What about the clinical research sites in Latin America?
Valentina Jaramillo
Investigacion Clinica Latam
Valentina Jaramillo gives an overview of clinical research sites in Latin America.
There have been discussions for a while now about the importance of developing countries in clinical research and I think it is pretty clear by now that all developing countries, not only Latin America, are needed in order for the industry to get better results, lower its costs and all other advantages already mentioned in past posts such as “Pharma emerging markets: what is Latin America’s place within R&,D?” and the recent post by Zheng Su “Challenges and opportunities in global clinical trials”. However, I think we are forgetting to mention the importance of what having global clinical trials means to the sites and its patients.
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"In Latin America the number of research sites is growing rapidly..."
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In Latin America, the number of research sites is growing rapidly. They started as regular doctor’s offices, with maybe a study coordinator and a pharmacy, but currently, investigators are noticing the importance of offering a better service to sponsors so that they get chosen to participate in different trials. The number of patients per site is no longer the huge problem it once was, because most sites have similar database sizes. Investigators have to understand that clinical research function is changing and the investigators and sites that don’t keep up with the new trend will find themselves with no trials to work with.
What sites and investigators had to first understand is that they are offering a service to the pharma industry, by including the patients they need in order for their trials to occur and their molecules to be approved. This meant a big change for sites in Latin America, because it meant that they needed to stop being reactive and wait for pharma to come and tell them what to do, starting with the regulatory process. Now sites have to be proactive and since Good Clinical Practices and all other regulations are available to investigators and site personnel they have to use them and produce their own Standard Operational Procedures according to the regulations of each country.
This hasn’t been a simple change since Latin American sites were accustomed to just doing what pharma said. Now most sites have their SOPs and when a sponsor contacts them they have the first regulatory package ready according to what the regulation says. This is speeding up time frames for sponsors to enter the MoH in at least half the time it used to take to present the first site package. Since what has to be submitted is dictated by the regulations and not each sponsor, if sites have this package ready there is less time wasted. There is still more work to do, so that all sites work in a similar way, but by now the sites that aren’t doing it this way have noticed that they either need to catch up and improve their start-up times or they will be left behind.
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"This meant a big change for sites in Latin America because it meant that they needed to stop being reactive..."
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The change has been a cultural change through research sites. Many of them have joined in networks or are starting to do so and this makes it easier for sponsors, because different sites around the country are working with the same SOPs and in very similar and organized ways, improving the quality of data that sponsors are collecting. Investigators are now analyzing the whole clinical trial process and beginning to see it not just as something else to do in their practice to give them prestige, but they are learning that they are the ones who have the patients, so sponsors need them. If they do a good job throughout the trial then they will get more work and better recognition.
Investigators are starting to invest in their staff by having their study coordinators and co-investigators attend continuing education courses on clinical research, for not only the regular GCP courses, but more complete site management courses. These courses include more project management type subjects and business management classes so as to become more professional with what they do every day. This change of paradigm from the sites is happening at a higher rate every time and the number of professional sites in Latin America is growing continually.
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"The change has been a cultural change through research sites."
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The challenge now would be to have a Latin American network of sites that use the same standards. That way, investigators would be able to get more involved in the necessity of having one regulation for clinical trials in the region (Buenas Prácticas Clínicas: Documento de las Américas) instead of having one per country. Since the regulatory environment in Latin America is one of the industry’s biggest challenges, having investigators help the pharma industry show the advantages of one regulation for the region would be a great opportunity. This would help the different MoHs understand that this is best for Latin America as a region and is part of what the region needs to stay competitive against other emerging markets, such as India and China.
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About the author:
Valentina Jaramillo DVM is co-founder of Investigacion Clinica Latam. She is also founder and moderator of the twitter hashtag #hcsmla. She can be contacted at vale.jaramillo@gmail.com.
What can be done to improve the regulatory environment in Latin America?
