Clinical Trial Essay

Weaknesses to this design are that some questions do not permit random assignments of the participants. They do not provide answers as to how the treatment will benefit patients. In order to achieve statistical significance the number of participants has to be quite large and may not be representative of the general population.

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

The history of clinical trials dates back to approximately 600 B.C. when Daniel of Judah conducted what is probably the earliest recorded clinical trial. Randomised controlled trials are the most rigorous way of determining whether a cause effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment.

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.

What is your style of learning? I would consider my style of learning to be a hands on approach, but I also need to be able to have visual access to information to reference in order to have a complete understanding. What are some of your strengths and challenges? I would consider my strongest strengths to be my communication and people skills with patients and peers, having the ability to demonstrate understanding, empathy, and compassion.

Study Design: This was a randomize and quasi-randomized where the author discusses at public meetings, through radio or leaflets.

However, both studies only use Randomized Controlled Trial study, Clinically Controlled Trial and Trial Study were selected. According to Abalos E, Carroli G, Mackey ME, Bergel E (2001), Randomized controlled trials provide the most reliable results with regard to the effectiveness of interventions. This review is clearly defined about the sample condition, the intervention, a comparison and control, and the outcome measure that is to be used to determine the effectiveness. It is important as the effects of the intervention may be different in different groups.

Randomization curbs bias. In this study, much detail remains unclear in the description of the trial design, methods, results and the conclusion. It is problematic in the non- adherence to the CONSORT statement, notwithstanding, the full trial protocol, availability and accessibility and its entry into the trial registry. Accordingly, registration precludes post hoc changes in the primary outcome whilst lessening the chances of outcome reporting bias. Surprisingly, the role of the sponsor or the funder has little attention paid given that it plays a role in generating a conflict of interest. Unsatisfactorily, a CONSORT flow diagram as a requisite in an RCT has been overlooked. This study has claims of stratified randomization, nevertheless, questions abide on the generation of the blocks, who generated the random allocation sequence, were there an allocation concealment mechanism, who enrolled the

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.

Within-participants designs is when a researcher have all the participate in both levels of the independent variable and conditions. The strength of within-participants designs is that it does not require a large pool of participants and can also help reduce errors associated with individual differences. Each participant serves as his or her own baseline. One of the weaknesses is that the sheer act of having participants take part in one condition can impact performance or behavior on all other conditions. In between-participants designs, is an experiment that has two or more groups of subjects each being tested

The first article that was examined was “A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowl Syndome Associated with Constipation”. This article was written concerning a study that was done to examine the effectiveness of using probiotics to alleviate symptoms of irritable bowel syndrome (IBS). The main symptom that was being examined was constipation but bloating, abdominal pain, abdominal cramps, and flatulence were also looked at. Patients with IBS have been shown to have microbiota in their gastrointestinal tract that is much less stable than the microbiota in a healthy adult. This imbalance leads to problems in the digestive system including the symptoms that have been previously listed. Probiotics that are typically found in the digestive tract could be used to alleviate symptoms and restore balance. However, the correct probiotic must be chosen in order to be beneficial to the patient because probiotics are species and system specific.

For randomization, sealed envelopes were prepared in advance and marked inside with A or B, indicating the experimental group or the control group. The randomization was performed by a third party who was unaware of the study content. The characteristics of the subjects and all the outcome measures before and after treatment were assessed by Physician 1, who was blinded to the treatment allocations. The rTMS and sham treatments were administered in a closed room by Physician 2, who was not involved in the assessment of the subjects. Both physicians were instructed not to communicate with the subjects about the possible goals or the rationale of either treatment.

A quasi-experimental study is a subcategory of experimental design where randomization of participants is not possible or not needed (Wildemuth, 2009). These studies occur in natural settings when limited control over the variables is possible. The independent variable (treatment) is manipulated to see if a causal relationship exists (Haas & Kraft, 1984). Naturally occurring groups such as classes are generally used. The goal is “to produce reliable causal knowledge” (Haas & Kraft, p. 229). Internal and external validity are important to this design. Internal validity is determined when

The principle of clinical trials is exploration, so that the studies follow strict rules. These rules help the outcome more reliable for study results and protect the patients. Clinical trials are one of the last stages in the long and careful exploration process. The step often starts in a lab, setting scientist to develop and test new theories.

The World Health Organization Clinical Trials Registry Platform and clinicaltrial.gov were used to search for ongoing or unpublished data. Total number of adult participants were 4985. Two reviewers performed data extraction and assessment of risk of bias and intervention quality. The disagreements were settled by discussion.