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Why register trials?
Why apply for an ISRCTN?
A randomised controlled trial (RCT) is a clinical study in which two (or more) forms of care are compared; the participants are allocated to one of the forms of care in the study, in an unbiased way, by using the play of chance. RCTs are indispensable for safeguarding and improving people’s health, but they are difficult to identify, especially while they are going on and before they are published.
The metaRegister of Controlled Trials (mRCT) is a pioneering response to the challenge of identifying ongoing and unpublished RCTs. The only international online register of RCTs open to trials of all types of intervention in all healthcare specialties, the mRCT has been built by pooling databases of ongoing (and some completed) trials from public, charitable and commercial organisations.
The ground-breaking International Standard Randomised Controlled Trial Number (ISRCTN) scheme was conceived by a working group (brought together by Current Controlled Trials), 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these innovative tools, clinicians, researchers, patients and the public will remain in ignorance about ongoing and unpublished trials or confused about which trial is which.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.
Not reporting RCTs 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. Please click here for details of support from other bodies for prospective registration of trials.
How to do it
The Current Controlled Trials site offers the opportunity to register your trial - in one of two ways - and to obtain an ISRCTN... Sponsors may:
- Click here to register trial details and obtain an ISRCTN
- Click here to share a trial register with the mRCT (and obtain ISRCTNs if requested).
By taking part 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.
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