Outsourcing of clinical trials raises many issues related to data integrity and quality control of clinical trials. Regulatory control, language barriers, the meaning of informed consent among a much poorer population, the quality of clinical care, and the ethical problem of raising a population's expectations for drugs that most of that population cannot afford are consequences of outsourcing clinical research. More importantly, it raises the question of whether the results of clinical trials conducted in one population can be applied elsewhere. This then leads to the main question of whether clinical trials should be outsourced as the consequences lead to harmful effects for doctors and patients. Doctors are heavily relied on for the best prescription and/or advice based on their patients' needs 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 “Quality of Clinical Trials: A Moving Target,” believes that a systematic approach to the entire clinical trials process would help solve the problem of data integrity. The globalization of clinical trials is a fairly new phenomenon, and the price tag for developing new drugs costs an average of $1 billion, and most of that cost comes from human clinical trials. In the essay “Ethical and Scientific Implications of the Globalization of Clinical Research,” the reason for outsourcing clinical trials to developing countries is the increasingly bureaucratic and expensive regulatory environment of many rich countries. Regulating clinical research has become very complex, data at the heart of the paper (which influences a person's response to drugs) is needed. This information will help identify drugs that benefit populations in all parts of the world and better enable local regulators to interpret the relevance of study results from other countries to their target populations. In the long term, solutions to the problems arising from clinical trial outsourcing will require contributions from collaborators from academia, industry and regulatory agencies around the world. The future of the pharmaceutical industries depends on solving these problems. We must ensure the ethical and scientific integrity of clinical research globally, promote organization and uniformity in the field of international research, and provide information on the benefits and risks of new medicines in the populations and environments in which patients live, wherever they are..
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