Biotech tropicana Journal
SMARThivTECHS: A Trial Perspective
Aboubakar YARI1*; and Venus YARI 1.
Biotech tropicana, Inc, Parakou, Benin
*Corresponding Author: Aboubakar YARI, Bioteh tropicana, Inc, 02 Po Box 1038, Parakou, Benin Republic. email: ayari@biotechtropicana.com
Citation: Aboubakar YARI and Venus YARI: SMARThivTECHS: A Trial Perspective . Biotech Tropicana Journal (2009), 1(1):25-37
Keywords: Clinical Trials; Alternative Technologies; Resource-Poor Settings.
Published Online December 26, 2009
Editorial
Here we describe a tentative scheme of clinical trials organization for our SMARThivTECHS system. SMARThivTECHS are a system of alternative technologies designed with special features to permit widespread implementation of individual centered three tests in monitoring HIV patients in the resource-poor settings. Three laboratory tests are generally performed in monitoring HIV patients in the developed world. Most developing countries performed only CD4 tests. Cost and Complexity of required technologies are the major challenges to the developing world to meeting the three tests standards. SMARThivTECHS are designed to permit performance of the the three tests in the developing world. See YARI, A et al; www.pubmed.gov
We planned a three steps clinical trials of the SMARThivTECHS system, 1- simulation of all aspects of the clinical trials, 2- pre clinical trials of the prototype of the SMARThivTECHS, 3-clinical trials of the products of the SMARThivTECHS.
1- Trial Simulation of The SMARThivTECHS
The simulation phase aims to highlight potential issues that may arise during a real clinical trial. The simulation phase will re-enact the trial as close as possible to a real trial. The simulation trial will focus on three aspects of the trial, a-testing the PCR system for in lab application using manual sample prepartion PCR protocol, and testing the PCR system for out lab application using robotic PCR sample preparation protocol, b- testing the elisa system for in lab and out lab manual protocol execution, and execution for new automated elisa systems using homogeneous elisa protocols, and dot elisa protocols, c- the mobile version of SMARThivTECHS will be tested for PCR system in a simulated motor vehicle for both manual and robotic PCR protocols, and for elisa system using manual and automated protocols. the simulation is set to start on January 1st 2010 at 8 AM Greenwich Mean Time.
2- Pre Clinical Trials of the Prototype of the SMARThivTECHS
SMARThivTECHS are a platform of multiple components. Here, each component will be tested in clinical settings for PCR and ELISA systems using both manual and automated protocols. Here again a mobile version in a motor vehicle will be tested for each component, and for the platform, SMARThivPACK.
3-Clinical Trials of the Products of the SMARThivTECHS.
Using results from phase I -simulation- and phase II -pre trials-, clinical trials of the products will conducted.
SMARThivTECHS are designed based on principles established in the United Nations Millennium Development Goals -MDG- and the United States Millennium Challenge Corporation -MCC-. One of the main purpose of the first two phases of the trials is to get the system ready, for an official presentation to the United Nations in New York.
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