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Table 4 Quotations illustrating research environment-related factors

From: Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada

I think a second consideration in trials is certainly also regulatory. So for example, I tell you one important issue of recruitment relates to women. And we are always discussing, why is it so difficult to recruit women. But one really daily hurdle to overcome is the pregnancy test. So obviously this comes out of an era where there has been drug adverse effects, but it has been carried on into more recent trials. And it becomes ridiculous to the degree that we are, for example, studying patients who are octogenarians, yet if we include female patients we have to prove that they have a negative pregnancy test. And that shows you a little bit that also regulatory hurdles can play a certain role in impeding recruitment; let's say across gender in equal rates. R21 Clinical trialist
It’s more difficult to make clinical trials in the academic setting because it’s getting more and more complicated, you have more and more government rules to fulfil, more and more paper you have to fill out. T8 Principal Investigator of a discontinued trial
The other reason is if it is an indication when there are good other treatment options, so where the clinical study is not the only option where you get for example a very new medication for the disease...that’s also a point where maybe patients are not willing to participate in the study. R29 Representative of Federal Office of Public Health
The other element of course is, if you make your life difficult by adding protocol requirements that are nice to have rather than really essential, then you slow down your own recruitment because you don’t get the patients that you would need. There is another element that has been used by certain companies that to derail…let’s say development of a competitor product is, you place a very simple study or a relatively simple study in a site and you pay pretty high patient fee, then this might then divert patients to your study rather than into a study from another company. R22 Representative of pharmaceutical industry