Clinical Trial Essay

In the book As I Lay Dying by William Falkner. The mother, Addie, is dying and she wants to make sure her dying request is fulfilled. She wants to be buried with her family in a nearby town called Jefferson. She also want her coffin to be well built so Cash, her son, builds the coffin right outside her window. When she dies the family starts their expedition to bury her.

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.

As seen throughout the novel, Melinda presented major symptoms of self-destruction to the audience as a result from the rape. First of all, there are many signs of this type of behavior, one that Melinda has shown on various occasions are acts of physical harm. The most serious example of this is was in “Rent Round” on page 87 when Melinda was in her closet after a rough day. “I open up a paperclip and scratch it across the inside of my left wrist…… I draw little windowcracks of blood, etching line after line until it stops hurting”. At this point in the novel, we know this quote proves an act of attempted suicide, which greatly relates with self-destructive behavior. This quote/event is great evidence of how the rape affected Melinda mentally.

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.

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

Gould et al (1999) trail was randomised however it was uncontrolled. This kind of clinical trial does not involve a control treatment. Any study that does not have a control group consisting of patients treated and followed up over the same time period as those in a treated group.

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

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.

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.

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.

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.

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

“Lord Randall” and “Get Up and Bar The Door” are short ballads from the Middle Ages. Ballads are a song like poems that is put to music. The word ballad derives from an Old French word meaning “dancing song”. Scops and bards sing the ballads as a source of entertainment. The people present in the Middle Ages use the ballads that the Scops and Bards sing to also dance. Our music now in the twenty-first century originates from the old ballads. The ballads “Lord Randall” and “Get Up and Bar The Door” contain refrains that appeal to everyday people life. In both ballads, the characters represent the Middle Ages people life plus their culture. Both ballads tell the citizens of the Middle Ages social class. “Lord Randall” consists of the characters

Clinical trials can be conducted by government agencies such as private industry, independent researchers, researchers from universities or hospital medical programs, or NIH (National Institutes of Health). Voluntaries are recruited, but in some cases subjects may be paid.

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.