AN APPROACH TO THE VALIDATION OF MARKERS FOR USE IN AIDS CLINICAL-TRIALS

Dr. Mildvan and coauthors have thoroughly reviewed and documented what is known about the validation of surrogate markers for use in clinica l trials, They have proposed a classification system based on the usef ulness of available immunologic and virological assays as measures of prognosis, drug activity, and therapeutic efficacy. The latter, a type II marker in the proposed classification, should estimate the proport ion of treatment effect explained by change in the marker induced by t herapy and, if complete, can substitute for clinical endpoints, HIV cl inical trialists have had a long-standing interest in using surrogates for clinical endpoints to facilitate conduct of experimental protocol s and to decrease the time and effort required to develop new treatmen t strategies, The approach outlined in this review by experienced clin icians, biostatisticians, and immunologists provides a framework to ev aluate currently available and potential surrogate markers.