Enhancing the QUAlity and Transparency Of health Research
Oncology-related reporting guidelines
There are a number of generic reporting guidelines available on the EQUATOR home page, which can be used for reporting oncology research. However, there are now 39 oncology-specific guidelines which can also be found on the EQUATOR website at: oncology-specific reporting guidelines
The International Society for Quality of Life Research and the National Cancer Institute Webinar Series on Best Practices for Integrating Patient Reported Outcomes in Oncology
Session 6 Webinar: How to report PRO study findings from clinical trials
Presenters: Michael Brundage MD & Melaine Calvert, PhD [Watch webinar]
Professor Paula Williamson, Professor of Medical Statistics and Director of the MRC NW Hub for Trials Methodology Research at the University of Liverpool.
Improving the feasibility of clinical trials (presentation at HeRC Launch Event,16.04.2013.) [Watch video]
The EQUATOR Network has a YouTube channel
EQUATOR Network YouTube videos available at: https://www.youtube.com/user/EQUATORNetwork
Professor Doug Altman, Centre for Statistics in Medicine, Oxford, UK opens the first EQUATOR symposium and talks about “Improving the quality and value of research publications — how can we speed up progress?” [Watch video]
Erik von Elm, Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Switzerland, talks about “Garbage in — garbage out? Impact of poor reporting on the development of systematic reviews” [Watch video]
Slide presentations from the EQUATOR Toolkit for teachers
Iveta Simera, EQUATOR workshop, Geneva, 2013.
What are reporting guidelines – brief [View slides]
Outcome measures in clinical trials
The COMET initiative has made available a database of studies that relate to ‘core outcomes’ in the context of clinical trials. They define a core outcome set as follows: ‘A “Core Outcome Set” is an agreed minimum set of outcomes or outcome measures. It is a recommendation of ‘what’ should be measured and reported in all trials in a specific area’. It is possible to search this database for the term ‘cancer’ or for individual diagnostic groups within oncology such as ‘lung cancer’ (http://www.comet-initiative.org/studies/search/).
A systematic approach to making trials more efficient.
European Organisation for Research and Treatment of Cancer (EORTC)
Access the EORTC bibliography database
Booth CM, Tannock I. Reflections on medical oncology: 25 years of clinical trials–where have we come and where are we going? J Clin Oncol. 2008;26(1): 6-8. PubMed ID: 18165630
Three themes are discussed in this review: (i) appropriate design and size of trials, (ii) the selection of clinically relevant endpoints and (iii) reporting and the avoidance of bias. The authors discuss the evolution of clinical trials over the last 25 years, and make suggestions as to how trials should be designed, conducted and reported.
Booth CM, Cescon DW, Wang L, Tannock IF, Krzyzanowska MK. Evolution of the randomized controlled trial in oncology over three decades. J Clin Oncol. 2008;26(33): 5458-5464. PubMed ID: 18955452
This study describes the trends in methodology and reporting of 321 randomised controlled trials in breast, colorectal and non-small cell lung cancer. The authors discuss sponsorship, and the interpretation of results by authors.
Kirk R, Hutchinson L. Oncology trials-the elephant in the room. Nat Rev Clin Oncol. 2012;9(4):185-186. PMID: 22456332
A related special issue on clinical trials is available at: http://www.nature.com/nrclinonc/focus/clinicaltrials/index.html
References specifically about reporting issues in oncology:
Raghav KP, Mahajan S, Yao JC, Hobbs BP, Berry DA, Pentz RD, Tam A, Hong WK, Ellis LM, Abbruzzese J, Overman MJ. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology. J Clin Oncol. 2015;33(31):3583-3590. PMID: 26304898
This paper describes a systematic review of seventy four randomised oncology trials published in three major journals in 2012. Published reports of trials were compared with the published protocols for those same studies, in particular the authors examined the reporting of various ‘endpoints’. They also examined study objectives and plans for statistical analyses.
A database of studies that relate to ‘core outcomes’ in the context of clinical trials is available from the COMET Initiative.
