Quality Clinical Trials Should Follow GCP Guidelines
Additional attributes can be incorporated to exceed standards
MONDAY, April 14 (HealthDay News) -- Oncologists wishing to design and conduct quality clinical trials should follow Good Clinical Practice (GCP) guidelines, with sites wishing to exceed these standards incorporating additional attributes, according to a statement published online April 7 in the Journal of Clinical Oncology.
Robin Zon, M.D., from Michiana Hematology Oncology in South Bend, Ind., and colleagues described the characteristics of sites conducting quality clinical trials and exemplary clinical trials based on a review of the literature, current regulatory requirements, and the consensus of a group of academic and community clinical researchers.
The researchers note that a quality research site complies with the International Conference on Harmonisation GCP guidelines, which are the accepted international standards for clinical trials involving humans. Sites wishing to exceed these guidelines may incorporate additional attributes, including maintenance of high educational standards, quality assurance and multidisciplinary involvement in the clinical trial process.
"Meeting the minimum criteria ensures conduct of quality clinical trials; however, some sites may wish to incorporate value-added attributes to exceed GCP compliance," Zon and colleagues conclude. "These attributes are proposed as performance goals rather than requirements, recognizing that all sites conducting research will not necessarily meet each attribute but may still conduct high-quality clinical trials."