Table 2.

Respondents’ views on learning from written materials

Lack of availability, awareness, or usefulness of written documents “… there’s not much [in the literature] in terms of surgical  interventions and the risk, at least not much that you could find. They’re probably out there but they’re not easily findable or  searchable.”

“I don’t think any of them [the printed research ethics material] discussed the issue. I  mean this was really out of left field, I guess, except for [one other trial], and theirs was slightly different…”

“I don’t know where the methodology for this is in any document we did. I don’t think we [had a] good textbook for  randomized trials and design. I’m not aware that we did.”

Benefits or lack thereof from reading published literature as groundwork for a clinical trial

“We looked at the literature … at what the current accepted best [perioperative] practices were. There were a lot of places  where there were best practices. There were some places where there were no  best practices. So places where there were no known best practice, we let [participating centers] basically do what they were currently doing without trying to change their  practice, because it would have been a whole other level to try to not just do the study intervention but also change the  practice at any one hospital. We felt that that would negatively impact patient enrollment at the hospitals, and since there  was no other guidance as to what the best practice was we didn’t feel that there was any reason for trying to change the  practice at any one place.”

“… there had been a few studies done before of [procedure]. Actually I wrote a little critique of those studies way  back … that expressed my frustration with the lack of scientific rigor of the studies that had been done and summarized  what I saw as the problems with those studies, mainly that they were done on [patients] who … if I remember correctly,  didn’t really come near meeting, for the most part, any reasonable minimum standards for surgery. They were just sort of  collected. They compared [patients] who had surgery with [patients] who didn’t have surgery without too much regard for  what the indications had been.”

“My study had never been done before. So certainly there wasn’t anything there [in the literature as examples or guidance]. I  did not look up surgical intervention trials. Take that back. I did, after I came back here and the first time I got slammed. I  did look it up again. And then you get a bunch of stuff that was not helpful. I did go to clinical trials.gov to see the active  clinical trials but you know that’s not that helpful either for their design aspect… it would be nice to have had a review  article or a resource where it was written about how to design a surgical clinical trial. Like that was the title [of the published  article].”

“In order to answer that [clinical] question, I started looking through the literature and I saw that there were very small case  reports about this but no large case series for me to refer to see if this was reasonable for my patients.”

“There’s a lot of documentation out there, sure. I mean I looked at previous research protocols to go through and see how they  were set up. And obviously the whole published literature on clinical trials in [condition]. Then we looked at you know  protocols that were in progress, like we went to the [cooperative group name] site and downloaded their protocols … And  it’s all published on the web so you can download all of that. You can look at it. There are obviously NIH resources that you  can go to look for how you deal with all of these regulatory issues.”

Views on required human subjects research credentialing process

“It [the human subjects research credentialing training from institution] didn’t help me for this [trial], did not. I mean those  sorts of things are important and mandatory and compulsory. And I recognize why. Maybe they should have [been helpful  during the trial]. Maybe I’m not smart enough to figure out how they should have. I view those things as more ethics  involved.”

“I think the [institution] has gone to Collaborative Institutional Research Training (CITI) training, and I think that training is  very reasonable, and it hits all of the high points. Certainly it’s not in depth, and I think the classroom training from the  Fundamentals [of Clinical Trials Course] is an important supplement to that. But I think to get the basics across. I think the  CITI training is pretty good.”

“I’ve had to go through that [CITI training] I guess [several times] now because I’ve been here for [N] years on faculty … But  that has kind of minimal educational value I would say. It’s more of a testing thing. It’s not a ’here’s how you do it’ deal.”

“I learned as I went through the CITI course. It was not testing knowledge that I already had. I basically had to read through  the course and figure out what was right and wrong and then took the test and passed and said that I was certified. And you  know there were questions in there that I thought were somewhat helpful in designing a study. You know, they’d ask you the  difference between a phase one, phase two, phase three trials and basic things like that. But they certainly didn’t go through  like say a grant writing class would break it down into sections and say, ’This is how you write a grant.’”