Use of SF Patient-reported Outcomes in Clinical Trials
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QualityMetric Incorporated is the leading developer and provider of the SF General Health Surveys:
SF-36®, SF-12®, and SF-8™ and other disease-specific health surveys for clinical trials that require practical and precise measures for risk screening and sensitive, patient-reported outcomes measures.

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Many drugs and devices in the discovery and development pipeline hold great promise for reducing the impact of chronic health problems on everyday life. These drugs/devices also represent a significant health care cost, making it incumbent on the pharmaceutical and biotechnology industries to document health benefit.

QualityMetric scientists have more than three decades of experience in the development and application of patient-reported health outcomes for clinical trials that:

• Quantify the consumer's experience of improved health-related quality of life (HRQOL)
• Deliver proof of efficacy in a currency that goes beyond traditional clinical endpoints
• Provides a scientifically valid body of evidence to facilitate timely regulatory approval

Our pharmaceutical and biotechnology clients recognize the need to define benefits more broadly than traditional clinical endpoints by including patient-reported outcomes (PROs) in clinical trials. Additional clinical evidence based on PROs also commands increasing attention from the Food and Drug Administration (FDA), making it critical to the drug review and approval process.

Our disease-specific surveys can be used alone to screen for and monitor impact on functional status and well-being, or paired with an SF general health survey to capture a more comprehensive picture of HRQOL benefits. Our surveys can be delivered in fixed-length format for administration in paper-and pencil, by telephone using speech recognition, on PDAs, and online. For innovators, our online computer adaptive software (DYNHA™) delivers surveys that offer real-time, short yet precise assessments that yield our pharmaceutical and biotechnology clients a strong return on investment.

Many pharmaceutical and biotechnology companies worldwide also utilize QualityMetric's scientific expertise for consulting on the:

• Selection of patient-reported outcomes measures for use in all phases of drug/device development and testing
• Design of clinical trials, data collection protocols, and analytic plans
• Analyses and re-analyses of clinical trials data
• Preparation of abstracts, presentations, and manuscripts reporting results from clinical trial analyses

For information on any QualityMetric product or service, visit us at:

www.qualitymetric.com

If you can improve health care, QualityMetric will help you prove it.