Access to information about ongoing, completed or published clinical research is essential for appropriate decision-making. Researchers, research funders, policy-makers, medical practitioners, patients and the general public need such information to improve research practices, policy, and clinical decision-making.
For several decades, many health researchers have proposed public registration of clinical trial data. Although many registers for ongoing clinical trials now exist, they are designed for a variety of purposes and there has been no comprehensive global registration process until now. Incomplete registration and register fragmentation make it impossible to identify with certainty - even within a narrow field or for a single intervention - all existing controlled trials.
Recently, a consensus for public registration and reporting of clinical trials has been growing following safety concerns involving at least three drugs where availability of relevant clinical trial data could have favourably affected prescribing behaviour outcomes. As a result, several pharmaceutical companies have announced plans or have actually begun their own trial registers. This announcement has further been supported by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) (see page 129).
The International Committee of Medical Journal Editors (ICMJE) has called for public registration of clinical trials (1) and the ICMJE has stated that as of 1 July 2005, only registered trials will be eligible for journal publication. (See page 128).
The World Health Organization has now established an international clinical trial registration platform (2). This platform will link registers into a comprehensive network, harmonize register and trial registration standards, provide global trial identification and search capability, promote compliance, and help strengthen research monitoring capacity where needed. WHO will undertake this effort with the advice and input from clinical research stakeholders.
A public and readily-searchable register of clinical trials overseen by an objective international body drawing on input from relevant stakeholders will underpin good research practice, assist in making treatment decisions, and increase public trust in clinical research. In April 2005, a consultation was convened by WHO to initiate a framework for development of the international clinical trial registration platform. Progress was made during the meeting on determining essential elements of the strategy and discussion took place on the development of a guide for trial registration. Following are some of the basic provisions of the initiative.
Registration
• Any research project that prospectively assigns human participants or groups to one or more health-related interventions to evaluate the effects on health outcomes should be registered.
• Trials aimed to assess all health and health care interventions, not only medicines and medical devices, should be registered. The intent of this definition is to include trials that could inform health and health care practice.
• Exploratory studies that are not designed to influence health practice and that serve only to set direction for future testing need not be registered.
• When trial sponsors are unsure whether to register or not, registration is recommended.
• Trials should be registered as early as possible, ideally before recruitment of the first participant.
• The informed consent form should include the trial identification number.
Trial characteristics
The minimum data set recommended is set out in the table overleaf. Data set should be reported in English.
Table: minimum registration data set
Item |
Comment |
1. Unique trial number |
The unique trial number will be established be the primary registering entity (the registry). |
2. Trial registration date |
The date of registration will be established by the primary registering entity. |
3. Secondary IDs |
May be assigned by sponsors or other interested parties (there may be none). |
4. Funding source(s) |
Name of the organization(s) that provided funding for the study. |
5. Primary sponsor |
The main entity responsible for performing the research. |
6. Secondary sponsor(s) |
The secondary entities, if any, responsible for performing the research. |
7. Responsible contact person |
Public contact person for the trial, for patients interested in participating. |
8. Research contact person |
Person to contact for scientific inquiries about the trial. |
9. Title of the study |
Brief title chosen by the research group (can be omitted if the researchers wish). |
10. Official scientific title of the study |
This title must include the name of the intervention, the condition being studied, and the outcome |
11. Research ethics review |
Has the study at the time of registration received appropriate ethics committee approval (yes/no)? (It is assumed that all registered trials will be approved by an ethics board before commencing.) |
12. Condition |
The medical condition being studied (e.g., asthma, myocar dial infarction, depression). |
13. Intervention(s) |
A description of the study and comparison/control intervention(s) (For a drug or other product registered for public sale anywhere in the world, this is the generic name; for an unregistered drug the generic name or company serial number is acceptable). The duration of the intervention(s) must be specified. |
14. Key inclusion and exclusion criteria |
Key patient characteristics that determine eligibility for participation in the study. |
15. Study type |
Database should provide drop-down lists for selection. This would include choices for randomized vs. non-randomized, type of masking (e.g., double-blind, single-blind), type of controls (e.g., placebo, active), and group assignment, (e.g., parallel, crossover, factorial). |
16. Anticipated trial start date |
Estimated enrollment date of the first participant. |
17. Target sample size |
The total number of subjects the investigators plan to enroll before closing the trial to new participants. |
18. Recruitment status |
Is this information available (yes/no) (If yes, link to information). |
19. Primary outcome |
The primary outcome that the study was designed to evaluate
Description should include the time at which the outcome is measured (e.g., blood pressure at 12 months) |
20. Key secondary outcomes |
The secondary outcomes specified in the protocol. Description should include time of measurement. |
All items listed are required for scientific and ethical reasons. Therefore, all fields in the minimum data set should normally be entered into the register at the time of trial registration. However, one or more of data items 10, 13, 17, 19, 20 may be regarded as sensitive for competitive reasons by the sponsor who may wish to delay release of the information. In this event, all data items should be made publicly available by agreed dates. WHO will convene a group to develop a mechanism to advise on requests to delay release of one or more of data items until a requested date.
Results disclosure standards
The results database will be useful for multiple constituencies (reviewers, patients, and policy-makers). The database is assumed to be an extension of the trial register and the data are meant to complement, but not replace, peer-review and publication. Thus, results disclosure should not be a barrier to peer-review journal publication.
While there is no single agreed definition of study completion, the results should be disclosed within one year of completion as a general rule. Results of trials of commercially developed drugs (newly registered drugs) should be disclosed within one year of first product launch. In deciding the extent of disclosure, the ICH E3 synopsis is proposed as a guide (with the addition of the trial register number).
The sponsor is responsible for ensuring that results are disclosed. For unsponsored trials, the principal investigator takes responsibility and for marketed products, the license holder is responsible for updates.
References
1. International Committee of Medical Journal Editors(ICMJE) on http://www.bmj.com
2. International Clinical Trials Registry Platform on http://www.who.int/ictrp/background/en/
3. WHO facilitates international collaboration in setting standards for clinical trialk registration. www.thelancet.com online 24 May 2005.
Chargement en cours...
