Discussion on Countries’ Justification for Trials
- South Africa
- Eastern Europe
- South America
Impact of draft protocol
- Influence of trials on countries targeted
Health Care: Global Diabetes Trials
Clinical research has gone global. As such, diabetes research is just one segment of the numerous trials being conducted around the world every day. This presentation highlights 10 countries in which these studies can be expanded. They are United States of America; Russia, India, China, South Africa, Brazil, Eastern Europe, South America, Asia and Canada.
Discussion on Countries’ Justification for Trials
Reports from the Association of Clinical Research Organization (ACRO) endorsed that United States of America and Canada already have an established market for clinical trials. Confirmations came in also for emerging markets in Eastern Europe, Asia, and Latin America. India was cited as having immense potential for conducting clinical trials. A study revealed that 92% of
Indian patients consulted with family or friends before enrolling in a trial. This was compared to 62% of American doing the same thing (Applied Clinical Trials, 2009).
Further ACRO discoveries regarding globalization of trials indicate that these emerging countries contribute significantly towards the advancement of medical science. Importantly, there is great promise in diabetes drug testing since stakeholders are enthusiastic about promoting use of more modern diabetic drugs, which ought to be on the market once successful trials have been conducted (Applied Clinical Trials, 2009).
Tarun Garg, Onkar Singh and Shil Arora (2011) further explored India’s potential for clinical trials and concluded that India is a most preferred country for contract pharma research and development. Its high patient enrolment rate, human resources, and technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, reliable data
quality and changing economic environment’(Garg et.al, 2011) are the essential criteria informing this assumption.
Countries in the European Union despite a few constraints still show a great deal of promise for trials whereby newer diabetic drugs could be tested for distribution among those nations. Precise reports are that they offer incentives to clients and researchers to conduct studies. As such, there is no doubt that countries like France, Spain and Greece have very high potential for drug trial and subsequent distribution (View from Brussels, 2012).
Beyond Europe into territories such as South Africa, China, Brazil and Russia do contain their uniqueness in contributing favorable to clinical research in establishing safer blood sugar control through drug intervention. Perspective informatics stressed that priority ought to be for countries with the most recent and frequently featured sites where non-EU trials were done to support EU marketing authorization applications. These include South Africa, India, Philippines,
China, Thailand, Brazil, Costa Rica, Peru, Russia, and Ukraine. The consideration is that more developed countries ought not to benefit more from exposure to trails than developing or underdeveloped ones (Perspective Informatics, 2012)
Importantly, in arguing for South Africa analysts have identified two major factors, which distinguish South Africa among nations in the continent. According to its economic profile it is the most developed nation in the continent. Besides, there are better established regulatory standards for conducting clinical trials. Factors influencing this clinical research development are related to its huge population of 48 million. This offers a large, diverse patient population (Virk, 2009).
The second strength in South Africa being one of the best countries to conduct trial sin diabetes drug testing is that the most participants enrolled in these clinical trials never received any previous treatment for their disease. This is due to poor health care services and traditional beliefs regarding scientific medicine. Also, many people cannot afford to buy medication. Hence, recruitment of subjects is facilitated and these trials are less costly to conduct (Virk, 2009).
Impact of Draft Protocol
Impacts of the draft protocol for this trial project would inevitably pertain towards seeking permission from health authorities with these regions; obtaining consent from clients and following the established research protocols of participating countries. While this is a standard protocol it is not universal for all countries. As such, modifications will have to be entertained for application in the various settings across these 10 nations. Major considerations are sample size adaptations and clinical settings be it hospitals, clinics or homes.
Influence of trials on countries targeted
A few of these countries have established markets for trials. These include United States of America and Canada. It may impact the success due to the already established market. There may be a difficulty getting subjects enrolled because they may be engaged in other trials. The costs of conducting trials in developed nations with established markets would be more costly also.
In countries such as South Africa where fewer trials are being conducted and subjects are often not taking any medications it would be less stressful in recruiting participants. Besides costs of conducting these trials are far less because there is seldom no competition from other researchers. Countries with emerging markets could, however, pose a threat to these trails. Such countries include in Eastern Europe, Asia, and Latin America. While emerging means that it is highly likely that they will encourage trials of this nature the competition with other researchers may be greater. Hence, this could be a negative factor in promoting this trial.