Improving Patient Compliance
Mark Taggart, Cenduit’s Head of Patient Reminders, discusses the challenges of patient compliance and how incorporating a patient reminder program at the start of your study can improve compliance and retention.
Lex Raleigh: Hi and welcome to the first of many Cenduit quickcasts. I'm your host Lex Raleigh. Today we're excited to welcome Cenduit's head of patient reminders, Mark Taggart, to the show as we discuss tips for reducing site work load and improving compliance. Mark, thanks for joining us. It's great to see you again.
Mark Taggart: Hi Lex, how you doing?
Lex Raleigh: Doing pretty well, pretty well. Mark let's dive right in. Can you talk to us about what you see as the two biggest challenges for investigator site staff today?
Mark Taggart: Yeah, two of the issues, amongst many that sites face, are making sure the patients turn up on time, and making sure they do the things they need to do in the clinical trial, adhere to protocol and do things correctly.
Lex Raleigh: Right. Are those challenges wide spread across protocols or are they hit and miss?
Mark Taggart: Well that's a really good question. Protocols vary as you know with different compounds. They have different types of people in them, with different indications, different illnesses. I think some of the challenges that you face are really problems that we face in day to day life. We're all busy, we all lead hectic schedules. You know, just remembering the things we need to do. Patients sometimes willingly look out for clinical trials and get paid to join clinical trials. Others actually are doing it for a treatment option, so therefore they just want to participate. In some studies people are highly motivated and they've got very good reasons to be compliant. For example, AIDS, HIV patients, are classically incredibly compliant. They don't need to be reminded to take the dose for very good reasons. Whereas diabetes sufferers joining long, new treatment regimes that they now have to adhere to has life changing circumstances.
Again, [compliance] changes depending on the indication and depending on the patient population. One thing that is for sure is that we all lead busy lives. Given the advent of smart phones, electronic calendars, text messages and email, wouldn't it be great if we actually had a way of communicating to clinical trial participants and helping them do the things they need to do in a timely manner?
Lex Raleigh: Right those are great points, Mark. What are sponsors doing to to address those challenges? I think you mentioned some of those about text messages, but is that an option for sponsors?
Mark Taggart: Yes it is. Some of the most enlightened leaders that we're speaking to today in pharmaceutical companies, these are the very senior people. They've noticed that clinical trials typically have a few problems, across all clinical trials. One of them is clearly recruitment, the other one would be retention, adherence and compliance. This is doing the things you need to do to prove the efficacy of the compound. Those guys, when I'm speaking to them, they're saying well, we know the adherence, compliance, and retention is an issue across all studies.
I think what happens is in the early start up phase of the clinical trial, the company is spending millions, and there's absolutely no doubt in anybody's mind that these really clever teams of people are putting together a study and that study is going to succeed. So they have no doubt in their minds. Because the studies are of long duration, sometimes the people that start the study aren't even the people who finish the study. It's not the study teams fault that they struggled to recruit or retain enough people. It's just that they're dealing with patients. Many of them incredibly sick, some of them just participating for the good of mankind in the clinical trial. Their motivations are very different.
I think we're now beginning to see really enlightened senior people in these clinical teams telling study team members, "look, retention, compliance/adherence, are going to be issues in your study. If people don't turn up in the correct state, at the right time at the investigator visit, we're not going to get the efficacy - the primary and secondary endpoint data that we need to prove the efficacy of our compound." Doesn't it make sense? It costs very little to implement a patient reminders program right to the design of the study. After all, we get them when we go to our dentist, from our hairdressers to turn up on time. If I was looking after my mom in clinical trial it would be great to get timely reminders, my calendar populated with all the things I need to do, and I could help my mom stay on track with the clinical trial. That would be good. It doesn't cost much money. It's very quick, very easy to do.
Lex Raleigh: Right, that makes a lot of sense. Especially the way you explained it there. What I've heard was there's a lot of challenges, and these studies are very complicated. This is maybe one of those challenges that goes beneath the radar. They don't really pay a lot of attention to it because they have so many other things to think about as they're setting up their study. Only the sponsors that are really focused on the long-term success of their study would recognize this as one of their primary challenges. Is that fair?
Mark Taggart: That's exactly it. That's exactly it. I guess it's the job of senior people who are watching the money ... We all know that studies cost millions of dollars to run, and if you divide the cost of a clinical trial by the number of patients participating in it - let's say it's a million dollar study, 100 patients. A million dollars may not seem like a large amount of money in clinical trial terms, but if you divide it by 100 patients, that's a very very high cost per patient. If each patient falls out because they haven't done the things you need them to do, that's a huge waste. It seems a shame when it's so cheap and easy to implement a patient reminders solution.
Lex Raleigh: Right, so maybe an ounce of prevention is worth a pound of cure. If you get the reminders right from the beginning of the study, you'll have more retention throughout and ultimately cost you less.
Mark Taggart: That's exactly it.
Lex Raleigh: So Mark, with retention being such an important topic in a clinical trial how important is it to have it early on? Is it okay to bring it in later in the study or do you really need it from the start?
Mark Taggart: Those are two really good questions. You can bring it in later on. The challenges that you have with bringing it later on is the informed consent. As you know, people that participate in the trial, they sign their informed consent. So if you haven't got messaging organized and contracts informed consent, then it's very difficult for you to actually add patient reminders later, because you're really sort of "spamming" them. Let's put it like that. So yes, it's very important to have it right from the start. I think that one of the things that's really nice that we've done here at Cenduit is we've integrated patient reminders right into the randomization technology. What that means for sites is they go into one system, randomize the patient and organize the drug supply. They can then just turn around and switch on reminders right to the patients. That really helps everybody stay adherent and compliant with various tasks.
Lex Raleigh: Right, that's fantastic. You can have it at any phase, but really getting it right from the beginning streamlines the whole process. Obviously you have more retention early on and not just at the end.
Mark Taggart: Yeah, that was leading back to one of the things you and I were talking about earlier. How senior management are really getting that clinical trials always have issues. They're not easy to conduct and very complicated. That's one of the reasons why they're so expensive. When people think about it, senior management now has really got to grips with this, and they're actually saying why don't we have reminders right at the start of the clinical trial? It's very easy, it's very low cost to implement. It's very straight forward. We will appreciate getting little alerts. Even just to attend this meeting with you today a little calendar reminder popped up and told me it's time to go. I've got five minutes. We depend on those now. Obviously, my grandmother is not as used to looking at her Outlook calendar and seeing her reminders pop up, she's got to go have a blue rinse. If she did, I'm sure she'd attend more efficiently.
Lex Raleigh: Fantastic information. Unfortunately that's all the time we have today. A big thanks to to Cenduit's head of patient reminders, Mark Taggart, useful insights as always.
Mark Taggart: Well, thanks.