Purpose of this test is to assess the following abilities:
• Basic programming skills.
• Performing basic analysis.
• General knowledge regarding clinical studies.
• Understanding the dataset structure.
• Be able to map the dataset(s) for each question.
The study Trial-SS22 is an international, parallel, randomized, double-blind, placebo-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of a new drug therapy. Subjects who enrolled in the study were randomized in 1:1 manner to receive blinded treatment for either the drug Valix 20mg or Placebo during the study period. Subjects’ information was recorded in the following mock datasets attached below.
Dataset Name Label Structure Key Variables (Explanation) Dataset Attached
ADSL Subject level analysis dataset One observation per subject USUBJID (unique subject identifier)
SEX (M = male, F=Female)
ARM (study arm: Valix 20mg or Placebo)
ADAE Adverse event analysis dataset One observation per subject per event per onset time USUBJID
AEDECOD (standard terms for adverse events)
AESEV (severity level for adverse events)
ADAY (days of onset since the treatment start date)
ADLB Laboratory analysis dataset One observation per subject per parameter per visit time USUBJID
PARAM (laboratory parameter i.e., creatinine, glucose)
AVAL (numeric values for lab tests)
AVIST (analysis visit window at Baseline or at Week 12)
Datasets are provided in .csv format. Please let us know if you have any issues to complete this task regarding the datasets.
You will be required to answer 3 questions (question 1-3). Question 4 is optional for this quiz. R program is recommended; however, you can use any other programming languages or statistical software, such as SAS and Python, to answer the questions.
You are expected to complete the quiz within 1 hour. Please provide your answers for each question in the Answers Section below, copy and paste your code/scripts under the Answer Section, and return this document with your answers to us by email.
Please delete this document and associated datasets from your computer; do not disclose any contents of this document upon completion of the quiz.
1. What is the total number of subjects enrolled in the trial and how many subjects are randomized in the study drug arm (Valix 20mg) and placebo arm?
2. What percentage of the total study population experienced the adverse event of diarrhoea and what percentage of subjects in the Valix 20mg and Placebo arms experienced diarrhoea, respectively?
3. How many subjects have a hemoglobin (g/L) value of less than 90 in the total study population? And what are their unique subject identifiers?
4. Optional: Please provide the subject identifiers with their demographic information (SEX, AGE, RACE), for subjects who had severe hyperglycemia (blood glucose level of over 250 mg/dL) at baseline.
• Please use ADSL dataset to answer question 1.
• Please use ADAE dataset to answer question 2. But you may also need the answers in questions 1 to calculate the percentage. Also please round up answers to one decimal place.
• Please use ADLB dataset for question 3. You may also need to use the variables of PARAM and AVAL to locate the blood test of Hemoglobin (g/L) with values.
• For question 4, of note, the international standard way of measuring blood glucose level is in terms of a molar concentration and is measured in mmol/L; in the United States and some other countries, blood glucose level is measured in mass concentration as mg/dL. For unit conversion, 1mmol/L is equal to 18.02 mg/dL. Please round up answer to one decimal place.
1. Of a total of XXX patients enrolled in the trial, XXX subjects were randomized into the Valix 20mg arm and XXX subjects were randomized into the placebo arm.
2. During the study period, there was a total of XX.X% subjects who experienced diarrhea, XX.X% subjects in the Valix 20mg arm and XX.X% subjects in the placebo arm.
3. There was/were XXX subject(s) who had a hemoglobin (g/L) value of less than 90. The unique subject identifier(s) was/were XXXX-XXXX-XXXX.
4. There are XXX patients with abnormal glucose level over 250 mg/dL at baseline.
USUBJID ARM SEX AGE RACE AVAL AVISIT
XXX = Please provide your answer as a numeric value
XX.X% = Please provide your answer in percent
XXXX-XXXX-XXXX = Please provide subject identifier(s)
Please copy and paste your overall code/scripts below.