Examples Of Prescribing Experimental Drugs

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.

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 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.

IND application submitted with pre-clinical safety data of pharmacology and toxicology study gathered during a clinical trial in an animal, drug composition, information of manufacturers, stability of the drug, and controls utilized to process the drug, a constant supply of batches, a copy of clinical protocols which has been permitted by the Institutional Review Board (IRB), and s information regarding investigators who is conducting the clinical trials (Manuts, 2008). Good clinical practices (GCPs) are followed in all phases of clinical trials conducted in human by law of the human subject protection (HSP) stated in the CFR 45, Part 46. The FDA website, the Clinical Trials.gov offers to register the clinical

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.

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.

The controlled and randomized double blind trials refer to a situation in which a medicine investigator is not familiar with the nature of a drug. The term may also mean that a scientist does not realize that a drug is being tested maybe for certain diseases. Such medicines may be under surveillance, and they are only administered in a small prescribed amount in case of any side-effects. For a typical scientific research, the desires, expectations and beliefs can subconsciously influence, often, how people perceive things. In clinical research and preliminary psychology, these values are broadly recognized, thus explaining the rationale on why studies from subjects are regularly carried out under

The drug approval process is a complicated labyrinth that sometimes seems impossible to navigate. There are guidelines, protocols, procedures and standards that each person in the process are expected to follow. This includes the doctors, principle investigators, researchers, pharmaceutical companies, the regulatory bodies and yes, the patients. The patients are by far the most important aspect of a clinical trial and obtaining drug approval. Without the willing volunteers in clinical trials there would not be treatments and cures for many diseases today. There are a lot of factors that go into getting a new medication to the open market, including many phases of clinical research. The roles of the FDA, various research laboratories and the pharmaceutical companies all play a pivotal role in the time that it takes to obtain drug approval. There are many obstacles associated with each step including funding and how that impacts the consumer costs.

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;

The discovery of new drug without involving human subjects is called as non clinical studies. Goals of non-clinical testing of Biologics are: characterization of potential adverse drug effects, identify end organ toxicities, identify reversibility of toxicity , characterization of pharmacokinetic profile, characterization of beneficial pharmacodynamic effects -proof of principle , guideline for safe use in human clinical studied determination of a safe and reasonable starting dose and provide monitoring guidelines for the clinical study, provide sufficient clinical data to conclude that there no

As mentioned in class, as well as in the Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).

Clinical trials are often designed to test new biomedical or behavioral interventions such as new treatments/drugs, prevention strategies, screening programs, diagnostic tests, and educational models. The rapid increase in the costs of conducting clinical trials has made the efficient design of clinical trials more important in recent years. For example, a new report published by Tufts Center for the Study of Drug Development (CSDD) expresses that the costs of new drug development which is one of the wide applications of clinical trials have been pegged at $2.558 billion, with a 145% increase over an estimate made in 2003 [9].

Once the IND is submitted the sponsor must wait 30 calendar days before initiating any clinical trials. During the preclinical phases the drug was subjected to in vivo testing. In vivo testing is when a drug is tested in animals and is monitored for chromosomal damage and how toxicity levels are effected. During to clinical phases the drug goes through 3 phases of testing. Phase 1 is when a small group 20-100 of healthy volunteers are administered the drug dosage in small doses and gradually increased. This phase’s purpose to establish dosage and compound safety. Phase 2 is quite the same as phase 1 but with a larger group 100-300 people that are drug candidates. This phase determines effective dosage, methods of delivery and dosing intervals. Phase 3 and final phase is same as its predecessor phase but with a much larger group of 1000-3000 individuals that are drug candidates. This phase provides patients with the drug in the exact form as it will be given will on the market and is compared to similar drugs on the market. Oftentimes double-blind studies are done in this phase with the drug and a placebo.

To approve a candidate cancer drug into clinical use, clinical trials upon human bodies would be performed after preclinical tests which have already shown potential of compounds through in vivo and in vitro tests. Usually, the clinical tests can be classified into three main phases of phase I, phase II, and phase III. Phase 0 and phase IV are also sometimes included.

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 have limited information on many aspects of research conducted outside their jurisdictions or countries, including the sites, investigators, and participants and the quality of trial data.