Skip to main content

Table 4 Differences in priorities causing conflict – example from RCT 3

From: ‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

#14B, Co-Chief Investigator (Co-CI), RCT 3: ‘So it might be also helpful [trial statistician], to look at the scenarios of seeing if there was a greater difference. I’m not suggesting that’s our primary strategy, I think the best strategy is to go for power. But I think it would be nice to have the scenarios of looking for a 70% difference and a 90% difference. So (trial statistician), would you be able to just do that?’  
#13, Statistician, RCT 3: ‘Yeah, we can do that, but when I was speaking to [senior trial statistician], yesterday he said it’s not really good practice to meddle with the difference coz you know…’  
#14B, Co-CI, RCT 3: ‘Well it’s very easy to say that but the other option is the trial stops, do you see what I mean? So good practice is to make sure that we fulfil the commitments of the families who have consented to this study. So we appreciate what good practice is, but I think it’s also looking for a number of scenarios in which we can present to everyone including the Data Monitoring Committee, the (Trial) Steering Committee and the funders to find a pragmatic solution to a problem of recruitment, okay. So it’s just to have those figures available really for discussion’.  
#12, Senior trial manager (TM), RCT 3: ‘[CI], I think it’s just being aware that obviously if you’re changing the difference that you’re looking for, then you are leaving yourself open to criticism, so you need to be ready to…’  
#14B, Co-CI, RCT 3: ‘We are –’  
#14A, Co-CI, RCT 3: ‘We are aware. [Senior trial manager], we’re open to ever greater criticism, so this is not been talked about lightly or picked from thin air. There’s a real and present danger that if we go up in front of (funder) in (month) not having met our target of [x] patients in the last 6 months, there is a very real present clear danger that they will stop the trial. That is not in the best interest of the patients who have participated, that’s not in the best interest of any of us’.  
  1. Co-CI Co-Chief Investigator, RCT randomised controlled trial, DMC Data Monitoring Committee, TSC Trial Steering Committee, TM Trial manager