Clinical studies in pediatric respiratory-tract infections: what is desirable, feasible, or simply misleading.
In recent years, attempts have been made to make the regulatory requirements for clinical studies more uniform, and much has been discussed on the issue of good clinical practice. There is no doubt that clinical trials involving new drugs have to be conducted according to the highest standards. However, ideal design is not always feasible or ethical. The ideal design for efficacy studies demands randomization, double-blind comparisons, adequate group size, specification of the type of patients and isolated organisms. The present paper points out some difficulties regarding these points when studying cephalosporins in pediatric respiratory-tract infections, and proposes some solutions.
Dagan
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Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel.
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002437:Cefazolin / Q000009:adverse effects; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D005240:Feasibility Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D011018:Pneumonia, Pneumococcal / Q000188:drug therapy; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000382:microbiology; D013223:Statistics as Topic / Q000379:methods
D000900:Anti-Bacterial Agents; D002437:Cefazolin