The US Food and Drug Administration and the Critical Path Institute's Patient-Reported Outcome (PRO) Consortium convened a cosponsored workshop on the use of PRO measures to inform the assessment of safety and tolerability in cancer clinical trials. A broad array of international stakeholders involved in oncology drug development and PRO measurement science provided perspectives on the role of PRO measures to provide complementary clinical data on the symptomatic side effects of anticancer agents. Speakers and panelists explored the utility of information derived from existing and emerging PRO measures, focusing on the PRO version of the National Cancer Institute's Common Terminology Criteria for Adverse Events. Panelists and speakers discussed potential ways to improve the collection, analysis, and presentation of PRO data describing symptomatic adverse events to support drug development and better inform regulatory and treatment decisions. Workshop participants concluded the day with a discussion of possible approaches to the patient-reported assessment of an investigational drug's overall side effect burden as a potential clinical trial end point. The Food and Drug Administration reiterated its commitment to collaborate with international drug development stakeholders to identify rigorous methods to incorporate the patient perspective into the development of cancer therapeutics.
To investigate consumers' perceptions of appearance and handle of the chest area and the lapel in men's tailored jackets, both objective measurement using FAST and subjective assessment utilising semi-structured interview were employed. It was found that objective measurement provides insuf®cient information to predict the tailorability if reliance is placed purely upon properties obtained from shell fabrics. Use of the fabric and interlining laminates, however, provides better prediction of tailorability, especially those aspects associated with appearance and shape retention. It was also found that objective measurement results do not agree with the subjective assessment results, particularly with regard to the subjective assessment of the female interviewees. It is suggested that thought should be given to devising a method of evaluating objective measurement results suitable to fabric and interlining laminates that can also take account of market trends directly related to consumer perception.
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