OFFICIAL VOICE OF THE COMMUNIST PARTY OF CUBA CENTRAL COMMITTEE
Director Carlos Manuel García noted that the National Clinical Trials Coordinating Center has expert staff in all provinces. Photo: Anabel Díaz

Browsing the web reveals an extraordinary number of sites citing the strength of Cuba's pharmaceutical and biotechnology industries, along with the number of countries purchasing Cuban products for their populations. Yet the corporate media makes little mention of this accomplishment.

Among the country's most important, latest-generation medications is Heberprot P, used by more than 225,000 patients in many countries to treat diabetic foot ulcers and avoid a large percentage of amputations. It is currently administered via nano-capsules, making the drug's anti-microbial impact very effective.

In an incessant search for solutions to human health problems, Havana's Genetic Engineering and Biotechnology Center (CIGB) has made an important contribution conducting clinical trials of the CIGB 500 molecule, a novel product which has shown a significant effect on the heart, with promising potential in the treatment of acute myocardial infarction.

Among 2016 accomplishments, Cuba was able to register its patent with the European Union for the medication Heberferón, a combination of interferon-alpha 2b and recombinant gamma, to treat non-melanoma skin cancer.

Notable successes include new evidence of the neurological effect of a
molecule named JM-20, which appears encouraging for the treatment of cerebral isquemia.

The list of diseases which remain incurable is long, but Cuban research institutions continue their work with perseverance, seeking medications, clinical evidence, and therapeutic procedures which can be implemented to save lives within the immediate future.

The latest scientific achievement of the country's Molecular Immunology Center (CIM) is CIMAvax-EGC, an injectable medication to treat advanced lung cancer which has effectively prolonged the lives of patients. Also promising is Nimotuzumab, used to treat malignant tumors in the breast, prostrate, lungs, cervix, anus, and rectum.

To provide the clinical evaluations required to register patents, and distribute pharmaceuticals and biotechnology produced in Cuba, the National Clinical Trials Coordinating Center (CENCEC), affiliated with the Ministry of Public Health, was established in 1991.

The Genetic Engineering and Biotechnology Center. Photo: Orfilio Pelaez

The National Coordinating Center is equipped with the latest technology to guarantee that best practices are followed. These international norms (BPC), developed by the World and Pan American Health Organizations, establish procedures to ensure the scientific quality and ethics of clinical trials.

Over its 25 years of work, the Center has taken responsibility for transparency and implementation of BPC in more than 150 research projects on 59 products for the treatment of cancer, neurological, cardiovascular and skin diseases, among others.
The Center likewise trains health professionals in the management of clinical trials; evaluates medical technology; supervises the gathering of evidence to allow the Ministry to make decisions; and ensures quality control throughout clinical investigations.

The institution has had several headquarters, director Dr. Carlos Manuel García told Granma International. It was first located on the 11th floor of the Cardiovascular Medicine Institute, then in a house in the Atabey neighborhood, followed by a stay in a wing of the building at 200th and 21st Streets in the same area, and currently in the so-called "smart building" found in the Miramar neighborhood of Plaza municipality. These many relocations reflect the rapid growth of the institution as the Ministry's needs have risen dramatically.

"Our entity," said Dr. García, who also holds a Masters in Clinical Toxicology, "has as its mission the control of all clinical investigations in the country, undertaken by the Department of Control and Attention for the national network, that interacts with assistance institutions, medical schools, provincial public health authorities, the medical-pharmaceutical industry and biotechnology centers."

A large number of pharmaceutical firms are looking to conduct clinical trials in Cuba, and since diplomatic relations have been reestablished with the United States, this country has shown a marked interest in joint work on several scientific projects. this comes as a result of the prestige Cuba's public health system has gained, and the novel products developed here to treat a variety of ailments.

Conversations continue, and memoranda of understanding have been signed.
Maite Amoroto Roig, MSc in Pharmacy and assistant director in charge of clinical trials, adds that the Center has a staff of 138 workers, 78.3% of whom are university graduates, who take charge of supervising research activities, beginning with the planning of projects, through the presentation of results. They are divided into three departments: Data management and processing; Randomization and Information; as well as Project Design and Management.

