G-BA approves Staburo supported study on cancer treatment through stem cell transplantation

A new study in collaboration with Universitätsklinikum Hamburg-Eppendorf (UKE) and CTC North GmbH & Co. KG has been approved by the German Gemeinsamer Bundesausschuss (G-BA) on December 4. The G-BA has commissioned the UKE to research the benefits of allogeneic stem cell transplantation to treat multiple myeloma in relapsed/progressive patients. The project is led by principal investigator Prof. Dr. Nicolaus Kröger of UKE. Staburo GmbH is responsible for the statistical analysis. More information can be found in the press release of the G-BA (https://www.g-ba.de/presse/pressemitteilungen/917/).

Staburo presented @ workshop from the working group Pharmaceutical Research (APF)

On November 27, Staburo Managing Director Dr. Hannes Buchner gave a talk at the 74th workshop of the APF (Arbeitsgruppe Pharmazeutische Forschung) of the Deutsche Region der Internationalen Biometrischen Gesellschaft (IBS-DR). Together with Kaspar Rufibach from Roche Pharma, he presented new findings from their Oncology Estimand Working Group in the talk “Estimands update: Summary of world-wide authority interaction”. In his part of the talk, Dr. Hannes Buchner explained how to correct for treatment switching in clinical trials and how it can be included into the estimand framework.

The virtual APF workshop titled “COVID-19: Effects on statistics, methodological aspects and operational implications” was organised for biometricians working in pharmaceutical research and development, to accelerate the exchange of methods among colleagues as well as to transport mutual information on official regulations, methodological developments, and scientific events.

UPDATE 22-DEC-2020 (Thanks for sharing, Kaspar Rufibach)

For those interested to learn more: the slidedeck Hannes Buchner and Kaspar Rufibach presented is available on the webpage of the oncology estimand WG: www.oncoestimand.org (go to “Events”).

Staburo @ the DIA Global Clinical Trial Disclosure & Data Transparency Conference 2020 

Staburo participated in the 2020 Global Clinical Trial Disclosure & Data Transparency Conference hosted by the Drug Information Association (DIA) from the 16 – 18 November, this year online due to – you guessed it – covid19.

During the conference different regulatory agencies such as the FDA and the EMA provided updates concerning their disclosure platforms. The FDA provided an overview of new and upcoming features of ClinicalTrials.gov which are of immediate use to us in our day to day work disclosing studies on this platform. The EMA discussed the upcoming release of their new central European disclosure platform CTIS (Clinical Trials Information System) which will mark a major shift in the way clinical trials are disclosed in the EU.

Besides the regulatory agencies a range of industry experts joined the conference, leading to interesting discussions about topics such as the global harmonization, BREXIT, disclosing medical device studies and the future of clinical trial regulation. These talks provided valuable insights into the current state and future goals of global clinical trial disclosure.

We are looking forward to participating in next year’s conference where we can hopefully meet the speakers and attendees in real life!

If you have any questions about our disclosure services, don’t hesitate to contact us!

Staburo @ working group pharmaceutical research (APF) workshop 

Staburo Managing Director Dr. Hannes Buchner will talk about “Estimands update: Summary of world-wide authority interaction” together with Kaspar Rufibach from Roche at the 74th Arbeitsgruppe Pharmazeutische Forschung (APF) workshop on November 27, 2020.

The current workshop will take place virtually on November 27, 2020, on the topic “COVID-19: Effects on statistics, methodological aspects and operational implications”. The current agenda can be found here: http://www.biometrische-gesellschaft.de/fileadmin/AG_Daten/PharamzeutischeForschung/PDFs/Agenda_APF_74_virtuell_Nov_2020.pdf

APF aims to establish contacts between biometricians working in pharmaceutical research and development, to accelerate the exchange of methods among colleagues and, if necessary, to develop new methods, as well as to transport mutual information on official regulations, methodological developments and scientific events.

Pre-registration for the workshop and for the virtual evening meeting is required and can be done here: http://www.biometrische-gesellschaft.de/fileadmin/AG_Daten/PharamzeutischeForschung/PDFs/Anmeldung_APF_Workshop_Nov2020_01.pdf 

To register, please download the registration form, fill it out and follow the instructions in the document. Registration is requested by November 20, 2020.