Researchers are as subject to human nature as anyone else and so may be inclined to only publish, or at least to slant study design and conclusions toward, positive results of clinical trials.
That seems to be changing as the National Institutes of Health's (NIH’s) push for transparency in trials gains momentum.
The progress comes to light in a PLOS One study published Aug. 5.
Robert Kaplan, PhD, chief science officer at HHS’s Agency for Healthcare Research and Quality (AHRQ), and Veronica Irvin, PhD, of Oregon State University set out to explore whether there has been an increase in reporting of null results—and a decrease in positives—in large trials funded through the National Heart Lung, and Blood Institute (NHLBI) in the years since 2000.
That was the year the NIH launched its ClinicalTrials.gov registry, in the process phasing in transparent reporting standards.
Kaplan and Irvin found that 17 of 30 pre-2000 randomized controlled trials (RCTs) evaluating drugs or dietary supplements aimed at treating or preventing cardiovascular disease came back with a thumbs-up on the primary outcome under consideration.
That was a 57 percent positive rate—an eye-catching 49 points higher than the 8 percent (just two among 25) in post-2000 trials.
Pre-registration in ClinicalTrials.gov “was strongly associated with the trend toward null findings,” they write.
The authors state that they homed in on NHLBI because of the institute’s championing of transparency as well as its openness to having its trials examined.
They winnowed the field to 55 NHLBI-supported trials that had direct costs of greater than $500,000 a year, reasoning that big and pricey trials are unlikely to go unpublished regardless of results.
In the study report, they suggest that their findings probably indicate better transparency across medical specialties.
“Although we focused on cardiovascular trials, null results are common in other areas of medicine,” they write, citing a 2014 study showing a strong correlation between ClinicalTrials.gov registration and failure of Alzheimer’s drugs in development.
Kaplan and Irvin further found that industry co-sponsorship was unrelated to the probability of a significant benefit getting reported.
“[N]ull findings in large RCTs may be disappointing to investigators, but they are not negative for science,” the authors write. “A growing collection of trials suggests that promising treatments do not match their potential when systematically tested and transparently reported. Publication of these trials may lead to the protection of patients from treatments that use resources while not enhancing patient outcomes.”
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.