Human Drug Trials : An Experimental Study

During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.

The Helsinki declaration was founded in 1964 and since here they have been updating principles of good practice in this kinds of experiments. They say, “Welfare of animals used for research must be respected”. Since here the ethical views for non-humans subjects started. Later on the APA gave instructions to determine whether an experiments on animals is acceptable or not. For example animal research should not harm the animal or distress it on any way. If the researchers don’t follow this code, they wont be allowed to keep on with the experiment.

Clinical trials, or a test before a treatment is approved to be safe for human consumption, have been dated back to the biblical times. Recorded in the “Book of Daniel” a king and military leader performed the first known clinical trial (Evolution of Clinical Research). Although his experiment was nowhere near what we conduct in today's society scientist, doctors, and other researchers before them have learned through trial and error, and they have used clinical trials to study diseases. In 1774 James Lind followed through with the first clinical trial of the modern era studying scurvy.

The method can be seen as an alternative to more extensive trials, which may take place later, prior to a release of a product.

Before putting this to effect, the drug had to be tested to see possible drastic side

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 today's society there is so much dependency on the perceived usefulness of material things and items. This approach has evolved the medical system into a giant, profit-orientated machine that treats health as merely a means to gain further competitive advantage. As a result drugs are often used as wonder treatments that allows healthily lived life. With so much dependence on this way of life, it should be no surprise that there certain side effects that may display themselves in other aspects of society.

The importance of this report, Secrets of the drug trials, is that we understand the conflict between the financial gain of the pharmaceutical industry in comparison to the actual health benefits that the drugs provide. The demand for bigger, better drugs has grown exponentially due to stigma connected with mental illness. In Secrets of the drug trials it became evident that the recovery of the patients was secondary to the public opinion of the drug. This is a common occurrence when the drug analysts are also benefiting when the drug passes its review. Although there are many objective companies and review boards that go through their data,they can only review the data that is made available to them. Findings that are not beneficial to the company can be hidden and in turn not discovered until it has deadly repercussions.

Forty suggested that the knowledge of his experiment may raise an aware and better improve the use of pharmacological management in patients (Forty., et.al 2008).

Introduction: Researchers will select a group of qualifying participants for the study. The participants will be randomly divided into two groups. Researchers will then manipulate the variables by administering the Physostigmine drug to one group and placebo to another. Researchers will then measure the variable and compare the groups, to see if the drug Physostigmine produced its desired effect. The experiment will be a double-blind study, neither the subject nor experimenter will know what treatment the subject is receiving; a third-party administrator will be the only one who has the knowledge of which patient receive what treatment, until the tests are concluded and the comparisons can begin.

These treatments must be tested in order for them to be deemed effective. For example blood thinners this treatment can be very effective to a point then it can be dangerous. It is important that we understand this boundary. Another thing that must be tested is psychological effects. Many people suffer from psychological issues. An example of this would be stress. Stress can easily put a person into a state of overall misery. We have tested various animals to see how they respond to stress and now have many

Clinical research trials can be defined as tests of new medications or devices on human participant subjects. Clinical trial sites participate in operations by which they recruit patients that may be eligible in their studies, and conduct such tests on them. I chose to observe patients diagnosed with schizophrenia participating in clinical research trials at the Neuropsychiatric Research Center of Orange County, where I have been a clinical research assistant for seven months. The focus of my observations has been particularly on the effects of antipsychotic medications on these patients with schizophrenia.

Bryant, B., & Knights, K. (2014). Pharmacology for Health Professionals (4th ed.). Chatswood, NSW: Elsevier Health Sciences.

to conduct a trial with limited patients and still be able to obtain useful information in

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.