Trial registration - why it is important
This section contains the following:
Introduction
The opening paragraph of an article in The Economist (The sounds
of silence. Sep 9th 2004) sums up the problem of not registering
trials:
"SOMETIMES, no news is news. In clinical trials, where new medical
treatments are tried out on human subjects, no news—an inconclusive
result, indicating that the treatment is useless, or a negative one,
indicating that it is harmful—can be as scientifically important as a
positive result. Unfortunately, such a result is much less likely to be
reported."
Not reporting the results of randomised controlled trials is
increasingly seen as scientific and ethical misconduct, and the
pressure to register trials to reduce biased under-reporting is
growing. Legislation in some countries now requires registration
of trials, while some funding agencies and official bodies recommend
it. By registering a trial you will:
• Bring your trials to a
wider audience
• Support the drive for
greater openness
• Lead the way, before
legislation demands it
• Add to the body of
knowledge available to patients, researchers, funders, and policy
makers.
One way of registering a trial is to use the International Standard
Randomised Controlled Trial Number (ISRCTN) scheme. The
following text is taken from the ISRCTN website, with which the
Practihc collaboration has no connection.
The International Standard Randomised
Controlled Trial Number (ISRCTN)
The International Standard Randomised Controlled Trial Number (ISRCTN)
scheme (http://www.controlled-trials.com/isrctn/)
was conceived by a working group to address the difficulty of
differentiating between trials. Confusion arises because different
trials may have the same title, different titles may be applied to the
same trial, and the titles of publications may frequently bear little
resemblance to the original trial title. The solution offered is the
creation of a unique numbering system for all RCTs, to simplify
identification and provide a means of unambiguously tracking a trial
throughout its life cycle – the ISRCTN. Records of trials to which
ISRCTNs have been assigned are available in the ISRCTN Register.
Without these tools, clinicians, researchers, patients and the public
will remain in ignorance about ongoing and unpublished trials or
confused about which trial is which. Opportunities for collaboration
and reducing duplication of research effort will be missed. Publication
bias and undeclared over-reporting will lead to misleading conclusions
being drawn about the forms of care most likely to benefit patients.
Patients may even be subjected to trials seeking evidence that is
already available.
There is a charge for
registration but it is modest (for 2005 it was US$190/€150/£100
per trial). Fees may also be waived for trials that are
sponsored, funded and done in developing and transitional
countries. More details of registration are given at http://www.controlled-trials.com/isrctn/submission/
Back to top
Things to consider when writing a
protocol
- Trial registration is sometimes a condition of funding and some
journals will not publish a trial that was not registered.
- If you do not plan to register the trial, explain clearly why.
Back to top
This page was last updated 18th April 2005.