Table 5.

Respondents’ perspectives on how education and career development in surgical trials might be improved

Obtain formal training in clinical trials

“There are a lot of programs in this now that are available now that weren’t available when I was starting my career … there  are even degrees you can get in this or certificates … fellowships you can do as a clinical trialist, and I think it’s worthwhile  to do that. This has become such an incredibly complex field. You can’t just, like I was doing [in my early career] sort of on  the back of the napkin, sketching out the trials and then kind of just doing it with whatever you could find, you know,  resources and so forth. It’s become so complex. And the statistics have become incredibly complex. So you need a knowledge in trial design and you need a knowledge  in statistical design. And I would recommend that they either take courses or they  actually do a year fellowship and you know, get some formal education in this. It will make it much easier because it’s very  painful to start to do these trials on your own and then sort of learn as you go, as you’re doing it. That becomes a very  painful experience.”

“If they [young surgeons or physicians] want to do clinical studies I don’t think anything substitutes for going and getting the  formal training … School of statistics, epidemiology, study design, bias. Formal education … NIH sometime back, funded at  many, many, many, many medical schools short courses in how to do clinical research. Some of them were better than others.  I personally believe that they are too superficial. I believe that you need to go get a level of masters of science, MPH,  whichever you want, but that it is a master’s in epidemiology, statistics and studies if you want to be conversant in doing  good clinical research.”

“… Anyone who is going to be a researcher and have research as a significant part of their career needs formal research  training … People who refuse or don’t feel they have the time and aren’t that committed I try to get them all to take the  [Fundamentals of Clinical Investigation course] … I feel very strongly because I didn’t have that formal training. I think at  least the Fundamentals of Clinical Investigation where they teach the basics of ethics and trial conduct and IRB and animal  care … But I really feel strongly that they should have either an MPH, a masters in clinical investigation or at the very least  take the Fundamentals of Clinical Investigation course.”

“… time is what you make it. If you have the priority then you make the time for it. I think people don’t understand what it  takes to do a human clinical trial. I think you know we don’t learn it in medical school. And then you say, ’Oh, this is not a  big deal. I’m going to test whether this works better than that.’ … [you]start out on the path to get it done and then you’re  first learning all of the hurdles that you have to overcome to get it done. That’s why I think if you’re going to do it you  should have the training up front and then plan after. And the problem, you know, for us as surgical investigators, is there’s  not a lot of infrastructure in place to facilitate it.”

Find mentors

“I think they [potential trialists] need to find a mentor. And for me, I really didn’t have a good mentor. And I just had to do  things kind of on my own. They need to identify a mentor, somebody who has been there, done that, to tell them how to  proceed … don’t be shy to get in touch with people from other institutions and ask them to mentor you. ”

“… what other resource could’ve helped me? ########… .perhaps a mid level to a senior surgeon who could discuss it [the research]  with me in a little greater detail, a little bit more holding my feet to the fire in terms of trial design.”

“… I think the biggest lesson is mentoring is critical at the medical school and college level. If you haven’t got it down by the  time you graduate medical school it’s probably not going to happen. That’s my take, over and over again.”

Establish a network of collaborators

“… try and go to societies or workforces or task forces and see who you might want to collaborate with. And from my  experience in the [professional society for surgical specialty], we have a monthly conference call in which junior faculty bring  up their ideas and bounce them back and forth with experts on the phone, telephone conference. And I can tell you that  there are some really good ideas going back and forth, in terms of where to get the data, how to design the trial, what  sources of funding are there and how to proceed.”

“The American College of Surgeons [offers] a two day symposium for clinical scientists. And that’s one resource for them. The  other resource is that as surgeons there’s lots of professional societal platforms that they can use. And I got to be involved in  this in reverse. Rather than knowing about it and joining it as a junior faculty, I actually got to be known through my  research and I got contacted by our society [of surgical specialty], to become a member of their clinical research trial work  force. So now that I know those things, if I have a junior faculty come to me, I could point him in the right direction and  the resources. I found out that there’s extensive resources. I found out that there’s multiple potential sources of funding but  that junior faculty are not aware of them … I’ve learned them by, I keep saying osmosis. Because I really wish I knew them  right away.”

Participate in all aspects of clinical trials

“I think the best training would be to participate in one [a trial] and just keep your eyes open and see you know what’s  involved, what the work is.”

“Certainly if you’re doing human subjects research you should spend time on the IRB.”

“I recommend that they [aspiring surgical trialists ] have incremental increases in their exposure and skill acquisition … hanging out with people who do this, going to their research conferences, listening to the minutia of why we  make the decisions we do in trial design and conduct and how we do surveillance of ongoing trials … it’s not just designing  a three-page concept. There’s so much more.”

Role of the departmental chairperson

“First of all no one really has the means or time to allocate to any formal training. So we as chiefs have to really provide the  funding for them and the time to do it. When we are developing the leaders of the future, when we are building the career of  young individuals we have to support them and we have to allow them the time to do these kinds of things. And so for chiefs  of department, we end up paying for those courses and we end up allocating the time for them to do it. You know in those  surveys, when we go back, the major barrier to those young individuals for being successful in becoming principal  investigators has been clinical time … most of the time is allocated to clinical work. This is what ends up generating the  most money for a department. I think this is sometimes short-sighted, especially on the side of chairmen of departments  because if a person is successful in research that ends up bringing revenues and recognition to a department as well. So we  have to give them the time and money to do it.”

“To do a clinical trial you have to have considerable resources. Practically the only person who can do it is the chairman of the  department, unless it’s something very simple. I mean a multi-center study is not simple … a smaller clinical trial, like a small drug  trial, yes, that’s simple, and one person could do that. But once you start getting to large numbers I think you need a lot of  resources—either you are the chairman and have the resources, or your chairman is backing you and will give you the resources.”

“I only provide the support for people who are serious and have potential to get funded. We have a limited amount of resources. I  can’t help everyone who wants to do a little chart review project. So if they’re really committed and show me that they’re really  committed to getting the training and potentially moving towards the possibility of submitting for independent funding, I try to use  those resources for those people. So they have to demonstrate to me that they’re serious about what they’re doing.”

“The chairs of departments are also cornered into a situation where they have to generate money and also have an academic  department and be successful academically. And they have to do a balancing act. I think the days when you know each person can  do everything are really over. You’re going to have as a chair of a department identify those people who can really be successful in  research and promote their career by protecting their time and giving them the seed funding. And then you know for those who  have little research inclination or have not been as successful is to direct them into the clinical arena and have them just work  clinically.”