PhD 19 University of Washington 20 Steven Goodman, MD, PhD 21 Stanford University School of Medicine 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 3 1 A P P E A R A N C E S 2 Frank Harrell, Jr., PhD 3 Vanderbilt University School of Medicine 4 Telba Irony, PhD 5 Office of Biostatistics and Epidemiology, CBER, 6 FDA 7 Laura Lee Johnson, PhD 8 Office of Biostatistics, CDER, FDA 9 Stefanie Kraus 10 Office of Regulatory Counsel, CDER, FDA 11 Lisa LaVange, PhD 12 University of North Carolina at Chapel Hill 13 J. Jack Lee, DDS, MD 14 MD Anderson Cancer Center 15 Gracie Lieberman 16 Genentech 17 Gregory Levin, PhD 18 Office of Biostatistics, CDER, FDA 19 Roger Lewis, MD, PhD 20 University of California, Los Angeles; 21 Harbor-UCLA Medical Center 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 4 1 A P P E A R A N C E S 2 Olga Marchenko, PhD 3 Bayer 4 Cyrus Mehta, PhD 5 Cytel Corporation; Harvard University 6 Will Meurer, MD 7 University of Michigan Health System 8 Thomas Permutt, PhD 9 Office of Biostatistics, CDER, FDA 10 Dionne Price, PhD 11 Office of Biostatistics, CDER, FDA 12 Karen Price, PhD 13 Eli Lilly and Company 14 John Scott, PhD 15 Division of Biostatistics, CBER, FDA 16 Rajeshwari Sridhara, PhD 17 Office of Biostatistics, FDA 18 Joseph Toerner, MD 19 Division of Anti-Infective Products, CDER, FDA 20 Z. John Zhong, PhD 21 Biogen 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 5 1 C O N T E N T S 2 PAGE 3 I Welcome, Opening Remarks and Introductions 4 Aloka Chakravarty, PhD 8 5 Session I: General Considerations for Complex 6 Adaptive Clinical Trial Designs to Support the 7 Effectiveness and Safety of Drugs or Biologics 8 Presentation 9 Gregory Levin, PhD 15 10 Discussion 11 Frank Bretz, PhD 26 12 Scott Emerson, MD, PhD 28 13 Panel Discussion 32 14 Audience Q&A 82 15 Session II: General Considerations for Other 16 Innovative Designs Including External/Historical 17 Control Subjects, Bayesian Designs and Master 18 Protocols 19 Presentation 20 Lisa LaVange, PhD 92 21 Discussion 22 Roger Lewis, MD, PhD 110 www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 6 1 C O N T E N T S 2 PAGE 3 I Frank Harrell, Jr., PhD 117 4 Panel Discussion 123 5 Audience Q&A 155 6 Session III: Clinical Trial Simulations for 7 Confirmatory Trial Design and Planning 8 Presentation 9 John Scott, PhD 167 10 Discussion 11 Scott Berry, PhD 180 12 Cyrus Mehta, PhD 189 13 Karen Lynn Price, PhD 196 14 Panel Discussion 201 15 Audience Q&A 228 16 Session IV: Complex Innovative Design Pilot Program 17 Presentation 18 Dionne Price, PhD 240 19 Discussion 20 Gracie Lieberman 244 21 Z. John Zhong, PhD 251 22 Panel Discussion 257 www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 7 1 C O N T E N T S 2 PAGE 3 Audience Q&A 297 4 Closing Remarks 5 Dionne Price, PhD 306 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 8 1 P R O C E E D I N G S 2 DR. PRICE: Good morning. We're going to go 3 ahead and get started, realizing that there are many 4 attendees that are trying to get through the lobby 5 security right now. But we'll go ahead and get 6 started, realizing that in the afternoon we'll have to 7 keep a check on the weather. 8 So we'll -- I'll ask Dr. Aloka Chakravarty, 9 who's the acting director of the Office of 10 Biostatistics in CDER to begin with welcoming remarks. 11 WELCOME, OPENING REMARKS AND INTRODUCTIONS 12 DR. CHAKRAVARTY: Good morning, everyone. I'm 13 Aloka Chakravarty, acting director of the Office of 14 Biostatistics, CDER, FDA. 15 Welcome to the FDA public workshop, public 16 meeting on promoting the use of complex innovative 17 designs in clinical trials, which is being convened by 18 the Center for Drug Evaluation and Research, and the 19 Center for Biologics Evaluation and Research. 20 We're pleased to be joined for these 21 discussions by leading experts across government, 22 academia, industry, and care delivery for a productive www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 9 1 exchange on the issues on-hand. 2 Our purpose today is to facilitate discussion 3 and information sharing about the use of complex 4 innovative designs in drug development and regulatory 5 decision-making. 6 This meeting fulfills obligations under both 7 21st Century Cures Act and PDUFA-VI to convene a public 8 meeting to discuss various complex adaptive, Bayesian 9 and other novel clinical trial designs with particular 10 focus on clinical trial designs for which simulations 11 are necessary to valid operating characteristics. 12 We have seen examples of innovative designs at 13 various stages of development. But its use can be 14 improved by consistent acceptance in regulatory 15 decision process of such designs and clarity may be 16 needed to -- how to proceed with such a design. 17 Today's meeting is meant to be the beginning 18 of an ongoing effort to discuss and explore the use of 19 complex innovative designs in drugs and biologics. And 20 it will be a chance for the leading experts to discuss 21 their experiences with these techniques and to provide 22 input as FDA develops a pilot program for complex www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 10 1 innovative designs. 2 Throughout the day, we encourage meeting 3 participants to consider opportunities for increased 4 collaboration, both across industry and with agency to 5 support these efforts. 6 In a few moments, we will hear from the 7 speakers about their thoughts on complex innovative 8 designs and where they'll see potential for additional 9 work. 10 We will be specifically talking about four 11 topics: a session on complex adaptive clinical trial 12 designs, a session focused on other innovative designs 13 including external or historical control subjects, 14 Bayesian designs and master protocols, a session 15 looking at clinical trial simulation for confirmatory 16 trial design and planning and a session where 17 stakeholders share their thoughts about the upcoming 18 pilot program for complex innovative design. 19 Before we get started, a few housekeeping 20 notes. As you'll note in the agenda, each session will 21 begin with 15-minute presentations, followed by panel 22 discussion. We also have time set aside for broader www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 11 1 discussion with audience participants. 2 For those in attendance, we have microphones 3 setup in the room, in the aisle, for you to use during 4 the question-and-answer during the day. Formal 5 comments can be sent to the open docket. The link is 6 listed on the agenda. 7 I want to remind everyone that this is a 8 public meeting, and the event is being broadcast 9 online. So everything you say will be part of the 10 record. For those in the room today, if you need to 11 purchase a lunch, please be sure to order and pay for 12 it at the Sodexho kiosk before the end of the first 13 break. 14 Finally, a reminder that although this meeting 15 is being convened by the FDA, it's not a federal 16 advisory committee. The meeting will be a success if 17 there is a robust discussion of ideas and open 18 discussion. 19 So with that, I would like to thank all the 20 panelists and the audience for participation, and we 21 welcome and look forward to an active discussion. 22 Thank you. www.CapitalReportingCompany.com 202-857-3376 Meeting March 20, 2018 Page 12 1 DR. PRICE: Thank you, Dr. Chakravarty. 2 Before we being our first presentation, I would like to 3 thank all of our panelists for traveling near and far 4 to be with us today. We look forward to a very 5 interesting and robust discussion.
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