We invited clients, employees and friends to our summer party on 8 June 2018. There were many reasons to celebrate, such as the move to our new shiny office earlier this year, and the 10 years anniversary of our business plan seminar participation at unternehmerTUM. After all guests have been greeted by our Staburo “flower girl”, we had tasty summer drinks and juicy roast beef with shrimps. As a special highlight – our guests could taste custom made “red ale” beer, which was actually re-brewed at the summer party! Upon request, tastings can be arranged in six weeks, in Munich. At night, the band “Felix and the Machines” played wonderful live rock/indie/pop music and we were delighted to see almost everyone dance. We thank all our guests and helpers to make our Sommerfest a party to remember and we hope to repeat such an event, soon! After such a great evening, we might even wear our Hawaiian shirts again …

UPDATE *** JUL 26, 2018 +++ UPDATE:

Look at these beautiful babies, 6 weeks after our Sommerfest – don’t they look delicious? They are all little “Staburators”. Tastings can be arranged in our office! Just contact us!

Staburo poster presentation at PSI 2018

Staburo Managing Director Dr. Hannes Buchner will present the enhanced rank-preserving structural failure time method (eRPSFT), to adjust for treatment switching in 3-arm superiority trials. Meet Hannes personally at the PSI 2018 conference “Breaking Boundaries in Drug Development” from 3rd to 6th June 2018 in Amsterdam.

Introduction to the topic

Rapid progress in oncology and the according approvals of medications leads to fast and frequent change in the standard of care (SOC). Therefore, in trials with more than 2 arms, the comparison between investigational therapy (A) and former SOC (C), and the comparison between treatment (A) and alternative treatment therapy (B), the new SOC, are of interest. With new effective treatments, some of the patients will switch from treatment B or SOC therapy at some time point during the study period to treatment A. Treatment switching is not just an issue for economic evaluation. It is a problem for clinical and economic assessment.

Conclusions from our work

The enhanced RPSFT performed good with small bias for the calculations. Calculated confidence limits from the RPSFT model containing the true expected HR, for every comparison made. The uncorrected HR overestimates the true effect much more than the corrected HR. Only the confidence limits of the comparison of A vs. B in each scenario for the uncorrected HR contains the true expected HR, all other confidence limit exceed the HR. eRPSFT improves the estimation and should be used to adjust for treatment switching in 3-arm superiority trials.

If you are interested in Crossover Correction methods in Oncology, feel free to approach our colleague Hannes at PSI 2018 in Amsterdam or send us an email to info@staburo.com.

The Staburo Managing Directors Josef Hoefler and Roland Stieger had the opportunity to join the AGAH Annual Meeting in April 2018, here in Munich.

The conference focused on how to prevent or predict adverse drug reactions in early phase drug development. The major target organ systems were liver, kidney, CNS, cardiac function. Further sessions were dedicated to local tolerance and immunotoxicity.

The following questions were addressed in excellent expert talks and panel discussions.

• How can animal models and in vitro data help to estimate risk regarding human administration?
• How can kidney and liver function best be monitored in the settings of early phase trials?
• What do we need to know to assess potential CNS adverse drug reactions early on?
• What are the pathophysiological mechanisms leading to potential cardiac toxicity?
• What are the guidelines on non-clinical local tolerance testing?
• How to monitor immunotoxicity in novel immunological therapies?

The conference gave participants the opportunity to discuss these and additional questions with expert speakers, regulators and ethic committees members as well as colleagues from pharmaceutical industry, CRO and academia.

The meeting started with a one-day pre-conference workshop about basic terms and key concepts of pharmacovigilance with a strong focus on early phase drug development. This workshop offered an excellent preparation for the annual meeting for those who are not yet experts in the field.

Staburo participated in the conference and the networking opportunities and we were very happy to get to know new people in the field of clinical trials and to catch up with partners from client companies. Thank you for this great event in Munich!

Staburo at the Biometric Colloquium 2018 in Frankfurt

Staburo participated in the 64th Biometric Colloquium 2018 in Frankfurt, the annual meeting of the German Region of the International Biometric Society (IBS-DR). The conference was hosted by the faculty of medicine at the Goethe University and statisticians from pharmaceutical industry, academia and regulatory agencies from all over the world attended. The Colloquium’s main topic was “Biometry: Living Diversity”, which promised interesting talks, great discussions and new insights to a variety of topics. Some of the themes were “Bayesian Approaches”, “Survival Analysis”, “Adaptive Designs” and “Meta Analysis”, but also hot emerging topics as “Estimands and Missing Values in Clinical Trials” and “Health Technology Assessment” were discussed with statistics experts. On the other hand, more technical presentations about “Machine Learning”, “Multiple Testing” or “Non-parametric Methods” were held.

The reception in Frankfurt’s town hall and the conference dinner in the “Eisenhower Rotunde” at the Goethe University Frankfurt offered a great opportunity to meet participants and speakers of the conference, in a very festive environment. We are looking forward to next year’s conference!

Tumour growth over time

Longitudinal Data, Joint Models, and Surrogate Endpoints for Survival Analysis

Tumour burden has been shown to be associated with clinical outcomes in many oncological indications. To explore the impact of treatment on tumour growth over time, all available tumour measurements can be used. Patients with at least two valid tumour images and corresponding sum of diameters of target lesions, measured by RECIST, contribute to the Tumour-growth-Model. Mixed-effects models can be used to quantify the non-linear individual relationships between time from randomization and tumour burden. The model needs to be flexible, allowing for a wide range of different shaped growth curves (u-shaped, j‑shaped, n-shaped, linear-shaped). Finding the optimal parameterisation via AIC and visual inspection of all individual fits, is time consuming but crucial. Such a Tumour-Growth-Model can be used to

• better understand the mode of action and investigate other factors influencing tumour growth
• investigate the influence of tumour kinetics on survival
• develop new (additional) surrogate endpoints for overall survival to improve future phase II go/no-go decisions
• improve future early PFS estimation in the same indication and line.

If you are interested in this topic, feel free to contact us anytime!