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Registration of clinical trials (July 22, 2005)
Category: Publication bias
International Committee of Medical Journal Editors (ICMJE) has called
for a requirement for registration of clinical trials. All clinical trials that start
recruiting on or after July 1, 2005 must be placed in a public registry before enrollment of
the first patient. This includes
"trials that test a clinical hypothesis about health outcomes"
but not phase 1 trials that only assess toxicity and/or
pharmacokinetics. There is a gray area.
"Between these two extremes are some clinical trials whose
prespecified goal is to investigate the biology of disease or to provide preliminary
data that may lead to larger, clinically directive trials. We recognise that requiring
public registration of trials whose prespecified goal is to investigate the biology of
disease or to direct further research might slow the forces that drive innovation.
Therefore, each journal editor will decide on a case-by-case basis about reviewing
unregistered trials in this category. Authors whose trial is unregistered will have to
convince the editor that they had a sound rationale when they decided not to register
their trial. The ICMJE will maintain this policy for the next two years. We will then
review our experience."
There are twenty elements that should be part of the registration.
-
Unique trial number
-
Trial registration date
-
Secondary IDs (if any)
-
Funding source(s)
-
Primary sponsor
-
Secondary sponsor(s)
-
Responsible contact person (public inquiries)
-
Research contact person (scientific inquiries)
-
Title of the study (can be omitted if the researchers wish).
-
Official scientific title of the study This title must include the
name of the intervention, the condition being studied, and the outcome
-
Research ethics review
-
The medical condition being studied
-
A description of the study and comparison/control intervention(s).
The duration of the intervention(s) must be specified.
-
Key inclusion and exclusion criteria
-
Study type. This would include choices for randomised vs. non-randomised,
type of masking (eg, double-blind, single-blind), type of controls (eg, placebo,
active), and group assignment, (eg, parallel, crossover, factorial).
-
Anticipated trial start date
-
Target sample size
-
Recruitment status Is this information available (yes/no) (If yes,
link to information).
-
Primary outcome. Description should include the time at which the
outcome is measured.
-
Key secondary outcomes.
The full text of the ICMJE statement can be found at the the Medical
Journal of Australia (MJA 2005; 182 (12): 609-610) and the full free text is on the web at
It also appears in the New England Journal of Medicine ( N Engl J Med
2005 352: 2436-2438)
and CMAJ (CMAJ; June 21, 2005; 172 (13))
and JAMA, although JAMA does not allow you to view the full free text on
the web.
07/08/2008.
