Let’s discuss how you choose which research trials you should or should not be doing as a research site. I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. I want to speak to the sites today – business development professionals or others at the sites that are making those business development decisions. How do you decide when you should do a research trial and when you should pass on a research trial? It can be complicated. I’m going to drop it into three categories. Let’s make category one The Greater Good, let’s make category two Business Development, and let’s make category three Business.

So, category one: The Greater Good. Why should you do research trials for the greater good? Well, because it betters all of humanity and the future of humankind. So, what are examples of that? There are plenty of research trials in oncology, infectious disease, cardiology, and any field that you can think of where it’s going to be a hard-to-find patient population, the trial doesn’t pay all that much, and/or it’s not necessarily your tried-and-true area of expertise. But the trial makes a difference and the research should be done. Oncology has a lot of that – trials where you’re looking for one patient a year and you’re never going to make a lot of money doing this trial. It’s a risk because you could come up on a trial and just never find the appropriate patient in the next year, and then you’ve got a goose egg. You enrolled zero patients, which is embarrassing, and it’s what sites never want to see happen. But you came up on the trial because it was for the greater good of humankind. The research needs to happen and there’s a tough to find patient population. So what we need to do is cast a very wide net and have lots of sites everywhere so that if the right patient comes in and that site is prepared, we end up enrolling that patient and we get the data that we need to advance oncology care in triple negative breast cancer, or pancreatic cancer, or whatever the case may be. So, reason number one you might want to take a trial is for the betterment of humankind, for the greater good.

Reason number two, I said, was Business Development. What does that mean? Well, maybe it’s a stretch for you. So, you’ve got a great – no, let’s make it less than great – you’ve got a mediocre or decent trial opportunity, so you’re kind of on the fence: should I, or should I not do this trial? But maybe it’s with a sponsor or a CRO that you don’t have a lot of experience with and you’re looking to prove to them that you know what you’re doing and that you can do high quality research. And this isn’t the greatest trial in the world, but you believe that you can do it. The fact that you don’t have a relationship with them could be something that makes you want to do this trial and tip you towards saying yes to doing the trial, because it’s an opportunity for business development. It might not be a trial that’s going to be a slam dunk for you. It might not be a trial that’s going to make you a lot of money. But you’re doing it for the business development rationale. That’s going to help you build a relationship with companies that you don’t have a relationship with today. The same could be true of therapeutic areas. Maybe you are incredibly well known in cardiology and gastroenterology, and for some reason or another, nobody considers you capable of doing pulmonary trials. But you know that you’re capable of doing pulmonary trials. You’ve got internal medicine doctors who are doing research. They have pulmonary patient populations. Maybe you even have a pulmonologist. Saying yes to a mediocre pulmonary trial could be a very smart business development reason to take that trial, because it pushes you into a therapeutic area that you don’t have a lot of experience on your CVs today.

Reason number three is pure Business. Reason number three to say yes to a trial is because it is a slam dunk. It’s a trial that you’ve got a ton of experience in, a therapeutic area you have a ton of experience in, a patient population that you have a ton of experience with, a patient population that you have a robust known database with, a trial that is very well designed, a protocol that you’ve got a ton of experience with, and a contract and budget that is really in your sweet spot – a contract and budget that is very favorable to the success of your research site. That’s the business reason to say yes to a trial. You know that you’re good at that trial type. And that type of protocol? Man, that’s your sweet spot! You can do that. And this relationship – this particular contract and budget with this sponsor and CRO? It’s excellent! It’s exactly the kind of relationship we want to have. Well, that’s the simplest of the three, right? That’s the simplest reason to say, “Of course, we’re going to do that trial.

So when you’re thinking about ‘should I or shouldn’t I,’ the three reasons that you have to think through as to why you should are 1) because it’s for the greater good of humankind, 2) because it’s a smart business development thing to do, 3) because it’s a smart business thing to do. Beyond that, you really have to train yourself to say no. It’s far too easy to say yes. If you don’t have a good, justifiable reason to say yes, you should say no, and you should say no fast. You should say no before feasibility, or certainly say no before the PSV. And last case scenario, say no before the SIV. Ask others whether or not you’re being stupid. You may think, ‘You know, I really need to do this trial for the greater good of mankind.’ Ask others whether or not you’re being silly. Someone else may look at the same situation and say, “I don’t think this is really worth doing. I really don’t think you’re going to be successful with it.” And if you’re not going to be successful, then you actually didn’t move the needle on the greater good of humankind. Ask others because you might get different perspectives on whether or not you should or shouldn’t be doing a given trial. Be quick to say no; be solid in your reasons for saying yes if, in fact, you do so.

As always, thanks for riding along. Take care! I look forward to riding along with you again in the future.

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How do you decide when you should do a research trial and when you should pass on a research trial? It can be complicated. I’m going to drop it into three categories: The Greater Good – it betters all of humanity and the future of humankind; Business Development – to build a relationship with companies that you don’t have a relationship with today; Business – you’ve got a ton of experience in that area and the contract and budget is very favorable to the success of your research site. If the trial doesn’t hit one of these 3 marks and you don’t have a good justifiable reason to say yes, you should say no. Be quick to say no, but on the other hand, be solid in your reasons for saying yes.