Geographic location of antineoplastic agent clinical trials conducted in developed and developing countries

Abstract

Background For the past 30 years, clinical trials have been increasingly conducted in developing countries. These trials allow results to be generalizable to similar populations, offer access to treatment for patients in need, and examine diseases with differing patterns than developed countries. However, the characteristics of antineoplastic clinical trials and recent trends in study location in developing countries are unknown. Objective The primary objective was to evaluate the location, study phase, results, funding source, and ethics board approval of randomized double-blind controlled clinical trials evaluating antineoplastic agents by geographic location. Setting This is a retrospective evaluation of studies indexed in the PubMed/Medline database published in 2007–2011. Methods Clinical trials were identified with the search terms “drug therapy”, “antineoplastic agents” and “double blind method” and limited to English language, human, and randomized controlled trial. Main Outcome Measure We assessed frequencies of characteristics of antineoplastic clinical trials. Results A total of 116 trials evaluating antineoplastic drug therapy were identified. The highest frequency of clinical trials were published in 2009 (27.6 %), followed by 2011 (23.3 %), 2010 (20.7 %), 2007 (14.6 %), and 2008 (13.8 %). According to geographic region, 33.8 % were conducted in North America, followed by Europe (31.5 %) and Asia (16.2 %). Based on economic status, the majority (77.8 %) of clinical trial locations were in developed countries and 22.2 % were in developing countries. No significant difference was found between study locations in developed countries and developing countries from 2007 to 2011. When comparing studies conducted in developing and developed countries, there was no difference in the year published, study phase, results, funding source, or investigational review board approval and informed consent. Studies conducted in developed countries were significantly more likely to be single country studies (p = 0.02) and published in a journal with an impact factor greater than 10 (p = 0.013) when compared to studies conducted in developing countries. Conclusions Based on economic status, there was no significant location change of antineoplastic clinical trials from 2007 to 2011. Clinical trials conducted in developing countries were more often multi-country studies and published in journals with lower impact factors.