• Canadian Critical Care Trials Group
    The Canadian Critical Care Trials Group (CCCTG) is a highly collegial group that is dedicated to the pursuit of excellence and advancement of critical care research in Canada.
  • Canadian Critical Care Trials Group
    The CCCTG has are more than 30 research programs underway and over 100 peer-reviewed publications to its credit, with direct impact on clinical practice in critical care.
  • Canadian Critical Care Trials Group
    The Canadian Critical Care Trials Group (CCCTG) is a national organization of more than 300 individuals with research interests in the management of the critically ill patient.
  • Canadian Critical Care Trials Group
    Endorsement by the CCCTG communicates our full commitment to ensure that the work is undertaken in a rigorous and ethical manner, and communicated in a timely and effective way.

Terms of Reference

We aim to co-operatively help develop protocols that benefit from the diverse expertise and constructive advice of the CCCTG membership. In so doing, we aim to merge scientific rigour with clinical relevance, within the constraints of feasibility and available resources.

The focus of the CCCTG is the development and execution of protocols which are investigator-initiated and officially affiliated with the CCCTG. The Trials Group acknowledges that research that has originated from a pharmaceutical or technology related company is important for the advancement of critical care research. However, to date it has been the agreement of the CCCTG membership that such projects not be directly supported by the Trials Group.

Process

Any CCCTG member is welcome to bring protocols to our meetings. This requires pre-circulation of a written protocol to the membership. Before a study is affiliated with the CCCTG name in a grant or publication, the protocol must be discussed at a meeting of the CCCTG, and approved by the membership.

After protocol presentations, revisions are often recommended by the group before grants may be submitted with the affiliation of the Canadian Critical Care Trials Group name. A grant application for funding under the auspices of the CCCTG must be endorsed by the CCCTG Executive Committee prior to its submission. In the latter situation, the Executive in association with one or more members will provide an internal review of the protocol and provide feedback within 2 weeks. The goal of this feedback is provision of constructive comments to investigators about their studies which represent CCCTG membership views on issues of methodology and implementation.

CCCTG Authorship

CCCTG authorship must be acknowledged in the grant proposal submitted for funding if all of the following criteria are fulfilled a) the protocol has been presented at a CCCTG meeting, b) support has been given to the project by the CCCTG membership at one of the meetings, c) explicit agreement regarding grant submission was obtained, and d) feedback on the grant itself was provided by the CCCTG Executive. Without these 3 steps, investigators are requested not to make reference to the CCCTG in their proposal.

CCCTG authorship must be acknowledged in all manuscripts submitted for publication if in the opinion of the CCCTG Executive and the investigators, substantial scientific support has been provided by the group at our meetings and between meetings. Without this agreement, investigators are requested not to make reference to the CCCTG in their manuscript.

Before CCCTG authorship is finalized, the CCCTG Executive must review all manuscripts to be submitted to peer-review journals. To allow for (inevitable) last minute preparation, abstracts of CCCTG projects may be submitted to scientific meetings without a priori review by the Executive.

CCCTG Executive Committee

The function of the CCCTG Executive is to provide scientific and administrative support to the membership. As requested, the Executive will review all protocols that require review outside the regular CCCTG meetings. The Executive will also review every manuscript prepared based upon work of the CCCTG. Written feedback will be provided to investigators in a timely manner, but always within 2 weeks.

Meetings

We meet thrice per year, once in January (in Lake Louise), once in May/June (in a rotating location in eastern Canada) and once in October (at the Toronto Critical Care Medicine Symposium).

Visitors at CCCTG Meetings

  • Are sponsored by Chair, Exec or any member
  • Fund themselves
  • Have clear objectives (e.g., starting TG, participating in CCCTG study, not just seeking enrolment in their own study)
  • Are invited by Chair in writing (including confidentiality / intellectual property clause)
  • Are introduced to CCCTG (background, objectives)
  • Address the CCCTG at the end of the meeting (observations, plans for future collaboration)
  • Are to limited to 1-2 visitors / meeting

Presentation Guidelines:

New Studies

  • Brief background
  • Question/Hypothesis
  • Objective(s)
  • Design
  • Plans (implementation, timelines etc)
  • Questions for the CCCTG?

Ongoing Studies

  • Brief review of background, question, hypothesis, objective(s), design
  • Update
    • Issues raised by group at last meeting
    • Work done since last meeting
    • Milestones
    • Problems
    • Solutions
    • Plans
  • Questions for the CCCTG?

Responsibilities of PIs to the CCCTG

  • Pre-circulate documents in advance
  • Follow presentation guides
  • Explain responses to feedback
  • Be clear on collaborator commitments
  • Provide detailed study update
  • Share challenges as well as successes
  • Attend each meeting or send representative
  • Develop & commit to (revised) timelines
  • Ensure study completion

Responsibilities of the CCCTG to Each Study

  • Read pre-circulated documents in advance
  • Provide constructive feedback on rigour, relevance, ethics, feasibility & fundability
  • Consider mentorship & partnership
  • Problem solve during ongoing trials
  • Share tips, study aids & other documents
  • Ensure to study completion
  • Help to interpret study results
  • Review grants & manuscripts within 2 wks

Responsibilities of PIs to the Site Investigators

  • Provide all necessary study documents
  • Provide initial training & ongoing feedback
  • Communicate study progress & set-backs
  • Advise on local feasibility issues
  • Seek advice on study issues
  • Follow through on commitments
  • Develop & commit to (revised) timelines
  • Publish scientific progress
  • Ensure study completion

Responsibilities of Site Investigators to Each Study

  • Understand collaborator commitments
  • Problem solve local feasibility issues
  • Communicate study progress & set-backs
  • Advocate locally for the study
  • Follow through on commitments
  • Suggest improvements
  • Collaborate on scientific progress reports
  • Ensure study completion

Responsibilities of the Chair to PIs & Site Investigators

  • Summarize CCCTG feedback
  • Write support letters for CCCTG grants
  • Advocate for each study across sites
  • Help to problem solve
  • Ensure the CCCTG honours commitments
  • Ensure study completion
  • Ensure publication
  • Liaise with funding partners as necessary