Study: Delays in publishing oncology data near 1 year

A new study highlights a marked delay between completion of clinical trials and when the results reach practicing clinicians.

The study, published online in JAMA Oncology, found that even for the most pressing findings, the median publication of final clinical data is nearly 1 year.

Lindor Qunaj of Brown University, Providence, R.I., and colleagues measured the time frame between when eight large pharmaceutical companies issued press releases announcing completed phase 3 oncology clinical trials and the public sharing of the results either on ClinicalTrials.gov or a peer-reviewed biomedical journal. Collectively, the eight companies accounted for 72% of all oncology sales in 2015. The press releases were posted between January 2011 and June 2016. Investigators found the median time from press release to publication of data was 300 days.

Clinical trials with negative results had median delays of more than 100 days longer than positive results, the investigators found. Of the 100 press releases studied, only 31% included the magnitude of study findings. Most press releases (66%) reported outcomes of studies involving drugs already approved by the Food and Drug Administration for some indication. Press releases regarding preapproval drugs were less likely to contain quantitative reports of effect sizes. The majority of final clinical results (90%) were either posted, published, or both, within 2 years. No difference existed in the median delay between trials studying approved drugs compared with unapproved drugs.

Mr. Qunaj and associates noted that their analysis emphasizes the ongoing criticism of the speed at which pharmaceutical companies publish findings from clinical trials. The authors suggested that pharmaceutical companies, publishers, and journals work to minimize such delays. For instance, they might consider preprinting, the practice of publishing “draft” findings prior to, or in tandem with, peer review. Through preprints, companies could post all relevant study data, including measured outcomes and toxic effects, as well as study protocol, Mr. Qunaj and associates wrote. In addition, the authors suggested that publishers continue to consider innovative efforts to “responsibly accelerate the peer review process, or to further shorten the time between manuscript acceptance and data availability.”

“We do foresee possible objections from pharmaceutical companies, scientific journals, and medical societies,” the authors wrote. “Embargoed, timed data releases are a potent tool for marketing study findings and drawing traffic to the journal or meeting where the results are presented. However, these interests are narrow, while the needs of science more generally, and the patients with the conditions that these companies have studied, matter more.”

A coauthor, Peter Bach, MD, received personal fees and grants from numerous sources. No other disclosures were reported.

SOURCE: Qunaj L et al. JAMA Oncol. 2018 Apr 12. doi:10.1001/jamaoncol.2018.0264.

A new study highlights a marked delay between completion of clinical trials and when the results reach practicing clinicians.

The study, published online in JAMA Oncology, found that even for the most pressing findings, the median publication of final clinical data is nearly 1 year.

Lindor Qunaj of Brown University, Providence, R.I., and colleagues measured the time frame between when eight large pharmaceutical companies issued press releases announcing completed phase 3 oncology clinical trials and the public sharing of the results either on ClinicalTrials.gov or a peer-reviewed biomedical journal. Collectively, the eight companies accounted for 72% of all oncology sales in 2015. The press releases were posted between January 2011 and June 2016. Investigators found the median time from press release to publication of data was 300 days.

Clinical trials with negative results had median delays of more than 100 days longer than positive results, the investigators found. Of the 100 press releases studied, only 31% included the magnitude of study findings. Most press releases (66%) reported outcomes of studies involving drugs already approved by the Food and Drug Administration for some indication. Press releases regarding preapproval drugs were less likely to contain quantitative reports of effect sizes. The majority of final clinical results (90%) were either posted, published, or both, within 2 years. No difference existed in the median delay between trials studying approved drugs compared with unapproved drugs.

Mr. Qunaj and associates noted that their analysis emphasizes the ongoing criticism of the speed at which pharmaceutical companies publish findings from clinical trials. The authors suggested that pharmaceutical companies, publishers, and journals work to minimize such delays. For instance, they might consider preprinting, the practice of publishing “draft” findings prior to, or in tandem with, peer review. Through preprints, companies could post all relevant study data, including measured outcomes and toxic effects, as well as study protocol, Mr. Qunaj and associates wrote. In addition, the authors suggested that publishers continue to consider innovative efforts to “responsibly accelerate the peer review process, or to further shorten the time between manuscript acceptance and data availability.”

“We do foresee possible objections from pharmaceutical companies, scientific journals, and medical societies,” the authors wrote. “Embargoed, timed data releases are a potent tool for marketing study findings and drawing traffic to the journal or meeting where the results are presented. However, these interests are narrow, while the needs of science more generally, and the patients with the conditions that these companies have studied, matter more.”

A coauthor, Peter Bach, MD, received personal fees and grants from numerous sources. No other disclosures were reported.

SOURCE: Qunaj L et al. JAMA Oncol. 2018 Apr 12. doi:10.1001/jamaoncol.2018.0264.

A new study highlights a marked delay between completion of clinical trials and when the results reach practicing clinicians.

The study, published online in JAMA Oncology, found that even for the most pressing findings, the median publication of final clinical data is nearly 1 year.

Lindor Qunaj of Brown University, Providence, R.I., and colleagues measured the time frame between when eight large pharmaceutical companies issued press releases announcing completed phase 3 oncology clinical trials and the public sharing of the results either on ClinicalTrials.gov or a peer-reviewed biomedical journal. Collectively, the eight companies accounted for 72% of all oncology sales in 2015. The press releases were posted between January 2011 and June 2016. Investigators found the median time from press release to publication of data was 300 days.

Clinical trials with negative results had median delays of more than 100 days longer than positive results, the investigators found. Of the 100 press releases studied, only 31% included the magnitude of study findings. Most press releases (66%) reported outcomes of studies involving drugs already approved by the Food and Drug Administration for some indication. Press releases regarding preapproval drugs were less likely to contain quantitative reports of effect sizes. The majority of final clinical results (90%) were either posted, published, or both, within 2 years. No difference existed in the median delay between trials studying approved drugs compared with unapproved drugs.

Mr. Qunaj and associates noted that their analysis emphasizes the ongoing criticism of the speed at which pharmaceutical companies publish findings from clinical trials. The authors suggested that pharmaceutical companies, publishers, and journals work to minimize such delays. For instance, they might consider preprinting, the practice of publishing “draft” findings prior to, or in tandem with, peer review. Through preprints, companies could post all relevant study data, including measured outcomes and toxic effects, as well as study protocol, Mr. Qunaj and associates wrote. In addition, the authors suggested that publishers continue to consider innovative efforts to “responsibly accelerate the peer review process, or to further shorten the time between manuscript acceptance and data availability.”

“We do foresee possible objections from pharmaceutical companies, scientific journals, and medical societies,” the authors wrote. “Embargoed, timed data releases are a potent tool for marketing study findings and drawing traffic to the journal or meeting where the results are presented. However, these interests are narrow, while the needs of science more generally, and the patients with the conditions that these companies have studied, matter more.”

A coauthor, Peter Bach, MD, received personal fees and grants from numerous sources. No other disclosures were reported.

SOURCE: Qunaj L et al. JAMA Oncol. 2018 Apr 12. doi:10.1001/jamaoncol.2018.0264.