Outsourcing clinical trials raises many issues related to data integrity and quality control of clinical trials. Regulatory oversight, 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. Most importantly, it raises the question of whether the results of clinical trials using one population can be applied elsewhere. Then this leads to the main question on whether clinical trials should be outsourced since the consequences pose harmful effects to doctors and patients. Doctors are heavily relied on for the best prescription and or advisement to their patients’ needs and it is very challenging to make the necessary decisions without having all of the evidence to support the decision making process. Researchers have explained and proposed solutions to data integrity and quality control of clinical trials. For instance, Arun Bhatt, the author of “Quality of clinical trials: A moving target”, believes that systemically approaching the entire process of clinical trials would help solve the issue of data integrity. The globalization of clinical trials is a fairly new phenomenon and the price of developing new drugs on average costs $1 billion and most of that cost stems from human clinical trials. In the “Ethical and Scientific Implications of the Globalization of Clinical Research” essay, the reason for outsourcing clinical trials to developing countries is the increasingly bureaucratic and expensive regulatory environment in many wealthy countries. Regulating clinical research have become very complex, placing a... ... middle of paper ... ...s affect a person’s response to drugs) data are needed. This information will help identify medications that benefit populations in all parts of the world and will better enable local regulators to interpret the relevance of trial results from other countries for their target populations. In the long-term, solutions to problems arising from outsourcing clinical trials will require input from collaborators in academia, industry, and regulatory agencies around the world. The future of the pharmaceutical industries depends on addressing these issues. The ethical and scientific integrity of clinical research globally must be ensured, promote organization and uniformity in the field of international research, and provide information about the benefits and risks of new drugs in the populations and environments in which patients live, wherever they may be.
2. In recent years, there has been a growing attempt to measure the performance of health care providers. The federal government and the states have published data on how hospitals are compared to acceptable clinical standards with regard to pneumonia. Explain how these data could affect the consumer decision-making process.
The varieties of pharmaceutical and prescription drugs that are available to the public provide many different consequences, which could lead to other health problems among users. Opioids, for example, are typical...
Third world countries and underdeveloped nations have become the new proverbial Petri dish of experimentation and offer particular conditions which researchers would never be able to find in their home countries. This only serves to highlight the problem that inherently faces all research studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to expect the same standards to apply in certain countries where an economical imbalance between what is possible and what is not can be the largest hurdle to overcome? These are key issues examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co-authors Harold Varmus, M.D. and David Satcher, M.D. in their respective articles that consider the ethical standards that should prevail in such circumstances. Should researchers be upheld to universal standards, or are the standards more applicable in a “local” sense, where the conditions and the constraints of the location provide the context for how the principles should be applied?
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
For instance, 20 largest United States (“U.S.”) based companies are now conducting one third of their clinical trials outside the U.S. According to a report from the inspector general of Department of Health and Human Services (“DHHS”) the number of clinical trials conducted at foreign sites has increased to 6,485 in 2008 from 271 trials in 1990. This trend suggests that the outsourcing of clinical trials has become one of important aspects of business fostering development of safe and effective drugs and devices that are interest of through out the world but at same time raising many ethical and scientific concerns.
...obert J.. Ethics and regulation of clinical research. 2nd ed. Baltimore: Urban & Schwarzenberg, 1986. Print.
team in an agreement that the ARO-CRO model will turn out to be “the new model” for new drug discovery, trial and approval. An examination of recent trends between ARO-CRO and ARO - Big Pharmaceuticals partnerships, I have concluded that there is a different paradigm than Goldenberg et al. team has described. AROs were uncommon before Goldenburg et al, exposed the ARO-CRO model, available in “Blood” in 2011. This paper has described the significance of the roles and accountabilities for chief partners, including AROs, CROs, pharma organizations and regulators. We are learning the importance of the AROs that compete with the current paradigm of clinical development in outsourcing of clinical trials to CROs. AROs play a more essential role in pharma clinical research and development
Mordini, Emilio. Ethical considerations on pharmacogenomics. Vol. 49. El Sevier, 2004. 4 vols. 22 March 2014. .
Many tests and laboratory experiments on alternative medicines based on animal venom and plants have shown promise. Some have even prevented the spread of cancer cells, or become pain killers. And that is not even the best part: natural therapies are not loaded with the chemicals so common in mainstream medicine, thus making them safer. Yet these results are stifled by the medical community, which is not only unethical, but it is potentially dangerous for those battling disease. In some cases, the pharmaceutical owned medical community goes so far as to sue or debase physicians who practice alternative medicine, thereby keeping their clientele safely in their grasp. Lives are being played with and new ideas are being stifled: in the United States. Other nations- European, Asian, and Australian- are practicing and discovering the merits of alternative medicine. Yet the nation so proud of its freedoms is shutting down research on treatments which may save lives- all for money. Because nat...
Kendrick’s Doctoring Data, is an extremely engaging, and thought-provoking book in which he makes a lot of compelling arguments about medicine in general. It left me puzzled with just about any scientific claims that have been made so far. Most importantly, Kendrick looks into depth at both the medical and pharmaceutical research leaving me to question the motivations behind the manipulation, and the use of dirty tricks by pharmaceutical companies would practice to convince their audiences into thinking that their products are the best. In addition, I was confused with what the morality behind medical establishment in the United States are. Are they valuing money more than lives? How did money become so involved? What can we, as patients, do to solve this problem? What can doctors do to solve this problem? How do we advertise information to consumers of healthcare to be aware of the bias and gamesmanship of medical research? On the other hand, I dispute Kendrick’s explanations of medical research. Kendrick made an argument that one of the core reasons behind why researches conducted are
The most common way that the pharmaceutical industry uses their power and influence to create lifelong customers is in the manipulation of clinical research. When a pharmaceutical company creates a new drug, it must first get the go ahead from the Foo...
Biopolitics plays a huge role in the medication of the mass population. Joseph Dumit writes Drugs for Life to show how the consumption of medicine and the cost of healthcare came to be and how it is taken for granted. Dumit gathered his information by attended pharmaceutical industry conferences and speaking with the marketers, researchers, doctors, patients and looking at the strategies used to expand markets for prescription drugs. What he discovered from his study was that the continuous growth in medications, disease categories, costs, and insecurity is a new perception of people and they feel as if they are ill and in need of chronic treatment. This perception is based on clinical trials that have been largely outsourced to pharmaceutical
Miller, F. G., & Brody, H. (2002). What Makes Placebo-Controlled Trials Unethical? American Journal Of Bioethics, 2(2), 3-9.
Drawing correct conclusions regarding the safety and effectiveness of healthcare interventions requires data to be as accurate as possible. Moreover, systematic errors in data can lead to biased results and incorrect allocation of resources (Adler-Milstein and Jha 2013).
Recently, Biocon has been compelled to move various Indian projects to the US and Europe. The situation only makes the process more cumbersome but also results in a 10-20 times hike in the cost of drug development. In the past two years, companies like Piramal Enterprises and Lupin were also forced to go abroad for conducting clinical trials, due to slow and uncertain approval processes in India with the matter being challenged in court.