MSc Julián Rodríguez Álvarez, head of International Sales and Cooperation, clarifies that the Center is certified by the Ministry of Science, Technology, and Environment to provide research services, focusing on the design of protocols to gather information and results needed to legally register a patent for a new medication, and introduce it on the market.

Rodríguez added that investigations seek to develop innovations and generate new knowledge, and must therefore register the evidence they gather from the very beginning of a project, through a product's ultimate registration, backed by all technical, logistical, scientific, and methodological requirements needed to produce reliable results.

The Center intervenes in the research process via quality control audits in which the use of best practices is verified, in the areas of documentation, selection of areas of investigation, management and processing of statistical data, according to Dr. Sandra Álvarez Guerra, head of the quality control management department.

Toward this end, an internal system and manual were developed with more than 60 procedures to standardize investigative activities in each phase of a clinical trial, in accordance with norms established internationally, which allowed the Center to be certified in 2008 as meeting ISO 9001 requirements regarding quality control.

This procedural manual received the country's annual National Health Prize in 2016, and describes the certification process from the exploratory-diagnostic stage and the implementation of institutional strategies in diverse contexts, through training of personnel and the creation of a culture of quality control.

"Our work," Dr Álvarez said, "is perfectly applicable in other organizations, because it reflects methodologies to design a quality documentation system. Toward that end, we have created web pages, we send e-mail messages, and generate information to create an institutional culture of respect for quality norms.

"We additionally give courses that are currently accredited as post graduate, and we identify tools like internal and external client satisfaction surveys, to surpass expectations. Work is being done with a process focus on critical, vulnerable points, and action is taken when possible risks are noted."

In another area, the Public Cuban Register of Clinical Trials (RPCEC) contributes to the process of maintaining transparency in research. MSc Gladys Jiménez Rivero, who has studied both computer science and clinical trails, emphasized that this is the first such registry in Latin America, in Spanish, to comply with all requirements established by the World Health Organization.

"Beginning in 2005," she said, " the International Committee of Medical Journal Editors has expressed its opposition to the manipulation of scientific research, with the implementation of a policy which requires the registration of trials in public registers before incorporating the first subject of investigation, so that it may be consulted by any person whosoever. Thus, at the end of 2006, Cuba began the development of its own registry. It should be noted that, at that time, the only registers in existence were in the English language.

"Since 2017, the Cuban registry is accessible online at www.rpcec.sld.cu.  To register a trial, a form must be completed in Spanish and English, and from that moment on, guidelines of responsibility are set to guarantee the transparency of information," the expert explained.

All trials listed in the registry are appropriate for publication in any scientific journal, nationally or abroad, helping to disseminate what is being done in Cuba by the pharmaceutical-medical industry. The Cuban registry has also incorporated trials conducted in Colombia, Venezuela, and Mexico, among others, since these countries do not have a register of their own with the same characteristics. This is possible since researchers can register their work in any data base that meets World Health Organizations standards.

To celebrate the 25th anniversary of the National Clinical Trials Coordinating Center, the 6th International Workshop on the Design and Conducting of Clinical Trials was held in November, 2016, in Havana's International Convention Center, with the participation of 280 delegates from more than 10 countries, who heard reports on Cuba's experience in this field. The schedule of events allowed for discussion, updatings, and an exchange of experiences to strengthen national and international collaboration.

Likewise presented was a workshop on protocols for studies of herbal remedies; a master lecture on the importance of clinical trials to efficient, sustainable public health systems; and pre-congress courses on issues such as the search and recovery of evidence-based medical information; innovation in management; and improved competitiveness, among other topics.

Challenges to be faced by the institution in 2017 include meeting the needs of current clients; extending their services abroad; perfecting supervision of clinical trials; completing the certification of professionals who conduct research; and achieve recertification in quality management based on 2015 ISO-9001 norms.