FDA's Patient-Reported Outcome (PRO) Guidance & Responder Analysis of PROs
FDA's Patient-Reported Outcome (PRO) Guidance & Responder Analysis of PROs
Not applicable, NY
Below are the titles and abstracts of the two talks by Laura Lee Johnson (FDA) and Joseph C Cappelleri (Pfizer). Title: Statistical Highlights of Recent FDA Guidances: Piecing Together Clinical Outcome Assessments, Patient Reported Outcome Measures, Endpoints, and Analysis Decisions Abstract: T…
Friday, October 25 2024
1:00 PM
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2:00 PM
Benefits of joining our community of stats in small biotech
Benefits of joining our community of stats in small biotech
Not applicable, NY
short description
Wednesday, January 17 2024
7:30 AM
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8:00 AM
40 years of Contributions to Statistical and Regulatory Sciences - Honoring Prof Chow
40 years of Contributions to Statistical and Regulatory Sciences - Honoring Prof Chow
Not applicable, NY
Come learn about and celebrate a statistician's 40 years' journey and contributions to statistical and regulatory sciences. Part of a session at the Duke-Industry Statistics Symposium 2024 will be streamed online. This includes speakers, Thomas Gwise (formerly FDA), Mark Chang (Boston University), …
Friday, April 5 2024
12:00 PM
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1:00 PM
Backfilling Patients in Phase I Dose Escalation Trials
Backfilling Patients in Phase I Dose Escalation Trials
Not applicable, NY
In recent years there has been increased interest in incorporation of backfilling into dose escalation clinical trials, which involves concurrently assigning patients to doses that has been previously cleared for safety by the dose escalation design. Backfilling generates additional information on …
Friday, May 31 2024
11:00 AM
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12:00 PM
Real-World Evidence HHSU01 FDA grantees series Part 2
Real-World Evidence HHSU01 FDA grantees series Part 2
Not applicable, NY
Below are the titles and abstracts of the two talks by Wang & Yang, and Secrest. Title: Methods to Improve Efficiency and Robustness of Clinical Trials Using Information from Real-World Data with Hidden Bias (Wang & Yang) Abstract: The use of external controls (ECs) from real-world data to supple…
Friday, August 30 2024
10:00 AM
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11:00 AM
Overview of HTA framework and commonly used statistical methods
Overview of HTA framework and commonly used statistical methods
Not applicable, NY
Abstract: Health Technology Assessment (HTA) is a systematic evaluation process that examines health technologies, including medications, medical devices, and prevention methods. It considers various factors such as medical, economic, social, and ethical aspects. The primary goal of HTA is to provi…
Friday, June 21 2024
10:00 AM
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11:00 AM
Real-World Evidence HHSU01 FDA grantees series Part 1
Real-World Evidence HHSU01 FDA grantees series Part 1
Not applicable, NY
Speakers: Marie Bradley, FDA; Tianxi Cai, Harvard; Ashita Batavia & Benjamin Ackerman, Janssen Date and Time: March 8 2024; 10.00am – 11.00 am Eastern Time Below are the titles and abstracts of the talks by Marie, Tianxi and Ashita/Ben, respectively. Title: Overview of CDER’s Real-World Evidence…
Friday, March 8 2024
10:00 AM
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11:00 AM
2023 Jan Testing
2023 Jan Testing
Not applicable, NY
nothing
Wednesday, January 17 2024
8:00 AM
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8:30 AM
It Is Never Too Early to Think About Statistical Leadership
It Is Never Too Early to Think About Statistical Leadership
Not applicable, NY
Speaker: Richard C. Zink, JMP Statistical Discovery Abstract: (Bio)statisticians and data scientists are technically proficient. This should come as no surprise, since their education focuses on developing quantitative scientists of the highest order. By the time one completes all of the required …
Friday, September 20 2024
3:30 PM
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5:00 PM
January 31 testing
January 31 testing
Not applicable, NY
Benefits of joining our community of statisticians in small biotechnology
Wednesday, January 31 2024
10:30 AM
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11:00 AM