Outsourcing

Clinical Trials – Considerations for Latin America

Outsourcing

10:00, May 17 2017

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Marisa Piaggio, Galmed Pharmaceuticals Ltd., provides tips on what companies should consider when starting trials in Latin America

There has been a great amount of discussion about the advantages and disadvantages of performing Clinical Trials in Latin America (LatAm). Anyway, I will not address this here. I will assume you have decided to come to this region already,or your client has requested you to do so and you are just about to begin with the Start- Up phase. In my experience, this stage is critical.

Ok, so, we are here, and we need to run a clinical trial in three or four countries in the region. What do I need to have in mind?

Local legal Representative

This is the first step: you need to have a legal representative in each country, which is not a physical person but a juridical one. Some years ago, most big pharmaceutical companies and CROs would have a local Clinical Research Associate who would act as such and submit on behalf of the company in some countries. However, that is no longer an option. In Bolivia, as far as I know, the Investigators submit the study to the Competent Authority (CA), but I really believe this will be changing in the near future as the region as a whole is trying to standardize its regulations.

Note 1: Please, take into account that companies doing Registries don't usually act as Legal representatives for conducting clinical trials. These are two separate activities and it is very rare that a company offers both services.

Note 2: The local legal representative becomes the "Sponsor" in the eyes of the local Regulatory Agency. This is the main reason the designated Company would prefer to do the monitoring of the study in the country. It is a risk for them not to do so, as they respond to the competent authority for the clinical study.

Language and Idiosyncrasy

You will need to translate every document into the local language in almost all countries. This is an obvious step. Only in some countries, the investigator´s Brochure, the Certificate of Analysis, and a few other documents can be submitted in English, but these are rare exceptions. It is important to note that even though we speak Spanish in most countries, except for Brazil, we have different meanings among countries for some words. A good option is to have a local partner or CRA, reviewing the translations and the content of the Informed Consent Form. This is important, not only to customize or adapt the content to local regulations in place, but also to review the whole document and put the focus on the local wording. Very often, regulatory bodies complain about the quality of the translated documents (some of them appear to have been so using an on-line translator) and this usually causes unnecessary delays in the review process. It is important to remind that the process in LatAm is usually sequential: first, we need the Ethics Committee approval and then, the CA approval. In Brazil - at some stage of the process - this can be run in parallel, but we won´t be able to initiate a site without both approvals.

The most common mistake is assuming that we are all the same because we are mostly Spanish speakers. LatAm is sold as a Region but each country has their own ways and idiosyncrasies and we act and/or react at different paces. If you have your Clinical Lead or Project Manager in Europe or the US, or even in Latin America (usually in Argentina or Brazil) you will need to understand this and try to adjust to the different ways and paces.

Importation and Logistics

Logistics is a particular topic. It is highly recommended to have a local depot in each of the participating countries. The Project Manager running the study should be aware of the different regulations about importation, and if this is not the case, it is encouraged that you learn as much about the process as possible. Without sufficient knowledge of the basics on importation processes and customs particularities, your medication or kits could easily sit there for quite some time - paying taxes while you try to solve the issue - and delaying the initiation of the study. Large Logistics Companies appear to be the solution here, but the local CRA or contact would know much in detail on what to do and what not to do (the "what-to-do and not-to-do-list").

Timelines

Timelines vary among countries, but to give you a general idea, I would say Chile is the fastest country to get the approval these days (with fewer restrictions at the time of importing) and Brazil would be the country taking more time to get the approval. Having this in mind, if you sell the Region, you can get the First Patient in with Chile and complete the recruitment when Brazil starts. After Brazil, I would say Mexico has the second longest timelines. This is only an example and my intention is not to diminish other countries' potential but to give an example on how to market the Region to a potential client.

Summary

Briefly, I would say that we are a large and interesting region, with great recruitment potential and good quality data. Investigators are qualified and very cooperative. Given the good relation patients have with their doctors, this plays a great role in recruitment and mostly, in compliance. I hope these few tips would help you to avoid one or two bumps in the road and maybe save you some time and resources.

 

Marisa Piaggio

Clinical Project Manager Latin America

Galmed Pharmaceuticals Ltd.

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