Advancing the Science of Study Endpoints

Bethesda North Marriott Hotel and Conference Center

Sample Sizes: 2 Monotherapies With Single Approved Dose Level

By Seung-Ho Kang, PhD; Juhee Park, MS Found in: Article, Statistics, Clinical Development & Operations

In this article, we study the sample size calculations for the combination drugs of 2 monotherapies with a single approved...

DIA Annual Canadian Meeting

Ottawa Marriott Hotel

Ethical Considerations in Adaptive Design Clinical Trials

By Thomas Laage, MD, MPH,; John W. Loewy, PhD; Sandeep Menon, PhD; Eva R. Miller, PhD; Erik Pulkstenis, PhD; Natalia Kan-Dobrosky, PhD; Christopher Coffey, PhD Found in: Article, Statistics, PE / Quality of life / Health, Clinical Development & Operations

Adaptive design clinical trial methodologies offer both opportunities and challenges for observing basic ethical principles...

Real World Evidence Conference

InterContinental San Francisco

Analysis of Japanese Patients Enrolled in Oncology MRCTs

By Akihiro Hirakawa, PhD; Fumie Kinoshita, MSc, RPh Found in: Article, Statistics, Clinical Development & Operations

The Japanese regulatory agency, the Ministry of Health, Labour and Welfare, requires sponsors to enroll a specific number or...

Biostatistics Industry and Regulator Forum

Bethesda North Marriott Hotel and Conference Center

“Less Well-Understood” Adaptive Designs Challenge

By Weili He, PhD; Paul Gallo, PhD; Eva Miller, PhD; Yannis Jemiai, PhD; Jeff Maca, PhD; Ken Koury, PhD; Xiaoyin Frank Fan, PhD; Qi Jiang, PhD; Cunshan Wang, PhD; Min Lin, PhD Found in: Article, Clinical Development & Operations, Statistics

The draft adaptive design guidance released by FDA in 2010 included references to adaptive study designs that were described...

Estimands & Sensitivity Analyses in Clinical Trials

By C. Fletcher, MSc; S. Tsuchiya, MS; D.V. Mehrotra, PhD Found in: Article, Clinical Development & Operations, Statistics

An addendum to the International Conference on Harmonisation E9 (ICH E9) guidance document (Statistical Principles for...

Sample Sizes: 2 Monotherapies With Single Approved Dose Level

By Seung-Ho Kang, PhD; Juhee Park, MS Found in: Article, Statistics, Clinical Development & Operations

In this article, we study the sample size calculations for the combination drugs of 2 monotherapies with a single approved...

Ethical Considerations in Adaptive Design Clinical Trials

By Thomas Laage, MD, MPH,; John W. Loewy, PhD; Sandeep Menon, PhD; Eva R. Miller, PhD; Erik Pulkstenis, PhD; Natalia Kan-Dobrosky, PhD; Christopher Coffey, PhD Found in: Article, Statistics, PE / Quality of life / Health, Clinical Development & Operations

Adaptive design clinical trial methodologies offer both opportunities and challenges for observing basic ethical principles...

Analysis of Japanese Patients Enrolled in Oncology MRCTs

By Akihiro Hirakawa, PhD; Fumie Kinoshita, MSc, RPh Found in: Article, Statistics, Clinical Development & Operations

The Japanese regulatory agency, the Ministry of Health, Labour and Welfare, requires sponsors to enroll a specific number or...

“Less Well-Understood” Adaptive Designs Challenge

By Weili He, PhD; Paul Gallo, PhD; Eva Miller, PhD; Yannis Jemiai, PhD; Jeff Maca, PhD; Ken Koury, PhD; Xiaoyin Frank Fan, PhD; Qi Jiang, PhD; Cunshan Wang, PhD; Min Lin, PhD Found in: Article, Clinical Development & Operations, Statistics

The draft adaptive design guidance released by FDA in 2010 included references to adaptive study designs that were described...

Estimands & Sensitivity Analyses in Clinical Trials

By C. Fletcher, MSc; S. Tsuchiya, MS; D.V. Mehrotra, PhD Found in: Article, Clinical Development & Operations, Statistics

An addendum to the International Conference on Harmonisation E9 (ICH E9) guidance document (Statistical Principles for...

Less Well-Understood Adaptive Designs Best Practices

By Eva Miller, Paul Gallo, Weili He, Lisa A. Kammerman, Kenneth Koury, Jeff Maca, Qi Jiang, Marc K. Walton, Cunshan Wang, Katherine Woo, Cynthia Fuller, Yannis Jemiai Found in: Article, Clinical Development & Operations, Statistics

Adaptive design (AD) clinical trials use accumulating subject data to modify the parameters of the design of an ongoing study...

Sivelestat Versus Standard Acute Lung Injury Therapy

By Satoru Fukimbara, PhD; Kouji Niibe; Michio Yamamoto, PhD;Takuhiro Yamaguchi, PhD Found in: Article, Clinical Development & Operations, Statistics

To confirm the effectiveness of sivelestat, a clinical trial was conducted comparing sivelestat with conventional treatment in...

Program-Level Considerations for Phase 2 Designs

By James Bolognese, MStat; Jaydeep Bhattacharyya, MS; Chris Assaid, PhD; Nitin Patel, PhD Found in: Article, Clinical Development & Operations, Statistics

Traditionally, sample size considerations for Phase 2 (Ph2) trials are based on the desired properties of the design and...

5th Basic Statistical Concept Workshop in Japan

By Satoru Fukimbara, PhD; Ayano Takeuchi, PhD; Junichi Nishino Found in: Article, Statistics, Clinical Development & Operations

Non-statisticians need to understand when and what (and not only “how”) to apply statistical concepts in the context of...

How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs

By Mark Geanacopoulos, PhD; Ruth Barratt, PhD, DVM; CDER, Office of Translational Sciences Found in: Article, Regulatory, Statistics

Since 2008, the Critical Path Initiative has supported FDA’s program of intramural research projects in regulatory science, with…

The DIA Statistics Community: Turning Data into Knowledge

By Joan Buenconsejo and Susan Duke Found in: Article, Statistics, Regulatory

Our mission includes providing global forums for the sharing of statistical knowledge and experience, and identifying...

The DIA Statistics Community: Turning Data into Knowledge

By Joan Buenconsejo and Susan Duke Found in: Article, Statistics, Clinical Development & Operations

Our mission includes providing global forums for the sharing of statistical knowledge and experience, and identifying and...

Advancing the Science of Study Endpoints

Bethesda North Marriott Hotel and Conference Center

DIA Annual Canadian Meeting

Ottawa Marriott Hotel

Real World Evidence Conference

InterContinental San Francisco

Biostatistics Industry and Regulator Forum

Bethesda North Marriott Hotel and Conference Center