mic Report 2022
international clinical trial day
By Dr. Dora Inés Molina / IPS mic Clinical Research Center
Every May 20th we celebrate the International Day of Clinical Trials. Starting this year we will do it from the perspective of clinical research centers, with a reflection as a report. We’ve called it the 2022 mic report.
- The good, the bad and the future for clinical research.
Hi, I’m Dora Inés Molina, full professor at the University of Caldas, principal investigator and director of the mic Clinical Research Center, Ips internists in Caldas.
Let’s go with the good:
The good for clinical research in Colombia
- The countries with the highest scientific production in Latin America at times of high prevalence of covid 19 were: Brazil, Colombia and Mexico.
- So, we ratify our relevance as a receiving country, regulated and with high quality standards to carry out clinical studies for registration purposes.
- In addition, new economic income arrived that strengthened the structural foundations of the clinical research centers that we had the opportunity to participate in covid 19 studies.
- In Colombia there are a total of 76 ethics committees and 134 clinical research centers certified by INVIMA.
- As of 2022, 1,653 clinical studies have been registered in Colombia – the majority in phase III and only 80 clinical studies are on covid 19.
Now let’s talk about the bad.
The bad for clinical research in Colombia
- The cyber attack on INVIMA and the reaction of the regulatory entity.
On February 6, 2022, the invima page suffered a cyber attack and disconnection with physical and virtual servers, which was restored normally on April 1, 2022 and it was shown that this entity did not have a backup service, so that there was a significant delay in the approval of clinical studies during this period, which is a negative factor for the development of clinical research in Colombia.
- They significantly decreased the number of clinical studies in cardiometabolic areas.
Let’s go with the future:
The opportunities offered by the future of clinical research
INTIC (the national initiative for clinical transformation in Colombia) constituted by AFIDRO, ACIC and AVANZAR, continues to work hand in hand with Procolombia, INVIMA, MPS, MIN Sciences, patient associations and ethics committees.
Today, clinical research for registration purposes is part of the national development plan.
We invite the new national government to strengthen alliances to make Colombia an attractive, competitive country with high quality standards for clinical research in Latin America and the world.
We must recognize the media and scientific societies that in times of pandemic, gave clinical research the opportunity to be known by the community in general by communicating the status and development of the different vaccines against covid-19 , many of them already registered and marketed.
At the moment there is a platform in Colombia called SIMÉTRICA that records information in real time from each of the actors in clinical research and whose objective is to make Colombia an attractive, competitive country with the highest quality standards in clinical research. different areas of scientific knowledge development.
Blessed day of clinical trials and clinical research.
By Dr. Dora Inés Molina and the team at the mic Clinical Research Center
At the time the WHO declared COVID-19 a public health emergency of international importance on January 30, 2020, up to a year later, a total of 101 studies have been carried out in Colombia.
Of this total, 8 have been completed, 68 are in recruitment, 6 are active but not recruiting, 6 pending recruitment, 1 suspended, 1 abandoned, 4 terminated, 7 recruiting by invitation.
As for the most frequent sponsors are:
- Merck 27,
- Universidad de Antioquia 16,
- AstraZeneca 13,
- Universidad Nacional de Colombia 10,
- Hoffman-La Roche 9,
- Bayer 8,
- Novartis 8,
- Fundación clínica valle del Lili 7,
- Pfizer 6,
- Pontificia Universidad Javeriana 6,
- Universidad de la Sabana 6. (4)
Based on this information it is possible to establish the following:
Therefore, it is important to strengthen the work between the companies dedicated to clinical research in Colombia that are part of ACIC and the support of virtual platforms such as SIMETRICA, which allow reducing the opportunity time for selecting research centers based on the profile of each site and thereby increase recruitment significantly in each research center.