Taking a Look at Clinical Trials

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 process used to pool the data together was clinical trial decision making. The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010).

People should participate in clinical trials because they are safe, a way to earn money, a positive impact on the medical field, easy to perform in, and highly successful. A clinical trial is similar to a research study that is conducted for many reasons.

In a study done by Emadedin et al. in 2012, they injected MSC from each respective patients bone marrow, into six female volunteers with evidence of knee OA that was severe enough to require joint replacement surgery. The authors described a detailed, meticulous procedure in how they obtained the MSC from the patient’s bone marrow, and made it into the cells they needed for the procedure. They injected the patient’s affected knee joints with the stem cells and followed up with them in one year. At the one year mark, Emadedin et al. (2012) found that overall, the study was successful in decreasing pain and increasing the patients walking distance for the first 6 months. However, they discovered that 3 of 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.

Evidence-based nursing practice is a result of research studies or randomized controlled trials (RCT). However, from these trials, a compilation of the evidence is gathered that determines the direction of future trials. Often, the results or findings of the research article will indicate if further studies are warranted and indicated why these studies would be beneficial. Also, the possibility of any sampling error, or selection bias that may have of skewed results of the RCT. Wong and Myers (2015) place the responsibility in the hands of the managers, educators, and clinical nurse specialists to stay abreast of recommended changes, educate and evaluate their clinicians(p. 18). However, the weight of their due diligence begins with gaining

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

The trial is first investigator-initiated; a steering committee will be the responsible to design, execute and conduct the study. The monitoring board (professional of the health system) will review the intern results, monitor the safety of the patients, and examine the efficacy of the therapies. Local ethic committee and FAMHP have to approve the study before initiating it.

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.

This is a great critical thinking question to ask. I feel that the investigational drug process phases are in place for the safety of patients. Although there could be a cure for cancer or a disease, it is important that clinical trials are done so that we may know whether a drug is effective and safe rather than effective but deadly. There are patients who have been diagnosed with cancer or a disease and would do anything to help find a cure, similar to those who donate their bodies to research. Which is why, with the help of the patients doctor, or the patients approval they are willing to be a part of the drugs clinical trial. However, there are also patients who will do anything to receive any type of treatment that will prolong life. Majority

First, I would try and convince the nurses by pointing out that the randomized controlled trials are not perfect but they are objective and eliminate the responsibility and difficulties of making a more subjective decision. Any other alternatives would take longer, and this research is time-sensitive: the sooner we know the most effective intervention, the better for all the patients.

Meta-analysis of large randomized controlled trials (RCTs) is the highest level of evi-dence available for clinical practice and guidelines are possible to be based on the re-sults from this analysis. When patients in clinical trials are representative of the whole population seen by clinicians the findings of RCTs are most useful. The validity of generalised conclusion may lack in clinical trials, because participant’s population is not representative of population, being on average androcentric, younger and racist. All trials use stringent inclusion and exclusion criteria, often lead to a highly selected cohort of patients which are relatively homogenous and adapted to be more like to the target outcome. Therefore, those

The main goal in Phase I is to find out if the investigational new drug is safe. In this first phase of human testing, testing determines the correct dosing and exposes the most common side effects. If the investigational new drug is found to be safe, Phase II of human testing can begin. The main goal of Phase II is to find out if the investigational new drug is effective. Unlike in Phase I, the patients tested in Phase II are not healthy. In this phase, testing determines whether the drug works on patients it was designed to help. Results are obtained by comparing the group of test patients to other groups taking a different drug or taking a placebo.

Registration of clinical trials has been a controversial issue for years. According to ICMJE, a clinical trial is any research project that prospectively allocates people or a group of individuals to intervention, with or without concurrent comparison or control groups, to study the cause and effect relationship between a health related, intervention and a health outcome. Health-related interventions are those used in the modification of biomedical or health-related outcomes such as drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and the

Translational Science is a branch of medical research that attempts to more directly connect basic research to patient care. The emphasis is on the linkage between the laboratory and the patient’s bedside, without a real disconnect. This is often called’ Bench to bed side”. On broader definition, translational science is referring to the development and application of new technologies in a patient driven environment. This describes the transition of in vitro and experimental animal research to human applications1.