Trial registration - why it is important
This section contains the following:
Introduction
An editorial in the New England Journal of Medicine 2004, 315;12:1250-1251 from the International Committee of Medical Journal Editors (ICJME) states
"Altruism and trust lie at the heart of research on human subjects.
Altruistic individuals volunteer for research because they trust
that their participation will contribute to improved health for
others and that researchers will minimize risks to participants. In
return for the altruism and trust that make clinical research
possible, the research enterprise has an obligation to conduct
research ethically and to report it honestly. Honest reporting
begins with revealing the existence of all clinical studies,
even those that reflect unfavorably on a research sponsor's
product. "
They go on to highlight the selective reporting of trial results and how this can distort the body of clinical evidence.
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 Support 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 2008 it was US$300/€200/£150
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
- Trial registration is sometimes a condition of funding.
- Some
journals will not publish a trial that was not registered as is stated by the ICJME in their publication guidelines.
- If you do not plan to register the trial, explain clearly why.
Back to top
This page was last updated September 2008.