Investigate a new drug developed to relieve lower back pain. Please design an optimal intervention study (Phase III – clinical trial) and discuss its strengths and weaknesses.

You have been asked to investigate a new drug developed to relieve lower back pain.  Please design an optimal intervention study (Phase III – clinical trial) and discuss its strengths and weaknesses.

Background information:

About 10% of U.S. adults report having at least one episode of severe back pain that altered their daily activities for at least 5 days during the past year

About 3% of U.S. adults report having severe back pain during the past year that greatly altered their daily activities or ability to work for at least six weeks during the past year

For minor back pain, the current pharmaceutical treatment options reduce the pain score by 50% and decrease the days-of-work missed by 30%

For major back pain, the current pharmaceutical treatment options reduce the pain score by 20% and decrease the days-of-work missed by 10%.

a) Describe your selection of study participants. You should provide information about who, how many, and how allocated. 

b) How would the treatment be administered in your experiment (you can assume the treatment is a pill) – What is administered, by whom, under what circumstances, etc.? 

c) What outcome(s) would you collect or measure (and how would it (they) be collected or measured)? 

d) What type of data is your independent variable(s)? What type of data is your dependent variable(s)? What type of graph would you use to display your study results? 

e) What are the weaknesses (limitations) of your study? 

d) While you advertised widely in order to attract persons of both genders, and all ages and races, the only people who were willing or able to commit to the study were male laborers presently receiving Worker’s Compensation benefits for work-related injuries. The drug does seem to reduce lower back pain in your trial and the pharmaceutical company wants to start a mass-marketing campaign to coincide with the beginning of “lawn-mower” season. Should this concern you? If so, what caveats might you place in your final report to the company? 

2). One thousand two hundred and five (1,205) persons, who were accidentally exposed to a large-dose gamma-radiation leak on December 1, 2019, were followed for a year and their mortality experience was recorded monthly (as at month-end).  Some were lost to follow-up during this time period and the whereabouts and outcome of these persons is unknown.

The management of the military installation where this leak occurred thinks that it is too expensive to keep following these people; the risk of death has become predictable, if not downright low.  Do you agree?  If so, why? If not, how might you convince them to keep funding the study?