Clinical Trials In Developing Countries Case Study

There are clear benefits to conducting trials in countries which are still developing. These include exchange of information among medical organizations globally and answering questions about the safety and efficacy of drugs that are of interest throughout the world, but at the same time, the globalization of clinical trials raises ethical concerns. Regulatory bodies are often structured to monitor the quality of clinical trial data and the safety of drugs and devices in their domestic markets. They

topic of “organising a global clinical trial involving a new serum marker to detect the early onset of lung cancer” has numerous potential discussion points. Firstly, it is necessary to understand what is meant by “clinical trial”. A clinical trial is any research or study which assigns human participants to one or more health related intervention3. These interventions are then evaluated to determine the effects on health outcomes, such as disease3. Since clinical trials are centred around human participants

Clinical trials are essential for the development of effective medical treatments and vaccnies1, but conducting clinical trials in only one setting severely limits the ability to generalise results to the entire population. To ensure a drug is safe and works in the same way across different populations, it is necessary to conduct clinical trials in multiple ethnic and geographic locations1. There are other clear benefits to conducting clinical trials in multiple locations, particularly in developing

Health care in third-world/developing countries is vastly different than that health care in first-world/developed countries. In 1994, AZT became the first approved treatment for HIV. Pertinent studies showed that prenatal administration of AZT to HIV positive pregnant and subsequent postnatal administration to their babies resulted in a reducing mother to infant transmission from 25% to 8%. This change in the course of such a devastating illness helped to alter the mindset that having HIV was

of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies Offshoring is a highly debatable topic throughout the country and the world. Many people base their opinions on different aspects of offshoring. Some people are against offshoring because they feel as if the working conditions in other countries aren’t up to par and are unethical. Some people are against offshoring because they feel it is taking jobs away from people within their own country. Some people are for offshoring

of people in developing countries in order to further their research more quickly and increase their profit. An ever increasing number of trials are being held overseas; in 2008, nearly 65 percent of trials on products registered from within the United Sates were conducted in other countries. With this growth, the need to make sure that vulnerable communities are not exploited also increases; while the FDA did inspect roughly two percent of domestic trials, the number of overseas trials which were

and some families were not informed that they were taking part in a drug trial, a clear violation of the Nuremberg Code and The Declaration of Helsinki. Alarmingly, when the American drug company Pfizer was bought before a New York judge to answer for their ethical and moral violations, the judge decided that the case should be heard in a Nigerian court (Woods & Simkin). Nigeria happens to be one of the most corrupt countries in the world, and its government has little to no international transparency

The global clinical trial is a very challenging job; it involves strategic decision making which can affect drug development and approval process. Many factors should be considered in selecting countries, most common in feasibility studies include: the prevalence of the disease, regulatory requirement, patients’ recruitment, experience clinical trial specialist availability, ethical issues, language barrier, and marketing strategy. In this report, we perform a thorough assessment of conducting clinical

Research in cancer occurs in a wide range of scientific fields. The major categories of research are: – laboratory; – epidemiological; – clinical; – psychosocial and behavioural; – health systems and health policies. Most laboratory research is currently conducted in industrialized countries. It focuses on the elucidation of the biological mechanisms underlying cancer. Recent investigations of genetic and molecular/biological processes have produced dramatic and very promising results. Despite this

viruses when she encountered a woman named Celine, who was a volunteer patient in the HIV clinical trial. Meeting Celine altered Titanji’s perception of the people, especially those living in developing countries, who gave their informed consent for research. Afterwards, Titanji became a strong supporter of ethical medical research, bringing attention to moral alternatives that researchers should follow in their studies. Her decision to advocate ethical medical research is justified, because research should