How To Solve The Inexperienced PI Dilemma In Clinical Research
Last week I received a question from a viewer that reads like this: “As you may recall you mentioned (in your webinar) that new Principal Investigators (PI’s) may have a hard time agreeing to work in clinical trials, because they’re still looking for a stable position or are just too busy. However our problem is not with recruiting them, it is getting them approved by the sponsor. So, our question is: What is some advice you have that will ensure new PI’s get approved by the sponsor?”
So, that is the catch 22, there’s actually quite a few dilemmas here when it comes to PI’s. The first one is this experience you are referring to. No sponsor wants to be the first one to give a study to a brand new PI; you are not going to get new studies unless you have experience, but you are not going to get experience unless you have studies, right. That’s a little paradox or dilemma that we have to deal with here.
The second one is, you have to find a balance between a PI that has a busy private practice and very little time to dedicate to research, versus a PI who doesn’t have a busy private practice, maybe doesn’t have a private practice at all, and has all the time in the world to focus on research. While this is another dilemma, there are pros and cons in both of those scenarios. So, I’ll get back to your experience dilemma in a little bit.
First, I want to talk about the PI’s that have busy private practices, but very little time versus the PI’s that don’t have any private practice, but have a lot of time. You can work with both; the idea is really, that you want both. You want to have a healthy mix of investigators at your site. You need those busy PI’s with the busy private practices, because they are going to be your main referral source for study participants. It’s a good way for them to earn passive income or as close to passive income as possible for them. By referring patients into their own studies, there are no ethical issues with referrals fees or anything like that. After all, it is their own study. You’re going to pay them a commission based on a percentage of your total revenue that you get from the study budget. So the question now becomes what can you do to run a clinical research study given the fact that this PI doesn’t have much time, but they still need to have oversight over the study? The answer is they can delegate duties to their sub investigators who have a lot of time, but don’t have a busy private practice and those Sub-I’s can do all the procedures and the two can work synergistically with each other. There is probably a way for them to work together so it is your job as site director or clinic owner to work the different angles. Look for ways for you as you as a research clinic, as a business person, or as the person in charge of running your research clinic, to actually help these doctors, even outside the immediate scope of research. Help them build their private practice. If you have a PI with a busy private practice who just doesn’t have time, you can find a Sub-I who has plenty of time and no private practice, maybe no business skills, or is having a hard time developing a private practice, put them together let research be that bridge, have them work on your research studies, so you benefit, they benefit, but they can also work with each other in their private practice arena as well.
Now this viewer’s second question was:
“What is some advice you have that would help ensure new PI’s get approved by the sponsor other than the CV?”
As much as I would love to give you an intricate answer or perhaps a step by step method for tackling this issue , there is really no other way, the sponsor looks at the CV of the PI when choosing which sites they will give a feasibility questionnaire to. What you should do is be proactive about it and maybe a few months before you know that you want to put this physician as a PI, put him or her as a Sub-I under the model I just talked about. Being a Sub Investigator, is so under rated, I believe that it is the most under rated word in research. If you are an MD and you are a Sub-I, you can do everything that the PI is qualified and certified and delegated to do, as long as the PI delegates that person. So, you can build up someone’s CVs in a hurry and in fact that’s what I do with a lot of my clients that I consult with, when we find them a PI, we first find them a Sub-I, we have them work with the clinic, under the model I’ve just explained, there is going to need to be some synergy there and a lot of it will depend on what environment they will be entering into. Is it a busy private practice, a not so busy private practice, does the PI have no time for research, a lot of time for research, etc. Once you plug in the sub-investigator into the system, the Sub Investigator should gain a lot of experience in a few months’ time.
Once this Sub-I gains some experience, it is time to apply for a study of their own. When a sponsor comes out to your site they are going to ask if you have any research experience; you are going to say yes. They are going to try to ask you if you were ever a PI; you will have to say no. But there is one hack to this if your PI is cooperating, you can agree before the study starts or during the study if the study has already started. Let your existing PI know that your Sub-I is going to be a Sub-I, but then sometime in the middle of the study you are going to switch them to the PI, and the PI will switch to be the Sub-I. This works best after you have randomized a good number of patients in your study and also if you are a relatively good site. You can assure the sponsor, that the PI’s not leaving, he’s just going to be a Sub-I, and now when another sponsor in the future asks you if you have ever been a PI, you can look at them, smile and say, “Yes!”
Hopefully this helps. Just remember to be practical with these things, use some common sense, and as is true in all business, work the angles.
