Clinical Research in Mexico: An Overview

The conduct of clinical trials in developing countries has received increased attention recently.

The outlook in Mexico.

By: Mario Castellanos, APC

Mexico plays 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.

Mexico’s 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 Autónoma de México (UNAM) and the Instituto Politécnico 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 Tecnología (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. Mexico adopted the principles recommended by the Belmont Report, including respect for persons (the recognition of any individual’s right to exercise autonomy), beneficence (the minimization of risk and maximization of benefits to research subjects and others), and justice (minimal participation in therapeutic investigations by subjects unlikely to benefit from subsequent applications of the research).

For 20 years, Mexico has had one of the most highly regarded pediatric research infrastructures in the world.

Furthermore, the past year saw the creation of the first private research organization in Mexico that conducts clinical trials according to international regulations and with quality comparable to that of the best institutions in the world. In most instances, this organization operates in a manner similar to that of the so-called site management organizations. This may mark the beginning of privately financed clinical research in Mexico.

Informed consent and protection for trial participants in Mexico

Support has been strong and consistent for clinical trials in Mexico to have the same requirements for informed consent as are mandatory in the United States.

In addition to the informed consent procedures that are recommended by international pharmaceutical companies and that have U. S. Food and Drug Administration (FDA) approval, most Mexican health institutions usually request that subjects sign a second consent form, written in simple language and requiring the signatures of two additional witnesses. In pediatric trials, the parents or legal guardians sign the informed consent form, and on those occasions in which age permits, children and adolescents sign an acceptance form.

As in the United States, serious attention is given to protecting study volunteers in Mexico, both to strengthen the position of investigators and to assure that subjects fully understand all potential risks and benefits of the clinical trial. Full disclosure is a necessary precondition for free choice. Accordingly, subjects who do not understand the potential risks of a research trial cannot be said to have chosen freely to face such risks. Fortunately, research volunteers in Mexico receive minimal or no payment for their participation in such activities.

By not offering money or other inducements, erosion of informed consent is prevented. In fact; the fundamental motivation for Mexican volunteers to participate in clinical research is the access to alternative treatments and competent medical care.

Subject selection must be fair and equitable and vulnerable populations protected. Risks must be reasonable in relation to the expected benefits, and privacy and confidentiality absolute. The recent national forum for education and research recommended the creation of an office for the protection against research risks.

Mexican laws permit the use of advertising for volunteer recruitment but do not allow misleading promotions or promises regarding cure of disease. All advertising must be approved by institutional review boards (IRBs) and by the Ministry of Health. All major national institutions and most important private hospitals have their own IRB or scientific and ethics committees that meet international and FDA guidelines. Some still have deficiencies in their composition, according to FDA standards. Those IRBs that meet the same standards as IRBs in the United States emphasize consistency of procedures and good research designs, and will not expose subjects to unnecessary risks.

Guidelines for clinical research

All major international pharmaceutical companies have Mexican affiliates. Their research activities have often been minimal, however, with little participation in important studies oriented toward drug approval for the international community. In recent years, contract research organizations (CROs), outsourcing companies hired by the pharma sponsors to perform some or all of the sponsor’s responsibilities in a clinical trial, have become interested in increasing the presence of Latin America in clinical research. Perhaps they may be the catalytic factor that will increase important research activities south of the border.

Mexico has a large group of experienced researchers, many of whom have been trained in the United States.

National authorities are embracing GCP and ICH guidelines.

Although Mexico has a complex system for the approval of clinical research protocols and the importation of study drugs, attempts have been made in the last years to update both the system and its efficiency. At this point, approval times of new research protocols are similar to those in the United States, and certainly better than in the majority of Latin American countries.

The new administration in Mexico has announced its intention to increase expenditures on health care and to create a new department that monitors the quality of health care.

The administration of the Mexican Presidency recently convened a national consultation forum to improve research activities at all levels, with strong emphasis on the participation of private enterprise in governmental and other institutional activities.

Mexico can be a fertile ground for clinical research in practically all areas of specialty. The high prevalence of cardiovascular disorders, diabetes mellitus, endemic infectious diseases, malignant tumors, degenerative processes, and gastrointestinal diseases creates a potentially large research-subject population in great need of alternative options of therapy.