Biomedical subjects
B Genesté
Publications and source records attributed to B Genesté.
Recommendations for evaluating the validity of quality of life claims for labeling and promotion.
The pharmaceutical industry, the medical device industry, and national regulatory agencies such as the United States Food and Drug Administration (FDA) are faced with a number of difficult issues related to the development and evaluation of health-related quality of life (HRQL) claims for product labeling and promotion. This paper outlines some of the unique challenges of HRQL research and makes recommendations for assuring that claims are based on the results of rigorous studies designed and conducted according to accepted scientific principles and practices. Standards of evidence for HRQL are discussed in terms of research design and methodology, instrumentation, statistical analysis, and interpretation. Examples are provided to highlight important points. The paper concludes with a brief discussion of future trends in HRQL outcomes evaluation.
Early modelling for assessing health and economic outcomes of drug therapy.
Models for assessing health and economic outcomes of new drugs have an increasing role in the early phases of drug development. Their input into go/no go and priority setting decisions can reveal that further development of a drug is unattractive from an economic viewpoint, or that developing a certain indication is more attractive than another. They may also influence the later choice of indication, positioning, comparators, length of follow-up, and other elements in the further development of drugs. Their specific nature, characterized by limited budget, timelines and data availability should not necessarily lead to compromises in design and conduct. It is argued that high quality early models form the breeding ground for later solid evidence on value for money, and are consequently both worthwhile to the pharmaceutical industry and to health care decision-makers and payers.