Wednesday, July 28, 2021

FDA Regulatory Education for Industry (REdI) - Learning about FDA and Regulatory Science

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FDA had their annual conference “ FDA Regulatory Education for Industry (REdI) ” last week. The REdI conference features three medical produ...
Sunday, July 25, 2021

Maximum Tolerable Dose (MTD) and Dose-Limiting Toxicities (DLTs)

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According to Wiley Encyclopedia of Clinical Trials, the maximum tolerable dose  (MTD) is defined as:  The “Maximum Tolerable Dose” (MTD), a...
Sunday, July 18, 2021

Imputation of partial dates for adverse events, concomitant medications, and disease diagnosis

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Many date variables are collected in the clinical trial database. The date variables include date of birth, date of disease diagnosis, date ...
Monday, July 12, 2021

Human Plasma-derived Products - Protein Therapies for Rare Diseases

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I recently listened to a podcast from NPR's planet money " Blood Money ". It discussed why only the U.S. and a few other coun...
3 comments:
Sunday, June 20, 2021

Early Phase Trial to Find Maximal Tolerated Dose (MTD) - 3+3, CRM, and BOIN Designs

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In early-phase clinical trials, determining the dose range and therapeutic window is critical. The purpose of the early-phase studies may ju...
1 comment:
Saturday, June 19, 2021

About Controversial Approval of Biogen's Alzheimer Drug

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Two weeks ago, the US Food and Drug Administration (FDA) approved aducanumab (brand name Aduhelm) as a treatment for Alzheimer's disease...
2 comments:
Tuesday, June 01, 2021

Decentralized clinical trials and in silico clinical trials

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These days, the buzzword in the clinical trial field is 'decentralized clinical trials' or DCTs. The Covid-19 pandemic seems to push...
4 comments:
Saturday, May 29, 2021

Patient Advocacy Groups in Drug Development and Clinical Trials For Patients With Rare Diseases

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I just saw an article on clinicalleader.com " Best Practices For Designing And Running Clinical Trials For Patients With Rare Disease...
Sunday, May 23, 2021

Are we moving away from data listings now that the standard data sets (such as CDISC-compliant SDTM and ADaM data sets) are mandated by FDA?

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After a clinical trial is concluded, the statistical group (statisticians and statistical programmers) will generate the tables, listings, a...