Show Transcript

Major:              Hey guys my name’s Major, I’m here with Darshan, and today we’re talking about why patients are not joining your clinical trial. Darshan.

Darshan:            So it’s been good to get back to this. It’s been a few weeks since we’ve recorded a couple, so this is exciting.

Major:              Yeah.

Darshan:            The question that we keep coming back to is why are patients doing this? And is this an addressable problem, right? So everyone’s coming at this question of why are there no patients in my clinical trials as if it’s a conundrum that can’t be solved, and oddly enough I think that the solution belongs to the patients and in this concept that everyone’s talking about but no one’s really doing anything about, which is around the concept of patient centricity. We’ll talk a little bit about patient centricity, but I think if you talk to your patients you might find out more about why they aren’t joining your clinical trials.

Darshan:            Let’s get to the seven reasons, ’cause you know, Major, I like starting with numbers and then destroying what I originally thought would be the list.

Major:              That’s how it works.

Darshan:            Exactly. I’m thinking we should start talking about the problems of why patients are not joining your clinical trials. The number one problem is the fact that no one’s talking and figuring out, amongst themselves, what is the recruitment strategy prior to study initiation? The most typical way studies are started is that you would go to, you being a sponsor, might go to a CRO and tell the CRO, “Who can you find me? Where you can you find these people?”

Darshan:            The CRO will reach out to a bunch of different sites and ask them, “Well do you have patients who might qualify?” And then depend on the sites to tell them, and then they might have a couple of sites that are, for lack of a better term, prestigious; and since they’re prestigious, say some of the more prestigious university hospitals in the country or in the world, and hope to get them in on the study, and neither one of those is necessarily the only or the best way to get people into your study. They might have some people who would qualify, but is that necessarily the only set of people who should be part of your study? So I think the first thing is having a discrete and distinct recruitment strategy.

Darshan:            The next piece is using that recruitment strategy, to have a component on identification of patients. So I think it’s a multi-step process, the first one is identification of patients. What does that actually mean? To me identification of patients comes down to the idea that you talk to the patients. I know this sounds surprising. I know this sounds mind boggling, but find out from patients and patient groups: “Do you know where these patients might be?” You’re surprised and people are often surprised on the fact that they can and should be reaching out to patient groups.

Darshan:            There are multiple scenarios, and there have been recent cases and settlements, on where patient groups have been wrongly engaged and multimillion dollar fines have been paid on this, but-

Major:              Now whenever you say patient groups, do you mean like a specific demographic that’s been targeted before? Or is this just in general, your patient group of test subjects?

Darshan:            That’s a great question. Thank you for calling me out on that. So when I think of patient groups, what I’m actually thinking of are these disease states often have one or more groups that will represent their interests. A really good example of that is the American Diabetes Association, obviously they represent the interest of patients with diabetes; and obviously there are hundreds of these groups if not more, if not thousands.

Darshan:            Depending on the disease state, depending on how they classify it, a lot of these patients may have symptoms and they may have a patient group that comes in and represents their interests. So it’s going to these patient groups, trying to build those bridges, and asking them, “Do you know where patients who might have this disease state may be?”

Darshan:            Some of the companies who deal with rare disease states, they do a really good job of building these bridges with these patient groups; however, the fact is that some of the larger studies were patient centricity is not necessarily required because there are so many patients, they may or may not be using these strategies, but the FDA has come out and said they want appropriate patient engagement. Congress has come out and said that, and patients have come out and said that, so to ignore that, it seems foolhardy for me.

Darshan:            The part is, once you start getting into patient centricity, the question then becomes, “How do we keep track of this?” Because patient groups necessarily don’t look at pharma as “You know what, I think pharma’s a wonderful steward of my information.” And it’s not based on whether it’s fact or fiction, we’ve just been burnt as patients over the last 20 years, as consumers in the last 20 years. I mean everyone’s heard of the Facebook, almost on a weekly basis, we seem to have some kind of problem or the other with privacy, so the question then becomes how do patients feel like their privacy is being controlled and maintained?

Darshan:            To that extent what you can start thinking about is how do you use distributed ledger technologies like what’s called DLTs, Blockchain is a type of distributed ledger technology where it is transparent to the right people, but secure and private if it’s not being distributed inappropriately. So if it’s stored on those private, transparent databases, which it sounds really weird, right? Private and transparent at the same time, but again as, and full disclosure, I am VP of Regulatory Strategy & Policy at a large multinational consulting company, and in that consulting company one of the things we are doing is using a DLT structure to actually help connect with patients, to help connect with other groups. So for anyone who’s interested feel free to reach out, I’m happy to make the connection.

Darshan:            The other piece is … So we spoke about planning a recruitment strategy. We spoke about identifying patients.

Major:              So we’re talking about today … we’re running through the gamut of problems a company would have when they have the question of, “Why are patients not joining my clinical trial?” And what we’ve discussed so far is designing the recruitment strategy prior to studying the initiation. That is having a distinct recruitment strategy, understanding what you’re actually doing, and the-

Darshan:            Right.

Major:              … second one we discussed was the identification of the patients. Speak with patient groups. Identify those patient groups and then go speak with them. Where would some good idea … Are these patient groups gonna have very independent places, like points of contact? Or is there gonna be a central location? I would assume that it’s more than just going on Facebook, for example, and throwing out an ad campaign.

Darshan:            So the funny thing is, sometimes it’s as easy as going onto Facebook. They often are on Facebook, because they are trying to reach these patients as well. These are people who need help and these patient groups have their mission statement of helping people like themselves. ‘Cause these patient groups are often staffed by patients who actually have the disease state.

