Case & Study Efficacy And Safety Of NicQb And Placebo.

Question: Discuss about the Efficacy and Safety of NicQb and Placebo. Answer: Introduction: Clinical trials are one of the most effective ways of conducting a research that primarily aims exploring medical strategy and treatment for a specific illness of people. The major objectives of executing clinical trials are improving the health of patients, restrict them from the unexpected harms and provide them necessary benefits. In this particular research proposal, the researcher has decided to deal with the efficacy and safety of Nicotine-Qbeta Vaccine versus Placebo in the healthy smokers. With the help of Nicotine Qbeta vaccine, the smokers would be able to quit the habit of smoking. On the other hand, Placebo is a medicine that is mainly prescribed for the psychological benefits of the smokers. Placebo is devoid any kind of side effects. Therefore, the researcher has intended to conduct the research proposal in order to understand which particular method would be more fruitful for the betterment of the smokers. Background: It has been observed that CYT002-NicQb vaccine helps the smokers to leave the habit of smoking. After the vaccination, the smokers would not be able to generate antibodies that are directed against free nicotine (Kodgule, Vaidya and Salvi 2012). On the other hand, it has also been noticed that Placebo treatment has also spread its widespread wings by providing a mental benefit and facilities to the addicted smokers. As a result, this particular treatment has also received immense reputation in the realm of medical. With the help of this research proposal the researcher would come into a conclusion which procedure is better for the treatment of the smokers. Eligibility Criteria: The researcher would like to conduct the research work in order to fulfill several objectives. The objectives are as follows: To understand the effectiveness of nicotine-qbeta vaccine for the smokers To evaluate the clinical efficacy of NicQb To understand the safety factors after receiving the vaccinations Study design: The study of the research proposal would be designed randomly by implementing one dose of 100ug NicQb + Alum versus one dose Placebo. More than 50 patients under a clinic would be involved in this program. They would be kept on observation for seven days. After seven days, the researcher would like to receive an immediate feedback from the patients (Lobendanz 2012). With the help of various data collection procedure, the researcher would be able to collect data and information from both the patients and the doctors. Trial flowchart: Drug injection Pre observation 1st observation 2nd observation 3rd 3rd observation 4th observation 5th observation 6th observation 7th observation Collection of smoking diary * * * * * * * * Carbon Monoxide * * * HVB and HCV * Haematology * * * * Serum for the anti nicotine * * * Table 1: Trial Flowchart (Source: Montoya 2012) Randomization Random sampling technique would be used for this particular research proposal. Random sampling technique is otherwise known as probability sampling method. With the help of probability sampling technique, the researcher would choose the patients randomly from various clinical centers of US (Montoya 2012). The patients would provide their opinion how they would be benefited after using the vaccine of NicQb. At the same, time the users of Placebo treatment would also participate in the random sampling method technique. Study calendar Program Activities 1st Week 2nd week 3rd week 4th week 5th week 6th week 7th week 8th week 9th week Study Design v v Trial flowchart v Randomization v v Sample size v v Methodology v v Table 2: Study Calendar (Source: Ngkelo and Adcock 2013) Sample size Sample size includes the number observations within a specific sample. In this particular research proposal, the researcher would like to involve fifty patients for participating in the sampling technique. From these fifty patients the researcher would be able to collect necessary data and information about the efficacy of NicQb vs. Placebo. The patients would provide their opinion which particular treatment would be effective more for quitting the smoking habit of patients (Yin et al. 2012). Moreover, this particular research proposal would like to involve three doctors of clinics as well under the guidance of which patients are receiving their medicine as well as treatment. Methodology Research methodology is the systematic procedure for conducting the entire research with the help of appropriate research approach, design and philosophy. Data collection procedure is one of the most effective ways for accomplishing the research process successfully. Data collection method consists of two types including primary and secondary data. Survey, interview, group discussion, focus group are the procedures for collecting primary information. Secondary data can be gathered with the help of books, magazines, journals and so many. For this research proposal, the researcher would like to choose primary data collection technique (Saini 2013). Both the qualitative and the quantitative data collection technique would be used in this particular proposal. By using quantitative data, collection technique the researcher would like to conduct an effective survey by involving 51 patients under the treatment of NicQb and 51 people under the treatment of Placebo. Patients would provide their opinion about the necessary effects of these treatments. Conclusion The entire research proposal primarily deals with the efficacy and safety of NicQb and Placebo. With the help of clinical trials, the researcher would be able to design the proposed study. By using proper methodology and data collection procedure, the researcher would be able to collect the responses of the patients who are under treatment in order to come into a sound conclusion. Reference List: Kodgule, R., Vaidya, A. and Salvi, S., 2012. Newer Therapies for Chronic Obstructive Pulmonary. Lobendanz, M., 2012. 2.3 Nicht medikamentse Hilfsmittel.berarbeitung der Standards der Tabakentwhnung Update 2010 Konsensus der GP sterreichische Gesellschaft fr Pneumologie in Zusammenarbeit mit folgenden Gesellschaften und Institutionen, p.84. Montoya, I.D., 2012. Advances in the development of biologics to treat drug addictions and overdose.Adicciones,24(2). Ngkelo, A. and Adcock, I.M., 2013. New treatments for COPD.Current opinion in pharmacology,13(3), pp.362-369. Saini, B., 2013. New drugs for chronic obstructive respiratory disease... and a few more on the horizon.Australian Pharmacist,32(6), p.58. Yin, Z., Nguyen, H.G., Chowdhury, S., Bentley, P., Bruckman, M.A., Miermont, A., Gildersleeve, J.C., Wang, Q. and Huang, X., 2012. Tobacco mosaic virus as a new carrier for tumor associated carbohydrate antigens.Bioconjugate chemistry,23(8), pp.1694-1703.