Time to publication of oncology trials and why some trials are never published

Abstract

BackgroundVery little is known about the proportion of oncology trials that get published, the time it takes to publish them, or the reasons why oncology trials do not get published.MethodsWe analyzed all clinical trials that closed to accrual at our cancer center between 2009–2013. Trials were categorized by study purpose (therapeutic vs. diagnostic), phase (pilot, phase I, II, or III), and sponsor (industrial, cooperative group, institutional, or peer-reviewed). Final publications were identified in MEDLINE and EMBASE by NCT numbers, or by querying the principal investigator. For trials not published, we surveyed the principal investigators to identify the reason for non-publication.Findings469 of 809 protocols (58%) had been published by November 2016. The calculated probability of publication 7 years after completing accrual was 70.4%; the calculated median time to publication was 47 months. Only 18.8% of protocols overall were estimated to be published within 2 years from completing accrual. The calculated probability of publication was higher for therapeutic trials than non-therapeutic trials, but there was no difference based on phase or sponsor. Among protocols not published, 45.3% had completed accrual, and among these, a majority had a manuscript in preparation or review, or the trial was still collecting data. Failure to publish due to a pharmaceutical sponsor was rare. 30.6% of unpublished trials had closed for various reasons before completing accrual, usually due to poor accrual or pharmaceutical sponsor issues.InterpretationAlmost 30% of trials were calculated to be unpublished by 7 years after closing to accrual at our institution. Failure to reach accrual goals was an important factor in non-publication. We have devised new institutional policies that identify trials likely not to meet accrual goals and require early closure. We should be able to shorten the time from accrual completion to publication, especially for pilot and phase I trials for which long follow up is not needed.

Relationship Between Response and Dose in Published, Contemporary Phase I Oncology Trials

“…Earlier research has established that not all phase I trials conducted are represented in the literature, nor do all phase I trials report specific dose levels, RP2D, and efficacy data by dose levels. [16][17][18][19] Whether our results would materially change with the addition of unpublished trials remains unknown but warrants exploration.…”

A multi-state model analysis of the time from ethical approval to publication of clinical research studies

“…Discontinued studies were less often (25%) published than completed studies (63%). There is little consensus in the literature regarding time to publication, with wide variation depending on the cohorts investigated [3,15,[37][38][39]. Previous evaluations, however, excluded studies with unknown completion date, which likely led to underestimation of time to publication [37].…”

“…However, there are several barriers inhibiting the translation of research knowledge into practice. Firstly, a large proportion of clinical studies are prematurely discontinued [2][3][4][5][6][7][8][9]. Secondly, not all research findings are ultimately published in peer-reviewed journals [10].…”

Clinical practice of renal cell carcinoma treatment with nivolumab

“…It is difficult to predict when trial results will be published because this is affected by numerous factors: recruitment time; assessed end-points; pace of maturing data; sources of financing; and others. According to a large analysis performed by American researchers the estimated median time from recruitment closure to publication is about 47 months -nearly four years [33]. Assuming that the recruitment for trials presented in Figure 3 require 12 months on average, we may estimate that half of the trials initiated in 2014 will be published before 2020.…”