Organizing A Global Clinical Trial Involving A New Serum Marker

There are some trials that are being worked on around the world right now. For example, in 2013 a trial of an experimental treatment for advanced malignant melanoma took place in London at the Royal Marsden Hospital. One of the patients received three intravenous infusions, and after the second one the lumps that had been in her throat and breast had vanished. While those results were extraordinary, it is by far not the only time to have happened. There have been many similar trials that had the same results as this one. These new anticancer drugs are being called cancer inhibitors and some scientists are saying it could be the “turning point in cancer treatment.” Instead of

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

Economic: Globalization of the pharmaceutical industry is an exciting opportunity to have research and development done at cheaper prices in other countries. However, this could be a double edged sword for companies because it is easy for other countries, such as India, to produce generic versions of the drug in bulk.

Expanding into Asia (including India) so as to implement lower cost clinical testing and share opinions with leaders in the medical industry appeared to be a viable option. Drug prices however were substantially lower in India, profits were capped at 6% and post manufacturing costs were limited at 100%.

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

Our country is one where every day, new medical treatments and medicines are being discovered and being approved to help Americans battle all of the different diseases and conditions that affect us. In order for us to be able to get access to those medications and treatments, many people agree to become part of clinical trials, they are the first to receive the treatments, this helps to understand how the body will be affected and if the medication will be effective. People who are part of these clinical trials, go through extensive medical testing, and they must be of sound mind and

Patient also feel that only allowing drugs to be used for clinical trials to encourage greater participation in testing is unfair. Being a part of a drug trial is not easy for patients. Chahal points out that tests are often conducted in major cities, requiring many patients to spend significant amounts of time away from their hometown (368). Leaving home requires extra expenses for travel, lodging, and food and extra emotional strain from being away from family and friends. However, many deem these hardships as necessary for the moment in exchange for the

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

“Obligation of sponsoring and host countries”, which highlights some of the most important aspects of clinical research, case in point, that ethically, it should be a sweeping consensus. I always find, when thinking of the powers that be, scientifically, it would be rather easy for a big pharm or clinical research sponsoring organization, to seek out human subjects in developing nations, simply because research guidelines aren’t as stringent there, because regulation isn’t as intrusive. Thus, guideline 15, is paramount, because it holds external sponsoring agencies, as well as the host country, accountable. Guideline 15, hallmarks the importance of holding high ethical standards, regardless of where the research is being

With the testing of new drugs, there must be drug trials to determine the effectiveness of the new drug, which brings to light a second moral issue which questions if drug trials are moved out of affluent nations to third world countries due to the expendability of the citizens living in there. I do not plan to argue the second moral issue, but I do believe

Critical issued of the appropriateness of conducting clinical trials in emerging countries has arisen over years. Being a leading company in biopharmaceutical industry, Novo Nordisk faces the critiques of whether it is justice to offshoring their clinical trials in developing economies. With the consistency of ethical principles brought up by Novo Nordisk, the company would be able to move their trials into emerging economies with the best interest for stakeholders. I will also propose ideas to Mr, Dejgaard for possible approach to media as well as the practices that Novo Nordisk could have changed over time at the end.

Language and cross cultural differences can be a barrier for participants to understand the research. Due to poor education in developing countries it's impossible to adequately inform

The pharmaceutical industry confronts several dilemmas every year. Most of these dilemmas revolve around money or whether or not to sacrifice now for a bigger payoff in the end concerning money and/or lives. Pharmaceutical companies tend to use shortcuts that create ethical problems. Drug companies have spent millions/billions of dollars in research, and they obviously want to see

Some countries lack medical facilities for diagnostics and empirical prescriptions provide a quick treatment, however, this is not acceptable practice and policy changes of a global standard are necessary (Laxminarayan et al., 2013).

There are numerous clinical trials being conducted around the world every day. In spite of the technological advances like Internet,