AIMS SIG - Open-Source Lunch Bites
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
How do Data Monitoring Committees Operate: Principles, Practicalities and Controversies
Agenda | Slides | Recordings
This one day meeting is aimed at people who serve on Data Monitoring Committees, people who organise them, and people involved in preparing statistical reports and safety listings for them. The day will cover the remit and organisation of DMC’s, together with speakers’ personal experiences of the proces
| 9:15 | Issues in the Construction and Conduct of DMCs Dr Richard Kay (RK Statistics Ltd) |
| 10:00 | The roles of a DMC other than ‘stop/continue’ decisions Andrew Stone (Astra Zeneca) |
| 11:00 | Experiences of data monitoring and interim analysis of trials in the public sector Prof. Diana Elbourne (LSHTM) / Dr Patrick Phillips (MRC) |
| 11:45 | Regulatory guidance and expectations concerning DMCs Dr Yolanda Barbachano (MHRA) |
| 13:30 | The role of a programmer during a DMC delivery Diana Stuart (CMed) |
| 14:15 | The role of the industry statistician during a DMC delivery Nicola Tyson (Roche Ltd) |
| 15:00 | Reasons why physicians and statisticians are needed for a DMC Dr Jo Glover (Coephycient Pharmaceutical Consultancy) |
| 15:45 | Controversial Case Studies on When to Stop a Trial Early Prof. Stuart Pocock (LSHTM) |
Issues in the construction and conduct of DMCs
The roles of a DMC other than stop/continue decisions
Regulatory guidance and expectations concerning DMCs
Reasons why physicians and statisticians are needed on a DMC
Please see below recordings from some of the talks presented on the day. The sound quality of some of the talks is imperfect due to some technical issues experienced at the venue.
Issues in the construction and conduct of DMCsOur monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
Date: Ongoing 6 month cycle beginning late April/early May 2026 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.
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