Monitoring Clinical Trials in Multiple Testing Sites: Can Good Laboratory Practice and Proficiency Testing Assure Uniform Testing?

As a means of ensuring laboratory quality, national regulatory schemes, such as the Clinical Laboratory Improvement Amendments (CLIA '88) in the United States, require good laboratory practices—basically analogous to good manufacturing practices in the drug industry—and proficiency testing. Laboratory regulations mandated to ensure clinical relevance of patient tests, however, may not provide the quality needed for drug efficacy trials. To allow valid conclusions to be drawn in drug efficacy trials, the introduction of intralaboratory protocols for clinical laboratories designed to produce the quality results needed is proposed. It is postulated that these protocols, while enhancing the quality of the data, will decrease, not increase, the cost of the trials.