Staburo @ BIO^M Workshop „Medical Writing in Clinical Trials“

Medical writers aim to communicate complex clinical and scientific information clearly to a variety of target audiences.

One important application of medical writing is the field of clinical trials and drug development.

The Bio^M workshop focused on the main task of medical writers in this area: regulatory writing. Examples were given, how to write effective clinical study protocols (CSP) and clinical study reports (CSR) and how transparency and disclosure impact clinical trial documents. According to the speakers, good project management and teamwork are crucial for producing high quality documents, since CSP and CSR writing is a complex process. Moreover, excellent writing is essential so that health authorities can judge the risks and benefits of a drug, a clinical program or a healthcare product.

The hands-on exercises “Protocol writing management” and “Anonymisation techniques” enabled attendees to experience the “bread and butter” activities of a medical writer. After the exercises, results were discussed and useful tools and practical approaches were given.

The “Medical Writing in Clinical Trials” workshop provided Staburo with a vivid insight into the daily life of a medical writer and also offered a chance to interact with other Bio^M event participants.

Since Staburo also offers to deliver statistical reports (standalone or as part of the CSR), this workshop will probably increase speed and quality of our services.

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.