DarshanTalks Podcast

Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

Once patients are enrolled in your clinical trial, how do you get them to stay? We will examine the factors that determine if patients will remain enrolled in your clinical trial.

Education during non-study visits

Creating a network of support for patients can extend beyond the study-related visits. In fact, the routine primary care visit is a good opportunity to expose patients to the possibility of a clinical trial in a no-pressure environment. It can be a space to provide some background information and let the patient decide to follow up (or not) regarding participation.

Remind participants of the big picture

In most cases, people do not decide to participate in a clinical trial for the money, but rather for the opportunity to help health research. Study participants might have been excited about contributing to health research when they enrolled, but after all the visits and time invested in the study, they lose sight of their impact. Remind patients why their choice to participate in the study is impactful. Spread positive awareness of clinical trials in your office, share good news about patients benefiting from health research. Participants will appreciate knowing the positive impact that their actions are having on patients.

Convenience to the patient

Some clinical trials require extensive in-person visits and travel, which can make patients question their commitment to participating in the study. If there are aspects of the study that could be done from the patient’s home, consider arranging for that. A nurse could visit the patient at home to draw blood take a measurement. Additionally, appointment reminders and flexible hours to work with differing schedules will help participants make and keep appointments.

Fear of the unknown

Patients are told what will happen in the course of the study, but it is not reasonable to expect them to remember every detail discussed during the informed consent process. Instead, it would be great to give patients a handout or takeaway folder that contains all the information presented in a format that those outside the medical professions can understand. Researchers should always make the informed consent form accessible to patients, so they can refer back to it throughout the course of the study.

Engage with patient communities

Patient Leaders

Some people with illnesses find other people with similar conditions to lean on for support and guidance. If you are enrolling a patient population in a clinical trial, you may consider reaching out to a patient group to interview the leaders. It may also help to organize a focus group with the group leaders to find out more about patient priorities and expectations. It may surprise some health care professionals that there are patient leaders since these leaders are not usually considered among the key opinion leaders in medicine. The patient leaders are trusted by patients and have intimate knowledge of the patient experience.

Contemporary Participants

Past and current participants can play a significant role in easing the concerns of recruited participants by talking them through what their individual experiences. Side effects that sound scary on paper might not be that important to patients, whereas a test that seems routine to the medical professional was frightening for patients.

Unblinding Concerns

It is also important to proactively address concerns around unblinding. The concern that patient groups could unblind patients from their course of treatment is valid, but there are ways to ensure the blind is maintained.

This is part 2 of a 2 part series on patient centricity in clinical trials.  You can read part 1 here.

In this follow-up to our recent discussion on clinical trial enrollment, we will discuss how an emphasis on patient centricity will help clinical trial researchers overcome a few challenges when trying to enroll in research subjects.

1. Complexity of the study

Although pharmaceutical companies and clinical research organizations (CROs) are fluent in the operational complexity of clinical trials, they must remember that potential research subjects are not. In fact, many patients may have only a basic understanding of what a clinical trial is and what they can expect to experience. Researchers must always think of the participants as people with needs, expectations, and fears; they are not simply potential data points in a study.

Researchers must communicate with potential study participants about not only what clinical trials are in general, but also what this specific clinical study will entail. This might include the types of procedures and tests they will have if they participate, how many appointments they will have, when, etc. By talking to participants and understanding their perspective, researchers can facilitate better clinical trials through patient centricity. The informed consent form is a helpful tool to facilitate this conversation, but it does not supplant the valuable face-to-face interaction that a potential subject has with a researcher. It is better to think of the informed consent form as an indication that a conversation took place, but not as a conversation in itself.

2. Fear of the unknown

If study participants do not feel that their questions are addressed by the researchers, or if they do not trust the information that they are given, they will seek other ways of getting the information. Some participants may turn to social media to connect with other participants through a private Facebook group or Twitter chat. These conversations between patients may result in inadvertent or intentional unblinding when patients compare symptoms or find out about how the other patient is reacting to the drug or placebo. Of course, this can have damaging implications for data integrity if the conversation ‘un-blinds’ the subject.

