Highlights from ExL Pharma's 4th Latin America Clinical Trials


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  • For this grant application, the focus is really creating a partnership between 2 ethical review committees, one in a developing country and one at a US institution. The reasoning behind this is twofold:Bureaucratic – the funding comes from ARRA and in order to use them as a funding source, the focus of the grant must be to accelerate the speed of research through IRB collaboration.Limited Funds – This is viewed as a pilot project to develop relationships between IRBs which can be built upon in the future and used for larger grant opportunities.Although the justification for this funding opportunity comes from the Federal requirement that NIH supported investigators must obtain ethical approval at both the US and foreign institutions, any improvements in the ethical review process will benefit all research sponsors.
  • Developing country as defined by World Bank (according to Gross National Income per capita as “low income” “lower middle income” and “upper middle income”
  • Launched in 2005, the EDICT Project was developed to design practical and realizable policy solutions to disparities in clinical trial participation. The community health worker or promotora model is used becausepromotoras are effective communicators and may act as the bridge between external systems and the community they serve. They may act as change agents within their naturally occurring social networks. Serving as a bridge promotoras are able to break through barriers to participation in clinical trials based upon our experience in the US. For examples, many populations do not turn to health care professionals for health information but seek out authority figures in their own social network. This also contributes to the lack of knowledge of the existence of clinical trials within the community.Promotora services are delivered for the most part through home visits and group presentations. Promotoras go where people congregate; health fairs, church, neighborhood meetings, factories gas stations, grocery stores.This model has been used successfully for decades as an approach to reducing disparities in health status and health care access in the US.Many states in the US have certification programs and the CHW/Promotora is recognized job classification by the US Dept. of Labor.
  • The Microfinance Industry became active in Latin America in the 1990s and even more so in the early 2000sThe MFI industry includes small short-term loans, insurance, banking products, Microcredit in the true sense of the term, always enables the borrower to create wealth.
  • Each Loan Officer has approximately 10-20 Trust Groups they work with or on average about 200 clients at one time.Within the Trust Group is where the action is. Basic business education plus health education, discussion on social and public health issues as well.For many MFIs, the majority of staff is native to the local community in which they work.Investment It varies from country to country but between 60-80% of all clients are women.
  • Typically, MFIs operate in places where it is difficult to conduct research.Geographically isolatedPolitically unstableTechnologically backwardEducationally disadvantagedHowever, MFIs working in these countries focus on teaching entrepreneurs the following topics:Cash flow (control, management); financial literacy (budgeting, profit); value chain (suppliers, customers)So if they are able to understand these topics, then they should be able to comprehend issues such as experimental, consent, etc..
  • Deviation in just a few centers can invalidate/change the results of an entire trial (as patient data is excluded), jeopardizing submissions (or even existing approvals if issues are found very late)Such events potentially have widespread reputational and credibility impact in the public domain Even in cases where problems are discovered relatively early, the resource and time spent in remediation far out-weighs that which would be expended in “getting it right the first time”
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