Smartphone solutions for clinical trials

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Anthony Sterns and Napoleon Monroe ARTICLE IMAGE

New Directions Technology Consulting and iRx Reminder have recently signed an agreement to develop bidirectional smartphone-based solutions for improving clinical trials. Please can you give an introduction to bidirectional communication and how this differs from many mHealth applications currently on the market today?

Napoleon: mHealth broadly refers to the use of a mobile device to send patient information to or from a medical service provider. In most medication management mobile applications that are out there now, the “information” sent is usually a unidirectional nagging reminder to the patient. The application may populate a diary or it may not.

In the bidirectional applications that we anticipate both the patient and researcher are enabled to send information in both directions interactively so that the researcher can respond to the patient’s call or to sensed data. Sensed data could be from a ruggedized micro-sensor in a medication dispenser or another app that captures heart-rate data or other information.

The researcher can intervene in real time to a mobile patient with the benefit of knowing what medications the patient has taken and what his or her vital signs are.

What makes this compelling even beyond clinical trials is that true bidirectional communication can eliminate some of the needs for emergency-room visits, frequent repeated hospital admissions, and unplanned patients’ office visits.

For clinical trials, we can gather better data more easily, and make data gathering convenient and immediate for both patient and researcher, which can significantly reduce costs.

The products that we are developing use a combination of sensors in the medication dispenser and smartphones for communications. That provides the possibility for remote professional intervention.

While dispenser companies making medication dispensers are moving in the same direction, we have the advantage of years of work in the area and have already secured patents on many key enablers for these systems.

In some cases we anticipate monitoring if patients have their medications available; i.e., whether patients and medications are at the same location, as well as the condition of the medications (for example, not expired, undamaged, prepared as required and ready to be taken).

All of this is important, especially for critical meds; for example, such emergency-use products as seizure treatments, expensive biotech products, and the personalized medications that we anticipate in the future.

Anthony: Currently there are nagging communications from either calls, texts, or alarms that go off to remind you to take medications whether or not you have already taken them. Or technologies that are flawed, such as blister packs, which really just encourage turning in empty blister packs, not the taking of medications as planned and when planned. Recent pilots with Kent State University, Case Western Reserve University, and Summa Health System have demonstrated that study participants are significantly more satisfied with the iPhone-based medication support than with alarmed pillboxes. They say it fits well with how they organize and self-manage their medications compared to alarmed pillbox devices.

Bidirectional communication allows for more accurate data collection to know when and under what circumstances medications are taken. Equally informative is having the knowledge that people are not complying. By monitoring, the researcher can lower costs. If you can intervene in a timely manner, you can keep individuals in the study.

In what ways do you think bidirectional communication can improve clinical trials?

Anthony: You can closely follow the patient’s compliance to the protocol. We’re largely ignorant, particularly in phase 3 trials, of when medication taking happens. Using our systems noncompliance can trigger an alert that leads to an intervention. In this way we can help stop dropout.

Dropout represents about 30% of the cost of current clinical trials and without that dropout we also can get the last patient through a study much faster. With the rule of thumb of a million dollars a day for each day the drug gets to market sooner, that generally means considerable additional profit potential by completing the trial on time as planned. Typically the planned date is much earlier than the actual final date of completion.

Finally, the data in our system is collected in the moment; so, instead of a participant being asked in the clinic about symptoms and health changes, thinking back about what has happened in the last 30-90 days, they are recorded right when things actually occur. So the researcher gets a measure of the intensity of treatment, the compliance, and the positives and negatives. The health outcomes are recorded much more accurately. That also improves the accuracy of the data, making it more valuable.

Napoleon: Both iRx Reminder and New Directions have focused on the clinical trial market because it is so important that pharmaceutical company researchers or their contract research organizations have this information to complete their work.

Patients are usually not put in a hospital for the duration of the trial; in most cases they are out there on their own. Researchers have critical, unmet needs to capture data from patients taking their meds while roaming about in the world. A patent examiner characterized this as capturing information “in the wild.” We can help capture information from the wild and take it to researchers.

Researchers also have funding and can use a device that may not yet be approved for broad distribution. Such devices can be tailored to specific needs. Therefore, iRx Reminder can move more rapidly into real-world use.

Why is real-time data collection so valuable?

Anthony: The data is collected in the moment so it is more accurately recalled as it just happened. Typically data is just collected episodically, usually infrequently in the clinic setting. Using our system it is collected in the field using our smartphone-based app and medication is validated using our patented iLidRx medication cabinet. The data and the outcome are then tied with the behavior being measured -- the compliance of drug taking, the required time for rehabilitation post-surgery, or perhaps after wound-care procedures.

