NIH to Researchers: Publish Data or Risk Funding Decrease

The National Institutes of Health (NIH) has informed research institutions that they will be at risk for loss of funding unless they comply with new standards for sharing clinical trial data, according to a story published in The Washington Post.1

“We, as a community, have a disappointing record of making [clinical trial] results available. [These new rules are] about maintaining the trust that we have with participants in clinical trials who volunteer to take part in these efforts with the expectation that it will add to the body of knowledge,” Francis S. Collins, MD, PhD, director of the NIH, said at a press briefing.

Dr. Collins cited a 2014 study showing that researchers in a third of clinical trials had not published trial results on ClinicalTrials.gov. A 2008 rule states that such data must be published on the website within a year after completion of the trial.

The NIH awarded more than $24 billion in research grants in fiscal year 2015, according to the Post. Starting on January 18, 2017, researchers conducting studies tied to funding from the NIH or the US Food and Drug Administration will have 90 days to comply with the new rules.

Dr. Collins said that the measure was partially made to encourage the publication of clinical trial data involving failed endpoints. Such data, he said, can be useful to future researchers.

The Post reported that Vice President Joe Biden played a large part in the new NIH rules. Quickened dissemination of research data is part of Mr. Biden’s Cancer Moonshot campaign, which aims to encourage cancer researchers to more openly share information. Approximately a third of research trials listed on ClinicalTrials.gov involve cancer research.

 

1. Bernstein L. Medical researchers will have to share more data more quickly. The Washington Post. September 16, 2016. Accessed September 28, 2016. www.washingtonpost.com/news/to-your-health/wp/2016/09/16/medical-researchers-will-have-to-share-more-data-more-quickly.

 

Study: Prostate Cancer Deaths at 1% After 10 Years

Approximately 1% of men with prostate cancer died from the disease after 10 years of follow-up, according to research published in the New England Journal of Medicine.1

Nearly 1,600 men diagnosed with prostate cancer were randomly assigned to active monitoring, radical prostatectomy, or external beam radiotherapy. No meaningful differences existed at baseline among the three groups in median age, median level of prostate-specific antigen, tumor severity, or rate of T1c disease.

In the active monitoring group, eight patients died from prostate cancer. There were five prostate cancer deaths in the surgery group and four in the radiotherapy group (P = .048). All-cause mortality was approximately 10%.

Although the differences in the primary outcome measure among the groups were not statistically significant, the rates of metastasis and disease progression were significantly higher in the active monitoring group compared with the other two groups.

“These differences show the effectiveness of immediate
radical therapy over active monitoring,” the researchers wrote. n

 

1. Hamdy FC, Donovan JL, Lane JA, et al; the ProtecT Study Group. 1-year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer [published online ahead of print September 14, 2016]. N Engl J Med.

 

Section Editor David S. Boyer, MD
• clinical professor of ophthalmology at the University of Southern California Keck School of Medicine, department of ophthalmology, in Los Angeles, Calif.
• member of the Retina Today editorial advisory board
• +1-310-854-6201; vitdoc@aol.com