Which
trials need to be registered and how?
What information is kept in the HAREC Registry?
What is happening around the world in regard to trial
registration? |
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Please
note that the International
Committee of Medical Journal Editors (ICMJE) requires trials
to be registered before their member journals consider submissions
for publication.
In
relation to this, the WHO
International Clinical Trial Registry Platform (ICTRP) is
being set up with a view to certify registers in the world around
1Q 2006. ICTRP certified registers will be acceptable to the
ICMJE.
ICMJE
has recently issued a revised FAQ
[cited 13 Feb 2006] indicating its current stances in (i) differentiating
its trials registration effort from that of the WHO ICTRP, and
(ii) advising investigators to follow its trials registry policy.
So far, ICMJE has recognized five Registries and they are accessible
at Australia,
United
States, United
Kingdom, Japan,
Netherlands.
It will also accept registration in any of the primary registries
that participate in the WHO International Clinical Trials Portal.
With
the launch of WHO Search Portal and Register Network on 4 May
2007. WHO
ICTRP advises that investigators should register in only one
register that is ICTRP certified, meets ICMJE requirements,
and is responsible for obtaining a globally unique identification
number (the WHO CT-UID).
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| Which
trials need to be registered and how? |
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If
investigators wish to publish their clinical trial results eventually
in ICMJE
member journals, they must register the trial at or before
the onset of patient enrollment. This applies to any clinical
trial starting enrollment after 1 July 2005.
For
trials that began enrollment before 1 July 2005, the ICMJE member
journals will consider for publication only if the trial is
adequately registered before
journal submission.
Investigators
may wish to register their trials with ClinicalTrials.gov which
accepts overseas registrations at no charge.
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| What
information is kept in the HAREC Registry? |
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| The
HAREC Clinical Trial Registry contains the trial information that
complies with international standard on trial registration being
developed by the WHO
International Committee on Trial Registration Platform (ICTRP)
and ICMJE.
Information kept in the Registry is maintained permanently and
is searchable on WHO International Clinical Trials Registry Platform
search
portal. |
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1. |
Primary
Register and Trial ID# |
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2. |
Date
of Registration in Primary Register |
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3. |
Other
Trial ID#s |
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4. |
Funding
Source(s) |
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5. |
Primary
Sponsor |
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6. |
Secondary
Sponsor(s) |
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7. |
Contact
Person |
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8. |
Lead
Principal Investigator |
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9. |
Public
Title |
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10. |
Scientifc
Title |
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11. |
Research
Ethics Board Approval |
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12. |
Disease
or Condition Studied |
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13. |
Intervention(s) |
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14. |
Inclusion
and Exclusion Criteria |
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15. |
Study
type |
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16. |
Date
of First Enrollment |
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17. |
Target
Sample Size |
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18. |
Recruitment
Status |
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19. |
Primary
Outcome(s) |
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20. |
Secondary
Outcomes |
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| What
is happening around the world in regard to trial registration? |
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| The
Registry has been monitoring these developments and will continuously
follow the standards available. |
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| The
International Committee of Medical Journal Editors (ICMJE) Statements |
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| Investigators
who wish to publish in ICMJE journals should observe ICMJE current
trials registry policy |
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1. |
Is
This Clinical Trial Fully Registered? (May 2005) |
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2. |
Frequently
asked questions: questions about clinical trials registration
(February 2006) |
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| 5
registries have been reviewed and accepted as of January 2006 |
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ACTR
(Australia) |
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ClinicalTrials.gov
(United States) |
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ISRCTN
(United Kingdom) |
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UMIN-CTR
(Japan) |
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Nederlands
Trial Register (Netherlands) |
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| The
WHO International Clinical Trial Registry Platform |
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The
World Health Organization (WHO) is close to arriving at a single
worldwide standard on the information that trial investigators
must disclose and establishing an International
Clinical Trial Registry Platform (ICTRP) Project.
WHO
ICTRP has launched
Register network in May 2007. The Network composes of Member
Registers and Associate Registers. Member Registers will mainly
be national or regional registers, and Associate Registers may
establish an Associate Membership agreement with a single Member
Register to ensure that the trial is affiliated with only one
Member Register.
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| International
pharmaceutical industry |
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| The
European Federation of Pharmaceutical Industries and Associations
(EFPIA), the International Federation of Pharmaceutical Manufacturers
and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers
Association (JPMA) and the Pharmaceutical Research and Manufacturers
of America (PhRMA) issue a joint
statement on the disclosure of clinical trial information
via clinical trial registries and databases. |
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| United
States Food and Drug Administration (FDA) |
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| FDA's
Guidance
for Industry (March 2002) requires new drug application holders
to register clinical trials of drug effectiveness for serious
or life threatening diseases. |
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| EudraCT
- European Clinical Trials Database |
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| EudraCT
is a database of all clinical trials commencing in the European
Community from 1 May 2004 onwards. It has been established in
accordance with EC Directive 2001/20/EC to include all trials
for which at least one site falls within the EC's member states.
The site is to facilitate submission by investigators, and the
database is not yet available to the public. |
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HAREC
Clinical Trial Registry Administrator
Last Update Date: 13 Oct 2008
Create Date: 31 August 2005 |
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