Clinical interventions (including clinical trials)
Registration of Clinical Trials
Researchers conducting clinical trials are to register them on a publicly accessible register before the clinical phase commences (refer National Statement, clause 3.3.12, page 36, see link below). Prior trial registration is a condition of publishing trials research. The International Committee of Medical Journals members agreed that from 1 July 2005 they would not publish in their journals results of any clinical trials not included on an authorised register at the trial’s inception.
A clinical trial (as defined by the International Committee of Journal Editors) is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. The National Statement defines a clinical trial as a form of human research designed to find out the effects of an intervention. Health- related interventions can include drugs, surgical procedures, devices, behavioural treatments, dietary interventions or process-of-care changes. Health outcomes include any biomedical or health-related measures obtained in participants, including pharmacokinetic measures and adverse events.
Prospective trial registration promotes research transparency by ensuring the existence of all trials is known so that a true picture of the evidence for a particular treatment, drug, medical device or therapy is publicly available. Registration may identify gaps in one’s own research and may also prevent unnecessary duplication of research.
There are a number of WHO Primary Registries in which clinical trials can be registered. A trial need only be registered once. Most Australian research would be registered with the Australian New Zealand Clinical Trials Registry.
Researchers are also to record the registry name and trial registration number in Themis.
Researchers conducting clinical trials are to register them on a publicly accessible register before the clinical phase commences (refer National Statement, clause 3.3.12, page 36, see link below). Prior trial registration is a condition of publishing trials research. The International Committee of Medical Journals members agreed that from 1 July 2005 they would not publish in their journals results of any clinical trials not included on an authorised register at the trial’s inception.
A clinical trial (as defined by the International Committee of Journal Editors) is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. The National Statement defines a clinical trial as a form of human research designed to find out the effects of an intervention. Health- related interventions can include drugs, surgical procedures, devices, behavioural treatments, dietary interventions or process-of-care changes. Health outcomes include any biomedical or health-related measures obtained in participants, including pharmacokinetic measures and adverse events.
Prospective trial registration promotes research transparency by ensuring the existence of all trials is known so that a true picture of the evidence for a particular treatment, drug, medical device or therapy is publicly available. Registration may identify gaps in one’s own research and may also prevent unnecessary duplication of research.
There are a number of WHO Primary Registries in which clinical trials can be registered. A trial need only be registered once. Most Australian research would be registered with the Australian New Zealand Clinical Trials Registry.
Researchers are also to record the registry name and trial registration number in Themis.
| Title & link: |
Interventions and therapies, including clinical and non-clinical trials, and innovations |
|---|---|
| Source: |
National Statement on Ethical Conduct in Human Research (National Health and Medical Research Council, 2007) |
| Section: |
Chapter 3.3 |
| Description: |
This chapter identifies general considerations relating to clinical research, focusing especially (but not exclusively) on randomised clinical trials. |