Pharma emerging markets: where does Latin America stand regarding phase IV?

Valentina Jaramillo

Investigacion Clinica Latam

Continued from “Conference coverage: how can Latin America remain competitive in R&amp,D?

In past articles we have discussed the potential for Latin America in the clinical trial business in general but this time I want to put emphasis on phase IV studies. The phase IV studies are the fastest growing area in clinical research for the pharmaceutical industry. This is mainly because concern of drug evaluations after new drugs reach the marketplace is growing every day. Pharmas are expected not only to develop new drugs but to make them safe and cost-effective therefore post marketing studies are a way to make this happen.

Latin America fits perfect into the phase IV picture of clinical trials because these studies require a larger number of sites and population than the pre-approval phases, which the region can offer. Not only are there large number of patients here but the retention rate is higher than in many countries. Latin America is well known in the clinical research field for having great patient compliance allowing the sponsors to collect valuable data to identify any issues related to product use. Patient number, retention and compliance are just the beginning of why the region is attractive for phase IV studies.

Since Latin America is a growing market for pharmaceutical companies, performing post- market trials will help accelerate the adoption of new drugs and therefore help achieve rapid peak sales and help the product maximize its potential. Investigators will be familiar with the product and therefore will use it and even help develop best practice guidelines and better standards of care that the region would otherwise probably not have access too. This is a clear example of the advantages working both ways, the pharmaceutical industries expand their market share and Latin American countries get access to drugs that would probably take longer to access.

“Not only are there large number of patients here but the retention rate is higher than in many countries.”

Another opportunity for the pharma industry when developing phase IV studies in the region is they get a chance to influence the market expansion and their product penetration so they can expand their reach. If they perform post marketing studies in Latin America the pharmaceutical companies will start to get more familiar with the region and this will help them identify under-treated populations which would benefit from the studies. At the same time these populations will help the pharmas generate new hypotheses for pre-clinical research that would help the pharmaceutical industry with their pipelines. If new hypotheses are generated, more research will be performed and new treatments will be developed to help with patient care. As you can see it´s a cycle that will be nurtured by having more phase IV studies in the region.

Performing post marketing studies in Latin America is a way for the pharmaceutical industry to demonstrate its commitment to patient care for the above mentioned reasons but it is also a way to show commitment to the healthcare professionals by including them in the quest for improving patient care. Latin American investigators feel involved in the new drug process and they value it because they want to be part of the development of better health care possibilities.

“Latin American investigators feel involved in the new drug process and they value it because they want to be part of the development of better health care possibilities.”

By performing phase IV trials in the region the pharma companies also show commitment to emerging markets and their population, demonstrating that they do care for their health and this trust is good for all pharma companies.

One important aspect to mention is that phase IV studies in Latin America are a great opportunity for Clinical Research Organizations (CROs). Since about 80% of the post marketing trials are outsourced the CROs that know the region need to partner up with pharma companies to develop their phase IV trials, and that way pharmas can get the most out of Latin America. For a CRO being known as an expert in phase IV studies in Latin America is an attractive strategy to show to the sponsors because it makes it more competitive than CROs that just carry out trials in the US and Europe. Therefore Latin America stands in a great place for both sponsors and CROs.

Before I finish I just want to leave you with this thought: At the moment there are 775 phase IV studies in the region compared to 4393 in the United States and 3954 in Europe so we see Latin America still has a long way to go but it has all the potential to be a leading region in this area. Pharmaceutical companies need to be aware of this potential and start exploring it, the sooner they start doing it the faster they will see the advantages.

What do you think?

Valentina’s next article will be published in October.

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 potential do you see for Latin America in phase IV studies?