June 2016 issue of the EQUATOR Oncology Project Current Awareness Bulletin

Welcome to the June 2016 issue of our EQUATOR Oncology Project 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, adverse events, patient-reported outcomes and early phase trials.

The EQUATOR Oncology Project welcomes your feedback and involvement! Please share your comments about the Project and any problems you have encountered in the planning or reporting of cancer research with project lead Angela MacCarthy: angela.maccarthy@ndorms.ox.ac.uk.

The bulletin is a work in progress – look out for changes over the coming issues!

To sign up to receive this bulletin by email please email Shona Kirtley, shona.kirtley@csm.ox.ac.uk

With best wishes from the EQUATOR Oncology Project Team

EQUATOR Oncology Project Quarterly Current Awareness Bulletin – June 2016

Statistical issues
Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance — too much of a good thing. Ann Oncol. 2016;27(5):760-762. PMID: 26861602
http://www.ncbi.nlm.nih.gov/pubmed/26861602/

Cuzick J. Statistical controversies in clinical research: long-term follow-up of clinical trials in cancer. Ann Oncol. 2015;26(12):2363-2366. PMID: 26433395
http://www.ncbi.nlm.nih.gov/pubmed/26433395/

Saad ED, Buyse M. Statistical controversies in clinical research: end points other than overall survival are vital for regulatory approval of anticancer agents. Ann Oncol. 2016;27(3):373-378.  PMID: 26578738
http://www.ncbi.nlm.nih.gov/pubmed/26578738/

Adverse events
Chen TW, Razak AR, Bedard PL, Siu LL, Hansen AR. A systematic review of immune-related adverse event reporting in clinical trials of immune checkpoint inhibitors. Ann Oncol. 2015;26(9):1824-1829. PMID: 25888611
http://www.ncbi.nlm.nih.gov/pubmed/25888611/

Seruga B, Templeton AJ, Vera-Badillo FE, Ocana A, Amir E, Tannock IF. Under-reporting of harm in clinical trials. Lancet oncology. 2016;17(5):209-219. PMID: 27301048
http://www.ncbi.nlm.nih.gov/pubmed/27301048/

Patient-reported outcomes
Di Maio M, Basch E, Bryce J, Perrone F. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016;13(5):319-325. PMID: 26787278
http://www.ncbi.nlm.nih.gov/pubmed/26787278/

Efficace F, Fayers P, Pusic A, Cemal Y, Yanagawa J, Jacobs M, la Sala A, Cafaro V, Whale K, Rees J, Blazeby J; European Organization for Research and Treatment of Cancer Quality-of-Life Group (Patient-Reported Outcome Measurements Over Time in Oncology Registry). Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials. Cancer. 2015;121(18):3335-3342. PMID: 26079197
http://www.ncbi.nlm.nih.gov/pubmed/26079197/

Gerritsen A, Jacobs M, Henselmans I, van Hattum J, Efficace F, Creemers GJ, de Hingh IH, Koopman M, Molenaar IQ, Wilmink HW, Busch OR, Besselink MG, van Laarhoven HW; Dutch Pancreatic Cancer Group. Developing a core set of patient-reported outcomes in pancreatic cancer: A Delphi survey. Eur J Cancer. 2016;57:68-77. PMID: 26886181
http://www.ncbi.nlm.nih.gov/pubmed/26886181/

Mercieca-Bebber RL, Perreca A, King M, Macann A, Whale K, Soldati S, Jacobs M, Efficace F. Patient-reported outcomes in head and neck and thyroid cancer randomised controlled trials: A systematic review of completeness of reporting and impact on interpretation. Eur J Cancer. 2016;56:144-161. PMID: 26851406
http://www.ncbi.nlm.nih.gov/pubmed/26851406/

Rees JR, Whale K, Fish D, Fayers P, Cafaro V, Pusic A, Blazeby JM, Efficace F. Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making. J Cancer Res Clin Oncol. 2015;141(12):2181-1292. PMID: 25910987
http://www.ncbi.nlm.nih.gov/pubmed/25910987/

Venkatesan P. New European guidance on patient-reported outcomes. Lancet Oncol. 2016. PMID: 27132873
http://www.ncbi.nlm.nih.gov/pubmed/27132873/

