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...
The data utilized for trial analysis are maintained anonymous, however the trial management data carry personal identifiers for conduct of study and to ensure patient safety. The patient source data is encrypted and password protected allowing access to authorized personnel and prevents transfer to electronic media device. The list of authorized personnel will be maintained in the Trial Master File. The audit trails captures all activities pertaining to conduct of clinical trials and tracks changes performed to data. The date and time stamp used impede chances of misuse. On completion of the trial, the data will be locked using DMS file locking facility to prevent tampering of
The IRB is an administrative body which has been established to make sure research participants' rights are protected. IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and informed adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised.
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
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.
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. .
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...
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...
...obert J.. Ethics and regulation of clinical research. 2nd ed. Baltimore: Urban & Schwarzenberg, 1986. Print.
In addition, this movie acts as a solid example of the grueling path one must take for permission in releasing a medical innovation to the public. Writing for the journal The Scientist, Jef Akst stated that the film acted as a good depiction of the “hard to swallow fiscal issues of drug development” (the scientist). However, this painfully hard process exists for good reasons: they must weed out the ideas that can not be safely practiced in modern society. Also, the regulations ensure that each innovation, whether drug, therapy, or procedure, will benefit the consumer more than the side effects could harm them.
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).
Miller, F. G., & Brody, H. (2002). What Makes Placebo-Controlled Trials Unethical? American Journal Of Bioethics, 2(2), 3-9.
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.