Major:              Okay.

Darshan:            So it is on Facebook. It is using a simple Google search sometimes, but sometimes it’s more than that because they do come together and there are, shall we say, groups that represent multiple patient groups as well. So it’s a little bit more complicated, depending on how complex you want to get into it.

Major:              Well, what about from the patient’s perspective? How do you increase the awareness of the issue? Maybe the don’t know that they have X, or X symptom does … is for a very specific thing and this as it so happens is for what you’re testing for.

Darshan:            Right.

Major:              How do you get that information to these people?

Darshan:            That’s a great question, Major, and that probably should be the third issue, I guess, we address, which is: How are you as a study sponsor or you as a CRO spreading awareness? And that awareness can be spread by advertising. It can be spread … actually putting out, I don’t know if you’ve been on the subway, but on the subway, at least in Philadelphia, we see these signs, “Would you like to be enrolled in a study on blah, blah, blah?” That’s one way of spreading it.

Darshan:            Newspapers, we all know newspapers. How many people still read newspapers? I don’t know the answer to that question, it obviously seems to be a dropping number, but people do, and the people who are part of your study may be using that. So the people who read newspapers tend to skew to an older generation. Having said that I do enjoy newspapers myself. These patients who would be part of your study may often be of an older generation. If that’s true, newspapers may be the right model.

Darshan:            Alternatively it may be online using Google ads or using Facebook ads, or using something else like that. So it’s-

Major:              It’s all about targeting your demographic, right? It’s about understanding your-

Darshan:            Exactly.

Major:              … patient population and going where they are. Obviously-

Darshan:            Exactly.

Major:              … for a younger crowd you’re not gonna be putting out an ad in the ‘Yellow Pages.”

Darshan:            Exactly right. That is exactly right. Thank you Major. And as you can tell, Major is a marketing guru, so him talking about designing and focusing Facebook ads is always fun because he can go down an entire rabbit hole with that so, we aren’t gonna discuss that right now.

Major:              So we’re talking about with the clinical is a lack of awareness. We’re talking about an awareness campaign to-

Darshan:            Yeah, that’s one.

Major:              That’s what we’re discussing. Well that’s number three, right? So to address the concern of why patients aren’t joining your clinical trial, one is designing your recruitment strategy, understanding what you’re actually doing.

Darshan:            Yup.

Major:              And make sure that you have that goal down. And then number two is identify your patient population. Speak with your patient groups, figure out where they are and figure out how to approach them.

Darshan:            Yup.

Major:              Because for number three you want to have an awareness campaign to fix that lack of awareness.

Darshan:            Absolutely right. So you wanna start having an awareness campaign, but that’s if you’re doing a direct-to-patient awareness campaign. Sometimes that may not be necessary. Sometimes you may want to just go and do this awareness campaign through your sites themselves.

Major:              Okay.

Darshan:            Specifically, you may want to reach out to a clinical research coordinator, and seeing if you can have a dedicated clinical research coordinator. There’s a study that talked about this as well. There was an actual study done, where they said that having a dedicated CRC would be useful in spreading awareness within the patients who come see those physicians that you have already identified as potentially having the subjects for your study.

Darshan:            It might be actually interacting with the medical community and saying, “You know what? We’re doing a study. This is going to be the site for the study, if you see patients like this would you please send them here?” Again it improves the awareness of your study. It helps you connect with physicians who may in the future be part of your recruitment strategy, but it also may help patients themselves because they may not even know that that study is something they either qualify for or want to be part of, and the study’s happening very close to them.

Major:              So here’s a concern about running a campaign like this, right?

Darshan:            Yeah.

Major:              So we’re not exactly selling paper, right?

Darshan:            Correct.

Major:              This is a medical … This is healthcare. This is a highly-regulatory space. It’s highly regulated, so how do you make sure that you’re actually staying in compliance with any campaign that you’re running?

Darshan:            Great question, Major. So I think what it comes down to is having an understanding of what could go wrong. So doing a promotional strategy around clinical trials is complicated, and the reason it’s complicated is because it doesn’t follow the same rules as a direct-to-consumer advertisement. If you did this wrong, you potentially look at advertising a drug for an off-label promotion, and that has exposed drug companies to multi-billion dollar fines. There are ramifications there and there are problems there, so drug companies will be, and device companies, will be very hesitant to engage with someone who doesn’t understand this space properly.

Darshan:            However, the fact is that there are ways to be compliant. There are ways to do FDA-compliant advertising and avoid making off-label claims. So be cognizant of that. Now recognize that those same issues of keeping things private, at the same time have to also be balanced against the SEC’s rules of making sure that important information is shared with investors. So it’s really weird. The SEC says disclose everything that’s material, and the FDA says that if you haven’t proven it you can’t disclose it. So it’s weird. How do you balance those two? One says tell me everything, the other one’s tell me nothing until you know it. It’s interesting shall we say.

Darshan:            Let’s sort of keep it at this at this moment. Let’s record a second part and we’ll talk about the other three reasons patients are not joining your clinical study. Major, do you want to sort of close this out and talk to people about how they can join in time for the next one?

Major:              Yeah, sure. Okay, I’m gonna stop it there. I’m gonna stop my recording, do you wanna stop yours or? Yeah go ahead and stop yours, just to make sure it caps it off.

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The opinions stated in this podcast are the sole and present opinions of the host and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.