Table 3.

Respondents’ views on experiential learning

Learning by doing or designing surgical trials

“[Trying to conduct research in a clinical center] it’s kind of seen as you know, are you here to kind of scoop up these patients?  So I had to be very careful to say I’m not here for taking patients away and that kind of stuff. And that was a huge challenge  to kind of get through.”

“In the process of kind of thinking through that [clinical research] project… all kinds of things came up that I really hadn’t  thought about. Like the consent process. Oh my Lord, I mean, to me the consent process should be pretty straightforward  because I’m not doing anything invasive to these people. But it turned out, of course, to be a multi-page document and we  were going to the [centers] to make it convenient for the patients. Well then they wanted their own consent form plus our  consent form etc. And then other things that I hadn’t really considered … I didn’t think about it but should we be  considering educational level in these patients you know? Are we considering you know kind of how do they feel about  themselves and doing quality of life indices and those things?”

“There are a lot of things, like … the trial initiation compliance with regulatory requirements… approval of the research  protocol by the Department of Defense, Human Research Protection Office, and harmonization of IRB requirements of each  center with the human research protection office, appointment of a central trial monitor, appointment of local trial monitors,  trial initiation meeting of all investigators, writing and signing of site agreements between the sponsor and the individual  hospitals, and so on. So you know there’s a lot of steps to go through. And if you haven’t done it I mean … you don’t know  what you’re getting yourself into.”

“[A colleague] actually suggested initially why don’t you try this for an RO1 type grant? And I said ok, well maybe, I never really  thought about that. Why not? So then … what about trial design? How are we going to design it you know? This is a surgery that  has been done before … So number one, who is going to pay for it? Are insurance companies going to pay for it because being  experimental, is it an experimental technique? No, but it’s a technique that’s experimental in this setting. So we called Medicare and  they said no way we’re going to pay for this. And another insurance company said no. And that is, it’s much more expensive than  you can imagine than most pills because you have the preoperative evaluation that takes place. The [operating room] OR time that  takes place. The postoperative care, hospitalization that might take place and then potential complications that one has to  anticipate, that patients might come back again. So figuring out a per patient cost for a surgical intervention and various things  that one might do to prepare for the surgical intervention was going to be [a] tidy sum of money. So to figure out how are we  going to do this and then the power of the trial might still be informative and etc … nonetheless I didn’t know any better and I  just … went to a particular individual, the head of the division, and we worked it out. ”

“So I think we all have, surgeons all have ideas of how we might be able to help someone. But I think a systematic resource of  how one can implement those, that’s statistically robust and ethically sound, ain’t available …#########. what I did originally was in  retrospect, really naive. I had a reasonable idea. But not really well thought out in terms of precisely of all the bad things  that could happen and then quantitating [sic] those and then yes, it really wasn’t. So now I look back on the second version  [of the grant application] I think my goodness. This is like night and day.”

“I thought I was being sensitive to the ethical nature of this trial. But perhaps clearly to some I was not enough. So I think  had the design been different initially it would have conveyed to the reviewers that I had a better appreciation for the ill  effects for the possible intervention.”

“… bottom line is what we learned from that trial is that powering is critical and number two that surgical trials are so  expensive that it’s very difficult to power a trial adequately unless you have a dramatic [change] from base line.”

“And I’ve actually written a couple of protocols that are unusable. And I wrote one protocol that got $70,000 of funding and  has yet to enroll a patient, [N] years later, which I think is a sin … our protocol is broken and we’re in the process of  revising it and trying to rewrite it. But had I known what I know now I would have written it completely different. And it  would have been better use of funding. So I think it actually was a mistake that we got funded. We didn’t really know what  we were doing … If you are a surgeon, you want to make sure that every surgery you do is the best you can make. Having  junior people who are inexperienced write protocols and do research can probably as much harm as do good.”

“I became the local investigator for the trial in [place]. And through that trial I just learned so much about clinical trials because you  know we had our conference calls every week, bigger conference calls every month. I became aware of what a data safety &  monitoring board is about. I became much more familiar with all of the IRB issues, change in protocol, protocol deviations. And  then I also attended all of the investigators meetings that took place over the course of five years. You know that ended up being  one of the best clinical trials that was ever conducted in general surgery. The main outcome was published in the [name of journal]  and we got about ten papers out of the trial … So it was a very good learning experience for me to just as a naive person going  and requesting to be a site investigator to the point where you know I became a more seasoned investigator throughout the trial.”

Learning by doing industry-initiated trials

“The [clinical condition] testing that we used for our screening study I basically took directly from one of our industry  sponsored trials, their methodology and that kind of stuff. The sad part about that is as we started doing it, and I went back  to them and I said, ’Ok, so how are you exactly scoring this now that you’re collecting all of this data?’ which perhaps I  should have asked beforehand. They had no idea how to score it. I mean they didn’t know if out of the nine points was one  going to be positive or did you mean two out of nine to be positive. Like I had no idea. I was like oh God, what was I  thinking. So I think there’s a little too much leap before we look carefully, a mentality probably particularly in surgeons.”

“I mean, they [industry trials] generate some funds which then you can turn and use for your other stuff. But you also, if you  become pretty active in those, get to go to the investigator meetings and get involved in the design of the next study, which  that’s been I think really good for a couple of these things that I’m interested in … you know, what should the end points  be, what is the FDA accepting or not accepting. And that’s helpful.”

“The two [people] that were the lead authors of [journal names] papers were there at those [industry sponsored trial] meetings,  and talked about the hardships in the study design and the agony over what was the primary endpoint going to be and the  fights back and forth with the FDA. And that was, I’m sure, painful for them to relive but it was really educational for me, as  a relatively young investigator trying to design my own trials and think about you know, where I’m going to go.”

“… I would say that in my area there are not enough investigators doing investigator-initiated trials really. Everybody’s doing  industry-sponsored trials where you’re handed the protocol, you search for the patients and go from there. And one of my  goals if I’m to stay in academics is really to generate some investigator-initiated trials. It’s sort of a trial and error process in  doing so though, right?”

“I feel like through error I’ve got a pretty good grasp on a lot of these things now, as I get spanked on monitoring visits, etc.,  etc … I go to enough investigator meetings to get this.”

“… some of the people involved are strictly there with industry and to make a buck and some of the people are there to really  make a great trial.”

Service-based learning

“I was invited to be on the [name] study section of the NIH and eventually became the chairman of the study section. So that  began a long period of time working with the NIH … So I think I got a certain amount of research training as part of my  exposure to the NIH and to that whole [review] process.”

“[My learning], it’s really by absorption … it’s multiple, accumulative experiences. I tend to read constantly, on a daily basis,  high impact journals in surgery and non surgery. I actually review lots of papers for high impact journals and in it I’m asked  to comment on the design, the rationale, the statistical aspect, the conceptual framework. I view on average three to four  manuscripts a week. And I’m on at least three program committees of three national meetings. I create lots of  abstracts … So it’s really by osmosis. It’s lots of experiences. I tend to go to lots of conferences. I go to research symposia.  And I have never read a book cover to cover but I could tell you that I’ve read numerous manuscripts from first line to last  line.”

“I was very fortunate then because some of the people serving with me on [board] were some of the leading clinical trialists in  the country … So I taught them [subject matter] and they taught me clinical trials design and we sort of worked things  through together. And so that was actually, not really a service thing, but again a really big learning thing. Then that was a  real big payoff.”

“… in those years there was one IRB and that meant we read more than 1000 protocols a year. And after about 15 years I  thought that was enough. But I did learn a lot, you know? After you read 15,000 protocols, you’ve learned quite a lot …”