Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health: Table 1.

Author:

Talbot George H.,Powers John H.,Hoffmann Steven C.

Funder

National Institutes of Health

NIH

National Institute of Allergy and Infectious Diseases [NIAID]

NIAID

Actelion, Basilea, Bayer, Cubist

The Medicines Company, Merck, Nabriva, Roche, and Tetraphase

Pfizer Inc

Shionogi Pharmaceuticals

Theravance Inc

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Reference22 articles.

1. US Food and Drug Administration, Center for Drug Evaluation. Guidance for industry. Antibacterial drug products: use of noninferiority trials to support approval. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070951.pdf . Accessed 15 January 2015.

2. Powers JH , Patrick D , Walton M et al . ISPOR Clinical Outcome Assessment Task Force. Developing and evaluating Clinician-Reported Outcome (ClinRO) assessments of treatment benefit; emerging good measurement practices. Value Health. In press.

3. Clinical Outcome Assessments: Conceptual Foundation—Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force

4. Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force

5. US Food and Drug Administration, Center for Drug Evaluation. Guidance for industry: acute bacterial skin and skin structure infections: developing drugs for treatment, 2013. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071185.pdf. Accessed 15 January 2015.

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