It is also important to point out that the data is all digital, completely paperless from patient to researcher. All field-collected information and outcome information can be easily brought together. In addition to saving additional costs entering and reformatting data, the analysis is easy. Understanding the impact of patients’ adherence to the study protocol in the context of all the study outcomes can be quickly evaluated.

I use an example that if a researcher has the cure for Alzheimer’s in a pill and some patients take the pill as instructed and are improved, and some forget completely or take on an irregular schedule (because the patients have Alzheimer’s), then you might conclude that the drug is not very effective. However, if the researcher knows how much of the drug has been taken and how regularly, and the compliance of each person, the proper conclusion can be reached. Namely, that the drug is effective when taken as directed.

With our system we know how much of a drug is being taken and the impact that it has.

Napoleon: You can also combine the information from various vital signs apps so you know both those and the pharmaceutical treatment. In the case of an Alzheimer’s patient you can tie the data together with the location based on the use of the GPS in the smartphone. In an Alzheimer’s situation this is very useful, and it can also be used in a number of other ways for other disease states. We have patent claims there, too.

Why do you think bidirectional smartphone-based solutions will reduce dropout rates from clinical trials?

Anthony: In the studies that we have completed, several funded by NIH, we have seen dropout rates between 0 and 10%. So these are considerably and significantly lower than the 30% in some other studies.

We are confident that our system will continue to have this kind of impact even in large-scale and longer studies because when patients are compliant they are empowered and both parties -- patient and researcher-- are aware of how well patients are complying. When patients do not comply, the researcher can intervene before the patient is so noncompliant that they voluntarily drop out or must be involuntarily dropped from the study. If the patient just misses a dosage or two for example, then those are recorded and we know that they happened.

With an alarmed pillbox technology often that alarm goes off no matter what. If you get a phone call and you haven’t taken a pill that day, you are not going to pick up and say you haven’t taken the pill; you are just going to let the call go. It makes you feel as if you got away with something and it reinforces not taking the pill.

The same thing happens with an alarm if you’ve already taken the pill and an alarm goes off reminding you to take it; you get annoyed and you dislike the technology.

When it’s a smartphone on your hip and it reminds you to do all sorts of things throughout the day and occasionally when it goes off you haven’t taken your pill - that feels good. You are glad that happens, just like when you are reminded it’s your sister’s birthday tomorrow.

So it’s much more reinforcing. Plus, there is some good psychology behind it, as well. One of the well-known hypotheses for self-empowerment is Bandura’s social learning theory. Bandura began his work in the 1950s. Essentially, his theory says that if you provide specific, personalized, relevant information at the right time and at a single point of action, then behavior will change.

And so we provide the medication schedules at the time they’re needed and always on a smartphone as that single point of action. We also provide behavior choice so you are always given the ability to take or skip the medications. You are always making the decision to take medications and not to skip them, which, is subtly reinforcing.

All this psychology research is built into our technologies and proven in the trials that we’ve conducted.

Please can you outline your current patented technologies and how this collaboration will help to develop them?

Napoleon: There are five granted U.S. patents and other pending foreign patents, including in the European community, in the mMed portfolio. The mMed patents disclose cases or dispensers for almost all dosage forms. These cases communicate with a communications device having both a long- and a short range communications capability. That would be a smartphone in the current embodiments that we are working with iRx Reminder.

We disclosed the use of features in the smartphone in combination with the cases – I mentioned the GPS ability before; there’s also the use of a 2D barcode or an RFID chip on the pharma product. As you may know, there’s legislation making its way through now requiring a new standardized marking system on both drugs and devices. There are also parallel efforts abroad toward harmonizing these requirements.

We invented from a patient’s point of view trying to figure out how to combine the technologies that were out there or coming soon, and with knowledge of what it takes to manage meds in the field. We filed around those – not so much around a single specific mechanism but some of the combinations that smartphones enable. Our inventions lead the way to providing professional attention to a patient, at the convenience and location of the patient.

Anthony: Our work began around 2002. Our early intellectual property focuses on a handheld personal digital assistant running what we call an app today – I think we just called it a program back then!

Our patents bring together the coordination of reminding programs, medication reminding with an alert, and a convenient way of carrying the medications integrated with the smartphone.

Our more recent patent-pending application is a gesture-based pill dispenser that knows you’ve picked it up, dispenses the pill and records that information. Those pill dispensing devices (PDDs or “pods” for short) are contained in a medicine cabinet.

When a patient uses the standard 7-day pillbox, or something like a traditional blister pack, there are concerns. The pillbox separates the pills from the information about them and. medication schedules can be changed over the course of time and not remembered by the patient loading the pillbox. A blister pack assumes a fixed dosing regimen. Our system has none of these negatives and several additional strengths. For example, if there is a weaning of a particular drug over time, that can be done by our bidirectional communication. No need for an appointment or visit to the pharmacy.

