IDEAS Dissemination Workshop

The IDEAS Dissemination events took place from the 24th-26th September 2018 in Basel, Switzerland.

Our events were planned to coincide with the EFSPI Regulatory Statistics Workshop, which took place on the 24th & 25th September in Basel.  Posters were displayed by all of our Early Stage Researchers (ESRs) throughout this workshop and three ESRs also presented their latest research at this event on the Tuesday afternoon.  The talks given were:

• Graphical approaches for subgroup analysis in clinical trials (Nicolas Ballárini, Medical University of Vienna, Austria)
• Cancer phase I trial design using drug combinations when a fraction of dose limiting toxicities is attributable to one or more agents (José Jiménez, Politecnico di Torino, Italy)
• Bayesian variable selection and classification with control of predictive values (Eleni Vradi, Bayer, Germany)

The EFSPI workshop was followed by the IDEAS Dissemination Workshop on Wednesday, 26^th September 2018 at Novartis in Basel.  This event was attended by around 70 delegates from academia and industry, with the aim of translating and promoting the novel methodologies developed by IDEAS over the three years of the project.  The following presentations were given by our ESRs:

• Bayesian pooling and sequential integration of small trials: a comparison within linear and nonlinear modelling frameworks (Fabiola La Gamba, Janssen, Belgium)
• A hierarchical Bayesian model for an in vitro-in vivo correlation (IVIVC) Model (Elvira Erhardt, Politecnico di Torino, Italy)
• Quantifying the association between progression-free survival and overall survival in oncology trials (Enya Weber, Lancaster University, UK)
• Identifying treatment effect heterogeneity in dose-finding trials using Bayesian hierarchical models (Marius Thomas, Novartis, Switzerland)
• Oncology Phase II Adaptive Designs: Efficacy estimates and their use in planning Phase III trials (Arsénio Nhacolo, University of Bremen, Germany)
• Adaptive incorporation of preclinical animal data into phase I oncology trials: a robust Bayesian meta-analytic approach (Haiyan Zheng, Lancaster University, UK)
• Optimal dose selection considering both toxicity and activity data; plateau detection for molecularly targeted agents (Maria-Athina Altzerinakou, INSERM, France)
• An information-theoretic approach for selecting arms in clinical trials (with applications to Phase I/II clinical trials) (Pavel Mozgunov, Lancaster University, UK)
• Testing strategies for claiming success on at least k out of m hypotheses with an application to biosimilar development (Johanna Mielke, Novartis, Switzerland) 
• Multiple testing and modelling techniques in dose finding studies in Phase II clinical trials (Saswati Saha, University of Bremen, Germany)
• Clinical trials with multiple objectives – optimal rejection regions based on Neyman-Pearson tests (Julia Niewczas, Medical University of Vienna, Austria)

Lunch was provided for all delegates, which gave our ESRs the opportunity to network and present posters on other aspects of their research.  The posters, which were also displayed at the EFSPI Regulatory meeting, are listed below:

• Improving a safety of the Continual Reassessment Method via a modified allocation rule (Pavel Mozgunov, Lancaster University, UK)
• Designs for oncology clinical trials: Exploring the relationship between time to progression and overall survival (Enya Weber, Lancaster University, UK)
• A Bayesian decision-theoretic approach to leverage preclinical information into a phase I first-in-man trial (Haiyan Zheng, Lancaster University, UK)
• Optimising the sample allocation across a multi-stage adaptive confirmatory clinical trial (Nicolas Ballárini, Medical University Vienna, Austria)
• Clinical Trial Designs with Data-Driven Selection of Subgroups (Julia Niewczas, Medical University Vienna, Austria)
• Incorporating historical information in biosimiliar trials (Johanna Mielke, Novartis Pharma AG, Switzerland)
• A multiple comparison procedure for dose-finding trials with subpopulations (Marius Thomas, Novartis Pharma AG, Switzerland)
• A Bayesian adaptive design in cancer phase I/II trials with drug combinations using escalation with overdose control (EWOC) and adaptive randomization (José Jiménez, Politecnico di Torino, Italy)
• Parametric inference for PK models defined by stochastic differential equations (Elvira Erhardt, Politecnico di Torino, Italy)
• New inference methods for adaptive Phase II designs with binary endpoint (Arsénio Nhacolo, University of Bremen, Germany)
• Multiple testing approaches for evaluating the effectiveness of a drug combination in a multiple-dose factorial design (Saswati Saha, University of Bremen, Germany)
• Cumulative risk of toxicity in Phase I trails of targeted therapies:  what to expect at the recommended Phase II dose? (Maria-Athina Altzerinakou, INSERM, France).
• Model selection based on combined penalties for biomarker identification (Eleni Vradi, Bayer AG, Germany)
• A novel Bayesian K-PD model for synergy:  Challenges and opportunities for sequential knowledge integration (Fabiola La Gamba, Janssen Pharmaceutica, Belgium)

After lunch, a keynote lecture on Changing the culture in drug development: The need to implement innovative scientific solutions was given by Frank Bretz, Global Head of the Statistical Methodology and Consulting group at Novartis.

ESRs Nicolas Ballarini and Elvira Erhardt, and Project Co-ordinators Pamela Forster and Allan Gordon also presented a light-hearted overview of the network-wide events which have taken place as part of the IDEAS programme.

Last, but not at all least, there was a short prize-giving ceremony where the following ESRs were presented with awards:

• Johanna Mielke:  Highest number of submitted publications (an impressive total of 10).
• Nicolas Ballarini, Eleni Vradi and Maria-Athina Altzerinakou:  Highest number of You Tube hits for their research videos with nearly 1000 views each!
• Marius Thomas:  Shortest secondment of two days.

The workshop was an excellent opportunity for our researchers to present their final research, network with delegates from across the world of medical statistics and was a fitting finale to an exceptional training programme.