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

Massey, Paul R.; Wang, Ruibin; Prasad, Vinay; Bates, Susan E.; Fojo, Tito

doi:10.1634/theoncologist.2015-0516

Cited by 34 publications

(44 citation statements)

References 46 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Prior studies have correlated larger patient enrollment with likelihood of publication,(25,34–36) which is similar to our data demonstrating the importance of research biopsy number and reporting. Similar to our finding with research biopsy reporting, prior studies have demonstrated that industry funding negatively impacts clinical trial publication.…”

Section: Discussionsupporting

confidence: 89%

“…(21–25) In particular, recent studies have shown that a substantial proportion of clinical trials have suboptimal reporting of harm, and severe toxicity. (26,27) This single center study evaluating the rate of reporting of research biopsies in clinical trials has produced findings demonstrating that, similar to clinical trial underreporting, the absence of research biopsy reporting represents a major limitation to the transparency of clinical research.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Underreporting of Research Biopsies from Clinical Trials in Oncology

Parseghian

Raghav

Wolff

et al. 2017

Clinical Cancer Research

View full text Add to dashboard Cite

PURPOSE Research biopsies are frequently incorporated within clinical trials in oncology, and are often a mandatory requirement for trial enrollment. However, limited information is available regarding the extent and completeness of research biopsy reporting. METHODS We identified a cohort of therapeutic clinical trials where non-diagnostic research biopsies were performed between January, 2005-October, 2010 from an IR database at our institution. Clinical trial protocols were compared with the highest level of corresponding publication as a manuscript or registry report. RESULTS A total of 866 research biopsies were performed across 46 clinical trials, with a median of 8 patients biopsied/trial and 19 biopsies collected/trial. After a median follow-up time of 4.3 years from trial completion, 36/46 trials (78%) reported trial results: published manuscripts (n=35), or registry report (n=1). A total of 635 conducted biopsies were reported in 18 of the 46 trials (39%). Six (33%) of these 18 trials under-reported the number of biopsies performed. Of 33 trials with mandatory research biopsies, 13 (39%) trials reported on these biopsies. Biopsy complications occurred in 8 trials (n=39 patients, 6 Grade 3/4 AEs) but only 1 trial reported these. Factors associated with biopsy reporting included a larger number of biopsies (P≤0.001), and serial biopsies (P<0.001). Twelve of 16 (75%) trials with >12 biopsies performed reported on these biopsies compared to only 20%(6/30) that performed ≤12 biopsies. CONCLUSION Despite ethical obligations to report research biopsies, the majority (61%) of trials do not report results from research biopsies. Complications are rarely reported in these studies. Improved reporting of results and AEs from research biopsies is needed.

show abstract

Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Underreporting of Research Biopsies from Clinical Trials in Oncology

Parseghian

Raghav

Wolff

et al. 2017

Clinical Cancer Research

View full text Add to dashboard Cite

show abstract

“…In particular, the publication percentage of the phase 3 trials (mainly RCTs) in our cohort (73%) was higher compared to previous cohorts investigating RCTs (overall, 54% published) [16,37]. Other recent research also supports that publication of phase 3 trials has been improved [17]. So, the regularly mentioned number of 50% non-publication [38] probably needs to be updated with regard to the phase 3 trials.…”

Section: Discussionmentioning

confidence: 61%

“…The waste and bias implicated in clinical research caused by non-publication over the past years [3,6,7,8,9,10,11,12,13,14,15,16,17,18] has strengthened the view of several organizations and governments that all clinical trials must be published [19,20,21,22,23]. Previous studies specifically focused on publication of randomized controlled trials (RCTs) [24], covered only trials within one medical specialty [25], examined a limited selection of determinants, or used incomplete trial cohorts depending on public registrations [26,27] or interview response rates [10].…”

Section: Introductionmentioning

confidence: 99%

Non-Publication Is Common among Phase 1, Single-Center, Not Prospectively Registered, or Early Terminated Clinical Drug Trials

Bogert

Souverein

Brekelmans³

et al. 2016

PLoS ONE

View full text Add to dashboard Cite

The objective of this study was to investigate the occurrence and determinants of non-publication of clinical drug trials in the Netherlands.All clinical drug trials reviewed by the 28 Institutional Review Boards (IRBs) in the Netherlands in 2007 were followed-up from approval to publication. Candidate determinants were the sponsor, phase, applicant, centers, therapeutic effect expected, type of trial, approval status of the drug(s), drug type, participant category, oncology or other disease area, prospective registration, and early termination. The main outcome was publication as peer reviewed article. The percentage of trials that were published, crude and adjusted odds ratio (OR), and 95% confidence interval (CI) were used to quantify the associations between determinants and publication. In 2007, 622 clinical drug trials were reviewed by IRBs in the Netherlands. By the end of follow-up, 19 of these were rejected by the IRB, another 19 never started inclusion, and 10 were still running. Of the 574 trials remaining in the analysis, 334 (58%) were published as peer-reviewed article. The multivariable logistic regression model identified the following determinants with a robust, statistically significant association with publication: phase 2 (60% published; adjusted OR 2.6, 95% CI 1.1–5.9), phase 3 (73% published; adjusted OR 4.1, 95% CI 1.7–10.0), and trials not belonging to phase 1–4 (60% published; adjusted OR 3.2, 95% CI 1.5 to 6.5) compared to phase 1 trials (35% published); trials with a company or investigator as applicant (63% published) compared to trials with a Contract Research Organization (CRO) as applicant (50% published; adjusted OR 1.7; 95% CI 1.1–2.8); and multicenter trials also conducted in other EU countries (68% published; adjusted OR 2.2, 95% CI 1.1–4.4) or also outside the European Union (72% published; adjusted OR 2.0, 95% CI 1.0–4.0) compared to single-center trials (45% published). Trials that were not prospectively registered (48% published) had a lower likelihood of publication compared to prospectively registered trials (75% published; adjusted OR 0.5, 95% CI 0.3–0.8), as well as trials that were terminated early (33% published) compared to trials that were completed as planned (64% published; adjusted OR 0.2, 95% CI 0.1–0.3). The non-publication rate of clinical trials seems to have improved compared to previous inception cohorts, but is still far from optimal, in particular among phase 1, single-center, not prospectively registered, and early terminated trials.

show abstract

“…Because of multiple rejections and prolonged review process involved with journal publications, investigators instead prefer a less intense, non-peer-reviewed process and report their results as congress publications, such as abstracts, oral presentations, or posters. 30 These delays have ensued in selective reporting, outcome reporting, and publication biases. Selective reporting has been a norm for the past few decades; however, the trend seems to have changed since the introduction of FDAAA act.…”

Section: Article In Pressmentioning

confidence: 99%