¶ … approved drugs are used in children and pregnant women, although these drugs have never been tested in these vulnerable populations. Do you think clinical trials should be conducted in children and pregnant women to determine the efficacy and safety of these drugs? Why or why not? Although clinical trials remain the gold standard for evaluating the efficacy of drugs, when it comes to vulnerable populations, there is little or no room for experimentation, especially when it involves potentially harmful substances. While some social science researchers might disagree with this view, an acid-test for these advocates would be to ask them if they would approve of such clinical trials being conducted on their wives, mothers, sisters and daughters if they represented any type of risk. It is reasonable to suggest that proponents of such clinical trials support their position only to the extent that such trials are conducted outside their own circle of family and personal relationships, and they would prefer that any such trials be conducted as far away from them as possible, preferably in a developing country where people have less to lose, after all. Because researchers are able to accurately extrapolate the effects of drugs on women and...
This is not to say that clinical trials are inappropriate in certain situations such as adult women who are not pregnant and are otherwise in a position to give their unqualified informed consent, but it is to say that such trials have the potential to exploit vulnerable populations and any such attempt must be viewed with close scrutiny for this potential.
Conducting clinical trials in the developing world also enables drug companies to keep costs lower for the trials and therefore renders the final product more affordable. This is an outcome which benefits all individuals in the long run. Demand for drugs that will treat increasingly common global problems such as diabetes is expanding, and proponents of these trials further add that it is necessary and beneficial that the populations they
Clinical Trial Outsourcing Contract Issues in the Outsourcing of Clinical Trials The increasingly common practice of outsourcing clinical trials for pharmaceutical research and development is fraught with legal and ethical complications, especially as much of the outsourcing finds these clinical trials taking place in underdeveloped countries that lack infrastructure and appropriate civil and social oversight. In a scenario such as the one described, where an unequal partnership shares certain rights to the
It would therefore be a major breach of ethics for the status of individuals in the study to be leaked. Another ethical challenge would be keeping the status of individuals from their significant others. Women are often in relationships where the power and economic disparities require them to remain in those relationships for mere survival. Should their status become known by their partner this may threaten the longevity of the
Outsourcing Firms outsourcing clinical research for a number of different reasons. The theory of comparative advantage underlies CRO, as firms in other countries might be able to do the research more effectively, or more efficiently. Often, CRO done in order to save money, as is particularly the case with India. In other instances, the outsourcing is done to firms that have developed particular specialties in research (Piachaud, 2002). In India, firms are
Recruitment Increasing Level Participation Clinical Trials Delays completion a clinical trial typically caused lack patient availability. In fact, studies 10% eligible patients participate clinical trials. Recruitment: Methods and challenges One of the most common recruitment strategies when soliciting individuals to participate in experiments is offering financial compensation through general advertisements on the web, radio, or in other publications. Financial compensation encourages individuals to participate in clinical trials and other types of research studies
Medical Procedures and Ethical Considerations Randomized Clinical Trials (RCT) is a medical study whereby the participants are randomly assigned to groups or team which are then used to compare different treatments. The members of the groups are then subjected to a chosen treatment hence the group members will have similar treatments though different from members of another group. The same treatment of the members of a group is aimed at having
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