Disclosure: FDA continues to take action on failure to submit required clinical trial information

Last month, the FDA sent out a 3rd notice of noncompliance for not submitted clinical trial results, for the first time to the primary investigator of an academic trial.
The previous notices, sent out in April and July of 2021, were related to trials from industry sponsors.
Trial sponsors risk a fine of up to $ 10,000 for noncompliance with US federal law.

The time to check your compliance with FDA’s disclosure regulations is now!

Staburo’s team of disclosure experts can provide exactly the advice and support you need: From checking general disclosure requirements of your studies, providing input to your trial protocols for disclosure readiness, to finally posting your study results in time on clinicaltrials.gov.

Get in touch with us – we are looking forward to working with you!

See: ClinicalTrials.gov – Notices of Noncompliance and Civil Money Penalty Actions

Staburo’s Isar picnic

Finally, some socialising again!

Since we all still work mainly from home, we were really looking forward to having a picnic together on the Isar – in the fresh air and with a lot of distance. Unfortunately, the weather didn’t quite play along, so we had to move our event from the Isar to our office courtyard equipped with large umbrellas.

The highlight of the get-together was the award ceremony for our Staburo Euro 2020 football tipp game, with lots of sweets and a real pinata for the winner!

The food with various tartes and salads was delicious and the atmosphere was great. Hopefully these get-togethers will be possible more often soon again!

JCO published results of Staburo-supported study investigating stem cell transplantation as a reasonable treatment option for older MDS patients

The results of the so-called VidazaAllo Study – with Universitätsklinikum Hamburg-Eppendorf (UKE) being the sponsor – has been published by the Journal of Clinical Oncology (JCO) on July 20. The key objective of the VidazaAllo Study was: Can allogenic stem cell transplantation (HSCT) in older patients with myelodysplastic syndromes (MDS) improve overall survival in comparison with standard 5-azacytidine (Vidaza) therapy? The project was led by the principal investigator Prof. Dr. Nicolaus Kröger of UKE. Staburo GmbH contributed to the conception and design of the study and was responsible for all statistical data analyses and interpretation. The article is published here.

You would like to meet Dr. Gabriele Bleckert and Dr. Hannes Buchner, who supported this study? They will be hosting our next Academy course – the Estimands workshop in September. Check out our Staburo Academy website and sign up!

Staburo estimands online workshop

The gold standard for evaluating medical interventions is a randomised clinical trial with statistical analysis based on the intention-to-treat population. However, even if a randomised clinical trial is well planned, post-randomisation events occur and affect or even challenge the interpretation and validity of the study results.

In November 2019, ICH published an addendum to the ICH E9 guideline to address such problems by the so called “Estimand Framework”. This framework aims to ensure an alignment of trial objectives, study design, data collection, and choice of statistical analysis methods – at the stage of protocol writing.

The interactive workshop is designed for all stakeholders of a clinical study and will include many active training elements (50:50 ratio of theory vs. training)!! You will be trained on all topics of the estimand framework. We will present and discuss examples from various study phases and different medical indications. After this hands-on training you will be confident in developing and writing estimands for study protocols.

The course will be held in English and the detailed agenda will be sent out a few days before the start of the course. You find more details and how to register here!

Staburo @ CDISC 2021 Europe Interchange 

Data standards are of vital importance to transparent, high quality, efficient analysis and decision-making in all stages of clinical (and preclinical) research. Staburo was represented at the Clinical Data Interchange Standards Consortium (CDISC) 2021 Europe Interchange virtual conference, which took place from 28-30 April, to keep track of the latest developments in the field. Among the major themes of the conference were the integration of the data standards environment (e.g. CDISC, HL7 FHIR, OMOP Common Data Model), the implementation of the “biomedical concepts” approach in CDISC, and automated metadata processing and utilisation (e.g. via metadata repositories such as the CDISC Library). Besides the discussion of new technical developments, the presentations included case studies, showcasing of educational material and software tools, and regulatory perspectives. The challenges posed by the Covid19 pandemic were given special attention, including a presentation on the current status of vaccine development by the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks.

Staburo Academy online course “Machine learning and high-dimensional methods”

Our course “Machine learning and high-dimensional methods” will be a 2-day course from 07 to 08 June 2021!

In the digital era where the collection of data is permanently increasing and phrases like “data mining” and “big data” are omnipresent, knowing how to turn the data into useful information is an essential skill. Therefore, basic knowledge of the most state-of-the-art machine learning techniques is an important instrument, not only for the ability to perform the appropriate statistical analyses in various settings, but also for a better understanding and interpreting of study results.

With this course you will get an insight into a variety of statistical methods for high-dimensional data ranging from parametric methods like PCA and LASSO to non-parametric machine learning methods like Random Forests, Boosting, SVMs and Neural Networks. In addition, these methods will be illustrated by real data applications in R.

The course will be held in English and the detailed agenda will be sent out a few days before the start of the course. You find more details and how to register here!