This situation can be mitigated by proactively connecting participants to one another. This would allow patients to have their questions about study experience answered, but can be done in a way to prevent improper disclosure of secure information.

3. Discussing patient experience

There are key aspects of patient experience that need to be discussed in order for study participants to feel comfortable participating in a research study.

Patients like to hear about the experience from the perspective of other patients. When a clinician describes a certain test or procedure, they describe the events that take place and what the possible risks might be. When a patient describes it, they describe how the event felt from their perspective; they will say if it was painful, or uncomfortable, or nothing to worry about.

However, there is a large part of the conversation that is not exactly clinical in that it is not focused on reactions to the drug. Still, when making any type of commitment or decision, people generally want to know what that entails so they can decide if it will work with their lifestyle. Some examples of common questions about patient experience might be:

How many appointments will I have and when will they be?

Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

This is part 1 of a 2 part series on patient centricity in clinical trials. You can read part 2 here.

Enrollment is the lifeblood of a clinical trial and is yet one of the most problematic issues. This blog explores the reasons why your patients may not enrolling and how they can be addressed.

Background

Most studies are initiated by a sponsor seeking out a clinical research organization (CRO) to handle recruitment. The CRO contacts potential study sites to ask if they may have patients who will qualify to be research subjects in the clinical trial. After that, there is sometimes little structured recruitment. Typically,  the CRO will reach out sites and ask them if they are treating patients who might qualify. In some cases, well-known or prestigious research sites (such as highly ranked university hospitals) may have qualifying patients. The sponsor would hope to get the more prestigious research sites on-board with the study. While they might have some patients who will qualify for the study, this recruitment model is not necessarily the best or only way to reach potential patients.   

1. Define a recruitment strategy

Sponsor clinical trial departments and clinicians routinely see marketing as a four letter word. However, once clinical trial recruitment fails, sites often request Sponsors for money for ad-hoc marketing advertisements. These advertisement plans are neither consistent nor necessarily effective. It is important that companies have a cohesive and consistent marketing plan that work together and produce consistent and planned efforts.

2. Identify patients

Patients and caregivers routinely join patient support or advocacy groups to get information about their disease. These groups maintain a network of people with the disease state and help them stay informed and supported. Patient groups can help connect sponsors narrow down their recruitment efforts to patients with specific disease states.  While direct patient outreach is allowed and benefits patients when done correctly, inappropriate methods can expose companies to significant liabilities (as seen here and here).

3. Maintain patient trust through the secure maintenance of information

For companies to begin engaging with patients, they must be prepared to maintain the security of patient information. Aside from the legal repercussions of improper disclosure of private health information, drug researchers are vying for patient trust. A patient may be reluctant to engage with organizations if they are not assured of the security of their information. Distributed ledger technologies (DLTs) such as Blockchain, help facilitate the appropriate sharing of information. Through Blockchain, sensitive information is transparent to certain approved people but is secure and protected when distributed improperly. Because it is both transparent and secure, Blockchain ensures data integrity and privacy and can be used to help build transparency and trust with patients.  

4.   Spread awareness!

Spreading awareness of a clinical trial can take many forms:

Traditional Marketing

Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

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Major:

Hey, guys. My name's Major. I'm with Darshan. We are with the Gavel & Pestle podcast. Today, we're talking about the pharmacist and patient centricity. This is a good episode. This is episode 206, right? 205 was marketer fraud. As a pharmacist, that's pretty ... Actually, that was a really interesting one. We had a series of four, plus a bonus tip on what to look for in a marketer to avoid fraud, right?

