Time: 10:30 - 12:30 UK Time Presenters: Mahesh Parmar (Medical Research Council), James Matcham (AstraZeneca) and Julia Saperia (Medicines and Healthcare products Regulatory Agency)
Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.
Mahesh Parmar, MRC Clinical Trials Unit at UCL
Abstract
Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Please click here to view Julia Saperia's slides.
Please click here to view James Matcham's slides.
Please click here to view Mahesh Parmar's slides.
Time: 10:30 - 12:30 UK Time Presenters: Mahesh Parmar (Medical Research Council), James Matcham (AstraZeneca) and Julia Saperia (Medicines and Healthcare products Regulatory Agency)
Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.
Mahesh Parmar, MRC Clinical Trials Unit at UCL
Abstract
Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Please click here to view Julia Saperia's slides.
Please click here to view James Matcham's slides.
Please click here to view Mahesh Parmar's slides.
Time: 10:30 - 12:30 UK Time Presenters: Mahesh Parmar (Medical Research Council), James Matcham (AstraZeneca) and Julia Saperia (Medicines and Healthcare products Regulatory Agency)
Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.
Mahesh Parmar, MRC Clinical Trials Unit at UCL
Abstract
Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Please click here to view Julia Saperia's slides.
Please click here to view James Matcham's slides.
Please click here to view Mahesh Parmar's slides.
Time: 10:30 - 12:30 UK Time Presenters: Mahesh Parmar (Medical Research Council), James Matcham (AstraZeneca) and Julia Saperia (Medicines and Healthcare products Regulatory Agency)
Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.
Mahesh Parmar, MRC Clinical Trials Unit at UCL
Abstract
Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Please click here to view Julia Saperia's slides.
Please click here to view James Matcham's slides.
Please click here to view Mahesh Parmar's slides.
Time: 10:30 - 12:30 UK Time Presenters: Mahesh Parmar (Medical Research Council), James Matcham (AstraZeneca) and Julia Saperia (Medicines and Healthcare products Regulatory Agency)
Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.
Mahesh Parmar, MRC Clinical Trials Unit at UCL
Abstract
Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Please click here to view Julia Saperia's slides.
Please click here to view James Matcham's slides.
Please click here to view Mahesh Parmar's slides.
Time: 10:30 - 12:30 UK Time Presenters: Mahesh Parmar (Medical Research Council), James Matcham (AstraZeneca) and Julia Saperia (Medicines and Healthcare products Regulatory Agency)
Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.
Mahesh Parmar, MRC Clinical Trials Unit at UCL
Abstract
Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Please click here to view Julia Saperia's slides.
Please click here to view James Matcham's slides.
Please click here to view Mahesh Parmar's slides.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK