From clinical trial to prescription.
There are many steps between drug discovery and prescribing for a patient. Each step has problems. In this issue of ARCHIVES, Klein and colleagues propose changes in clinical trials that would result in more meaningful information for the treating physician. Of particular importance is the gap between what a physician needs to know and what is produced in the clinical trials that leads to approval of a new drug by the US Food and Drug Administration (FDA). Their recommendations for improving clinical trials are cogent, but broad-based implementation depends on an organizational structure and political effectiveness not presently in place. Most important, as the authors note, is an effective work group representing industry, regulatory agencies, and academic and federal science, addressing clinical trials issues with public participation. While improved quality and relevance of data from clinical trials will strengthen the scientific foundation of pharmacotherapy, other problems impede the delivery of objective information to the treating physician. Most hotly debated is the role of money in the creation and dissemination of knowledge.
Carpenter
William T
WT
Maryland Psychiatric Research Center, PO Box 21247, Baltimore, MD 21228, USA. wcarpent@mprc.umaryland.edu
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D011307:Drug Prescriptions; D019317:Evidence-Based Medicine; D006801:Humans; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D011619:Psychotropic Drugs