title: Differences in implementation of HIV/AIDS clinical research in developed versus developing world: an evidence-based review on protease inhibitor use among women and minorities.
abstract: The aim of this revision is to evaluate ethnicity and gender rate of enrolment in registrative clinical trials of the protease inhibitors (Pls) from 1996 to 2009. Company-sponsored, phase II or III registrative clinical trials of PIs were evaluated. Forty-nine clinical trials were included. Clinical trials were conducted in centres in North America (n = 39), Central-South America (n = 22), Europe (n = 22), Africa (n = 8), Asia (n = 5), Australia (n = 10). Overall mean age was 39.6 years; median proportion of women was 16.3%. The most represented ethnic group was Caucasian. A test for trend over time (1996-2009) shows a significant increase in the proportion of women included (P = 0.012), and a decrease in the proportion of Caucasians included, reaching borderline significance (P = 0.061). An inverse correlation was observed between the proportion of Caucasians and that of women enrolled in each study (r = -0.65, P < 0.0001). Women were less likely to be included in double-blind studies (11.2% versus 17%, P = 0.019). Clinical trials for treatment-naive subjects were more likely to enrol ethnicities other than Caucasian compared with Caucasian (44.7% versus 27.1%, respectively, P = 0.04). Rates of enrolment of minorities in registrative clinical trials for Pls show a positive trend since 1996, mirroring the growing number of people of different ethnic groups accessing ART.
authors.affiliation: Clinic of Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, Piazzale Golgi 2 27100 PAVIA, Italy. e.seminari@smatteo.pv.it
authors.forename: E
authors.initials: E
authors.lastname: Seminari
authors.forename: A
authors.initials: A
authors.lastname: De Silvestri
authors.forename: L
authors.initials: L
authors.lastname: Scudeller
authors.forename: V
authors.initials: V
authors.lastname: Scotti
authors.forename: C
authors.initials: C
authors.lastname: Tinelli
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D019049:Developed Countries; D003906:Developing Countries; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008913:Minority Groups; D011480:Protease Inhibitors / Q000627:therapeutic use*; D012737:Sex Factors
chemical_list: D019380:Anti-HIV Agents; D011480:Protease Inhibitors