Quiz 3 Protocol and Study Design

1)A subject enrolled in a study is randomly assigned to one of two treatment arms. The subject receives placebo for 4 weeks, has a 2 week wash-out period, the nreceives investigational drug for 4 weeks. This is an example of what type of study design?

1. 1. Double blind
   2. Cross over
   3. Parallel
   4. Single blind

2. The investigator is aware of the study arm assignment, however the subject does not know if they received placebo or the investigational drug. This is an example of what type of study design?
   1. Single blind
   2. Double blind
   3. Cross Over
   4. Parallel

3. A subject enrolled in a study is randomly assigned to one of two treatment arms. The subject receives either the active comparator or

investigational drug for the duration of the study. This is an example of what type of study design?

1. 1. Single blind
   2. Cross Over
   3. Parallel
   4. Double blind

4. Both the subject and the principal investigator do not know if the subject received placebo or the investigational drug. This is an example of what type of study design?
   1. Parallel
   2. Cross Over
   3. Single blind
   4. Double blind

5 and 6.

You are a PI conducting a study on a new drug for chronic migraines with the following I/E criteria. The duration of the subject’s participation in this study is 2 years

Inclusion:

-History of chronic migraine for at least 6 months

-Age >18 years

-Age of initial migraine onset 60 years old or younger

-EKG performed in the last 12 months with no abnormal results

Exclusion:

-History of kidney failure or nephrolithiasis

-Contraindication to or prior intolerance to topiramate or propranolol

-A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control

-Use of other migraine preventative drugs within the last two months

5. Which of the following patients may be eligible for this study?

1. 1. 33 year old male with a history of chronic migraines for 5 months otherwise healthy
   2. 43 year old female with a 2 year history of chronic migraines and a history of allergic reaction to Inderal (propranolol)
   3. 25 year old female with a 3 year history of chronic migraines which began occurring shortly after the birth of her only child
   4. 47 year old male with a 5 year history of chronic migraines currently taking migraine medicine to prevent severe reoccurrences

6. One of your patients, Jane Doe, may be eligible for the study. On Feb. 19, 2015 you review Mrs. Doe’s medical records to obtain an accurate health history. Which of the following findings in Mrs. Doe’s medical records would most likely make her ineligible to participate in this study?
   1. Current medications are over the counter allergy medicine and Tylenol
   2. Date of birth is 6 JUNE 1982
   3. Patient states her and her husband are looking forward to starting a family and would like to have a baby within the next year
   4. No history of cardiovascular disease or kidney failure

7 and 8: You are a PI conducting a study on a new drug for Type 1 diabetes with the following I/E criteria

Inclusion:

-Duration of type I diabetes greater than or equal to 10 years

-HbA1c less than or equal to 9.0%

-C-peptide negative

-Ages 18-65, male or female

-BMI 18.5-32

-Non-smoker for at least 5 years

-No advance diabetes complications

-Not pregnant or breast feeding Exclusion:

-Arm or leg rashes, open wounds, or skin conditions

-Active heart disease or a history of heart disease requiring medication

-Participation in a clinical research trial in last 3 months

-Clinically significant acute illness

7. Which of the following patients may be eligible for this study?
   1. 43 year old female with a 9 year history of type I diabetes, a BMI of 30, and HbA1c-6.7%
   2. 67 year old female with a 30 year history of type 1 diabetes, a BMI of 24, and HbA1c = 7.1%
   3. 60 year old male smoker with a 15 year history of type 1 diabetes, a BMI of 31, and a HbA1c = 7.0%
   4. 50 year old male with a 29 year history of type 1 diabetes, a BMI of 21, and HbA1c =8.9%

8. One of your patients, John Doe, may be eligible for the study. On Feb 23, 2015, you review Mr. Doe’s medical records to obtain an accurate health history. Which of the following findings in Mr. Doe’s medical records would make him ineligible to participate in this study?
   1. Date of birth is 30 January 1953
   2. Currently taking medications for seasonal allergies, irritable bowel syndrome, high blood pressure, high cholesterol, and once-daily aspirin post-MI with stent placement
   3. First diagnosed with Type 1 diabetes on August 1974
   4. Routinely checks HbA1C every 6 months with the most current result = 7.2%

9. You are a PI considering conducting a new clinical research trial. You receive the protocol via email. The title of the protocol is:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia.

Which of the following is true regarding this study?