Category: Clinical Trial

One-tailed vs Two-tailed Test for P value

R day 3 In clinical trial studies, P-value is critical for measuring drug efficacy. Typically, the statistical analysis Plan will describe statistical significance as: P-value <0.05 for two-tailed Log Rank Test. Recently, I came across a study with the statistical significance as P-value <0.025 for one-tailed Log Rank test in the analysis plan. Question: Does two-tailed P-value= 0.05 means the…

ADaM. ADLB

ADaM DAY 2 : ADLB   Abstract: ADLB stands for Laboratory Test Result Analysis dataset is an important safety dataset, it captured all the Lab test results for each treatment cycle per patient. We can the Lab dataset to visualize the change of lab test results based on the time change for each patient (Spider Plot) or the overall lab-test distribution…

ADAM.ADAE

ADaM day 1: ADaM.ADAE stands for Adverse Event  Analysis dataset : This dataset is crucial for safety analysis in a new drug development progress as well as in post-market safety updates. it contains the information of ADSL, AE, SUPPAE. The dataset ADAE captured adverse event’s name, length, start and end date, relation to the drugs, actions to resolve the adverse…

ADSL

ADaM Day 1 In clinical trials, ADSL(Subject-Level Analysis Dataset) is the foundation of all ADaM analysis dataset, it is one record per subjects; it captures subjects’ population flag 🚩, treatment-related info, vital sign info♂, baseline disease info, and other info respect to different study designs.

Basic Oncology 101

  Today I will share some Basic Oncology Knowledge I found in my old notebook:  RECIST 1.1: Complete Response (CR): Disappearance of all non-nodal target lesion Partial Response (PR) : At least 30% decrease in the sum of diameters of target lesions compared with the baseline sum diameters.

ISS & ISE Info

  Background Story:       Once my friend said her team members cried during a meeting, i thought it was funny then. However, when I started to work in their team, I wanted to cry, too. What was the challenge? It was ISS/ ISE related work!  

SDTM.VS

SDTM day 6: Vital Sign Introduction: the Vital Sign domain captures all the measurements of body’s most basic functions, such as height, weight, blood pressure, heart rate… VS is a critical dataset in Drug Safety Analysis.

SDTM.EX

SDTM Day 5: SDTM.EX   Introduction: Exposure dataset contains the details of subjects’ study treatment information, it is one of the key safety datasets, and it is critical to efficacy analysis. The EX domain is intended for “protocol-specified study treatments” including placebo dosing. The EX dataset would present a complete and accurate of subjects’ exposure in one record per constant dosing to the reviewers.

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