Literature DB >> 27658006

Trustworthiness of Patient-Reported Outcomes in Unblinded Cancer Clinical Trials.

Thomas M Atkinson1, Jan-Samuel Wagner2, Ethan Basch3.   

Abstract

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Year:  2017        PMID： 27658006      PMCID： PMC5362349          DOI： 10.1001/jamaoncol.2016.3328

Source DB:  PubMed          Journal:  JAMA Oncol        ISSN： 2374-2437            Impact factor:   31.777


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  9 in total

Review 1.  Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

Authors:  Ethan Basch; Cindy Geoghegan; Stephen Joel Coons; Ari Gnanasakthy; Ashley F Slagle; Elektra J Papadopoulos; Paul G Kluetz
Journal:  JAMA Oncol       Date:  2015-06       Impact factor: 31.777

2.  Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer.

Authors:  G Sonpavde; V Matveev; J M Burke; J R Caton; M T Fleming; T E Hutson; M D Galsky; W R Berry; P Karlov; J T Holmlund; B A Wood; M Brookes; L Leopold
Journal:  Ann Oncol       Date:  2011-11-23       Impact factor: 32.976

3.  Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study.

Authors:  Hedy L Kindler; Tatsuya Ioka; Dirk J Richel; Jaafar Bennouna; Richard Létourneau; Takuji Okusaka; Akihiro Funakoshi; Junji Furuse; Young Suk Park; Shinichi Ohkawa; Gregory M Springett; Harpreet S Wasan; Peter C Trask; Paul Bycott; Alejandro D Ricart; Sinil Kim; Eric Van Cutsem
Journal:  Lancet Oncol       Date:  2011-03       Impact factor: 41.316

4.  Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer.

Authors:  M Dror Michaelson; Stephane Oudard; Yen-Chuan Ou; Lisa Sengeløv; Fred Saad; Nadine Houede; Peter Ostler; Arnulf Stenzl; Gedske Daugaard; Robert Jones; Fredrik Laestadius; Anders Ullèn; Amit Bahl; Daniel Castellano; Juergen Gschwend; Tristan Maurina; Edna Chow Maneval; Shaw-Ling Wang; Maria Jose Lechuga; Jolanda Paolini; Isan Chen
Journal:  J Clin Oncol       Date:  2013-12-09       Impact factor: 44.544

5.  Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

Authors:  Ari Gnanasakthy; Carla DeMuro; Marci Clark; Emily Haydysch; Esprit Ma; Vijayveer Bonthapally
Journal:  J Clin Oncol       Date:  2016-04-11       Impact factor: 44.544

6.  Patient-reported outcomes as a component of the primary endpoint in a double-blind, placebo-controlled trial in advanced pancreatic cancer.

Authors:  S Gail Eckhardt; Peter De Porre; David Smith; Joan Maurel; William P Steward; Olivier Bouche; Helgi van de Velde; Bart Michiels; Roland Bugat
Journal:  J Pain Symptom Manage       Date:  2008-08-23       Impact factor: 3.612

7.  Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer.

Authors:  Ronald B Natale; Sumitra Thongprasert; F Anthony Greco; Michael Thomas; Chun-Ming Tsai; Patrapim Sunpaweravong; David Ferry; Clive Mulatero; Robert Whorf; Joyce Thompson; Fabrice Barlesi; Peter Langmuir; Sven Gogov; Jacqui A Rowbottom; Glenwood D Goss
Journal:  J Clin Oncol       Date:  2011-01-31       Impact factor: 44.544

8.  Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

Authors: 
Journal:  Health Qual Life Outcomes       Date:  2006-10-11       Impact factor: 3.186

9.  Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

Authors:  Anjan K Banerjee; Sally Okun; I Ralph Edwards; Paul Wicks; Meredith Y Smith; Stephen J Mayall; Bruno Flamion; Charles Cleeland; Ethan Basch
Journal:  Drug Saf       Date:  2013-12       Impact factor: 5.606
  9 in total
  16 in total

1.  Clinical Activity of the γ-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors (Aggressive Fibromatosis).

Authors:  Shivaani Kummar; Geraldine O'Sullivan Coyne; Khanh T Do; Baris Turkbey; Paul S Meltzer; Eric Polley; Peter L Choyke; Robert Meehan; Rasa Vilimas; Yvonne Horneffer; Lamin Juwara; Ann Lih; Amul Choudhary; Sandra A Mitchell; Lee J Helman; James H Doroshow; Alice P Chen
Journal:  J Clin Oncol       Date:  2017-03-28       Impact factor: 44.544

2.  Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial.

