Taking it off the ground

A key clinical trial had to start quickly to test if an established Roche drug helped seriously-ill COVID-19 patients. We speak to Roche veteran Stefan Frings who is coordinating some of these efforts.

You and your colleagues have been working full speed to get this trial running. Can you tell us a bit more about the purpose of the trial?

COVACTA, as the trial is called, is studying Actemra in seriously ill patients with COVID-19 associated pneumonia. One of the endpoints is to see whether it will reduce the number of patients requiring mechanical ventilation or shorten the time on mechanical ventilation for those patients already receiving it. Every day we can save during this endeavour and have the results earlier, the better it is for all stakeholders involved. Everyone working on this trial is keenly aware of this responsibility, and the expectations on the biopharma industry during the pandemic, and is making every effort to deliver.

Since the trial had to get started so quickly, what are some of the things that went differently?

The typical timelines for clinical trials just do not apply for this trial. From idea to first patient in, it was a matter of weeks. In fact, in our planning tool the timelines could not even be properly mapped as they were shorter than the most aggressive timelines foreseen.

There is a growing body of anecdotal evidence and data from clinical studies investigating the potential role of Actemra in COVID-19 associated pneumonia. What are the differences between these trials and COVACTA?

The key difference is really the design of the studies. The gold standard in clinical development to generate definitive evidence are randomised controlled trials which are ideally placebo controlled and blinded. While there are exceptions to this statement it is in general true and randomised trials are able to limit all kinds of biases.

Why is this important?

In disease such as COVID-19 pneumonia fortunately many patients are getting better without any specific treatment, e.g. just supportive care. Retrospective data analyses or prospective single arm trials which report how many patients have improved, didn't need ventilation and have survived, can by design not elucidate whether a specific intervention, e.g. a drug treatment improved the outcome or not (and one may not even exclude whether the intervention potentially worsened the outcome). By allocating patients to an intervention or control by chance (= randomisation) and when the treating physician and the patient both do not know (= double blind) whether the patient is receiving an active intervention or placebo further biases are reduced. For COVID-19 patients the baseline status (requiring no oxygen, requiring oxygen but no mechanical ventilation or requiring mechanical ventilation) are known prognostic factors for key outcome parameters such as hospital discharge or survival and thus should be in similar proportion in treatment arms of properly designed randomised trials (learn more about clinical trials).
With the COVACTA trial we have designed on purpose a trial which will be able to generate data with the highest level of evidence as it is randomised, placebo controlled and double blind.

How does it make you feel to be part of something of this magnitude?

I feel honoured and humbled to be part of Roche’s efforts to combat this pandemic. I expect that we will tell our grandchildren stories of how it was back then, when we worked in 2020 on diagnostic tests and molecules to identify and potentially treat the disease.

What have your major learnings been as you move this trial forward?

It is just amazing how much can be achieved if capable and dedicated people challenge the conventional wisdom around how we conduct trials. While the efforts for the trial have been terrific, there is always the ambition to achieve more. It is still amazing to see everyone’s passion and energy to advance not just this trial, but all the deliverables required to ultimately serve patients in need.

What kind of an impact has this trial had on your personal life? How stressed have you been?

I have to admit that the most stressful part was not able to work adequately from home due to insufficient internet bandwidth. Living near Grenzach (Germany) in the border triangle area, we do not have good mobile phone coverage either. So not being able to have a good voice connection, let alone dreaming about video connections in Hangouts or missing numerous calls from Bill (Bill Anderson; CEO Roche Pharma) and others, caused quite a bit of stress. The good news is that my access to high-speed internet was prioritised and for the past few months, I have a glass fiber connection. So finally, working from home has become not just feasible but also enjoyable.

Stefan Frings is Global Head of Medical Affairs within Roche Pharma Product Development since July 2020, and was previously Global Head of Strategy, Portfolio & Clinical Operations at Roche Pharma Research and Early Development (pRED). Having previously worked in Roche pRED, Global Medical Affairs, five years as Medical Director in Roche Germany, and almost a decade in Global Product Strategy, he was well equipped to mount a coordinated Roche response to the COVID-19 pandemic.

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