The Literature Isn’t Just Biased, It’s Also Late to the Party

Animal studies of drug efficacy are an important resource for designing and performing clinical trials. They provide evidence of a drug’s potential clinical utility, inform the design of trials, and establish the ethical basis for testing drugs in human. Several recent studies suggest that many preclinical investigations are withheld from publication. Such nonreporting likely reflects… Continue reading The Literature Isn’t Just Biased, It’s Also Late to the Party

Uncaging Validity in Preclinical Research

High attrition rates in drug development bedevil drug developers, ethicists, health care professionals, and patients alike.  Increasingly, many commentators are suggesting the attrition problem partly relates to prevalent methodological flaws in the conduct and reporting of preclinical studies. Preclinical efficacy studies involve administering a putative drug to animals (usually mice or rats) that model the… Continue reading Uncaging Validity in Preclinical Research

Dirty Windows of Drug Development

Think of clinical trial data as a window on the efficacy and safety of a drug. Think of data protection and trade secrecy as soot. The above picture? This is the public view on drug safety and efficacy. According to a recent report in Nature Biotechnology (Feb 2011), medicine may be getting some soapy water… Continue reading Dirty Windows of Drug Development