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 Without enough participants, trials may run slowly or lose funding,
which limits the possibility of developing new treatments for
stroke, researchers write in the journal Stroke.
“There have been a number of recent efforts to improve recruitment,
and we felt that it was important to understand whether these
efforts were working,” lead author Dr. William Feldman of Brigham
and Women’s Hospital in Boston said by email. “We found that
recruitment has not improved and, if anything, may be declining.”
Because strokes need to be treated quickly after they occur,
researchers have only a few hours to recruit patients for studies,
which can make the process very difficult, he said. Patients also
might not be able to provide their consent because their stroke has
caused cognitive impairment.
To track the rate of recruiting stroke study subjects over time, the
study team searched three medical databases and a stroke trials
registry for randomized controlled trials of stroke treatments.
The team identified 10 hospital-based studies between 2010 and 2014
of various interventions for ischemic strokes, which are caused by
blood clots and are the most common type of stroke.
The researchers calculated how many participants enrolled in the
trials each month and compared this rate with that of 32 trials
conducted between 1990 and 2004. The average number of study sites
and participants were similar across the two time periods.
Between 1990 and 2004, the median rate of recruitment was about one
participant every 2.5 months for each site and about 27 participants
per month across all the study sites.
In the 2010-2014 studies, the rate of recruitment was one
participant every four months for each site and 19 per month across
all the sites.
Older trials were more likely to use clot-busting drugs while new
trials were more likely to test techniques for physically removing
of clots, known as endovascular therapy.
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Possible explanations for these trends include the fact that there
has been an increase in community hospitals designated as primary
stroke centers, the authors write. That may mean fewer patients are
being transferred to academic hospitals, where most clinical trials
take place.
Stroke trial protocols may also have become more complex over the
years, which can make finding participants more difficult. Finally,
stroke treatment sites may be shifting funding more toward medical
care for strokes and away from research, the authors speculate.
“New treatments only come from clinical trials. If we don't
successfully recruit suitable patients, then we cannot move
forward,” said Dr. Scott Kasner of the University of Pennsylvania in
Philadelphia who studies stroke research recruiting but was not
involved in the study.
Patients may also prefer to choose their own treatment, as opposed
to being assigned a treatment through a research trial, Kasner
added.
“Recruitment in acute stroke trials is not improving. We need more
timely completion of clinical trials to develop therapies that will
reduce the debilitating consequences of strokes,” Feldman said.
“If you or a loved one has a stroke, don't accept standard therapy
as enough - ask about additional clinical trial opportunities!”
Kasner said by email.
SOURCE: bit.ly/2jRkLiO Stroke, online January 19, 2017.
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