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I have met so many wonderful people along my SAS journey, they are precious like Sapphire to me.
Now I am trying to organize the common SAS functions and procedures I have used on a daily basis, summarize the different CDISC domains that I have worked on and some statistical method I have encountered.
Background Story: One day, my friend 77 asked me which one is more important ADRG (Analysis Data Reviewer’s Guide) or define.xml? I think define.xml focuses more on the ADaM dataset level, whereas ADRG provides an overview storyline for the study or additional info besides Define.xml. I decided to summarize the general format for the ADRG document.
Background: Systemic Anti-Cancer therapy is a collective to describe the treatment of cancer in conjunction with different categories therapies such as: Surgical Therapies, Radiation Therapy, Stem Cell Transplants, Other Anti-Cancer Therapy. The ADPSATA: Prior systemic Anti-cancer Therapy dataset presented a key overview of patients’ prior systemic therapy treatments, which may lead to different efficacy endpoint for patients’ current treatments.
Background Story: One day, I need to validate a SPM related files and ADSPM in a hematology study, I communicated with an experienced colleague many times and finally got the work done. Since each study has different data structure, there is no standard SPM process available for all. I will share my experience with SPM work, hopefully it is helpful…
Background Story: In ADLB avisitn means analysis visit number sequence, most of the time it is a standard variable, such that each Visit or Visname maps to a corresponding number. However we had a study with convoluted raw data, in which multiple visits were recorded on the same day or many additional visit. Today we will go over a basic…
Background Story: One day, I validated an AESI(adverse event of Special Interest) data, I found a discrepancy between two output datasets. After I notified my boss, she suggested checking the AESI excel sheet, and it turns out both versions are partially correct. Because the Prefered term Hepatic Failure belongs to both Hepatic Disorder and Hepatic Failure EOI in a particular…
Background Story: Missing dates are something the pharmaceutical industry deals with on a daily basis. There are some common methods. Completely missing year, month, and day then no imputation. Set a certain number( ex.Jan01) for missing month and day Compare with treatment start date, and manipulate accordingly. If the AE start date and the treatment start date have the same…
Background story: Last time, when we used R to calculate the sample size, we specified Type I error α and Type II error β, but what does the meaning behind α and β? Review: We define the “best” sample size that has less variation of the sample mean from sample to sample.
Factorial Design allows the investigation of sets of categorical predictors, and the interaction between them. Today we will go over some basics of One Fixed Factor and One Random Factor Design. Keywords: Factor: categorical predictors Fixed Factors: Estimate the difference in means between groups defined by specified categorical predictors. e.x. ANOVA model, one measurement per subject. Random Factors: Estimate the variance…
Background Movie: Based on my taste, 我不是药神 Drug Deal/Dying to Survive is one of the best movies in 2018. It was based on a true story that some cancer patients use a kind of cheap Indian medicine (Veenat 100) as a substitution of the authentic Novartis Glivec 400 to prolong their lives. Besides the touching story, Veenat 100 is a…
Background Story: Once, we need to do an Interim Analysis, I didn’t understand why we need to do it. Later I learned in Clinical Trial studies, our ultimate goal is trying to get approval for FDA submission at the end of studies. While exhausting and long progress, sometimes we perform Interim Analysis before the completed trial to access Safety, Futility,…