Sunday, September 10, 2006

Health Status and Will-being

In reading the book "Introduction to applied pharmacoeconomics" by Vogenberg FR, I found the following statement very true.

"We behave as if health status and well-being were synonymous. They are not. ...Heath status is the level of functioning - physical, mental, and social. Well-being, in contrast, may be thought of as happiness, fulfilment, and satisfaction with life. Certainly health status contributes to well-being, but many other factors do so as well. Examples are economic prosperity, spiritual growth, meaningful relationships, and intellectual discovery. A long, disease-free life is not necessarily a fulfilled one."

Also, the author cited the following quote by David Eddy "Keeping a child healthy requires more than periodic physical examinations and vaccinations; it requires good playgrounds, schools, parents with jobs, crime-free neighborhoods, and counseling about drugs, tobacco, and reproduction."

Sunday, May 07, 2006

IRB and patient privacy

Local IRB seems to become very picky nowadays. Recently, one of the local IRBs in New York insists that we can not collect patient's date of birth and initials concerning the patient's privacy. We responded to them that these are the industry standard. Then we tried to find the evidence to demonstrate that collecting the date of birth and initials are indeed the industry standard.

It turns out that some pharmaceutical companies (such as GSK) do not collect the patient initials. So collecting the patient's initials seems not to be an industry standard.

However, we will have to collect the date of birth in order to calculate the age accurately. I found some supporting document in ICH guidance.
In the following ICH guideline E2A (page 11), patients initials and age and/or date of birth are listed as items needed for SAE reporting.
Also under the ICH guideline E2B (page 17), it also says for patient identification information "The date of birth should be used if the precise birthday is known; otherwise the age should be used."

Friday, April 28, 2006

A joke about statistician

Even thoug this is a joke, I find sometimes it is very true.

A manager wanted to hire someone to work in her department and she had applications from a lawyer, an archeologist, and a statistician. She invited the lawyer for an interview and asked just a single question, "What is one plus one?" The lawyer explained "In matters of commercial law, the Supreme Court precedent in 1867 established that, in matters of commercial law, one plus one is considered to be prima facie evidence of equaling two." The manager was very impressed. Then she invited the archeologist for an interview and asked the same question. The archeologist replied, "Although many ancient cultures had solid concepts of numbers, the concept of addition was first established in the Egyptian culture, circa 2000 B.C. and it was at the tomb of Amenhotep that the first written evidence was found to establish that one plus one was equal to two." Again the manager was very impressed. She then invited the statistician in and asked "What is one plus one?" The statistician looked around very carefully, then went up and closed the door, lowered the window shades, and asked very quietly "What do you want it to be?"

Sample size considering the drop out rate

Thanks for my colleagure who point out my mistake in calculating the sample size adjusting for the drop out rate. According to the sample size calculation, we estimated that 100 subjects would be needed to detect the statistical differences. Considering 20% drop out rate, what is the # of subjects to be randomized?
It is not 100 + 100*20% = 120
It should be 100 / (1-0.2) = 125
It means that with 125 randomized subjects, if 25 subjects (20% of 125) drop out, we still have 100 subjects left. This is correct way to adjust for the drop out rate.


I am surprised to know that there is a SAS procedure for CDISC. Is this procedure really working?