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...
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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...
Monday, April 26, 2021

Within Patient Benefit-Risk Evaluation? Using Outcomes to Analyze Patients versus Using Patients to Analyze Outcomes?

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In our daily life, benefit-risk evaluation is something we always do whether we realize it or not. Benefit-risk evaluation is especially cri...
Monday, April 19, 2021

Restricted Mean Survival Time (RMST) for Handling the Non-Proportional Hazards Time to Event Data

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Time to event analysis (or traditionally survival analysis) is one of the most common analyses in clinical trials. In general, the time to e...
Monday, April 05, 2021

Non-proportional Hazards: how to analyze the time-to-event data?

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Time to event data is one of the most common data types in clinical trials. Traditionally, the log-rank test is used to compares the surviva...
3 comments: