Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting

Background.

Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology).

Materials and Methods.

Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4−6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results.

Results.

A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11–1.36], p < .001; and 1.64 [1.15–2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38–1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61–1.29]; p = .532).

Conclusion.

This is the largest reported study examining why oncology trials are not published. The data show that 4−6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory.

Implications for Practice:

The Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects notes the ethical obligation to report clinical trial data, whether positive or negative. This obligation is listed alongside requirements for risk minimization, access, confidentiality, and informed consent, all bedrocks of the clinical trial system, yet clinical trials are often not published, particularly if negative or difficult to complete. This study found that among American Society for Clinical Oncology (ASCO) Annual Meeting abstracts, 2009–2011, only 61% were published 4–6 years later: 75% of randomized trials and 54% of nonrandomized trials. Clinicians need to insist that every study in which they participate is published.     

Phase 1/2 study of hypofractionated intensity-modulated radiation therapy for prostate cancer including simultaneously integrated boost

Purpose

This study evaluates the safety and efficacy of moderately hypofractionated radiation therapy (RT) with simultaneous integrated boost (HSIB) intensity modulated RT (IMRT) that includes coverage of the seminal vesicles (SVs) and pelvic lymph nodes (LNs).

Evaluation of the Perth experience in treating with ionizing radiations and VHF (434 megahertz) radiations

Holt and Nelson's experience in 52 patients with head and neck cancer treated with 434 MHz microwave hyperthermia and ionizing irradiation in Perth, Western Australia was reviewed during the author's visit there in the spring of 1978. The 2 year disease-free survival of 47% for patients with advanced disease (T3, T4 or N2, N3) is promising. This is especially encouraging since these results were obtained with lower than conventional doses of irradiation and normal tissue tolerance was excellent. Phase 1/11 studies in this country appear warranted.     

Thoracic reirradiation with SBRT for residual/recurrent and new primary NSCLC within or immediately adjacent to a prior high-dose radiation field

Purpose

Local failure following concurrent chemoradiation and in-lobe failures following stereotactic body radiation therapy (SBRT) are common. We evaluated our institutional experience using SBRT as salvage in this setting.

《国际肿瘤学杂志》2000-2009年载文情况分析

目的 对<国际肿瘤学杂志>2000-2009年出版的文章进行分析,为该刊的编辑出版提供参考.方法 采用文献计量学方法,分析<国际肿瘤学杂志>2000-2009年出版的文章,分别统计其载文量、基金论文比、合著情况、作者分布等指标.结果 <国际肿瘤学杂志>2000--2009年共发表文章2 551篇,其中论著182篇.综述2 198篇,文摘171篇,篇密度是0.3篇/页.基金资助论文共536篇,基金资助论文比为0.21,均呈上升趋势.作者地区分布广泛,覆盖29个省、自治区和直辖市,论文作者合作度为1.6 人/篇,其中综述合作度为1.4人/篇,论著合作度为4.3人/篇.结论 该刊文稿来源广泛,基金资助论文比例较高,论著合著程度较高,对本专业读者群具有很高的利用价值.     

Synopsis of history of American Society for Therapeutic Radiology and Oncology 1958-2008

PURPOSE: To provide a synopsis of the history of the association of radiation oncologists in the United States, currently known as the American Society for Therapeutic Radiology and Oncology (ASTRO), with the occasion of the 50th anniversary of the organization. METHODS AND MATERIALS: The history of ASTRO, from its beginning as the American Club of Therapeutic Radiologists, is the subject of a book that is to be released with the occasion of the 50th Annual Meeting of the Society in 2008. This book was prepared by members of ASTRO's History Committee and History Working Subcommittee. The source material for the book was the archives of the Society and recorded interviews, conducted by members of the subcommittee, of members of the Society and of the past and present Society staff. The book was also based on previously published material. This article used the source material used for the Society anniversary book. RESULTS: This synopsis of the history of the Society will provide a source of reference for anyone interested in the history of the Society from its foundation in 1958 to the present, 2008.     

NRG Oncology medical physicists’ manpower survey quantifying support demands for multi-institutional clinical trials

Purpose

A survey was created by NRG to assess a medical physicists’ percent full time equivalent (FTE) contribution to multi-institutional clinical trials. A 2012 American Society for Radiation Oncology report, “Safety Is No Accident,” quantified medical physics staffing contributions in FTE factors for clinical departments. No quantification of FTE effort associated with clinical trials was included.

American College of Surgeons Oncology Group and the community surgeon

The American College of Surgeons Oncology Group (ACOSOG) conducts cancer trials that are relevant to surgeons who treat patients with breast, thoracic, and gastrointestinal cancers. ACOSOG is funded by the National Cancer Institute and is charged with conducting prospective clinical trials that address important questions in academic and community practice settings. Examples include role of axillary dissection for microscopic nodal disease, neoadjuvant therapy for organ-conserving surgery, laparoscopic rectal cancer resection, mediastinal nodal staging, and sublobar resection for early-stage non-small cell lung cancer. Such trials are relevant to most practicing surgeons.     

Informed consent in radiation oncology: is consenting easier than informing?

The patient’s right to be informed has been universally recognized and reflected in the legal system of many countries. This right to correct and complete information on behalf of the patient and his admission to proceed with the recommended diagnostic or therapeutic procedure is formalized in the document commonly known as informed consent. Although the legal and bioethical considerations regarding this document have been exhaustively discussed and consensuated, its content continues to create certain doubts and uncertainties. The formal content and the manner in which the consent is obtained are the most difficult aspects. In this article, we analyze what should be included in the written informed consent, with regard to the totality of the information which the patient receives, who should inform, and how the consent should be obtained, as well as how to reflect the different aspects of the variety of radiotherapeutic procedures in the informed consent.