Trials and Studies
The purpose of ICC-CTG endorsement is to ensure a consistent high standard of study design, conduct, analysis and dissemination and also to ensure that research capacity and study feasibility is optimised. Benefits of endorsement include fostering an environment to promote the development, implementation and dissemination of critical care research through peer networking, collaboration and support.
1. Studies must accord with the ICC-CTG’s mission statement and must conform to these Terms of Reference and all other relevant ICC-CTG
2. The ICC-CTG Executive will only endorse studies prospectively, that is before they commence recruitment in
3. Study proposals must be developed in accordance with ICH GCP Guidelines and should include:
- Nominated management committee and administering institution(s).
- A detailed protocol including a hypothesis, rationale and study aim(s)/objective(s)
- Evidence of feasibility including proposed budget, funding strategy, and / or a demonstration of in-principle support from
- Consideration of all relevant ethical issues where appropriate, applicants are encouraged to consider the issues of knowledge translation in their
4. The study management committee should include at least one individual employed as an ICU Research Coordinator in
5. The inclusion of at least one early career investigator on the study management committee and on related grant applications is strongly
- To be eligible for endorsement, new and revised study proposals should ideally be presented at least one ICC-CTG scientific meeting and presentation at an early stage of development is strongly encouraged. The essential elements of the final research plan should be presented at an ICC-CTG scientific meeting or a least to the Chair of the ICC-CTG Executive or a Chair-delegate prior to submission for
- Where there is a known deadline for obtaining ICC-CTG endorsement of a study proposal (such as for major grant submissions), applications need to be submitted allowing sufficient time for review and revision if
- The Chair of the ICC-CTG Executive or a Chair-delegate will supervise the review of each submitted
- All manuscripts that report results obtained from ICC-CTG Endorsed studies should be submitted for review and endorsed by the ICC-CTG Chair or a Chair-delegate prior to submission for publication or examination. This review may be undertaken by the Chair or Chair-delegate who will determine whether external review is required or whether the Chair or Chair delegate should recommend endorsement to the Executive without external review.
- All other manuscripts that are proposed to be published in the name of the group study investigators or the management committee of a ICC-CTG Endorsed study (e.g. editorials or review articles) must be submitted for review and endorsed by the ICC- CTG Executive prior to submission to a journal for publication. Such manuscripts proposed to be published in individual name(s) that do not include study data do not required ICC-CTG
- The default authorship for all ICC-CTG Endorsed study manuscripts is: “The X Study Investigators and the ICC-CTG”. Other arrangements may be acceptable, particularly for very large international studies, but this must be approved prior to endorsement by the management committee and the ICC-CTG chair or
- The default listing of individuals on lists of investigators or study sub-committees is the Chair followed by alphabetical order, unless prospectively agreed by the management
- All hospitals that participated in the study must be listed in the manuscript or on- line appendix. Individuals who contributed to the conduct of the study at each participating hospital must be listed, and where possible, as collaborators. It is usually the case that this will comprise one or more site Research Coordinator(s) and the Site Investigator(s). Variations to this requirement may be proposed by journals and may be acceptable with approval from the ICC-CTG Chair or Chair-delegate. Participating institutions will be listed alphabetically; individual(s) will be listed alphabetically within each institution, unless agreed by the Management Committee or otherwise as required by the
- Investigators may not indicate in a grant application that the study is endorsed by the ICC-CTG unless endorsement has been approved by the ICC-CTG
- Investigators may only indicate in a grant application that they have submitted, or intend to submit, for ICC-CTG endorsement with the approval of the ICC-CTG
- Obtaining funding for a study is neither a requirement for, nor a guarantee of ICC- CTG endorsement.
Currently Endorsed Studies
| Clinical Trials | Chief/Principal Investigator |
|---|---|
| Bonanza | G. Curley |
| REACT-SHOCK | B. McNicholas |
| PREVENTION | J. Laffey |
| PEGASUS | J. Laffey |
| Remap-Cap (Pre-2023 Domains) | A. Nichol |
| EPO trauma | A. Nichol |
| MegaROx | A. Nichol |
| Spice IV | A. Nichol |
Observational studies
| Clinical Trials | Chief/Principal Investigator |
|---|---|
| Sprint SARI | A. Nichol |
| Genomic | A. Nichol |
Recently Completed Studies
| Clinical Trials | Chief/Principal Investigator |
|---|---|
| APPROVE-CARE | B. McNicholas |
| TAME | K Ainscough / A. Nichol |
| TEAM | A. Nichol /K. Bricknell |
| CHARTER | J. Laffey |
| ECMOCARD | J. Laffey |
| AFTEROR | B. McNicholas |
| Ventibrain | G. Curley |
| Nutrient | K Ainscough |
| PHIND | D. McAuley |
| GEMINI | J. Laffey |