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  • Essay / Outsourcing of clinical trials - 1885

    Outsourcing of clinical trials raises many questions related to data integrity and quality control of clinical trials. Regulatory oversight, language barriers, the meaning of informed consent in a much poorer population, the quality of clinical care, and the ethical issue of raising a population's expectations of medications that most of this population cannot afford are the consequences of outsourcing clinical research. More importantly, it raises the question of whether results from clinical trials in one population can be applied elsewhere. This then brings us to the main question of whether clinical trials should be outsourced, as their consequences are harmful to doctors and patients. Physicians are heavily relied upon to obtain the best prescriptions and/or advice to meet the needs of their patients and it is very difficult to make the necessary decisions without having all the evidence to support the decision-making process. Researchers explained and proposed solutions for data integrity and quality control of clinical trials. For example, Arun Bhatt, author of “Clinical Trial Quality: A Moving Target,” believes that a systems approach to the entire clinical trial process would help solve the problem of data integrity. The globalization of clinical trials is a relatively new phenomenon and the cost of developing new drugs costs on average $1 billion and most of this cost comes from human clinical trials. In the essay “Ethical and Scientific Implications of the Globalization of Clinical Research,” the reason clinical trials are outsourced to developing countries is the increasingly bureaucratic and costly regulatory environment in many wealthy countries. Regulation of clinical research has become very complex, and data is needed middle of paper (data affects a person's response to medications). This information will help identify medicines that benefit populations in all regions of the world and allow local regulators to better interpret the relevance of trial results conducted in other countries to their target populations. In the long term, solutions to problems arising from clinical trial outsourcing will require input from collaborators in academia, industry and regulatory agencies around the world. The future of the pharmaceutical industries depends on solving these problems. The ethical and scientific integrity of clinical research worldwide must be ensured, promote organization and uniformity in international research, and provide information on the benefits and risks of new drugs in populations. and the environments patients live in, wherever they are..