Sunday, November 19, 2023

RCTs for Chinese Traditional Medicine and Botanical Drug Development

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In the latest issue of JAMA (Journal of American Medical Association), Yang et al published a paper " Traditional Chinese Medicine Com...
Monday, November 13, 2023

Operationally seamless design versus inferentially seamless design

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Biotech company, Aerovate Therapeutics presented a Phase 2b/Phase 3 study of their inhaled imatinib in the treatment of pulmonary arterial ...
Friday, November 03, 2023

Walk Distance versus Timed Walk - endpoints for measuring patients' function in clinical trials

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Drug development is now moved to the patient-focused era. Patient-focused drug development (PFDD) is a systematic approach to help ensure t...
Friday, October 20, 2023

Human Challenge Study Design in Action - a Dengue Fever vaccine trial

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A human challenge study, also known as a controlled human infection model (CHIM), is a type of clinical research study in which healthy volu...
Friday, October 13, 2023

Drugs Approved by FDA Despite Failed Trials or Minimal/Insufficient Data

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I have been trying to collect the cases of that drugs were approved by the FDA despite the failed trials or minimal/insufficient data. For d...
Friday, October 06, 2023

MCID (Minimum Clinical Important Difference) for 6MWD - how low can we go?

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I went back to watch the FDA CRDAC (Cardiovascular and Renal Drugs Advisory Committee) meeting to discuss Alnylam's drug Patisiran for ...
Tuesday, August 15, 2023

Platform trials in action beyond oncology trials

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One of the complex innovative designs is the study with 'Master protocol' that has been getting popularity in recent years. Master p...
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