On May 20th, the International Clinical Trials Day was celebrated. It was on January 1922 when Leonard Thompson, a 14-year-old diabetic who was about to die at Toronto General Hospital, was the first receiving insulin, discovered by scientists Frederick Grant Banting and Charles Herber Best. Day by day, after administering the medicine, the miraculous recovery was surprising, as well as the recovery of other patients under the same diagnosis. This substance improved the quality of life and survival of those affected. Clinical research has become a methodical, careful, and science-based exercise that seeks to help humanity by finding better ways to alleviate, cure or prevent diseases.
To celebrate this day, AFIDRO, Avanzar, ACIC, the Health Cluster of Bogotá, the Pharmaceutical Cluster of Bogotá and the Bogotá Chamber of Commerce held the online event Challenges and Opportunities of Clinical Research in Difficult Times (Desafíos y Oportunidades de la Investigación Clínica en Épocas de Coyuntura). Different organizations engaged in life sciences and medicine innovation in Colombia were invited to this event to speak about their perspective of the pandemic.
Research with new challenges
Yaneth Giha -Executive President, Afidro (Association of Pharmaceutical Research and Development Laboratories)- explained that the global urgency has created a space for collective construction that enables drawing a roadmap for the future. In the midst of the pandemic the world is experiencing, clinical trials face new challenges such as responding with safe and effective therapeutic solutions, adapting to work within a social distancing scenario and, last but not least, maintaining the rigor required from the ethical and scientific point of view, she said.
While Daniel Gómez -Bogota Chamber of Commerce Macro-sector Articulation Manager- said that currently, there are 885 research groups in Colombia that could take advantage of the momentum to “deepen efforts and improve the appeal of clinical trials.”
To analyze the medical perspective, Infectologist and National Coordinator designated by the WHO for COVID-19 trials, Carlos Álvarez was invited to participate in the event. He mentioned that although much is known about the virus, there is still much to learn. For example, it yet unknown how people are infected when the virus is in the environment; the transmission dynamics in the tropics or in high places has neither been understood, “this is an opportunity for clinical researchers, rather than a deficiency of information,” said Álvarez.
Regarding the global situation, the Infectologist Physician explained that one must “realize how the virus behaves in different places, not for comparison purposes, but to understand the evolution according to the measures taken by governments.” Considering the above, it is worth highlighting the case of Singapore, where the death rate is considerably low (from all the tests performed, 0.07 people have died). This is because most infections occurred in buildings full of young migrants who are more resistant to coronavirus, and not in nursing homes or places with older people. Similarly, testing programs in Singapore targeted young people who were more likely to be asymptomatic and thus to transmit the disease.
Discussing about the Colombian case, it was mentioned that the positivity percentage in Colombia –that is, the people who test positive– is below 10%; as Dr. Álvarez explained, indirectly this means “that in the country we have a low transmission rate.” Despite this, clinical research in Colombia still has many questions to resolve, for example, what is the real meaning of a positive PCR test? Is the person infected or infecting? If the person becomes infected and recovers, can he/she become infected again? Are the antibodies generated protecting the person from coronavirus?
Migrating at a fast pace
Likewise, the Coordinator of the Clinical Research Group of the National Institute for Food and Drug Surveillance in Colombia (INVIMA) Sindy Pahola Pulgarin, stressed that during the pandemic they have had to reorganize inter-institutional coordination, which has created an opportunity for the Institute to approach more to the academic and scientific community, as well as to the 427 active clinical trials. Based on their needs, INVIMA has migrated to complete the processing of applications in a virtual way, which saves time for both parties and streamlines processes.
Those patients who were receiving non-COVID19 disease therapies represented a challenge for INVIMA, because they had to direct their efforts for designing contingency plans and operational plans in the research centers that receive these patients. In addition, Pulgarin noted that despite the economic impact of the pandemic, research workers continue working relentlessly.
Finally, there are technologies being implemented for the first time in Colombia that, although not new, the legal procedures and costs of these options made them difficult to be implemented. Telemedicine, electronic consent, home visits, electronic medical records, electronic signatures, and online processing are now a reality, explained Dr. Liliana Rodríguez, president of AVANZAR.
In conclusion, it is an important time for clinical research where people are understanding its value. On the part of scientists and doctors, it is a space of challenge and opportunity, but it all depends on the perspective they have of this pandemic.
Published on 3rd June