Table 1 Key questions about the role of the Trial Steering Committee (TSC). Topics prioritised for discussion at the meeting are marked with an asterisk

1)* What is the role/remit of the TSC?

2) The membership of the TSC:

a. What should the membership of the TSC be with respect to size, members, and the choice of the Chair?

b. Do TSCs always need independent members and, if so, how many?

c. What is the definition of independence?

d. Should Funders be able to reject TSC members?

e. What, if any, are the implications of the same statistician being involved in production of DMC report (knowledge of unblinded comparative data) and being on the TSC?

3) What sort of experience and training should TSC members have?

4) What is the role of the TSC prior to trial recruitment?

5)* What material should be available to a TSC (meeting report contents)?

a. Should a TSC see any data split by treatment groups?

b. Should external evidence be incorporated and how?

c. How does the material differ for TSCs that cover multiple trials?

6) What are the questions that the TSC should not ask the DMC to make recommendations on, for example, change to primary outcome or target sample size (other than pre-planned internal pilot)?

7) If there is no DMC, what is impact on the role/remit of the TSC?

8) How should decisions be reached within the TSC?

9)* How should ethical issues be handled in TSCs? For example, what if higher rates of adverse events were observed in one site or with one surgeon or an occurrence of a potential serious breach has occurred, for example, in dosing?

10)* What should be done in difficult/complex situations?

a. What should be done when there is a recommendation from the DMC to stop the trial, who should be unblended, and what are the implications if the trial then does not stop?

b. What should be done when decisions are made on site closures guided by performance?

c. What should be done when Funders stop/withdraw funding?

d. What should be done when an external body wants access to the data while the trial is on-going, for reasons such as design of a new trial or interest from industry?

11) What should the TSC’s role be concerning publications? Please consider publications prior to the main trial report and subsequent articles.

12) What should the TSC’s role be concerning requests for data sharing? Please consider requests prior to and following the main publications.