Monday, July 22, 2019

Upversion of medical coding dictionaries (MedDRA and WHO-DD)

›
In clinical trials, adverse events, medical histories, concomitant medications (drug names) are usually entered as the free text fields (ver...
1 comment:
Thursday, July 18, 2019

Retire Statistical Significance and p-value?

›
In the March issue of The American Statistician, there was a special issue with 43 papers about “ Statistical Inference in the 21st Centur...

Generate Real-World Data (RWD) and Real-World Evidence (RWE) for Regulatory Purposes

›
Real-world data (RWD) and real-world evidence (RWE) have been hot topics in the drug development field and in the statistical field. With th...
Sunday, July 14, 2019

Regulations for Clinical Trials, Drug Development, Drug Approvals in China

›
The article by Bill Wang and  Alistair Davidson " An overview of major reforms in China’s regulatory environment " summarized th...
Saturday, June 22, 2019

Historical Control vs. External Control in Clinical Trials

›
Last week, I had an opportunity to attend the annual ICSA Applied Statistics Symposium in Raleigh, North Carolina. The symposium had a lot ...
Monday, June 03, 2019

Six-Minute Walk Test (6MWT), 2-Minute Walk Test (2MWT), 12-Minute Walk Test (12MWT), and Timed Walk (T25FW, T10MW)

›
Six-Minute Walk Test (6MWT) is to measure the distance in a fixed duration (6 minutes). It has been used as a clinical trial endpoint to me...
Monday, May 13, 2019

Pediatric Extrapolation for Pediatric Indication

›
In a previous post " Pediatric Study Plan (PSP) and Paediatric Investigation Plan (PIP) ", we discussed the requirements for PSP a...
Thursday, May 02, 2019

FDA and EMA Guidance on Adjusting for Covariates in Randomized Clinical Trials

›
Last week, FDA issues its draft guidance for industry titled ' Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biol...
Saturday, April 20, 2019

Hodges-Lehmann estimator of location shift: Median of Differences versus Difference in Medians or Median Difference

›
Hodges-Lehmann estimator has been used to compare the treatment effect while the data is non-normal distributed. See my previous posts: Hod...
5 comments: