Outsourcing of Clinical Trials to Developing Countries

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

Drug companies that test experimental drugs in foreign countries are not acting ethically. Testing of experimental drugs should be done in the host country where the drugs are being manufactured. A major ethical dilemma that is

Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

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%.

Clinical Trial Participation In the popular television drama, Grey’s Anatomy, the main stars conducted a series of clinical trials that introduced Seattle into a new form of research. After their trial called the “Shepard Method” grew into a success, the program's audience became aware of clinical trials in reality. In the previous years, clinical trials have evolved and made a big impact on society. However, there is controversy about whether or not one should take part in clinical trials.

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.

In recent years, it has become an increasingly popular practice for drug companies to perform their clinical testing of new drugs in foreign countries that might not have the consumer protections or product liability laws present in the United States.

The importance of drug trials is to properly inform pharmacologists and physicians of proper dosage amounts. Most trials conducted today are performed on the average adult. From these trials, the dosage amount is decided then sent to pharmacy companies to print on labels. The FDA (US Food and Drug Administration) has only approved 20% of drugs for pediatric use. Out of urgency, doctors and pharmacists have prescribed off-label drugs, which are drugs that have not been approved or tested

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.

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

Observations and experiments are required for each level. Systematic review is “the application of scientific strategies that limit bias by systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic.” Systematic reviews offer strong evidence. “For example, for a given research question, high-quality systematic reviews including high-quality trials would yield stronger inferences than systematic reviews of lower quality trials.” A randomized controlled trial is a study design that randomly assigns individuals into an experimental group or control group. When the individuals get divided into groups, one of the groups uses the treatment being tested. “The experiences of the other group of people provide control or comparison of the data.” This makes it possible to see what effects the treatment actually has. These studies work well with drug trials. Cohort studies are a type of medical research used to investigate the causes of disease. In retrospective cohort studies, researches look at data that already exists and try to identify the risk factors for a certain condition. In prospective cohort studies, researchers come up with a question to form a hypothesis about the potential cause of the disease. They observe a group of people over a long period of time. A case report is a report of the symptoms, signs, diagnosis, and treatment of a patient. According to the Journal of the

The cost of new medical drugs seems to be accepted by many people who use them. These pharmaceutical companies increase their profits more and more each year because many people assume that it does cost a lot of money for research and development. Where in reality, they are only spending about 15% of their profit margins on research and development alone. A huge percentage of these drugs are actually tested in other countries where people are more willing to do trials with these drugs because they cannot afford them. Not only are there more people who are more willing to try them, but also there is less regulation and oversight when it comes to testing. Conducting these clinical trials overseas not only saves

Who Enrolls in Drug Trials? Healthy experienced testers are used during Phase I where the side effects and safety of a potential new drug are tested. Phase II trials find dosing requirements and therapeutic efficiency. Phase III trials are on a much larger scale so they can compare the results with other medications on the market. Experimental drugs, biologics, and devices are just a few of the studies these “guinea pigs” can participate done.

The pharmaceutical drug manufacturers are moving towards adaptive design in a clinical trial as per the U.S.FDA guidance. The adaptive trial design is giving greater benefit than a traditional drug trial design through the new drug approval from the pipeline to the patients. The meaning of to accept adaptive trial design is to make clinical trial more efficient by allowing changes in clinical trials. Adaptive trial design allows researchers modification in the clinical trial and/or statistical procedure of the clinical trial after initiation of a clinical trial without harming trial’s validity and integrity. Traditional drug trials were conducted on a set of very strict rules without inflexibility.

Phase I: A small group of healthy human subjects enrolled to test the safety profile, efficacy of the drug.