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Running Head: SAMPLING AND DATA COLLECTION PLAN - GARDASIL
Sampling and Data Collection Plan - Gardasil
The Gardasil vaccine has been on the market since 2006 and as of Spring 2013, more than 56 million doses of HPV have been administered in the United States (Carlyle, 2013). Numerous studies report that the Gardasil vaccine is safe, and is cleared by the FDA to be indicated for girls and women, boys and men ages 9-26 to prevent cervical cancer (Merck.com).
Our learning team is researching the correlation between receiving the Gardasil vaccine and manifesting a cluster of physical symptoms defined as a severe adverse reaction.
H0: Gardasil vaccine is not correlated to a higher incidence of severe reaction
symptoms than initially reported.
H1: Gardasil vaccine is associated with a higher incidence of severe reaction symptoms
than initially reported.
The dependent variable is symptoms indicated that are part of the severe reaction category. The independent variable is the Gardasil vaccine.
Study Design
The design of the study will be a multicenter, randomized, double-blind, placebo controlled, trial with patients ranging in ages from 9-45 years of age who do not test positive for Human Papilloma Virus (HPV) and have not had a vaccine to prevent the disease. These patients will be followed for a duration of 6 months after the 3rd injection series of Gardasil. All of the patients in the trial will consent to receiving the Gardasil vaccine and followed for a duration of 6 months with a check in at 2 months assessing safety and tolerability. At the conclusion of the study those that were randomized to placebo will be given the option to receive the Gardasil injection series.
The patient population will be those that are randomized from many clinic sites nationwide and throughout Europe if they meet all inclusion criteria. The patient randomization will be accomplished using a computer generated randomization scheme, with stratification by country and research site location. During the interview and study inclusion process the patients will be blinded to the identity of the study drug, and during the double blind treatment, both patients and drug investigators will be blinded to the identity of the randomized drug assignment.
To access the tolerability, safety, and correlation of Gardasil to a higher incidence than previously reported safety assessments will include reporting of adverse events, clinical laboratory assessments, vital signs, and physical examination. The data will be collected at the time of the patient check in periods. The check in periods will be at baseline, 2 months (after 2ndinjection), and at 6 months (after 3rd injection). The data will be compiled and stored securely in the archives of our research database. All patients will receive a patient ID number to protect their identity and health records. The data will only be accessible to the lead investigators of the trial in question.
The sample size for each treatment group will be 385 patients to be randomized to achieve a 95% confidence level with a 5% margin of error (McClave, Benson, & Sincich, 2011, p 300). (See Appendix A). Based upon this calculation the study would have to have at least a total of 770 patients total, however based upon a dropout rate, ideally 1000 patients or more enrolled would be desirable across all research sites.
This study design will also be assessed for data reliability and validity throughout the study to ensure statistical power. Reliability is the degree to which as assessment tool produces stable and consistent results (uni.edu). While the study might be reliable it must also be valid. The study design being multicenter, randomized, placebo controlled trial accounts for the study having statistical power, including being reliable and valid. The equipment being used across all research sites will be calibrated and utilized by only research staff to ensure accurate data collection. Each treatment group will be randomized, and stratified by country and research location. The data will be correlated to ensure there are consistent findings across similar treatment groups.
The above sampling data and collection plan will be followed to ensure an accurate study to determine whether or not the Gardasil vaccine is correlated to a higher incidence of severe adverse reactions than initially reported in studies.
References
Carlyle, R. (2013). Huffington Post. How Accurate are the Recent Claims of the Dangers of the HPV-Vaccination Gardasil? Retrieved on August 20, 2016 from
FDA.gov. Product Circular Gardasil. (2016). Retrieved on August 20, 2016 from
McClave, J.T., Bernson, P.G., & Sincich, T. (2011). Statistics for business and economics. (11th ed.). Boston, MA: Pearson Publishing
Merck, Sharp, & Dohme Corp. (2009-2016).Merck.Retrieved on August 21, 2016 from
Phelan, C., Wren, J. (2005-2006). UNI Office of Academic Assessment. UNI.edu. Exploring Reliability in Academic Assessment. Retrieved on August 22, 2016 from
Appendix A
Calculating a sample size for an infinite population.
Z = 1.96 due to 95% confidence interval, 5% margin of error. The sample size must be at least 385 or greater in each treatment group.