The meaning of Clinical Research in a developing country
Dra. Constanza Rubio
The word science is derived from scientĭa which in Latin means knowledge, and its objectives are to generate hypotheses, deduce principles and elaborate laws. For this, a research method is established that raises criteria adjusted to reality and ensures permanent correction of the observations and results.
Colombia has been working in the area of human sciences, structuring a clinical research method that generates local and exportable knowledge. This knowledge contributes, for example,
information to entities that manage resources for high-cost chronic diseases (and therefore orient them in capital investment), or allows the development of therapeutic alternatives for the treatment of cancer, cardiovascular diseases, as well as conditions secondary to infections such as HIV, among others. Likewise, it constitutes the evidence through which doctors can make better decisions for the care of their patients.
The participation of Colombians in clinical studies could give the impression of being a recently used method for the study of diseases and new or improved drugs, however, in South America, clinical research began to be carried out in the first decades of the 20th century, producing advances in the knowledge of important diseases such as yellow fever, Leishmaniasis and Chagas disease. In Colombia, for more than 30 years, the State, academia and the private sector have joined forces to bring scientific development to the country, generating well-designed clinical studies conducted with qualified researchers, responding to ethical principles of global acceptance and whose results are accepted. by organizations such as the FDA in the United States, or the EMEA in the European Union.
In the country, every participant in a clinical study is protected by strict legislation on clinical research for human beings. This is based on Resolution 8430 of 1993, «By which the scientific, technical and administrative standards for health research are established» and it contemplates the formation of an Ethics Committee in Health Research that will be in charge of studying and approve research projects in humans. There is also Resolution 3823 of 1997 «By which the Advisory Commission on Science and Technology of the Ministry of Health is created and rules are issued to regulate scientific development activities in the health sector«, and establishes the Institute as a regulatory entity National Food and Drug Surveillance (Invima), which is responsible for certifying and being a guarantor before the world community of drug research projects.
Complementing the legal structure of the country in research, the state creates Resolution 2378 of 2008 «By which Good Clinical Practices are adopted for institutions that conduct research with drugs on human beings«, referring to the mandatory compliance with an international standard for design, conduct, register and report clinical studies that involve the participation of human beings based on ethical principles and scientific quality. These guidelines make us comparable in high quality scientific production to countries and economic zones such as the European Union, Japan and the United States; process that continues in constant growth with the support of discussions and work tables carried out by groups such as AFIDRO (Association of Pharmaceutical Research and Development Laboratories), ACIC (Association of Clinical Research Centers) and AVANZAR (Association for the Advancement of Research in Colombia), among others.
Until September 2012, according to international public registries such as clinicaltrials.gov, Colombia in South America ranked fifth in conducting clinical studies mainly in phases II, III and IV, sponsored by research pharmaceutical companies. Today we are the fourth country (after Brazil, Argentina and Chile) to be generators of clinical trials, showing significant scientific growth.
Additionally, over the years, Colombia has received direct benefits in its society thanks to clinical research, such as, for example, increased experience for researchers who early expose more advanced intervention techniques or their experience as doctors in high-risk pathologies. social impact and at the same time they learn how to do adequate research with the necessary resources; for patients allowing them access to innovative treatments and a better quality of care; to the health system with the improvement of the infrastructure for the provision of health services, and to the Country by a greater labor supply and investment of foreign capital.
In conclusion, the growth of Clinical Research in Colombia means an opportunity for economic development for the Nation, positioning of human and scientific resources worldwide and strengthening the social capital of our population.