Darshan:

Yeah. We were laughing, 'cause Major pointed out that I never know how to count. I always have a bonus, so why don't we just announce the bonus from the get-go? But I never ... The last one comes out of nowhere, so -

Major:

It's ... Sometimes, we do kind of come up with one at the end. It's like, "Oh. There's actually ... We totally forgot this. Let's dump it all together." So.

 

But today, episode 206, we're talking about pharmacist and patient centricity. Darshan, what is patient centricity?

Darshan:

So, you know what? Patient centricity is this new hot topic that everyone's talking about, whether it's pharmaceutical companies, whether it's doctor's offices, whether it's healthcare in general. Everyone's saying, "Patients should be the focus."

 

Here's the funny thing: Why weren't patients always the focus? It's ... In the end, all of us are just trying to help patients do better. Why does it take a new sort of wave of interest to go, "You know what? The ... It's all about patient centricity." Well, it should have been in the place. It's all about making sure that the patient's needs are met.

 

But when you think about it, when you think about the paternalistic doctor who's telling you, "This is what you need to do," that's what we always lived with. When you think about the pharmacy ... sorry, the pharmaceutical company, saying, "These are the medications. Suck it up." Well, that world is changing.

 

So patient centricity, what does that mean for the pharmacist?

 

Let's start with what it doesn't mean. It does not mean, when the patient comes in, they drop off the prescription, you've got that ... You've got the technician who's probably overworked, who's really unhappy, who takes the prescription, has this foul mouth, who's really upset, who's really tired, and goes, "Come back in 45 minutes." "But I need it right now." "Well,

PillPack was acquired by Amazon for almost a billion dollars. In this Gavel and Pestle podcast episode, we discuss what that means for pharmacists.

Amazon has made moves recently to get into the pharmacy space. In this podcast, we discuss 3 ways pharmacists can compete with the Amazon Pharmacy of the future.

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Darshan:

Hey, Major. It's good to hear from you again. How are you doing?

Major:

I'm doing pretty good. Today we're going to talk about fraud and pharmacists. This is the Gavel & Pestle Podcast. My name is Major, and this is Darshan.

Darshan:

Hey, Major. It's been a long time. So today we're going to be talking about pharmacists and when we do wrong and, "Is this a big deal?" Is it the equivalent of, "You know what, a pill here and there, do we worry about them?"

Major:

What are you talking about, fraud and pharmacists. Now, we defend pharmacists on the show, on the podcast, quite a bit, and for legitimacy. The thing is, we're talking about fraud and pharmacists, so pharmacists can be involved in fraud? How is that? How does that work?

Darshan:

So here's the funny thing. Today's news or yesterday's news was a pharmacist in Germany was involved in diluting chemotherapy for patients, for very expensive patients, and the fact was that patients potentially died because of this dilution. And if that same situation had happened in the US, that pharmacist would very much convicted of fraud, fraud by the government, and fraud to patients. So those would be things we're thinking about. Is that the only way? No. The dilution, which obviously would have hurt patients, for what, so that he could have a nicer house? That's not what he went to pharmacy school for. I mean, it's nice if he has a nice house. I have no problem with his nice house. But it shouldn't ever happen at the price of his patients.

Major:

Just to clarify, fraud is defined, and this is just strict Google definition, right, "Wrongful or criminal deception intended to result in financial or personal gain." So in that situation, he wasn't the most quality of an individual, just a personal-

Darshan:

There you go, exactly right. And that's the problem. Here's the other thing, most pharmacists think that we are operating effectively under the radar. We also sort of think that we're beyond reproach. I mean, for the longest time, pharmacists were the most trusted profession. In recent times, nurses have taken over. Clergy have come close. But pharmacists tend to be amongst the highest trusted professions, and that's been dropping, and that's a concern. We as pharmacists need to look back and figure out what's happening.

The next thing that we need to look at is, is this a common enough occurrence? So does it happen every day?

Major:

Are these guys just outliers that we're hearing about?

Darshan:

Yeah, exactly. These people obviously are outliers. It's not like every second pharmacist you see is cheating an...