Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making.

Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare.

Comparison of French and Japanese individuals with reference to Hofstede's concepts of Individualism and Masculinity.

The purpose was to examine whether Japanese individuals were oriented toward collective and masculine values attributed to cultures by Hofstede by comparing them with those of French individuals. There were 110 French participants (54 men, 56 women) and 128 Japanese participants (41 men, 87 women), selected from undergraduate students, employed workers, housewives, and retirees. Their occupational proportion and their ranges of age were balanced in both countries. Scales for Individualism and Masculinity dealt not only with work-related but also general items for workplace, culture, education, and family. Analyses generally showed that the Japanese individuals scored higher on the Masculinity scale and French participants scored higher on the Individualism scale. There was a mean difference between Japanese men and women in how they answered questions about the work-related items concerning Masculinity.