Drug development and the heart hospital.
Conducting clinical trials to support the development of new pharmaceutical entities or devices offers specialized heart hospitals unique opportunities. The populations they serve with cardiovascular diagnoses provide a predictable reservoir for recruitment of patients into trials of cardiovascular drugs or devices. The later stages in new chemical entity development require hundreds to thousands of patients to achieve statistical power. This need provides opportunities for rapid screening and identification of patients who would potentially benefit from and be appropriate for study. Clinically sophisticated support personnel to facilitate the conduct of research trials are likely to be available in the staff structure of a heart hospital. Meticulous attention to patient safety and privacy, good clinical practice, and high-quality data collection are imperative.
Kleiman
Jay H
JH
Division of Cardiovascular/Metabolic Research, Pharmacia Corporation, Lake Forest, IL 60045, USA. jay.h.kleiman@pharmacia.com
D002300:Cardiac Care Facilities / Q000458:organization & administration* / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000145:classification / Q000592:standards; D017277:Drug Approval; D004341:Drug Evaluation; D004345:Drug Industry / Q000458:organization & administration*; D015507:Drugs, Investigational; D028744:Ethics Committees, Research; D006801:Humans; D007373:Interinstitutional Relations; D018579:Patient Selection; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational