More Information
In this pre-workshop course, we will start from introductory definitions to adaptive designs in general and specific types of them used for different purposes/context. We will make introductory considerations to several important aspects of their design and analysis. These concepts will be delivered through a mixture of lectures, case study presentations and discussions.
Specifically, we are going to explore:
1. Types of adaptive designs commonly used, presented based on the research question they are geared to answering.
2. Bayesian Adaptive Designs
3. Design and analysis considerations
4. Discussion of case studies.
Ethical considerations
The ethics element of the course will cover (i) an introduction to research ethics in the context of clinical trials, (ii) harms, risks and benefits and (iii) the concept of equipoise in research ethics.
The discussion will be built around a number of case studies that will be used to draw out ethical considerations and arguments in order to explore the range of issues involved. Each of the specific topics will be examined in more detail through case discussion and the presentation of more theoretical material.
The introduction to research ethics session will consider in broad terms a framework for thinking about ethical issues in research. It will focus on the interrelations between informed consent, participant harms and benefits and overall social or scientific value. The case study of a trial of the use of a common analgesic to manage stroke conducted in Uganda will allow students to respond to the overall set of issues involved and will highlight the place of methodology within it. At the conclusion of the session we return to modify the framework in important ways.
The second session, on harms, risks and benefits, picks up on some of the ethical trade-offs involved research ethics for clinical trials. It considers examples of non-therapeutic research and examines an example of a challenge study. Finally, the session will examine distinctions between kinds of harms and kinds of benefits and the role that they play in the consideration of the ethical issues in research.
The final conceptual session will explore the concept of equipoise as it is discussed in the research ethics context. Equipoise has been understood in a range of ways: the development of thinking in this area is instructive in being able to appreciate the trade-offs that are involved between.
In the final part of the day we will return to the sets of issues considered across the full day of teaching to bring together the ethical and statistical considerations in the context of adaptive clinical trials. Students will be asked, by returning to the cases which have featured during the day’s session, to reflect on the ways in which the ethical trade-offs are affected by the use of novel statistical tools in the methodology for adaptive clinical trials.
The course is planned to have a day programme. Start time would be from 9:30. End time will be 16:00. The before timetables may change slightly.
Course objectives:
• Develop an understanding of the breadth of adaptive allocation designs available in the literature
• Identify design and analysis considerations specific to adaptive designs, including Bayesian analysis and design.
• To identify key case studies of clinical trials that use response-adaptive methods in practice
• Develop an understanding of the range of ethical issues involved in the design and implementation of clinical trials
• To identify and analyze the tradeoffs involved in dealing with methodological considerations in clinical trials, including harms, risks, benefits and considerations of equipoise
• To identify and reflect on the interactions between the ethical issues and the statistical/ design issues in the development of effective, ethical clinical trials
Course tutors:
Dr. Sofia S. Villar
Dr. David Robertson
Dr. Mark Sheehan (Oxford)
Dr. Mackenzie Graham (Oxford)
Intended audience: Trial statisticians, clinical trial methodologists, PhD/Masters students, ethicist, trial support staff, and clinical researchers.
Computing practical: there will be a practical in R exploring the performance of different types of response-adaptive allocation procedures on an example clinical trial
For further course details, please visit http://www.mrc-bsu.cam.ac.uk/training/short-courses/
For answers to conference queries, please email courseadmin@mrc-bsu.cam.ac.uk
Cancellation Policy
Full refunds will be given for cancellation 28 or more working days before the course start date. Otherwise the full course fee will be charged. However, registrations may be transferable to another course or individual.
In the unlikely event that the short course has to be cancelled, our liability is limited to refund of course fees only. We recommend that delegates have adequate insurance cover to reclaim any travel or accommodation expenses.
Please visit http://www.mrc-bsu.cam.ac.uk/training/short-courses/
