We are very happy to welcome Dr. Lena Herich and our new trainee Kim Hoang in our team. Lena joined Staburo earlier this year with her work experience and her excellent education background. She supports our clients in the areas of biostatistics & statistical programming as a Senior Biostatistician. Kim supports us, as a trainee, with her very good education and will further develop her practical skills in statistical programming and biostatistics. Click here to check out more informations about our Staburo Biostatistics Trainee Programm! We are looking forward to a great collaboration!

Staburo presentation on precision medicine @idalab

Dr. Nicole Krämer, project leader precision medicine and biomarkers, was invited to talk about precision medicine at the idalab seminar. In the talk, she discussed how data science may identify biomarkers that help patients choose their best treatment option.

After the talk, there was the opportunity to get together with the audience and discuss this exciting topic.

Check out the slides here:

https://www.slideshare.net/idalab/idalab-seminar-10-precision-medicine

Staburo’s Managing Director Roland Stieger will join the BIO-Europe for the fourth time and will enjoy the good organization and networking opportunities of this partnering conference.

For the first time, we will have our own booth at the bavarian pavilion. At our stand, you can approach Roland (if he is not at the partneringONE meetings) to talk about your current and future biostatistics challenges. If Roland is not there, please leave your card or a note and he will contact you.

Here you find some live footage of Roland by labiotech.eu from last year’s BIO-Europe in Berlin:

***UPDATE***8NOV2018***

We thank you for all the great meetings and visits to our booth!

Pilot study on Effectiveness of Cannabis to Reduce Opioid Addiction

We recently performed the analysis for a pilot study, investigating whether cannabis consumption may be beneficial in helping people reduce their addiction to opioids.

The results were also presented at the 19th Interdisciplinary Congress for Addiction Medicine congress at LMU Munich.

Background of this study

Of the approximately 79,000 opioid-substituted patients in Germany, about 50% regularly smoke cannabis (Wedekind et al., 2010). The prevalence is thus 15 times higher than in the general population (Orth, 2016). Basic data on the cannabis use of opioid-dependent patients are lacking. There are indications that the cannabinoid cannabidiol (CBD) may reduce the morphine-dependent reward response in the brain and the relapse rate in morphine dependence (Markos et al., 2017). Clinical data is missing so far.

Aim

The aim of this study is to gain insights into the cannabis addiction behaviour of ambulatory opioid-substituted patients. The focus here is on the amount of cannabis consumed, frequency of consumption, consumption motives, any withdrawal symptoms, wishes for change and cannabis-related problems. In addition, the relationship between cannabis use and co-morbidities and between THC, CBD, CBN, nicotine serum levels and consumption is examined. Special attention will be paid to the potential influence of substitution agents and dose on cannabis addiction.

Method

Cannabis-specific addiction history was collected in 129 opioid-substituted patients. Data on opioid substitution dose, additional medication and somatic and psychiatric co-morbidities were taken from the existing patient records. THC, CBD, CBN, and nicotine serum levels were determined in the blood.

Conclusion

Cannabis use had the following characteristics in the investigated patient group (n=129): Prevalence 41.9%, average consumption 1 g/day (min. 0.1 g/day, max. 5 g/day), average age at start of consumption is 14 years (min. 12 years, max. 35 years), SDS score >= 4: 56.9% of regular users.

Initial analyses indicated significantly higher opioid substitution doses (p=0.026) among regular cannabis users.

The collection of the cannabis-specific addiction history and comparable serum levels in this specific patient group, is the basis for further cannabis addiction research and therapy approaches in opioid-substituted cannabis users. The study population showed a significantly higher prevalence of cannabis use, compared to the total population and 56.9% of the users had a cannabis dependence, according to SDS score criteria (cut-off =4). The increased opioid substitution doses in the group of cannabis users, seem to contradict the hypothesis of a lower opioid requirement in this patient group, whereby a bias cannot be ruled out due to negative concomitant circumstances.

Change in non-small-cell lung cancer tumor size in patients treated with nintedanib plus docetaxel: analyses from the Phase III LUME-Lung 1 study

With the help of Staburo, a typeset manuscript has been published in its final form on the Dove Medical Press Ltd website. You can view and download it here: https://www.dovepress.com/articles.php?article_id=39709.

The study investigated the change in nsclc-tumor size in patients treated with nintedanib.

Background: Nintedanib in combination with docetaxel is approved in the European Union and other countries for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) of adenocarcinoma histology after first-line chemotherapy, based on the overall survival findings of Phase III LUME-Lung 1 study. Change in target lesion size over time as a treatment effect was assessed in patients from this study.

Methods: Tumor size was evaluated using predefined tumor measurements. Mixed-effects models were used to quantify individual relationships between time from randomiza­tion and tumor burden, measured as the sum of longest diameter (SLD) of target lesions and assessed by an independent review (Response Evaluation Criteria In Solid Tumors [RECIST] v1.0). Exploratory analyses were conducted on the overall adenocarcinoma popula­tion, adenocarcinoma patients with time from start of first-line therapy ,9 months (TSFLT ,9), adenocarcinoma patients who had progressive disease as best response to first-line therapy (PD-FLT), and in squamous cell carcinoma patients.

Results: Estimated mean baseline SLD was 82.5 mm in the adenocarcinoma (n=658), 88.3 mm in the TSFLT ,9 (n=405), 98.1 mm in the PD-FLT (n=117), and 94.3 mm in the squamous cell carcinoma (n=555) populations. Treatment with nintedanib/docetaxel showed a significant reduction in tumor size over time (P,0.0001) in patients with adenocarcinoma compared with placebo/docetaxel, and in patients with squamous cell carcinoma (P=0.0049). Treatment difference at 6 months was 9.7 mm in the overall adenocarcinoma population, 16.8 mm in the TSFLT ,9 population, 19.7 mm in the PD-FLT population, and 6.8 mm in the squamous cell carcinoma population. SLD at 2 months post-randomization was identified as a surrogate endpoint for overall survival, in addition to progression-free survival, for all except the PD-FLT population.

Conclusion: Treatment with nintedanib/docetaxel significantly decreased tumor burden and decelerated tumor size over time compared with placebo/docetaxel in the overall adenocar­cinoma population, including in patients with the poorest prognosis due to aggressive tumor dynamics.

Staburo supported Scientific Advice at BfArM

Staburo’s Managing Director Josef Höfler prepared and took part in a Scientific Advice meeting at the agency BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) in Bonn.

At the BfArM, roughly 1,000 employees (physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants, administrative staff etc.) are involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors. The most important aim of these activities is to increase the safety of medicinal products and thus that of the patients.

In this Scientific Advice, a client’s Biosimilar Clinical Development Program was discussed with the authorities, client representatives, consultants and Staburo’s Managing Director Josef Höfler. Main topics of the meeting were study design of the pivotal trial, including sample size considerations, primary endpoint and statistical analysis.