Matthew Clark, Scientific Services, R&D Solutions, Elsevier, Philadelphia, USA & Thomas Steger-Hartmann, Investigational Toxicology, Bayer AG, Berlin, Germany
Attrition of drug candidates in clinical trials due to safety issues still contributes to a significant part of project closures besides other reasons such as the lack of efficacy, PK issues or strategic reasons. While failure of a candidate during preclinical development is a reflection of the primary task of the functions involved in this phase (i.e. toxicology, safety pharmacology and DMPK), failures during the later clinical phases often raise the question whether the preclinical safety studies are sufficiently predictive for the human outcome. Due to the fact that the First-in-Man study requires pivotal animal studies normally performed in two species, the focus of analysis of the debated predictivity centers around these animal studies. After the seminal study from Olson et al. (2000) numerous publications have shown that animal toxicity studies are predictive to a certain extent and that the predictivity varies among endpoints, some of them such as hematological, gastrointestinal, and cardiovascular events being better predicted than others (e.g. cutaneous adverse events). Most of these analyses compared the preclinical – clinical correlation for a rather limited set of compounds (<150) or for specific field of indications. The authors will present the results of this purely statistical approach based on data available for 3290 compounds in the commercial database Pharmapendium. The work provides answers to the implication of an observation in an animal for human risk and more specifically to the question whether concordance, i.e. the translatability of an observation from animal to human is dependent on the animal species. The statistical methods and procedures will be described in detail.
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PSI New Starters Half-Day Networking Event
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.