Patient-reported outcomes (PROs) that measure health status are increasingly used in all phases of clinical trials to demonstrate
the effectiveness of treatment beyond traditional efficacy and safety. Frequently, the purpose of evaluating
PROs is to use that information in product labels and/or promotional materials that reach a broad range of
consumers, including patients, physicians, pharmacists and healthcare decision makers.
Such information can demonstrate product value in relation to other competing treatments.
In the US, pharmaceutical companies must obtain FDA approval to include these claims in their package inserts. Such claims are
important as they provide evidence of drug benefits or detriments from the patient's perspective. Physicians and other health care
providers can then utilize this information for treatment decision-making.
An informal survey of QualityMetric's pharmaceutical clients conducted in 2005 demonstrated rapidly growing interest
in the inclusion of health status benefits claims in package inserts. In our experience, companies recognize the value of these claims to help
differentiate their products from the competition; to communicate with their target audiences; and in more general terms, to more effectively market their products.
As of 2004, seven drugs whose products include health status benefits label claims based those claims on SF-36® Health Survey results. One such claim relied on
testimony from SF-36 developer and QualityMetric founder John E. Ware, Jr., PhD, to obtain FDA approval for its inclusion in the insert.
As the developer of some of the world's leading generic and disease-specific PRO measures, QualityMetric is uniquely qualified to help companies pursue product insert objectives.
Our Outcomes Insight™ Consulting Division has developed a six-stage "path" for successfully achieving FDA approval for label claims. Called PRO Path™
Strategic Services, the sequence is designed to support pharmaceutical, biotechnology, and medical device companies in their marketing efforts.
Generic
QualityMetric's SF-36, SF-36v2™, SF-12®, and SF-12v2™ Health Surveys are recognized as leading generic PRO measures for use in clinical trials.
Their reliability and validity in assessing the burden of disease and the effects of treatment have been demonstrated in over 60 different conditions.
They have been linguistically adapted in up to 70 languages.
Disease-specific
QualityMetric disease-specific PRO surveys can be used alone to screen for and monitor impact of disease on functional status and well-being.
They can also be paired with an SF™ Generic Health Survey to capture a more comprehensive picture of the health status benefits resulting from treatment.
Modes of Administration
In addition to paper and pencil survey administration, many QualityMetric surveys are available for online, fax/scanning, PDA or IVR administration,
offering accurate data capture and scoring, real-time patient reports, and aggregate-level data with interpretative guidelines.
QualityMetric's Outcomes Insight Consulting Division has collaborated with clinical, outcomes, pharmacoeconomics, product development, and marketing professionals,
supporting the development and application of PRO measurement throughout the clinical trial process. From development of a disease-specific PRO survey or
designing protocols to presentation before an FDA panel on clinical trial results, our consultants provide broad-based support and expertise involving the
use and application of any scientifically valid generic or disease-specific PRO survey.
For a list of clinical trial-related services, click here .
Outcomes Education
QualityMetric offers an array of educational programs that can be customized to meet the needs of pharmaceutical, biotechnology, and medical devices companies
exploring the value associated with PRO measurement in clinical trials and in product labeling and marketing:
Manuals and User Guides
The breadth of QualityMetric's scientific measurement expertise is best evidenced in the manuals and user guides that accompany each of our survey products.
They are also used independently for their research and interpretive value. Manuals include:
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