Cuban CRO-alternative must continue standards evolution

02-Feb-2011 - Last updated on 02-Feb-2011 at 10:43 GMT

The Cuban clinical trial centre must continue evolving to keep pace with the multinational CROs to which it provides an alternative.

Established in 1991 to improve research success, the National Clinical Trials Coordinating Center (CENCEC) operates as a Cuban alternative to contract research organisations (CRO). Mirroring CROs, services offered by CENCEC include trial design, data management and analysis.

“From the Center’s creation, it was designed to offer a complete range of services, usually only available from large global or multinational contract research centres”, according researchers writing in MEDDIC Review.

Now, as before, the challenge is to continue developing: The goal is: “To ensure a clinical evaluation process that meets international standards. Growing demands on the part of industry challenge the organisation to seek efficient solutions to reach goals unimagined 18 years ago.”

CENCEC & CROs

In some respects CENCEC differs from multinational CROs. “Some of CENCEC’s distinguishing characteristics include its national scope, its combination of scientific services with academic and health research, and continued human resource development”, say the researchers.

The research paper details the development of CENCEC since it was formed in 1991 to improve clinical trials. From 1992 to 2008 CENCEC conducted 103 clinical trials on behalf of 24 sponsors.

A complete picture of the number of trials, clinical sites, investigators and patient recruitment is shown in the table below. Of the 103 trials, 62 per cent were for biotech products and 18 per cent were for small molecules. Medical devices and natural products account for most other trials.

Overseas biotech

The large proportion of biotech trials is reflected in the list of sponsors, shown below. Another feature of the list is the low number of trials conducted as part of international studies. The report attributes this to CENCEC fulfilling its core mission of evaluating Cuban biopharm products.

Biotech in Cuba has, to a large extent, been cut off from much of the world. However, last month the US lifted some restrictions to allow greater educational and academic interaction between the two countries.