Following on from the successful and thought-provoking presentation at last year’s PSI conference by Paul Wicks from PatientsLikeMe, this webinar will continue to explore the ways in which patients are influencing the design of new clinical trials.
PSI Webinar Patient Engagement in Clinical Trials Date for Webinar: Tuesday 13th June 2:30-3:30pm UK time
Patients have long been an important part of clinical drug development – without them, there would be no new medicines. Recently, there has been a fundamental shift in their involvement in the drug development process. Today, patients are highly active in engaging in discussions about their disease, what they look for in new treatments, and how clinical trials are designed and conducted.
Following on from the successful and thought-provoking presentation at last year’s PSI conference by Paul Wicks from PatientsLikeMe, this webinar will continue to explore the ways in which patients are influencing the design of new clinical trials. We have two speakers who bring different experience and perspectives on this subject:
Dr Cathy Emmas, Partnership Director, Patient Centricity, AstraZeneca Title: Patient-centric medicines development – the value of online health communities
Abstract: How AstraZeneca’s collaboration with the PatientsLikeMe is accelerating our ability to generate the timely and relevant patient insight that enables informed decision making within our R&D programs. What patient-generated health data tells us about symptoms and outcomes that matter to patients. Optimisation of clinical trials from the patient perspective.
Biography: Cathy is the Partnership Director in AstraZeneca’s global Patient Centricity team where she leads a 5 year strategic collaboration with the PatientsLikeMe online health network. This alliance was established to accelerate our ability to generate the right patient insight that enables informed decision making within our R&D programs and shape healthcare delivery. In the first two years the collaboration has linked the experiences of over 70,000 patients into our lifecycle teams and patient preferences have helped shape 12 clinical studies across 7 diseases.
Professor Sue Pavitt, Dental Translational and Clinical Research Unit, University of Leeds
Title: Achieving Effective Patient Public Involvement in Clinical Trials: “No research about us without us”
Abstract: Patient public involvement in medicine research and development has gained significant momentum. Adopting a patient-centric approach in clinical trials and research is important to ensure new treatments embrace what is important to patients. Achieving effective Patient Public Involvement & Engagement (PPIE ) partnerships enhances the relevance of clinical research and improved likelihood of delivering patient benefits. PPI also contributes to the operational efficiency and success in clinical trial design, ethical approval, conduct and dissemination reach; collectively building cross sector communication and partnerships may enhance market head room long term. I will provide a background to patient public involvement and establishing effective partnerships and illustrative case examples that support patient awareness of their treatment options and healthcare choices. I will introduce EUPATI and its role in meeting the educational needs to deliver patient centric medicine R&D and facilitate partnerships between patients-academia and industry in clinical research. We are in an era of a paradigm shift in patient-centric clinical trials, by strategically bringing the patient lived experience to the forefront has the potential to change fundamentally how health care is practiced.
Biography: Sue Pavitt - Prof in Translational & Applied Health Research, University of Leeds. Her PhD was in Human Cancer Genetics and she had a high profile career working with Prof Sir Walter Bodmer mapping the first colorectal cancer gene. She worked on the Human Genome Project at UCL, Oxford and UCSF, USA. In 1998 she was appointed as the Founding Director of TayRen – the premier Scottish multidisciplinary Primary Care Research network and the academic focus of her career changed to applied health research. She became the Divisional Director at the Clinical Trials Research Unit, Leeds and has since gone on to Head the Division for Applied Health and Clinical Translation and is Director of the Dental Translation and Clinical Research Unit. She is a Specialty lead for the Oral & Dental Health National Institute of Health Research (NIHR) Clinical Research Network. She is Chair of Multiple Sclerosis Clinical Trials Network. She is a Board Member of the MRC-NIHR Efficacy & Mechanistic Evaluation and in this capacity evaluated clinical trial design. Her research portfolio spans several disease areas and is characterized by forging effective, multi-disciplinary research partnerships between clinicians, academics, sometimes industry and always patients; developing methodological sound projects that are patient-centric with research questions tailored to clinical priorities to maximize impact and patient benefit.
Sue is passionate about patient involvement in research with >30 years’ experience. She is the Academic Lead for EUPATI-UK – European Patient Advocacy for Therapeutic Innovation- a pan-European Innovative Medicines Initiative, led by the European Patients' Forum, in partnership with patient organizations, universities, not-for-profit organizations and pharmaceutical companies. EUPATI’s goal is to increase capacities and capabilities of well-informed patients to be effective advocates/advisors in medicines research.
An opportunity to meet statisticians from across the pharmaceutical industry in a relaxed and informal setting. An exciting program of events and a chance to work in small groups on a data analysis challenge. Lunch provided.
A Non-PSI Event - Protecting confidentiality and privacy in clinical trial and medical data sets
We are increasingly living in a data driven world. Data are collected in many different ways for a variety of purposes. As such, concerns around protecting the privacy of individuals have increased in recent times.
A PSI Training Course - Practical Approaches to Designing Adaptive Clinical Trials
This hands-on course will provide a deep dive into 4 software packages used to design adaptive clinical trials.
The course will start by providing a general overview of adaptive designs, explaining the different type of adaptations possible and the benefits of each design. Following this, participants will be given the opportunity to have a go at designing trials in R (using RPACTS), EAST, FACTS, and nQuery.
PSI Training Course - Bayesian Practical Course using R and SAS
This practical training course will give a deep dive into performing Bayesian analyses in R and SAS. It is aimed at statisticians who need to be able to conduct Bayesian analyses as part of their day to day work. By the end of the course participants will be able to conduct their own analyses.
This webinar will address operational issues of paramount importance within the healthcare industry with a view to using statistics for the benefit of patients. In attending this webinar, you'll hear more about work being conducted to address some operational issues we face in the health care industrys e.g. patient rectuitment, drug supply and meeting NHS 18 week targets.
PSI Toxicology SIG workshop – 16th and 17th March 2020
The Toxicology SIG provides a forum for statisticians working in regulatory/investigative toxicology, as well as most other pre-clinical areas, to discuss issues and interact with one another.
This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.
The afternoon of Day 1 will include a 4.5 hour Bayesian training course focused towards applications in toxicology/pre-clinical, provided by Prof. Dr. Katja Ickstadt and is included in the workshop fee.
The cost will be £270 including VAT per delegate, inclusive of food and one night’s accommodation (and the training course). The workshop is being held at the Crowne Plaza Hotel, Heathrow.
The agenda and topics that will be discussed are yet to be finalised, but please get in touch with email@example.com if you have suggestions. Full details will be circulated in the coming weeks.
This course is aimed at Statisticians and Programmers experienced in SAS, but little or no experience with R.
An Introduction to R studio and the R language, statistical graphics, programming statistical models, simulations and more…
Non-proportional hazards and applications in immuno-oncology
Designs of clinical trials with time to event primary endpoints usually rely on hazards being constant over time. A major challenge in immuno-oncology is the delayed onset of benefit with such therapies and the presence of non-proportional hazards. The impact of this needs to be accounted for in sample size calculations, analysis methodology and reporting. At this meeting, we will examine possible strategies to handle such features, which may not be fully known when the trial is initiated.
The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies from October 2020 to July 2021 to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 - 4 sessions in the UK. It promises to be a truly memorable course.