Enhancing the QUAlity and Transparency Of health Research
Welcome to the September 2017 issue of our EQUATOR Oncology Current Awareness Bulletin
We hope that this bulletin will help to keep you up-to-date with the latest issues in the reporting and methods in oncology research by highlighting links to interesting research papers, editorials, comments and other resources related to cancer research. Topics covered in this issue include statistical issues, trial guidance and trial outcomes.
We welcome your feedback and involvement! Please share your comments and any problems you have encountered in the planning or reporting of cancer research with project lead Angela MacCarthy (firstname.lastname@example.org).
The bulletin is a work in progress – look out for changes over the coming issues!
Please feel free to pass this bulletin on to colleagues.
With best wishes from the EQUATOR Oncology Team
EQUATOR Oncology Current Awareness Bulletin – September 2017
Clinical trials – guidance
Leary AF, Quinn M, Fujiwara K, Coleman RL, Kohn E, Sugiyama T, Glasspool R, Ray-Coquard I, Colombo N, Bacon M, Zeimet A, Westermann A, Gomez-Garcia E, Provencher D, Welch S, Small W, Millan D, Okamoto A, Stuart G, Ochiai K. Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup (GCIG): clinical trial design for rare ovarian tumours. Ann Oncol. 2017;28(4):718-726. PMID: 27993794
Kimmelman J, Resnik DB, Peppercorn J, Ratain MJ. Burdensome Research Procedures in Trials: Why Less Is More. J Natl Cancer Inst. 2017;109(4). PMID: 28376159
Korn EL, Freidlin B. Adaptive Clinical Trials: Advantages and Disadvantages of Various Adaptive Design Elements. J Natl Cancer Inst. 2017;109(6). PMID: 28376148
Korn EL, Othus M, Chen T, Freidlin B. Assessing treatment efficacy in the subset of responders in a randomized clinical trial. Ann Oncol. 2017. PMID: 28444115
Remon J, Ferte C. A step towards the harmonization of clinical trials inform consent forms. Ann Oncol. 2017;28(5):910-912. PMID: 28453709
Bleiberg H, Decoster G, de Gramont A, Rougier P, Sobrero A, Benson A, Chibaudel B, Douillard JY, Eng C, Fuchs C, Fujii M, Labianca R, Larsen AK, Mitchell E, Schmoll HJ, Sprumont D, Zalcberg J. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group. Ann Oncol. 2017;28(5):922-930. PMID: 28453700
Clinical trial endponts/outcomes
Kemp R, Prasad V. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? BMC Med. 2017;15(1):134. PMID: 28728605
Hinds PS, Wang J, Stern ED, Macpherson CF, Wharton CM, Okorosobo R, Cheng YI, Gross HE, Meany HJ, Jacobs S. Voices of children and adolescents on phase 1 or phase 2 cancer trials: A new trial endpoint? Cancer. 2017. PMID: 28581685
Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, Clarke M, Gargon E, Gorst S, Harman N, Kirkham JJ, McNair A, Prinsen CAC, Schmitt J, Terwee CB, Young B. The COMET Handbook: version 1.0. Trials. 2017;18(3):280. PMID: 28681707
Mamzer MF, Duchange N, Darquy S, Marvanne P, Rambaud C, Marsico G, Cerisey C, Scotte F, Burgun A, Badoual C, Laurent-Puig P, Herve C. Partnering with patients in translational oncology research: ethical approach. J Transl Med. 2017;15(1):74. PMID: 28390420
Statistical controversies in clinical research series – Annals of Oncology
Le-Rademacher J, Hillman SL, Meyers J, Loprinzi CL, Limburg PJ, Mandrekar SJ. Statistical controversies in clinical research: Value of adverse events relatedness to study treatment: analyses of data from randomized double-blind placebo-controlled clinical trials. Ann Oncol. 2017;28(6):1183-1190. PMID: 28184420
Park JH, Eisenhut M, van der Vliet HJ, Shin JI. Statistical controversies in clinical research: overlap and errors in the meta-analyses of microRNA genetic association studies in cancers. Ann Oncol. 2017;28(6):1169-1182. PMID: 28327894
Herrmann D, Sinnett P, Holmes J, Khan S, Koller C, Vassar M. Statistical controversies in clinical research: publication bias evaluations are not routinely conducted in clinical oncology systematic reviews. Ann Oncol. 2017;28(5):931-937. PMID: 28039176
Wages NA, Slingluff CL, Jr., Petroni GR. Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies. Ann Oncol. 2017;28(4):696-701. PMID: 28011450
Perlmutter AS, Tran VT, Dechartres A, Ravaud P. Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials. Ann Oncol. 2017;28(4):688-695. PMID: 28011448
Visit the EQUATOR Oncology web page (http://www.equator-network.org/library/equator-oncology/) for further information and other interesting and useful references.
To read previous EQUATOR Oncology Project bulletins please visit our bulletin web page.
This bulletin is not a systematic update of everything recently published in this area but simply a roundup of interesting publications and resources. Inclusion in this bulletin is not an endorsement of a research publication or of a resource.
Melissa Sharp, a second-year doctoral research student in the Methods in Research on Research (MIROR) program, recently spent 3 months with the UK EQUATOR Centre. MIROR doctoral fellows earn joint doctorates from two EU universities and spend time at partner...