Implementing Adjusted Imaging Metrics Within Roche With the Metrics Champion Consortium: Experiences and Outcome

Therapeutic Innovation & Regulatory Science
Andrew McDonald, Gudrun Zahlmann

Abstract

To implement adjusted performance imaging metrics on imaging clinical trials of a pharmaceutical company (Roche) in a business relationship with preferred imaging providers and to report on findings and lessons learned. In 2009 the Metrics Champion Consortium provided the first imaging metrics for use in clinical trials as industry consensus. Roche reviewed, adjusted, excluded, and extended these metrics and defined target values per metric in order to implement them in all clinical trials with 7 preferred providers. Roche preferred providers were able to report on all 19 metrics (8 unchanged Metrics Champion Consortium, 7 adjusted, and 4 Roche defined). Seventy-three Roche studies over 27 months form the basis for reporting; data are provided as mean and standard deviation per disease area with number of studies and for all studies reported for the specific metric for all providers. Disease areas are oncology, central nervous system, and inflammation. Seventeen metrics have proven to be useful; 2 metrics did not provide sufficient information; and 4 metrics need adjustments of target values. Imaging trial-related metrics are a new concept, and Roche and providers had to develop the same consistent understanding of content and ...Continue Reading

References

Feb 20, 2008·Clinical Trials : Journal of the Society for Clinical Trials·Christopher B Granger Feng Zhao

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imaging techniques

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Roche

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