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17 October 2007, Wednesday
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SESSION II:
REGULATORY PERSPECTIVES AND LESSONS LEARNED FROM CONDUCTING STUDIES WITH ADAPTIVE TRIAL DESIGNS |
8:30 Co-Chairperson’s Opening Remarks
Judith A. Quinlan, Ph.D., Director Statistics, Biopharmaceuticals, GlaxoSmithKline
| 8:45 Regulatory Perspectives in Adaptive Trial Design |
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Dietlind Gardell, MD, Ph.D., Office of Clinical Trials, Therapeutic Products Directorate, Health Canada |
| In the current Canadian regulatory environment the emphasis on effective risk management across the therapeutic product life cycle encourages more individualized novel therapeutic approaches in clinical trials. Adaptive study designs are emerging as attractive options for study modifications in relation to accumulating data and interim data analyses. The potential for accelerated drug development and optimized resource allocation needs to be balanced with an increased focus on rigorous planning of flexible designs and on the regulatory standards for continued trial integrity, validity and patient safety based on the scientific evidence in the regulatory decision-making process. |
| 9:15 FDA's
Perspective on Adaptive Trial Designs |
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Jerald S. Schindler, Dr.P.H., Vice President, Biostatistics and Research Decision Sciences, Late Stage Clinical Development Statistics,
Merck Research Laboratories
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| 9:45 Adaptive Clinical Trials – Making Them Happen |
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Tom Parke, BSc, Head of Adaptive Clinical Trial Solutions |
| There is increasing interest in using adaptive clinical trials to improve the efficiency and effectiveness of drug development, but currently there is a lot more interest than actual action. One of the significant barriers to the use of these trials is the perceived difficulty in implementing them. Tessella has however had the good fortune to be involved in some highly innovative adaptive clinical trials. This talk will draw on our experience, describing some of the strategies and techniques that we can see emerging from the trials we have run and those we are currently involved with. |
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10:00 Exhibit Viewing, Networking and Refreshment Break
| 10:45
Implementing Adaptive Clinical Trials - Tools of the Trade |
| Kathy Reinold, Project Manager, Adaptive Design Technology |
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| For nearly ten years, Tessella has worked behind-the-scenes to contribute the software for statistical models, randomization, and decision support on Bayesian-based adaptive clinical trials. From this experience, Tessella will present some innovative possibilities and insights into where things may go from here. |
11:00 Technology Spotlight
(Sponsorship Available. For more information, contact Arnie Wolfson at 781-972-5431 or
awolfson@healthtech.com)
| 11:15 Operational Planning and Implementation with a Cardiovascular Trial Using an Adaptive Trial Design |
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To Be Announced |
| There are many issues to be considered when planning for a trial that uses an adaptive design. This presentation will focus on; 1) operational considerations during study design, 2) planning and managing subject enrollment during a dose decision analysis and 3) lessons learned while conducting the trial. |
| 11:45 pm Luncheon Technology Workshop
Adaptive EDC: Critical Steps for Managing Adaptive Trials |
| Khaled El Emam, Chief Scientist, TrialStat |
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| Electronic data capture software will play a pivotal role in enabling clinical researchers to use adaptive clinical trial designs. Success, however, largely depends on how adaptive EDC can be. Understanding a framework for evaluating EDC in an adaptive clinical trial context, therefore, becomes a critical first step. |
| 1:15 How to Build and Manage a Clinical Study Database with an Adaptive Design |
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Lynne Dugan, M.B.A., Program Data Manager, Pfizer
Inc. |
- Overview of Pfizer Trial Using Adaptive Clinical
Design
- General Lessons Learned from Trial
- Database Build Issues with Trial
- Data Management Issues with Trial
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| 1:45 Acute Migraine POC Using CRM - The Power of Team Work and a Can Do Attitude... Overcoming Logistical and Operational Hurdles |
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Judith Quinlan, M.Sc.,
Director, Statistics, Biopharmaceuticals, GlaxoSmithKline |
| A great deal of theoretical debate exists around potential issues that may or may not exist when implementing adaptive designs. Concerns can range from possible introduction of biases, problems regarding confidentiality, maintaining the blind, etc. to concerns over the ease of implementation. Logistical challenges can often appear insurmountable or at least daunting obstacles. There is great potential to learn from early phase studies to increase our experience and understanding in regards to many of these issues. The case study to be presented is one such example. This was a phase II POC study in acute migraine, where patients needed to treat for migraine at early onset. In the face of existing processes and systems, the CRM method presented the team with many challenges. This presentation will examine the challenges and also the team’s solutions to implementation, and address how they handled the infamous, who saw what and when question! |
2:15 Networking Refreshment Break
| 2:45 Phase II Opioid Induced Constipation Dosing Study |
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Evan Tzanis, Associate Director, Medical Research, Wyeth |
| Opioids, are the mainstay of moderate to severe pain control for centuries. However opioids can cause a number of severe, and debilitating side effects as a result of the interaction with opioid receptors in the periphery. The most common of these peripheral side effects is constipation. Methylnaltrexone is a quaternary ammonium derivative of the opioid antagonist naltrexone. It is, therefore, possible to antagonize the undesirable peripheral side effects of opioids without affecting the desirable centrally mediated analgesic effects. Wyeth, in collaboration with our partner Progenics, is developing an oral formulation of methylnaltrexone for opioid-induced constipation. Key aspects of an adaptive design study that was conducted in patients with chronic non-malignant pain who also have opioid induced constipation will be discussed in this presentation. |
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| 3:15 Planning and Supplying Drug for Clinical Studies Using Flexible Designs |
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Micheline Marshall, R.Ph., MBA, Director of Clinical Pharmacy, Wyeth |
| This presentation will provide Clinical Supply Managers with an overview of adaptive trials as it relates to drug supply forecasting. A case study and lessons learned will provide real life experience with this new and exciting methodology. The focus will be on general requirements from a supply and technology perspective. It will highlight the challenge of managing global site inventories with an evolving randomization scheme. |
| 3:45 A Phase 2b Adaptive Dose-Finding Trial of a Novel Compound to Treat Acute Migraines |
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Xiaoyin Frank Fran, Ph.D., Senior Biometrician, Merck & Co., Inc. |
| Dose-finding is a critical step during drug development before the launch of the phase 3 program and where adaptive designs are commonly adopted. This case study of a novel migraine compound illustrates how we use a 2-stage adaptive design to go through multiple original doses, adjust sample sizes, and select the doses for later confirmatory trials. Theoretical and practical issues from the design, delivery, and decision-making perspective will be reviewed. The example demonstrates that with thoughtful planning upfront and appropriate monitoring during the trial, a well designed and executed adaptive trial can achieve objectives with great efficiency without weakening the results validity. |
4:15 Panel Discussion with Speakers
4:45 Close of Putting Theory into Practice: Adaptive Clinical Trial Designs Conference
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