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Original Research: Diffuse Lung Disease |

The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet)IPFnet Diagnostic and Adjudication Processes: Diagnostic and Adjudication Processes

Joao de Andrade, MD; Marvin Schwarz, MD; Harold R. Collard, MD; Tedryl Gentry-Bumpass, BSBE; Thomas Colby, MD; David Lynch, MD; Robert J. Kaner, MD; for the IPFnet Investigators
Author and Funding Information

From the University of Alabama at Birmingham School of Medicine (Dr de Andrade), Birmingham, AL; the University of Colorado at Denver (Dr Schwarz), Aurora, CO; the University of California San Francisco (Dr Collard), San Francisco, CA; the Duke Clinical Research Institute (Ms Gentry-Bumpass), Duke University School of Medicine, Durham, NC; the Mayo Clinic Scottsdale (Dr Colby), Scottsdale, AZ; National Jewish Health (Dr Lynch), Denver, CO; and the Weill Cornell Medical College (Dr Kaner), New York, NY.

CORRESPONDENCE TO: Robert J. Kaner, MD, Weill Cornell Medical College, 525 E 61st St, 4th Floor, New York, NY 10065; e-mail: rkaner@med.cornell.edu


FUNDING/SUPPORT: The IPFnet was funded by the National Heart, Lung, and Blood Institute [Grants U10HL80513 (data coordinating center), U10HL80413, U10HL80274, U10HL80370, U10HL80371, U10HL80383, U10HL80411, U10HL80509, U10HL80510, U10HL80543, U10HL80571, and U10HL80685 (clinical centers)] and The Cowlin Family Fund at the Chicago Community Trust.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;148(4):1034-1042. doi:10.1378/chest.14-2889
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BACKGROUND:  The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes.

METHODS:  The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures.

RESULTS:  The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were often not collected, particularly when subjects were evaluated outside of the primary study site.

CONCLUSIONS:  The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as they incorporate AExs and hospitalizations as outcome measures.

TRIAL REGISTRY:  ClinicalTrials.gov; No.: NCT00517933, NCT00650091, NCT00957242; URL: www.clinicaltrials.gov

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