Industry-sponsored research in developing countries.

BACKGROUND: Industry has become an important source of funding for clinical research; guidelines governing the relationship between industry and medical institutions are not clear in developing countries and hence we wanted to test attitudes and practices in those countries and compare them to developed countries. We conducted a survey amongst medical practitioners in developed and Arab countries representing developing countries, in order to document their views towards industry-sponsored research and their actual practice in this regard. METHODS: A structured questionnaire was distributed by email, mail and through personal contacts. The questionnaire included information on characteristics of the practitioners involved, their attitudes towards industry-sponsored research and their actual practices. The questionnaire was distributed to 510 medical practitioners of countries in both groups. Practitioners representing developed countries were from the United States, United Kingdom, Australia and New Zealand. Those representing developing countries included Arab countries from Asia and Africa. RESULTS: We found that there were contrasting views and practices between the two groups although more than 80% in both groups agreed that industry-sponsored research is necessary. 69.7% of respondents in developed countries participated in industry-sponsored research while only 30.1% did so in developing countries. Guidelines governing such research were better adhered to in developed countries than in developing countries. Where there were no authors who were not part of investigators in developed countries, 16.3% of industry-sponsored research in developing countries included authors who were not part of the investigators. Research ethics committees were present in 94% and 58% of institutions in developed and developing countries respectively. Review bodies were available in 57% and 41% in developed and developing countries. CONCLUSIONS: Industry-sponsored research is necessary; it is much more common in developed countries. Clear guidelines governing industry-sponsored research should be adopted in developing countries, including the establishment of research ethics committees and review bodies to monitor such research.

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.

The new rHuEPO alpha (epotin) in the management of anemia of end-stage renal disease in patients on maintenance hemodialysis.

Recombinant human erythropoietin has proved to be effective to treat anemia of end-stage renal disease (ESRD). The aim of this study was to assess the efficacy and safety profile of Epotin, a rHuEPO produced in the Middle East. One hundred thirty patients with Hct

The Effect of Short Term Use of Indomethacin, a Non-Steroidal Anti--inflammatory Drug, on Peritoneal Dialysis Patients.

In this study, the effect of indomethacin a nonsteroidal anti-inflammatory drug (NSAID) was studied to evaluate the effect of its short-term use on peritoneal clearance of urea and creatinine as well as protein excretion in nine chronic renal failure patients on intermittent peritoneal dialysis therapy. Four of them were males and five were females with mean age of 54.4 years. Clearance values and protein excretion in the dialysate effluents were measured before and after administering the indomethacin. There was no significant effect on the urea and creatinine clearance after the use of this drug. However, the mean +/- SE protein concentration in the dialysate effluents decreased significantly after the use of indomethacin from 43.1 + 4.5 to 37.0 + 3.5 mg/dl (p< 0.01). This reduction of protein excretion in the dialysate after the use of indomethacin might enhance the nutritional status of patients on peritoneal dialysis.