Latin American Physicians’ Attitudes Toward Participation in Clinical Trials

Abstract

Introduction: Latin America currently represents a relatively small but constant number of clinical sites for commercially funded studies. This article describes the profiles of sites and investigators involved in commercial clinical research and compares the results with published results of similar US investigators. In addition, the research examines investigators’ motives for taking part in clinical research and the concerns these investigators have with the operational challenge of conducting these studies. Methods: The data were drawn from a survey of investigators involved in commercially funded clinical trials in Argentina, Brazil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Peru and Venezuela. The questionnaire comprised a list of 12 reasons related to why an investigator might participate in a phase III clinical trial of a new compound being tested by a pharmaceutical company, and respondents were asked to rate the importance of each reason on a scale of 12–10, with 1 being not important at all and 10 being very important. Surveys were conducted in 2008–9 and data were compared with a published analysis of US clinical investigators. Factor analysis, ANOVA, chi-square, gamma statistics and approximate significance measures were used to analyse the survey responses. All analyses were conducted using SPSS version 17. Results: The clinical experience of Latin American investigators is generally somewhat less than that of US investigators. Among other things, Latin America conducts a vastly greater portion of its research in hospitals compared with the US; few investigators work in private practice, in contrast to the US pattern. In addition, a far larger percentage of clinical research is conducted at dedicated sites than is the case in the US. Latin American investigators, along with their US counterparts, stress the importance of taking part in medical innovation as the primary reason for their involvement in commercially funded clinical research. Latin American investigators especially value the opportunity to work with other physicians on the study. Financial considerations, while not unimportant in Latin America, are secondary to this desire to be a part of medical innovation. Latin American investigators do differ somewhat from the US respondents in the importance they place on certain operational aspects of a clinical study. For instance, Latin American investigators are distinctly more concerned that a major pharmaceutical company sponsors the study than is the case with US investigators. In general, with the one noteworthy exception of serious adverse event reporting, Latin American and US investigators seem to have fairly comparable areas of dissatisfaction in the conduct of clinical trials. Conclusions: Latin America represents a particularly attractive growth market for pharmaceutical products. With a population in the hundreds of millions the demand for prescription drugs will make the need to conduct clinical research there essential for global pharmaceutical companies. Understanding the motivation of Latin American investigators should be valuable in helping such companies develop their clinical trial strategies and tactics.