An interview with Heiko Goette, Biostatistician, Merck

SMi Group’s next 11th annual conference is thrilled to welcome Heiko Goette, Biostatistician from Merck speaking about simulated development programs that are shaping state of the art adaptive design techniques.

With the growing popularity in use and acceptance of adaptive designs in clinical trials – demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.

For this reason, the Adaptive Designs in Clinical Trials conference taking place 1st-2nd April 2019 in London, will be hosting in depth presentations from regulatory agencies, researchers and biostatisticians. The meeting will cover how personalized medicine, platform trials, response-adaptive randomization, signature designs, estimand framework, Bayesian methods and digital innovation are revolutionizing the drug development process both in Europe and North America.

SMi Group are delighted to have been able to catch up with Heiko Goette, Biostastician from Merck about the upcoming event in April.

Heiko has been a Biostatistician at Merck KGaA in Germany since 2009. Before this he spent 5 years working as a research assistant at the Institute of Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg-University Mainz, Germany. He graduated with a Statistics major, University of Dortmund, Germany in 2004 and received his doctorate in 2008 from Johannes Gutenberg-University Mainz, Germany.

Read a snapshot of his interview below:

Q: What is your area of expertise within the industry and what are your current interests within adaptive designs?

A: “Due to my consulting activities for internal Biostatistics colleagues, I think, I have a quite broad overview on different topics. However, innovative and adaptive designs as well as their associated decision rules are of special interest to me.”

Q: What do you see as the largest hurdle in the use of adaptive designs in clinical trials for the pharmaceutical industry?

A: “Thorough evaluation of risk and changes associated with a complex adaptive design require a lot of investment in terms of time and resources. In confirmatory adaptive designs decision rules even need to be prespecified in the planning phase and these decision rules are applied by an independent monitoring board. In contrast, non-adaptive designs can be planned quite fast and allow flexible decision making using the totality of data at the time of analysis. Therefore, taking all aspects into account non-adaptive approaches also have advantages.”

Q: Which presentation or topic are you most looking forward to at this year’s conference and why?  

A: “I would not pick one here. It is rather the diversity of topics around adaptive designs with the opportunity to learn from and interact with many colleagues from academia, regulatory and industry.”

Visit the event website to read Heiko’s full speaker interview and download the conference brochure at

Attendees of the two-day conference will have the opportunity to meet and network with key industry and thought leaders shaping state of the art adaptive design techniques.

For those looking to attend there is currently a £200 early-bird saving. Register online at



1-2 April 2019

Holiday Inn Kensington Forum, London, UK


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About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at