gms | German Medical Science

Kongress Medizin und Gesellschaft 2007

17. bis 21.09.2007, Augsburg

Medical imaging as a surrogate endpoint in clinical trials: late phase studies using centralized independent medical image review for FDA or EMEA submissions

Meeting Abstract

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  • Gunter Bellaire - Parexel International GmbH, Berlin

Kongress Medizin und Gesellschaft 2007. Augsburg, 17.-21.09.2007. Düsseldorf: German Medical Science GMS Publishing House; 2007. Doc07gmds029

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/gmds2007/07gmds029.shtml

Veröffentlicht: 6. September 2007

© 2007 Bellaire.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Introduction: Imaging techniques such as computer tomography (CT), magnetic resonance imaging (MRI), and conventional radiography can provide insight into drug safety and efficacy faster than traditional clinical endpoints. Surrogate endpoints in clinical trials are widely used. They speed up the drug development process and save cost.

Centralized Independent Review Method: Adopting an imaging strategy however, introduces challenges, particularly around the potential variability of imaging data collected in multicenter trials and the interpretation of that data. Centralized independent review of imaging data reduces the variability and bias inherent in these types of trials.

For pivotal clinical trials regulatory authorities request the inclusion of such a centralized independent review. The FDA offers a SPA (special protocol assessment) process to sponsors to make sure the imaging protocol (charter) is aligned with the authority’s expectations. Our current experience shows that 90% of phase III trials presented to the FDA use the SPA process. The charter describes the independent review process. It contains: protocol background and imaging endpoints, image acquisition and preparation for review, how the independent review process is carried out, used review criteria e.g. modified RECIST, WHO and how the selection and training of the independent reviewers ensures that reviewer variability is minimized.

Data Analysis: To demonstrate the advantage of independent central review we will look at phase III (pivotal) studies. We will discuss exemplary adjudication rates and at inter variability rates at a time point level.

Conclusion: Particularly in large multi-center trials, different clinical imaging standards at sites and technological discrepancies between available modalities can significantly impact the analysis of imaging data, endpoint derivation and trial outcome. Centralized independent review is thus vitally important. It ensures that the acquisition of images by sites is standardized and reviewer variability is minimized. Its value in trials is recognized, and this increases the likeliness of drug approval by regulatory bodies.


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