Imagine we had a cure for cancer, but patients don’t receive it?

This sounds very disturbing, but it can happen to the most effective drugs, if Crossover Correction is not taken into account.

To share our profound expertise on this topic, our Head of Biostatistics Dr. Hannes Buchner gave a presentation on “Introduction to Crossover Correction Methods in Oncology” at Roche.

In randomized controlled clinical trials, patients are divided into a treatment and a control group, in order to measure the effectiveness of a new drug. In Oncology studies, patients may receive additional anti-cancer drugs during the study – planned or unplanned – and can change treatment groups (crossover, cross-in), if disease progression makes this necessary.

This allows a good estimate of progression-free survival (PFS) in most cases, but not of the clinically more important overall survival (OS) outcome.

While drug approval by FDA or EMA can also be achieved without a significant OS effect (as long as PFS and other efficacy measures indicate drug efficacy), Health Technology Assessment benefit analyses often only value OS results.

As a consequence, correction methods such as RPSFT (Rank Preserving Structural Failure Time), IPE (Iterative Parameter Estimation), IPCW (Inverse Probability Censoring Weights), and IPTW (Inverse Probability of Treatment Weights), which were presented in this talk, are becoming very, very important, to reach an acceptable price for innovative new medicines.

Without Crossover Correction methods, e.g. with a simple ITT analysis, the effectiveness of a drug cannot be properly estimated, if crossover occurs. The timing of crossover can influence the progression of the patient’s condition and also its survival times.

The consequences for the well-being of affected patients can be devastating, since the wrong choice of the method or the ignorance of crossover implications in Oncology trials, can lead – in the worst case – to the non-admission of extremely effective medications.

At Staburo, we support our international clients in Crossover Correction method application, to prevent cases of very effective drugs not reaching the market and the patient. Our goal is to become the first point of contact on this topic, worldwide.

Staburo will take part in this year’s BVMA symposium on 24 November 2017, at the Westin Grand Hotel München, here in Munich.

The BVMA represents the interests of its German CRO members. The BVMA members maintain a lively exchange of information on all topics that are of importance to the CRO industry, e.g. on questions of liability and insurance, education and training, quality requirements and trends in the pharmaceutical and CRO industry.

Since this year will be the 25. BVMA symposium, the get-together will take place on 23 November 2017, in the festive atmosphere of the famous German Museum, probably with a much longer networking session then in recent years (like Night at the Museum).

This year’s symposium sessions will give an update on clinical research in a changing Europe (e.g. digital transformation, Brexit), regulatory changes and patient safety in clinical studies.

We are looking forward to learn more about the need of current partners and other companies in the area of biostatistics at the symposium. We thank the BVMA for the organisation of the event and for the invitation, already in advance!

Update:

Fotos of get-together in the German Museum and BVMA symposium:

Staburo’s Head of Biostatistics Dr. Hannes Buchner took part in the first Roche Future X Healthcare 2017 event in Munich. The topic was „Making Data Meaningful – from Science to Patients“, a motto that could easily fit to our daily work at Staburo.

The agenda started with an introduction by Dr. Ursula Redeker (Spokesperson of the Executive Board, Roche Diagnostics GmbH) and patron Ilse Aigner (Bavarian Minister for Economic Affairs, Media, Energy and Technology) and was followed by inspiration talks, networking @ its best and a panel discussion: „Personalised Healthcare in a Digital Era“, with networking opportunities in between. A little more diversity in the panel discussion would have added the cherry on the sundae.

The award winners for FXH Scientific Excellence and FXH Start-up were announced afterwards, in a oscar-like ceremony. Very professional video footage of the barcamps for participants in both competitions was shown, which was very entertaining. There were even unique awards designed and crafted by Munich art students. The FXH Scientific Excellence award was won by Lara Schneider, from University of Saarland. FibriCheck, a medically certified screening and monitoring application for the detection of irregular heart rhythms, won the FXH Start-up award – great idea and potentially a lifesaver!

The Roche Future X Healthcare 2017 was an event, which was a big advertisement for Roche, Bavaria and the connected healthcare data science start-up and academic scene.

We are very happy that media and client interest puts these former niche topics on the agenda, so if you need a partner to make your data meaningful, don’t hesitate to contact Staburo today!

Staburo’s Managing Director Roland Stieger joined the BIO-Europe for the third time and enjoyed the good organization and networking opportunities of this partnering conference.

The event started with a great panel discussion, with relevance for Staburo “The evolving role of Real World Evidence in regulatory approval and reimbursement decisions” (panelists: Stella Blackburn, IQVIA; Janice Haigh, PAREXEL; Athula Herath, Novartis).

Since some of these data analyses are pretty non-standard, we see a lot of potential to support big pharma clients for a niche data expert CRO like Staburo.

Furthermore, there were other relevant panel discussions about “Health Technology Assessment in Europe” and also very interesting ones, like a “Startup Slam” where entrepreneurs could pitch their biotech ideas.

Roland Stieger attended the well organized official BIO-Europe receptions and invite-only events like the BIOCOM PanAm-Lounge, great location by the way! Thanks to EBD for this conference and see you next year in Copenhagen.

Here you find some live footage of Roland by labiotech.eu:

In this talk, an introduction into CDISC, especially in SDTM and the strategy how to program it, were presented.

The talk started with general information and important terms about the fundamentals of SDTM. We discussed the different kinds of datasets and how variables can be classified. Furthermore, we talked about the use of the controlled terminology.

The second part of this talk was about programming of SDTM domains. Steps and tips how to create datasets, Trial design model datasets, sponsor defined domains, and the appropriate specification sheet, were presented. Finally, the QC with Pinnacle21 was discussed.