Clinical trials leading to drug approval (registration trials) play a central role in the drug development process. Since the introduction of the Good Clinical Practice (GCP) standard in 1997, the Japanese infrastructure for registration trials has improved. The contribution of support staff, including clinical research coordinators (CRCs), to clinical trials is now widely recognized in Japan. ...

Title Japan lags behind the UK in neurological drug approvals. Author(s) Shimazawa, Rumiko; Ikeda, Masayuki Citation British Journal of Clinical Pharmacology, 71(3), pp.473-475; 2011 Issue Date 2011-03 URL http://hdl.handle.net/10069/27394 Right © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society; The definitive version is available at www.bla...

The last decade in oncology has been marked by the identification of numerous new potential cancer targets and even more agents designed to inhibit them. The matrix of new targets, new agents, and the companion diagnostics required to identify the right patient for the right drug has created a major challenge for the clinical trial process. This has been compounded by the addition of new immuno...

The recognition process between a protein and a partner represents a significant theoretical challenge. In silico structure-based drug design carried out with nothing more than the three-dimensional structure of the protein has led to the introduction of many compounds into clinical trials and numerous drug approvals. Central to guiding the discovery process is to recognize active among non-act...

The introduction of newer classes of chemotherapeutic agents, with varying mechanisms of action by which they affect tumor growth and viability, has challenged the traditional norms of clinical trial design and drug approval in oncology. Most notably, the emergence of cytostatic biologic agents with antitumor efficacy has necessitated reassessment of appropriate primary endpoints for phase II a...

Evidence-based medicine (EBM) is not a old hat, a "cookbook" medicine perpetrated by arrogant to serve cost cutters to suppress clinical freedom, a mandatory, deterministic, totalitarian practice of medicine, a way to control cost and to ignore patient preferences, a limit to personal/ humanistic/individual medicine. EBM is a reference of excellence to guide clinical decisions, the integration ...

BACKGROUND Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. MATERIALS In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be e...

Resistance to antimicrobial drugs has compromised control of many bacterial pathogens. For foodborne pathogens, the most likely source of resistance is use of antimicrobials in food-producing animals. To control the human health impact from use of antimicrobials in animals, the U.S. Food and Drug Administration (FDA) recently announced plans to assess the microbial safety of all antimicrobials ...

We propose a new class of voting rules, called Size Approval Voting. According to this rule, the effective weight of a vote from a given individual depends on how many other alternatives the very same individual votes for. In particular, weights are assumed to be non-negative and weakly decreasing in the number of approved alternatives. Then, for a given profile of individual votes, all those a...

The British Post Office has joined Sweden, the US, and other postal services in issuing a commemorative set of stamps to mark the centenary of the first award of the Nobel Prizes in 1901. Sweden and the US are, in fact, issuing a stamp carrying exactly the same design; a profile of Alfred Nobel together with his image on one side of the Nobel Prize medals. But the British Post Office has done s...