Sivendran S, Newport K, Horst M, Albert A, Galsky MD. Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies. Trials. 2015; 16(1): 341. PubMed ID: 26253548
This systematic review assessed the quality of reporting of phase III clinical trial abstracts using a ‘completeness score’ score based on the CONSORT statement. It also examines the accessibility of full texts through open access.
Bariani GM, de Celis Ferrari AC, Precivale M, Arai R, Saad ED, Riechelmann RP. Sample Size Calculation in Oncology Trials: Quality of Reporting and Implications for Clinical Cancer Research. Am J Clin Oncol. 2014. PubMed ID: 24401665
This study examined the reporting of parameters required for sample size calculations in 140 phase III oncology trials that were published in six leading (mainly oncology) journals between 2008 and 2011.
Peron J, Pond GR, Gan HK, Chen EX, Almufti R, Maillet D, You B. Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review. J Natl Cancer Inst. 2012; 104(13): 982-989. PubMed ID: 22761273
This study assessed the reporting quality of 357 randomised controlled trials using the 2001 and 2010 CONSORT statements. The authors also described the characteristics associated with better quality reporting.
You B, Gan HK, Pond G, Chen EX. Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. J Clin Oncol. 2012; 30(2): 210-216. PubMed ID: 22162583
This systematic review examined the reporting and analysis of primary endpoints in randomised controlled trials registered in Clincaltrial.gov and International Standard Randomized Controlled Trial Number register.
Dechartres A, Charles P, Hopewell S, Ravaud P, Altman DG. Reviews assessing the quality or the reporting of randomized controlled trials are increasing over time but raised questions about how quality is assessed. J Clin Epidemiol. 2011; 64(2): 136-144. PubMed ID: 20705426
This study examined 177 review articles that assessed the quality of randomised controlled trials in various field of medicine. The use of the CONSORT checklist is examined. There is a web-based Appendix (2) giving details of the ten reviews in the area of Oncology.
Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S, Djulbegovic B. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ. 2004; 328(7430): 22-24. PubMed ID: 14703540
This study compares the content of reports of randomised controlled trials in the field of radiotherapy with the information contained in the study protocols. The objective of the study is to determine if poor reporting of methods reflects poor study methodology.
Bentzen SM. Towards evidence based radiation oncology: improving the design, analysis, and reporting of clinical outcome studies in radiotherapy. Radiother Oncol. 1998; 46(1): 5-18. PubMed ID: 9488121
This review describes the specific problems in reporting the outcome of radiotherapy trials. It also discusses publication bias.
Other issues in oncology research: outcomes and endpoints
Wilson MK, Karakasis K, Oza AM. Outcomes and endpoints in trials of cancer treatment: the past, present, and future. Lancet Oncol. 2015;16(1): e32-42. PubMed ID: 25638553
This paper discusses overall survival, surrogate endpoints and other endpoints such as time to disease progression or treatment, disease-free survival, hair loss treatment,event-free survival, and the objective response rate. It also discusses the robustness of methods used to measure clinical outcomes.
Wilson MK, Collyar D, Chingos DT, Friedlander M, Ho TW, Karakasis K, Kaye S, Parmar MK, Sydes MR, Tannock IF, Oza AM. Outcomes and endpoints in cancer trials: bridging the divide. Lancet Oncol. 2015; 16(1): e43-52. PubMed ID: 25638556
This review discusses the choice of endpoints that are clinically relevant, how these can be explained to patients, and how they can be used in trials.
Fumagalli D, Bedard PL, Nahleh Z, Michiels S, Sotiriou C, Loi S, Sparano JA, Ellis M, Hylton N, Zujewski JA, Hudis C, Esserman L, Piccart M; BIG-NABCG collaboration. A common language in neoadjuvant breast cancer clinical trials: proposals for standard definitions and endpoints. Lancet Oncol. 2012;13(6):e240-248. PMID: 22652232
In this review two groups (Breast International Group and the National Cancer Institute-sponsored North American Breast Cancer Group) propose standard definitions and endpoints for neoadjuvant breast cancer clinical trials. The aim of these recommendations is to improve and standardise the conduct and reporting of clinical trials in this area.
This page was last updated on: 25 September 2017
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