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Comparison of futility monitoring guidelines using completed phase III oncology trials

JOURNAL ARTICLE published February 2017 in Clinical Trials

Authors: Qiang Zhang | Boris Freidlin | Edward L Korn | Susan Halabi | Sumithra Mandrekar | James J. Dignam

Regulatory-grade clinical trial design using real-world data

JOURNAL ARTICLE published August 2020 in Clinical Trials

Authors: Mark S Levenson

Nonparametric estimator of relative time with application to the Acyclovir Prevention Trial

JOURNAL ARTICLE published August 2009 in Clinical Trials

Authors: Stephen R Cole

The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease

JOURNAL ARTICLE published April 2011 in Clinical Trials

Authors: Yili Pritchett | Yannis Jemiai | Yuchiao Chang | Ishir Bhan | Rajiv Agarwal | Carmine Zoccali | Christoph Wanner | Donald Lloyd-Jones | Jorge B Cannata-Andía | Taylor Thompson | Evan Appelbaum | Paul Audhya | Dennis Andress | Wuyan Zhang | Scott Solomon | Warren J Manning | Ravi Thadhani

Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial

JOURNAL ARTICLE published February 2023 in Clinical Trials

Research funded by Medical Research Council (MC_UU_00004_09 and MC_UU_123023_29) | World Health Organization (UNDP-UNFPA-UNICEF-WHO)

Authors: Babak Choodari-Oskooei | Soe Soe Thwin | Alexandra Blenkinsop | Mariana Widmer | Fernando Althabe | Mahesh KB Parmar

Use of joint models to assess treatment effects on disease markers and clinical events: the ProscarTM Long-Term Efficacy and Safety Study (PLESS)

JOURNAL ARTICLE published August 2004 in Clinical Trials

Authors: Weili He | Weichung Joe Shih

The ethical relevance of two types of adverse health effects on research bystanders as applied to HIV, mosquito bednet and organ transplant trials

JOURNAL ARTICLE published October 2019 in Clinical Trials

Research funded by National Institutes of Health (1 R01 AI114617-01A1)

Authors: Gerard Vong

Dynamic use of historical controls in clinical trials for rare disease research: A re-evaluation of the MILES trial

JOURNAL ARTICLE published June 2023 in Clinical Trials

Research funded by national center for research resources (RR019498 andRR019259) | food and drug administration (FD003362) | national heart, lung, and blood institute (U01HL58440)

Authors: Nusrat Harun | Nishant Gupta | Francis X McCormack | Maurizio Macaluso

A multi-center, randomized, double blind placebo-controlled trial of estrogens to prevent Alzheimer's disease and loss of memory in women: design and baseline characteristics

JOURNAL ARTICLE published October 2008 in Clinical Trials

Authors: Mary Sano | Diane Jacobs | Howard Andrews | Karen Bell | Neill Graff-Radford | John Lucas | Peter Rabins | Karen Bolla | Wei-Yan Tsai | Peter Cross | Karen Andrews | Rosann Costa

Evaluating markers for the early detection of cancer: overview of study designs and methods

JOURNAL ARTICLE published February 2006 in Clinical Trials

Authors: Stuart G Baker | Barnett S Kramer | Martin McIntosh | Blossom H Patterson | Yu Shyr | Steven Skates

Addressing the quality of submissions to ClinicalTrials.gov for registration and results posting: The use of a checklist

JOURNAL ARTICLE published December 2020 in Clinical Trials

Research funded by National Center for Advancing Translational Sciences (UL1 TR001079)

Authors: Oswald Tetteh | Prince Nuamah | Anthony Keyes

Subpopulation Treatment Effect Pattern Plot (STEPP) analysis for continuous, binary, and count outcomes

JOURNAL ARTICLE published August 2016 in Clinical Trials

Authors: Wai-Ki Yip | Marco Bonetti | Bernard F Cole | William Barcella | Xin Victoria Wang | Ann Lazar | Richard D Gelber

Recruitment of participants to a multiple sclerosis trial: The CombiRx experience

JOURNAL ARTICLE published April 2014 in Clinical Trials

Authors: Minal J Bhanushali | Tarah Gustafson | Steve Powell | Robin A Conwit | Jerry S Wolinsky | Gary R Cutter | Fred D Lublin | Stacey S Cofield

A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial

JOURNAL ARTICLE published December 2023 in Clinical Trials

Research funded by Patient-Centered Outcomes Research Institute (ME-2018C2-13253) | National Cancer Institute (K22-CA234400) | National Cancer Institute (P30-CA008748) | National Cancer Institute (P50-CA92629) | national institutes of health (CL010538)

Authors: Andrew J Vickers | Emily A Vertosick | Mia Austria | Christopher D Gaffney | Sigrid V Carlsson | Scott YH Kim | Behfar Ehdaie

Poor effort on cognitive testing in voluntary research predicts failure in US Army Ranger School: Implications for clinical trial design

JOURNAL ARTICLE published December 2023 in Clinical Trials

Research funded by Aker BP (8B422-01)

Authors: Travis H Turner | Jill C Newman | Bernadette P Marriott

The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States

JOURNAL ARTICLE published December 2023 in Clinical Trials

Research funded by National Cancer Institute (K08CA251654)

Authors: Henry Onyeaka | Daniel B Weber | Onyema Chido-Amajuoyi | Chioma Muoghalu | Hermioni L Amonoo

Design of the Dialysis Access Consortium (DAC) Aggrenox prevention of access stenosis trial

JOURNAL ARTICLE published October 2005 in Clinical Trials

Authors: Bradley S Dixon | Gerald J Beck | Laura M Dember | Thomas A Depner | Jennifer J Gassman | Tom Greene | Jonathan Himmelfar | Lawrence G Hunsicker | James S Kaufman | Jeffrey H Lawson | Catherine M Meyers | John P Middleton | Milena Radeva | Steve J Schwab | James F Whiting | Harold I Feldman

A general formulation for a one-sided group sequential design

JOURNAL ARTICLE published December 2005 in Clinical Trials

Authors: Barry K Moser | Stephen L George

Challenges in the research ethics review of cluster randomized trials: International survey of investigators

JOURNAL ARTICLE published April 2013 in Clinical Trials

Authors: Shazia H Chaudhry | Jamie C Brehaut | Jeremy M Grimshaw | Charles Weijer | Robert Boruch | Allan Donner | Martin P Eccles | Andrew D McRae | Raphael Saginur | Zoë C Skea | Merrick Zwarenstein | Monica Taljaard

Randomized controlled trial of Nuevo Amanecer: A peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer

JOURNAL ARTICLE published April 2014 in Clinical Trials

Authors: Anna M Nápoles | Jasmine Santoyo-Olsson | Carmen Ortiz | Steven Gregorich | Howard E Lee | Ysabel Duron | Kristi Graves | Judith A Luce | Peggy McGuire | Marynieves Díaz-Méndez | Anita L Stewart