A multicenter clinical trial in the Arab world.
Financial, social, and perhaps religious, ethical, and other factors hinder investment and performance of clinical research in Arab countries. We report in that conducting multicenter clinical trials is feasible in the Arab world, describing our experience in planning and conducting one of the first multicenter, multinational, clinical trials in the region. A multicenter clinical trial sought to document the efficacy and safety of Epotin for the treatment of anemia in patients on maintenance hemodialysis. Among 29 centers contacted for participation, a positive response was obtained from 17 (62%) located in eight countries. The initial recruitment period of 3 months was extended to 1 year. Among the participating centers, 16 forwarded their results in time, with one being late. There were minor and a few major protocol violations, the latter requiring exclusion of data from the final analysis. Sponsorship was mainly by a local pharmaceutical company (Julphar). A co-coordinating body was crucial to trace and gather the data. Since conduct of the trial required considerable time and effort from investigators, the use of modern information technology could have reduced the effort and improved the outcomes. We conclude that multicenter clinical trials, which are essential can be conducted in this region. This experience needs to be repeated and refined.
Abbas
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Saif Bin Gobash and Ibrahim Bin Hamad Obaidullah Hospitals, Ras Alkhaima, UAE. eeabbas@emirates.net.ae
Dham
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Shaker
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D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D006397:Hematinics / Q000627:therapeutic use; D006801:Humans; D008877:Middle East; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000009:adverse effects*
D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa