Learn from Michael Krams how to create an environment where adaptive designs can become the norm

LONDON - Jan. 30, 2014 - PRLog -- "Adaptive clinical trials might be globally embraced if the current preoccupation with fixed trial designs was viewed as an “engineering problem” requiring a lot of talk and teamwork between adaptive design experts", said Michael Krams, MD, vice president & head of the neurology franchise at Johnson & Johnson (J&J).

Michael Krams is widely considered the ultimate champion of adaptively designed trials, having implemented them at Pfizer, Wyeth, and now J&J (see, “Michael Krams, Biting the Adaptive Trials Bullet,” May 2007). But more important than the trials themselves is the potential beneficial impact of adaptive designs on societal health, he said.

Reformulating entrenched processes to favor adaptive designs requires top-down leadership and the enabling infrastructure at individual companies as well as industry-wide collaboration, said Krams.  A cooperatively developed and published “integrated blueprint for efficient support infrastructure” is among his key proposals for moving the industry from a “fast-to-milestone to a fast-to-patient” mindset. The education piece is also crucial and might include high-level workshops, university courses on the pharmacological basis for adaptive trials, and efforts directed at change opponents within individual companies, he adds.

To take root, the adaptive approach needs to be implemented across therapeutic sectors, if not entire companies, Krams said. At J&J, every new molecular entity declaration prompts a roundtable meeting to map out a development strategy using scenario analysis to scout out opportunities across study programs. Support from not only drug supply management but also finance is critical, as study budgets might range from $1 million to $20 million versus traditional point estimates.

“It’s all about change management,” said Krams. “If the objective is to get to the correct answer, then the decision-making framework needs to identify the best research question and the best way to answer that question in the most cost-efficient manner.”  Instead, large companies “incentivize for faster-to-next-milestone thinking.” The quality of phase III studies is consequently “a societal problem of incredible dimension,” he said. “Billions of dollars are wasted because we don't talk enough.” Outcomes would likewise improve if more time was spent analyzing study results, planning subsequent ones, and key experts “endorsed” patients into phase III trials. - Krams: How to Popularize the Adaptive Approach, Bio-IT World, by Deborah Borfitz, November 20, 2012

Dear Ms Jocelyn G Noon, on this topic, SMi would like to invite you to learn from Michael Krams how to create an environment where adaptive designs can become the norm at the 8th annual Adaptive Designs in Clinical Trials conference, held in central London on the 24 & 25 March 2014.

Mr Krams will be giving a presentation about Application of Adaptive Design in PPP's:

Building infrastructure to apply broadly in a scalable fashion

Creating an environment where adaptive designs can become the norm

The execution and how to ensure this happens

He will also be participating in a panel discussion, sponsored by Cytel, about Adaptive Designs: Barriers and the Future

Critical appraisal of adaptive designs: where are the real gains?

Is wider acceptance linked to how the methods fare in the public sector?  To become common practice more people need to be using the approach – not just the pharmaceutical industry

Has there been a collective "undue advocacy" of adaptive trials by proponents?  Have we unintentionally created unrealistic expectations of improving outcomes and/or efficiencies?

Will the adjective "adaptive" be dropped some day, as all trials will be adaptable (in one form or another)?

How will trends toward modeled patients (physically and virtual) change the future of trials? Will we see trials without humans in our lifetime?

Christopher Jennison, Professor of Statistics , University of Bath
Michael Krams, MD, Global Head, Quantitative Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson
Pantelis Vlachos, Principal Biostatistician, Strategic Consulting, Cytel
Loic Darchy, Head of Statistical Methodology Group , Sanofi R&D
Sue Todd, Professor of Medical Statistics, University of Reading

For more information about the programme and speakers visit http://www.smi-online.co.uk/2014adaptivedesign37.asp or contactHusaina Durrant on +44 (0) 20 7827 6070 or email hdurrant@smi-online.co.uk