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CLINICAL NEWS
Data Stream
Do You Know Where Your Data Are?
Missing or incomplete reporting of clinical trials data to ClinicalTrials.gov or peer-reviewed
publications may leave behind a distorted body of evidence, according to researchers from
the National Institutes of Health.
To determine how completely sponsors report results, the authors looked at 96 trials
conducted by the same industry sponsors that evaluated the same drug for the same
indication.
Breakthrough Breakdown
and 13
Only 58
60.4 %
had results available
for all trials
13.5
The U.S. Food and Drug Administration’s “breakthrough-therapy” designation
was intended to speed the review of drugs to treat serious or life-threatening
conditions, but few of these drugs actually offer an improvement over existing
treatments, according to a report published in the Journal of Clinical Oncology.
%
had no results available
from either
ClinicalTrials.gov
or PubMed.
Comparing 25 breakthrough anti-cancer drugs and 33 non-breakthrough
anti-cancer drugs approved between 2012 and 2017, there were no statis-
tically significant improvements in:
• progression-free survival: 8.6 vs. 4.0 months (p=0.11)
• response rates for solid tumors: 37% vs. 39% (p=0.74)
• mortality: 6% vs. 4% (p=0.99)
• serious adverse events: 38% vs 36% (p=0.93)
Breakthrough drugs, however, were approved an average of 2 years sooner
than non-breakthrough drugs (p=0.01).
The included trials were completed or terminated by 2009, the authors noted, meaning
that these results went unreported for more than 7 years.
Source: Hwang TJ, Franklin JM, Chen CT, et al. Efficacy, safety, and regulatory approval of Food
and Drug Administration–designated breakthrough and nonbreakthrough cancer medicines. J Clin
Oncol. 2018;36:1805-12.
Source: Fain KM, Rajakannan T, Tse T, et al. Results reporting for trials with the same sponsor, drug, and condi-
tion in ClinicalTrials.gov and peer-reviewed publications. JAMA Intern Med. 2018;178:990-2.
Flooding the Market
Opioid manufacturers have cut back their budgets for marketing pain-management
medications to physicians, suggesting that they are beginning to accept responsibility
for their role in the U.S. opioid epidemic.
According to an analysis from NPR and ProPublica, marketing payments to doctors
(in the form of speaking, consulting, meals, and travel fees related to promoting
opioid drugs) in 2016 declined 33% and 21%, respectively, compared with the
previous two years:
19.9 million
$
2015: 23.7 million
$
2016: 15.8 million
2014:
$
$25 Million
$20 Million
$15 Million
$10 Million
$5 Million
Analysts called this decrease “impressive, but not surprising,” given the growing
ethical concerns about pharmaceutical companies’ marketing of opioids.
Sources: NPR and ProPublica, June 28, 2018.
$0
2014
2015
2016
MARKETING PAYMENTS
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ASH Clinical News
August 2018