Many approaches for designing and analyzing clinical trials using historical (or other external study) data have been proposed in the recent past. For example, proposals have been made for bridging studies, the combination of randomized and non-randomized evidence, and also for more general problems such as across-phases probability of success calculations. In addition, the ever-increasing number of patient registries and databases for routinely collected data, and recent data sharing initiatives (e.g., TransCelerate), further underline the importance of these approaches. However, there are still many open questions concerning the role which clinical trials that use such data can have in drug development. In our opinion, the three most important questions are:
The scope of this SIG is to provide some answers to the above questions through a variety of activities. These will include:
| Name | Company/Institution |
| Nicky Best (co-lead) | GSK |
| Simon Wandel (co-lead) | Novartis |
| Byron Jones (Chair) | Novartis |
| Lisa Hampson | Novartis |
| Sebastian Weber | Novartis |
| Frank Fleischer | Boehringer Ingelheim |
| Nelson Kinnersley | Octa Consulting |
| David Dejardin | Roche |
| Ros Walley | UCB |
| Adrian Mander | MRC Cambridge |
| Graeme Archer | GSK |
Contact: Byron Jones (Novartis)
Email: byron.jones@novartis.com
Coming soon...
In this webinar we will explain the how to understand the sequences of issues and how to fix it in order to drastically improve the replicability of the results. Through example the presentation will cover concepts such as OFAT vs DoE, p-values and Bayesian statistics and Power vs Assurance as easy opportunities to improve robustness of decisions.
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.
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…
PSI Toxicology SIG workshop – 24th and 25th November 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 gareth.thomas@covance.com if you have suggestions. Full details will be circulated in the coming weeks.
GSK has a thriving global community of Oncology statisticians supporting our commitment to the development of new oncology therapies with the life-changing potential of helping patients with cancer. Click to learn about our exciting career opportunities.
GSK has a thriving global community of Oncology statisticians supporting our commitment to the development of new oncology therapies with the life-changing potential of helping patients with cancer. Click to learn about our exciting career opportunities.
Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, analytics and interpretation of AstraZeneca’s portfolio.
GSK has a thriving global community of Oncology statisticians supporting our commitment to the development of new oncology therapies with the life-changing potential of helping patients with cancer. Click to learn about our exciting career opportunities.
We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.
We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.
Wish you were here? Recognised recently as a Top CRO by Life Science Leader, Premier Research is a medium sized, full service, global CRO with circa 1,500 employees worldwide, perfectly positioned to be big enough to help, yet small enough to care.
We currently have vacancies in our Early Phase and Late Phase Teams, for either home or office based positions across EMEA, so please reach out for more information.
Why not come and work for a company recognised as one of the UK's Top 25 Best Big Companies to Work For. The continued growth of our pipeline means we have opportunities for exceptional statisticians at all levels to join our Biostatistics group.
