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Roberto Chiprut, MD, FACP, was CEO at the Instituto Mexicano de InvestigaciÃ³n ClÃnica (IMIC), S.A. de C.V. as well as clinical professor of medicine at UCLA and Cedars Sinai Medical Center at the time of his death in 2002.
Mario Alejandro Castellanos, MD, is principal investigator at IMIC and an epidemiologist at the National University of Mexico.
The United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?
The conduct of clinical trials in developing countries has received increased attention recently, and accompanying this attention come ethical concerns. These include informed consent from vulnerable populations, recruitment practices, and the responsibilities of researchers as to subjects welfare.
One reason for the increased attention arises from the furor over the trials of interventions to prevent maternal-infant and heterosexual transmission of the human immunodeficiency virus in Africa.1,2 Critics of these studies made allusions to the infamous Tuskegee study that ultimately deprived people of a known, effective, affordable intervention.3 Proponents stressed that the studies were conducted according to widely accepted bioethical principles and guidelines.1 These arguments highlight the need in underdeveloped countries for extensive efforts by local medical communities and local governments to protect human research subjects, but also to participate in study design. Then, the results of clinical trials carried out in such countries will lead in time to therapies that improve the welfare of those countries populations as well as other populations, thus correcting an imbalance.
In some Latin American countries, endemic diseases, poverty, and, in general, poorly financed local health care systems may lack a comprehensive infrastructure for clinical trials. This results in difficulty both in carrying out clinical trials and in selecting those clinical studies that have the greatest promise for benefiting Latin American populations.1,2
Moreover, the use of indigent subjects in such countries to test drugs that will be used exclusively in developed countries represents a violation of the most basic clinical ethics. Clearly, scientific knowledge obtained from all clinical trials performed in Latin America should be used to benefit Latin American as well as other people.1,2,4As we move into the 21st century, clinical research is performed principally in the United States and Europe. During the last few years, researchers in these countries have encountered growing difficulty in recruiting volunteers, even though there are often monetary incentives. Yet clinical research that could benefit many more people should be performed all over the world where possibleand if the right safeguards are in place.
The outlook in Mexico
Mexico does not play a major role in clinical research, but because of its strategic importance, proven research infrastructure, and adequate study population, it could easily host many more clinical trials. In the past, cumbersome regulatory and quality issues discouraged the global pharmaceutical industry from participating in pivotal drug-approval studies. The horizon is changing. There is a genuine interest to solve these issues and capture the interest of the major pharmaceutical players.
Mexicos medical infrastructure consists of a massive social security organization called Instituto Mexicano del Seguro Social (IMSS), which provides medical care to more than 50 million working Mexicans. IMSS includes a network of hospitals, clinics, and full-time physicians, and also a number of federal government-financed public hospitals that provide medical care to indigent people. Additionally, 10 national health institutes are devoted to medical education, research, and excellence in health care.
Mexico has two major public teaching institutions, the Universidad Nacional Autnoma de Mxico (UNAM) and the Instituto Politcnico Nacional (IPN). Many talented clinical scientists are on the faculties of UNAM and IPN, but their participation in clinical research is limited. Several private and prestigious teaching institutions do not participate in clinical research activities to a great extent, either.
Hence, more than 70% of clinical trials in Mexico are conducted in government-backed hospitals and public institutions. Placebo-controlled trials, necessary for accurate determination of drug efficacy and safety, are routine. Most of the medical research is financed through grants offered by Consejo Nacional de Ciencia y Tecnologa (Conacyt), with a smaller portion supported by international pharmaceutical companies.In addition, Mexico has a very sophisticated and well-established system of continuing medical education and offers board certification by specialty. This has resulted in continuing improvements in quality of care.