Sample Sizes: 2 Monotherapies With Single Approved Dose Level

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

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 Research

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 Research

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 Research, 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 Research, 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 Research, 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 Research, 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 Research, 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 Research

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 Affairs, Statistics

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

Sample Sizes: 2 Monotherapies With Single Approved Dose Level

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

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 Research

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 Research

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 Research, 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 Research, 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 Research, 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 Research, 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 Research, 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 Research

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 Affairs, 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 Affairs

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 Research

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