Authors:  David Cella; Robert J Motzer; Cristina Suarez; Steven I Blum; Flavia Ejzykowicz; Melissa Hamilton; Joel F Wallace; Burcin Simsek; Joshua Zhang; Cristina Ivanescu; Andrea B Apolo; Toni K Choueiri
Journal:  Lancet Oncol       Date:  2022-01-12       Impact factor: 54.433

3.  Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial.

Authors:  Hannah L Rush; Laura Murphy; Alicia K Morgans; Noel W Clarke; Adrian D Cook; Gerhardt Attard; Archie Macnair; David P Dearnaley; Christopher C Parker; J Martin Russell; Silke Gillessen; David Matheson; Robin Millman; Christopher D Brawley; Cheryl Pugh; Jacob S Tanguay; Robert J Jones; John Wagstaff; Sarah Rudman; Joe M O'Sullivan; Joanna Gale; Alison Birtle; Andrew Protheroe; Emma Gray; Carla Perna; Shaun Tolan; Neil McPhail; Zaf I Malik; Salil Vengalil; David Fackrell; Peter Hoskin; Matthew R Sydes; Simon Chowdhury; Duncan C Gilbert; Mahesh K B Parmar; Nicholas D James; Ruth E Langley
Journal:  J Clin Oncol       Date:  2021-11-10       Impact factor: 50.717

4.  Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial.

Authors:  Areej El-Jawahri; Jamie M Jacobs; Ashley M Nelson; Lara Traeger; Joseph A Greer; Showly Nicholson; Lauren P Waldman; Alyssa L Fenech; Annemarie D Jagielo; Jennifer D'Alotto; Nora Horick; Thomas Spitzer; Zachariah DeFilipp; Yi-Bin A Chen; Jennifer S Temel
Journal:  Cancer       Date:  2020-01-03       Impact factor: 6.860

5.  A randomized trial of exercise and diet on health-related quality of life in survivors of breast cancer with overweight or obesity.

Authors:  Justin C Brown; David B Sarwer; Andrea B Troxel; Kathleen Sturgeon; Angela M DeMichele; Crystal S Denlinger; Kathryn H Schmitz
Journal:  Cancer       Date:  2021-06-23       Impact factor: 6.921

6.  A Pharmacometric Analysis of Patient-Reported Outcomes in Breast Cancer Patients Through Item Response Theory.

Authors:  Emilie Schindler; Lena E Friberg; Bertram L Lum; Bei Wang; Angelica Quartino; Chunze Li; Sandhya Girish; Jin Y Jin; Mats O Karlsson
Journal:  Pharm Res       Date:  2018-04-19       Impact factor: 4.200

7.  Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer.

Authors:  Martin Reck; Thomas Wehler; Francisco Orlandi; Naoyuki Nogami; Carlo Barone; Denis Moro-Sibilot; Mikhail Shtivelband; Jose Luis González Larriba; Jeffrey Rothenstein; Martin Früh; Wei Yu; Yu Deng; Shelley Coleman; Geetha Shankar; Hina Patel; Claudia Kelsch; Anthony Lee; Elisabeth Piault; Mark A Socinski
Journal:  J Clin Oncol       Date:  2020-05-27       Impact factor: 44.544

8.  Kanuka honey versus aciclovir for the topical treatment of herpes simplex labialis: a randomised controlled trial.

Authors:  Alex Semprini; Joseph Singer; Irene Braithwaite; Nick Shortt; Darmiga Thayabaran; Melanie McConnell; Mark Weatherall; Richard Beasley
Journal:  BMJ Open       Date:  2019-05-14       Impact factor: 2.692

9.  Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial.

Authors:  Mikyung Kim; Jung-Eun Kim; Hye-Yoon Lee; Ae-Ran Kim; Hyo-Ju Park; O-Jin Kwon; Eun-Jung Kim; Yeon-Cheol Park; Byung-Kwan Seo; Jung Hyo Cho; Joo-Hee Kim
Journal:  BMC Complement Altern Med       Date:  2017-07-05       Impact factor: 3.659

Review 10.  Investigating the impact of open label design on patient-reported outcome results in prostate cancer randomized controlled trials.

Authors:  Guillaume Mouillet; Fabio Efficace; Antoine Thiery-Vuillemin; Emilie Charton; Mieke Van Hemelrijck; Francesco Sparano; Amélie Anota
Journal:  Cancer Med       Date:  2020-08-26       Impact factor: 4.452
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