Examples of Trial Steering Committee in a sentence
Each modification will be subject to approval from the International Trial Steering Committee (ITSC) in conjunction with advice from the International Statistics Interest Group (ISIG) and the Data Safety and Monitoring Board (DSMB).
In such a circumstance, the DMC will inform the Trial Steering Committee who will make the results available to the public and amend the trial arms accordingly.
Significant issues arising from management meetings will be referred to the Trial Steering Committee or Investigators, as appropriate.
The Trial Steering Committee may elect to pause one or more of the arms in order to increase trial efficiency during a fluctuating epidemic.
A Trial Steering Committee (TSC) will be established to oversee the conduct and progress of the trial.
Unless this happens, the Trial Steering Committee, Chief Investigator, study staff, investigators, study participants, funders and other partners will remain blind to the interim results until 28 days after the last patient has been randomised for a particular intervention arm (at which point analyses may be conducted comparing that arm with the no additional treatment arm).
The Trial Steering Committee will have the right to review and comment on any draft manuscripts prior to publication.
However, while the study is in progress, access to tabular results of study outcomes by allocated treatment allocation will not be available to the research team, patients, or members of the Trial Steering Committee (unless the DMC advises otherwise).
Proposals for substudies must be approved by the Trial Steering Committee and by the relevant ethics committee and competent authorities (where required) as a substantial amendment or separate study before they begin.
In considering such proposals, the Trial Steering Committee will need to be satisfied that the proposed substudy is worthwhile and will not compromise the main study in any way (e.g. by impairing recruitment or the ability of the participating hospitals to provide care to all patients under their care).