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Impact of FDA Guidance for Developing Diabetes Drugs on Trial Design: From Policy to Practice

  • New Therapies for Cardiovascular Disease (KW Mahaffey, Section Editor)
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Abstract

In 2008, the US Food and Drug Administration (FDA) issued guidance requiring robust assessment of cardiovascular safety for all antidiabetic drugs to be licensed in the future. Here, we review the circumstances giving rise to the FDA guidance and describe the characteristics of clinical trials registered on ClinicalTrials.gov in the 36 months before and after the guidance was issued. We noted a doubling in the number of cardiovascular outcome trials registered and a sixfold increase in the median number of patients included in cardiovascular outcome trials in the latter 36 months. As the size and duration of follow-up for these trials increases, the clinical trials industry will need to adapt. The present review summarizes current attempts to streamline trial design and management to meet the requirements efficiently while adhering to the highest scientific standards.

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Abbreviations

PROactive:

Prospective Pioglitazone Clinical Trial in Macrovascular Events

RECORD:

Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

TECOS:

Trial Evaluating Cardiovascular Outcomes with Sitagliptin

TIDE:

Thiazolidinedione Intervention with Vitamin D Evaluation

TOSCA IT:

Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents Intervention Trial

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Papers of particular interest, published recently, have been highlighted as: •• Of importance

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Acknowledgment

We would like to thank Ada Tse for her assistance with management of the exported ClinicalTrials.gov data for this analysis.

Disclosure

No potential conflicts of interest relevant to this article were reported.

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Authors and Affiliations

  1. Diabetes Trials Unit, University of Oxford, Churchill Hospital, Old Road, Headington, OX3 7LJ, UK

    M. Angelyn Bethel & Harald Sourij

  2. Division of Endocrinology, Department of Medicine, Duke University Medical Center, Durham, NC, USA

    M. Angelyn Bethel

  3. Division of Endocrinology and Metabolism, Medical University of Graz, Graz, Austria

    Harald Sourij

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  1. M. Angelyn Bethel
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Correspondence to M. Angelyn Bethel.

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Bethel, M.A., Sourij, H. Impact of FDA Guidance for Developing Diabetes Drugs on Trial Design: From Policy to Practice. Curr Cardiol Rep 14, 59–69 (2012). https://doi.org/10.1007/s11886-011-0229-7

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  • DOI: https://doi.org/10.1007/s11886-011-0229-7

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