EXACT Qualification

Qualification for use in drug development trials in COPD

The history of the EXACT and E-RS are described in Leidy and Murray 2013 and Murray and Leidy 2018.

A list of publications using the EXACT and/or E-RS are provided here.

8 March 2016

8 March 2016
- The FDA released a Draft Guidance on Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use.
13 April 2015

13 April 2015
- The EMA released a Draft Qualification Opinion of Qualification of Exacerbations of Chronic Pulmonary Disease Tool (EXACT), and EXACT-Respiratory Symptoms Measure (E-RS) for Evaluating Treatment Outcomes in Clinical Trials in COPD.
9 January 2014

9 January 2014
- The FDA released a Draft Guidance on the Qualification of the EXACT for the Measurement of Symptoms of Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease.

These documents specify that the EXACT and E-RS:COPD are qualified for use as exploratory endpoints in drug development trials evaluating the effect of treatment on exacerbations (EXACT) and respiratory symptoms (E-RS:COPD) of COPD.

This does NOT preclude their use as secondary, co-primary, or primary endpoints. Sponsors should discuss their proposed use of the EXACT and/or E-RS with regulatory authorities prior to positioning in pivotal trials. Decisions related to positioning and potential for labeling claims will be made on a case-by-case basis.

Qualification

Qualification for use in drug development trials in COPD

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