Skip to main content

Table 3 TSC as ‘critical friend’, provider of ‘tough love’ or ‘critical advisor’: exemplifying quotes

From: What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges

TSC as ‘critical friend’

The ideal function of the Trial Steering Committee [is to] act as a critical friend to the trial, whereby they support the trial to some extent but then they do also ask the awkward questions and hold them to account. (50, Senior statistician)

It was really important to have that external objective view of looking at the data independently, but also, them being our critical friends, advising us and supporting us through this… they’re there to support and help, they’re not just there to chastise. (40, Senior trial manager, trial 7)

TSC as provider of ‘tough love’

[The role of a TSC] is, I think, tough love. (Laughter)… They’ve got to be on your side… Because if you’ve got a TSC that’s against you, you might just as well hand the money back now. (Laughter)… They’ve got to kind of be in your corner, but I think they've got to be tough. (20, TMG member, trial 4)

If I don’t walk out of these meetings feeling like I’ve been given a bit of a kicking then they haven’t done their job properly, that’s what they’re there to do … it’s their job to… point out the things that we should be doing better. (23, CI, trial 5)

TSC as ‘critical advisor’

Interviewer: When I’ve asked that question of other people, they value the TSC being a critical friend.

42, TSC Chair, trial 8: No, you can’t. It’s not a friend. A friend implies that the relationship is a good one and always amicable. I wouldn’t hesitate to be a non-friend if I thought it was wrong. Critical adviser – better. However, friend does imply that, “We’ll sit round the table like friends and we’ll just discuss this and what we say will be okay for you.” So criticism; yes, advice; yes. Friendship almost comes as a side issue.

Interviewer: Perhaps the friend bit was them implying that you need to be on their side?

42, TSC Chair: You’re not.

Interviewer: You’re not?

42, TSC Chair: No. You’re independent. So the words of wisdom that you give may be words they don’t want to hear. Maybe we’re going to say, “Right, this trial needs to be shut. It’s not working.” That’s happened three or four times it the last couple of years, in other trials groups. It’s not a matter of cutting your losses. It’s a question of making sure that it’s the ethically proper thing to do. So I’m very keen that meetings are conducted in a friendly environment but we are there as advisers and critics.