End points
Kramar A, Negrier S, Sylvester R, Joniau S, Mulders P, Powles T, Bex A, Bonnetain F, Bossi A, Bracarda S, Bukowski R, Catto J, Choueiri TK, Crabb S, Eisen T, El Demery M, Fitzpatrick J, Flamand V, Goebell PJ, Gravis G, Houédé N, Jacqmin D, Kaplan R, Malavaud B, Massard C, Melichar B, Mourey L, Nathan P, Pasquier D, Porta C, Pouessel D, Quinn D, Ravaud A, Rolland F, Schmidinger M, Tombal B, Tosi D, Vauleon E, Volpe A, Wolter P, Escudier B, Filleron T; DATECAN Renal Cancer group. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project. Ann Oncol. 2015;26(12):2392-2398. PMID: 26371288
http://www.ncbi.nlm.nih.gov/pubmed/26371288/

Early phase trials
Collette L, Tombal B. N-of-1 trials in oncology. Lancet Oncol. 2015;16(8):885-886. PMID: 26248830
http://www.ncbi.nlm.nih.gov/pubmed/26248830/

Paoletti X, Ezzalfani M, Le Tourneau C. Statistical controversies in clinical research: requiem for the 3 + 3 design for phase I trials. Ann Oncol. 2015;26(9):1808-1812. PMID: 26088197
http://www.ncbi.nlm.nih.gov/pubmed/26088197/

Wason JM, Jaki T. A review of statistical designs for improving the efficiency of phase II studies in oncology. Stat Methods Med Res. 2016;25(3):1010-1021. PMID: 26031358
http://www.ncbi.nlm.nih.gov/pubmed/26031358/

Other
Marous M, Bièche I, Paoletti X, Alt M, Razak AR, Stathis A, Kamal M, Le Tourneau C. Designs of preoperative biomarkers trials in oncology: a systematic review of the literature. Ann Oncol. 2015;26(12):2419-2428. PMID: 26371283
http://www.ncbi.nlm.nih.gov/pubmed/26371283/

Prasad V, Goldstein JA. Clinical trial spots for cancer patients by tumour type: The cancer trials portfolio at clinicaltrials.gov. Eur J Cancer. 2015;51(17):2718-2723. PMID: 26321010 http://www.ncbi.nlm.nih.gov/pubmed/26321010/

Dhingra K. Oncology 2020: a drug development and approval paradigm. Ann Oncol. 2015;26(11):2347-2350. PMID: 26374285
http://www.ncbi.nlm.nih.gov/pubmed/26374285/

Schwartz LH, Litière S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, Seymour L. RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer. 2016. PMID: 27189322
http://www.ncbi.nlm.nih.gov/pubmed/27189322/

Zhang S, Liang F, Li W, Tannock I. Comparison of Eligibility Criteria Between Protocols, Registries, and Publications of Cancer Clinical Trials. J Natl Cancer Inst. 2016;108(11). PMID: 27226519
http://www.ncbi.nlm.nih.gov/pubmed/27226519/

Di Maio M, Perrone F. Lessons from clinical trials on quality-of-life assessment in ovarian cancer trials. Ann Oncol. 2016;27(6):961-962. PMID: 27056997
http://www.ncbi.nlm.nih.gov/pubmed/27056997/

Vera-Badillo FE, Napoleone M, Krzyzanowska MK, Alibhai SM, Chan AW, Ocana A, Seruga B, Templeton AJ, Amir E, Tannock IF. Bias in reporting of randomised clinical trials in oncology. Eur J Cancer. 2016;61:29-35. PMID: 27151552
http://www.ncbi.nlm.nih.gov/pubmed/27151552/

Lee RT, Ramchandran K, Sanft T, Von Roenn J. Implementation of supportive care and best supportive care interventions in clinical trials enrolling patients with cancer. Ann Oncol. 2015;26(9):1838-1845. PMID: 25922064
http://www.ncbi.nlm.nih.gov/pubmed/25922064/

Visit the EQUATOR website to browse the 29 oncology-specific reporting guidelines currently available.

Visit the EQUATOR Oncology Project web page for further information and other interesting and useful references.

To read previous EQUATOR Oncology Project bulletins please visit our bulletin web page.