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Frequently Asked Questions
- What is the Stroke Trials Registry?
- Who operates the Stroke Trials Resgistry?
- How do I cite information from this website?
- How is the Stroke Trials Directory funded?
- Why do we need a stroke trials registry?
- What is the status of data entry in the Stroke Trials Registry?
How can I add a listing?
- Which trials are included?
- Where does the information come from?
- Does listing my trial in the Stroke Trials Registry violate
rules about advertising clinical trials?
1. What is the Stroke Trials Registry?
The Stroke Trials Registry is a registry (database) of clinical
trials testing therapeutic interventions for stroke and cerebrovascular disease.
Other features include a database of stroke interventions in clinical trials
(drugs or procedures), lists of stroke scales and clinical assessment tools,
and an archive of stroke trial news reports.
This web site does not advertise or organize trials.
All information is open and free of charge.
2. Who operates the Stroke Trials Registry?
The Stroke Trials Registry is a resource of the Internet
Stroke Center, a non-profit academic web site located at Washington University
School of Medicine in St. Louis. The Internet Stroke Center is dedicated
to providing educational information and resources about stroke for patients,
families and health care professions. Click here for
more information about the Internet Stroke Center, including our privacy
policy and health care disclaimers. The Stroke Trials Directory is collaboration
between Washington University, the American Stroke Association (a division
of the American Heart Association), and the National Institute of Neurologic
Disorders and Stroke (NINDS) at the National Institutes of Health. Visit
our staff and contributors area for a list of personnel
involved in this project. The Stroke Council of the American Heart Association
has designated the International Stroke Liaisons Committee
to act as an advisory committee for the Stroke Trials Directory, and each
trial entry is reviewed by our editorial review
board.
3. How do I cite information
from this website?
We provide links to primary literature (abstracts
and publications) whenever possible. To cite information
from this website, please use the following information:
Goldberg, MP (ed). Stroke Trials Registry. Internet
Stroke Center web site. URL: www.strokecenter.org.
Date accessed: .
Actual citation format will vary.
4. How is the Stroke Trials
Directory funded?
This project is funded in part by grants from the
American Stroke Association and the National Institutes of Health.
The Stroke Trials Directory web site does not accept commercial
sponsorship or advertising of any kind.
5. Why do we need a stroke
trials registry?
Excellence in evidence-based clinical care and advanced
research requires up-to-date information. A trials registry allows
professionals in the stroke field to be aware of ongoing trials
and updates their status much more quickly than possible using
the published literature alone.
Despite resources such as Medline, it is progressively
more difficult for clinicians and scientists to stay abreast of
research developments. There are several reasons for
this. More and more clinical interventions in stroke are
being tested in large, well-designed clinical trials. Most
trials last several years, and there is often a further delay
of 1-4 years between study completion and publication.
More importantly, some trials are presented only in abstract form,
while others are never published at all. This publication
bias is especially problematic when it applies selectively to
negative trial results. Indeed, it has been the case that
many recent large, well-designed trials with negative results
remain unpublished. This makes it difficult to evaluate
therapeutic approaches or to design new ones.
Clinical trial registries are also important for
non-professionals, including stroke families. They provide
an opportunity to assess progress in the field, and in some cases
may allow interested individuals opportunities to volunteer to
participate in appropriate clinical trials.
Clinical trials registries have long been available
for specific diseases, including cancer, AIDS, and heart disease.
Despite the importance and prevalence of stroke, there is no other
widely available database for stroke research. The Stroke
Trials Directory benefits from several other valuable resources
with overlapping strengths (see Resources). Two of
these deserve special mention. The Cochrane Collaboration
is an international organization which prepares systematic reviews
of the effects of healthcare interventions. The Cochrane
Stroke Group maintains a stroke registry and publishes regular
analyses of completed studies in stroke. The complete
Cochrane database is available by subscription, and most current
reviews are abstracted in Medline. The Stroke Trials
Directory provides links to Cochrane reviews when available.
The second resource is ClinicalTrials.gov, a new internet database
provided by the National Library of Medicine at NIH.
This outstanding web site is mandated by congress to list all
US Phase 3 clinical trials. At present, the site includes
only stroke trials funded by the NIH. The Stroke Trials
Directory includes links to ClinicalTrials.gov, and will soon
convert the database format to be completely compatible with that
of ClinicalTrials.gov. The Stroke Trials Directory
includes considerable information not planned for ClinicalTrials.gov,
including past trials, non-US trials, and early phase studies.
6. What is the status of data entry in
the Stroke Trials Registry? How can I help? How can I add a listing?
This is a new project which has only recently obtained funding
support. As a result, much of the information in the database is still
preliminary or incomplete. Some entire research areas are not
yet included (below). You can help with this. If you are
aware of missing trials, changes in trial status, errors or omissions, please
let us know. To add a new
listing, please complete our online data entry form.
7. Which trials are included?
The priority of the Stroke Trials Registry is to list all ongoing
and recently completed multicenter, randomized trials of therapeutic interventions
for acute ischemic stroke or secondary stroke prevention. We hope
to add trials of hemorrhagic stroke, intracerebral hemorrhage, and stroke
recovery in the near future. Trials of primary prevention are included
only if stroke is a primary outcome measure. Other types of studies
are sometime included. For example, we will include Phase 1 or 2 trials
of newly developed interventions and may include non-randomized studies such
as large registries.
8. Where does the information come
from?
Information in the clinical trials and intervention
databases comes from several sources. We attempt to
list the source, and to provide appropriate links whenever possible.
In most cases, the data are contained in published manuscripts
or abstracts presented at scientific meetings. Several
trial entries have been provided by trial investigators, coordinators,
web sites, or sponsors. We hope this will become the major
source of information, as it is likely to be most accurate and
timely. We obtain information from other public sources
including company web sites and press releases. We
do not make use of privileged information from study investigators
or unauthorized sources.
9. Does listing my trial
in the Stroke Trials Directory violate rules about advertising clinical
trials?
No. There is no restriction on listing United
States clinical trials in a database format such as this one. The
FDA does not require prior Institutional Review Board (IRB)
approval. This is an excerpt from the FDA's "Guidance
for Institutional Review Boards and Clinical Investigators"
(1998):
"IRB
review and approval of listings of clinical trials on the internet
would provide no additional safeguard and is not required when
the system format limits the information provided to basic trial
information, such as: the title; purpose of the study; protocol
summary; basic eligibility criteria; study site location(s); and
how to contact the site for further information. Examples of clinical
trial listing services that do not require prospective IRB approval
include the National Cancer Institute's cancer clinical trial
listing (PDQ) and the government-sponsored AIDS Clinical Trials
Information Service (ACTIS). However, when the opportunity to
add additional descriptive information is not precluded by the
data base system, IRB review and approval may assure that the
additional information does not promise or imply a certainty of
cure or other benefit beyond what is contained in the protocol
and the informed consent document."
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