In Colombia there are a total of 76 ethics committees and 132 clinical research centers, including 5 hospitals that are among the best in Latin America according to América Economía magazine, such as Fundación Valle del Lili, La Cardio, Hospital Pablo Tobón Uribe , among others.
Article published in the Bulletin 06 – February 2022 of ACIC, the Colombian Association of Clinical Research Centers. Website: www.accicolombia.org
Original Title:
STATUS OF CLINICAL RESEARCH IN COLOMBIA. ECONOMIC IMPACT.
By Prof. Dora Molina de Salazar / Former ACIC President, Full Professor U de Caldas.
Dr. Sergio Prada. Sergio I. Prada MPA, PhD., MINCIENCIAS Senior Researcher, Deputy Director of Research and Innovation, Valle del Lili Foundation.
The year 2012 described how the arrival of the pharmaceutical industry with research protocols in phase 2, 3 and 4. Not only did it open the door for us to obtain data on innovative molecules evaluated in the Colombian population, but it also generated opportunities and employment to promote and develop protocols with high quality standards.
The contract research organizations “CRO” for its acronym in English, seek that the country and its researchers are selected and clinical research centers are included in global trials, and tend to speed up the times of approval of protocols by the ethics committees and by regulatory bodies. At the time, in 2012, the approval procedures took a little over 6 months.
Year 2016
Towards 2016 the country presented a growth in research centers, the processes to approve a research center were increasingly complex and Invima had promised to improve its approval times from 4.5 to 2 months, a goal that for him still presents an average according to AFIDRO of 2.6 months for 2019 is about to be met.
Year 2018
In Colombia, since 2018 an Interdisciplinary working group called INTIC was formed. An initiative to transform clinical research in Colombia, made up of Afidro, Avanzar and ACIC (Colombian Association of Clinical Research Centers).
INTIC members work hand in hand with Invima, the Ministry of Social Protection, Chambers of Commerce, Procolombia and most of the entities that are actors in the investigation process in Colombia.
One of its fundamental objectives is to work for the quality of Clinical Research for Registration purposes to be more competitive in the National and International environment, in addition to turning Colombia into a country of interest for institutions that promote research and development.
Since 2021, INTIC and the leadership of Afidro Colombia have had a Clinical Studies Monitoring System (SIMETRICA), a platform that will allow up-to-date information on the main actors involved in clinical research and thus make Colombia a an attractive and promising country in this field.
In addition, work is being done to systematize the Ethics Committees, to have electronic medical records and the management of quality indicators from the different clinical research centers, in order to make them more competent.
According to a working document carried out by Procolombia in 2018, in which they interviewed 23 companies, the main limitation to developing this activity in Colombia was unanimously the complexity and/or clarity of the regulatory requirements, followed by the lack of statistics on the prevalence of chronic pathologies and the lack of accessibility to eligible participants, among others. (ProColombia).
Although we all yearn for development and innovation in health to come from the efforts of each nation, in Colombia public and private resources dedicated to research do not reach 0.3% of GDP.
Benefits of studies for patients
The registry research industry provides health options that change the history of many patients. The most preferred areas are diabetes, cardiology, oncology, pulmonology, hematology and rheumatology.
A patient included in a clinical trial not only has the opportunity to receive the innovative molecule, but also to be evaluated by specialists more frequently, to be evaluated with advanced tests without requiring authorizations, to receive more education about his pathology and to receive complete care in case of a complication.
Scientific contribution
Researchers, according to their performance, have the opportunity to participate in the process of reviewing and editing scientific articles, thanks to this they have been able to represent the country in the publication of clinical trials in major medical journals around the world such as the “New England Journal of Medicine ” or “The Lancet” among others. Without these studies, the probability of finding a Colombian scientist working in Colombia in these publications was very low.
Colombia has had the opportunity to participate in studies that have changed medical practice, studies such as those on vaccines for COVID 19, transcendental studies in diabetes such as EPAREG OTUCOMES, EMPEROR PRESERVED, and multiple studies from other areas.
The investment made by each sponsor per protocol is variable and is not publicly accessible (privileged information), but it is necessary to remember that there are Colombian companies that benefit from these expenses that the sponsors make in the country and that, if these studies do not exist, They would go to other countries.
Among these items we find: payments in administrative processes prior to approval, payments related to the importation of supplies, payments to companies in charge of written educational material, payment of national supplies, land and air shipping costs, taxes, payment of the entire process of health care for patients, and payment for the researchers’ meeting to analyze the protocol, the results, the complications, and agree on the steps to follow in response to each comment.
On the other hand, the sponsors must have processes to monitor in person or remotely with a stipulated frequency for each research center. Each monitoring visit implies travel expenses for the sponsor, with a frequency that ranges between 2 or 4 monitoring sessions per year.
Even, if the circumstances warrant it, there can be many more, for example, in the specific case of the Covid-19 Vaccine projects, there are 3 to 4 monitors in the clinical research centers that carry out the studies every week throughout the entire period. the development of the study.
For the contracted research center, it is necessary to form a team, which includes and is not limited to nursing for study coordination, pharmaceutical chemist for pharmacy management, medical assistance personnel, as well as auxiliary personnel for scheduling, and laboratory personnel, among others.
In Colombia there are a total of 76 ethics committees and 132 clinical research centers, including 5 hospitals that are among the best in Latin America according to América Economía magazine, such as Fundación Valle del Lili, La Cardio, Hospital Pablo Tobón Uribe , among others.
There is no survey to characterize the personnel and financial statements of the Clinical Research Centers for registration purposes.
However, preliminary calculations by the authors suggest that the sector could generate 3,400 direct jobs, with a contribution to the GDP of approximately 250 billion pesos, in wages and salaries and in surpluses.
Towards the future
Within the recent legal developments carried out within the framework of this type of research, in Colombia the optimization of processes and procedures was included within the National Development Plan of the current government. Ideally, a legislative modification of resolutions 2378 of 2008 and 8430 of 1993 is needed. This regulatory change should promote: the reduction of time in the evaluation and approval of research protocols (it is estimated that each day of delay in the development of a study implies USD$37,000 in operational costs); endorse the presentation in digital format of the research protocols (physical ones are currently requested); revision and modification of Guides of Amendments, Protocols and Manual of the Investigator; the possibility of having satellite research centers; the review of informed consent requirements, especially with regard to witnesses, the minor population and pregnant women.
There is a continuous growth rate in the number of new medicines or interventions in the world and it is key for Colombia to be able to continue participating in this development process. The current objective of Colombia, according to data from AFIDRO, is to be pioneers and streamline the weakest points such as the process of bringing medicines into the country. It is expected that by 2022 the investment of the sponsoring industry will be around 450 billion pesos and more than 20 thousand patients will be treated.
The reality is that CROs have low confidence in Latin America to bring studies, and this stems from ignorance of the region, but also from long approval times, lack of predictability, doubts about data quality, non-compliance with committed recruitment and union problems.
Final comment
Clinical research opens paths to improve currently accepted standards of treatment, increase patient safety, increase productivity, create direct and indirect jobs, reduce costs and promote innovation. Clinical research facilitates the practice of evidence-based medical care and benefits health outcomes, while contributing to the development of health agents and the growth of the country’s economy. It also creates scientific and logistical capacity in institutions and helps to find motivation so that with available funds, public or private, own research can be carried out, from the development of molecules or devices to conducting relevant studies to impact clinical practice.
