Table 2. Themes for domain 'pandemic context'
ThemesIllustrative quotes
Rapidly changing context'Right from the beginning it was clear that it was a very, very challenging project. A study with initially one drug that was not registered in Europe, implying higher risk, higher complexity — a pandemic study with inherent risk and complexity.' [P18]
'I think that the biggest stumbling block for the DAWN trial was the constantly changing context of the infection rates, which were very unpredictable and caused that we never reached our target sample.' [P4]
Timing'Even from quite early on, you know, it seemed to be a little bit late or a little bit behind the curve, so missing things, and I think it was also difficult because quite a few things changed. So, each time you make a change, a lot of effort is going into amendments to changing things. And therefore this is taking resources and your attention off getting patients in.' [P18]
'It was bad timing for the study to start when it did. I think that if it would have started a year or six months earlier, it would have made a big difference.' [P11]
'It’s difficult when you're up against time pressures when everything’s spread a little bit thin because of the resourcing, it’s very difficult to advance everything all at once. So, with hindsight I think piloting could have been, you know, the best way to go. I think piloting the different aspects, the different logistical aspects in a smaller region would have been a very good idea.' [P18]
'I think having to have the drug made in India, and the issues related to that and then you know you have a delay and therefore you're missing a certain wave.' [P13]
Care delivery during the pandemic'It was obvious that was really going to be a huge operational challenge to get those test centres on board and up and running to recruit.' [P3]
'The pandemic disrupted the normal way of working. With the introduction of teleconsultations, I found it difficult to pitch the study to a patient.' [P12]
'Recruitment via the GPs is not a bad channel because then you have some confidence about the study. I think it is a good channel, but the channel was overloaded during COVID-19.' [P15]
'Personally I do find it difficult to approach the patients about that. I don't want to make them feel obligated to participate or anything like that to do that. I guess this is something I should work on for future studies…' [P20]
Public opinion'People were fed up with COVID. Also, by that time they were not getting so sick, so they were not willing to take new medication.' [P7]