Napoleon: As you can see, iRx Reminder and New Directions with the mMed portfolio have both been working in this area for quite a long time. We came together because we have complementary experiences and skillsets, as well as shared values, and can build a good working relationship and move forward together more rapidly to meet the needs of the clinical trial market.

iRx Reminder has a lot of proprietary software already developed. They have claims in their pending and granted patents that we did not have. Similarly, we have claims that they don’t have.

So it’s a good collaboration from an intellectual property point of view.

Tony has the clinical trial and grant management skills; and behavioral science skills that I don’t. I came out of the pharmaceutical industry; I managed products for pharmaceutical companies. I have that skillset. So it is really a good combination of skills that we will put together collaboratively to develop our systems.

Anthony: From our perspective the mMed portfolio enhances our technology, expanding our potential capabilities in ways we didn’t initially conceive. And New Directions and Napoleon personally have deep pharmaceutical industry experience.

What are the aims of this collaboration?

Napoleon: We together want to develop products and services using the combinations of means as anticipated by our patents and apply our previous work to meet clinical trial customers’ needs.

Anthony: We want to support far less costly development and demonstration of safe and effective drugs, medical devices, and health behavior interventions. I think in the long term we see exactly the same kind of technology we are using in clinical trials being applied directly to coordinated care in the healthcare industry.

How important do you think smartphones and bidirectional communication will be in the future of clinical trials?

Napoleon: I think it is going to be extremely important. We saw a great interest when we exhibited at American Telemedicine Association.

Bidirectional communication is going to be very important. When I began in this area people told me that telemedicine for medication management was completely crazy, that no one was going to be able to do this. But with smartphones, the apps, and other work that is being done in related areas, mobile medication management is the key to cost-efficient clinical trials and to reducing overall healthcare costs.

Anthony: I think first of all as the cost has moved from $1 billion to develop a drug to $5 billion, getting that drug to market faster and less expensively is key.

In general, the cost for each patient participant in a trial is between $35,000 and $50,000; often, in cases of cancer, it climbs above $100,000 per study participant.

So every time you can stop someone from dropping out, it pays for quite a bit of technology to throw at the problem.

Our technology is not only more efficient than other technologies but broader. So not only do you get savings, but you also get more accurate data.

I think once this becomes available; i.e., once the first adopter succeeds and gets to market that much faster, there will be only one way to do clinical trials going forward. In the same way as if you don’t have a smartphone you are at a disadvantage in communicating today.

What are your plans for the future?

Napoleon: New Directions will work with iRx Reminder and other interested parties to advance the use of bidirectional medication management.

One example of this is that we are helping to promote a U.S nongovernmental not-for-profit organization that has furthered medication management initiatives. That’s the Council for Affordable Health Coverage and their Prescriptions for a Healthy America program. See:

Anthony: We are already conducting clinical trials. iRx Reminder has projects completed or in progress with such institutions as Case Western Reserve University, Kent State University, University of Wisconsin, and Summa Health System. Those institutions that are already dipping their feet in are very excited about this way of collecting data. It is much more empowering and direct for the researchers to work this way.

So I think the future is already here.

How do researchers generally approach you?

Anthony: Generally, researchers discover us or first meet us through referrals or at industry shows, such as the American Telemedicine Association event that we participated in.

As they spend more dollars on interactive voice response (IVR) technology, those nagging phone calls, they get excited about gaining the ability to follow the patient more closely. Plus they’re being asked to gather more information in the field than ever before.

They imagine in some respects that this technology already exists even though it doesn’t to the extent you’d expect. In other words they expect there’s an app for that already.

Napoleon: And while there are a lot of possibilities, they haven’t been applied as broadly as they could be and that’s really what we plan to do. To get the information out to a greater extent, to combine our skills, information and intellectual property so that we can further develop them.

Where can readers find more information?

Napoleon: There are some other points for further information, too:-

I’m building a medication management discussion group within the mHealth Special Interest Group for members of the American Telemedicine Association. Anyone who wants further information can also contact me at [email protected] .

About Dr. Anthony Sterns and Napoleon Monroe

Anthony Sterns and Napoleon Monroe BIG IMAGEDr. Sterns is a recognized national expert in the area of gerontechnology and a pioneer in the application of mobile computers and smartphones for improving the quality of life for individuals living with chronic illness.

With more than 20 years of experience designing and bringing to market products and services for “the silver industries” marketplace, he has led National Institutes of Health grants and contracts in the development of software for medication adherence on mobile devices since 2001. His extensive direct project experience includes serving as the principal investigator developing post-transient ischemic attack (mini-stroke) and heart-failure interventions delivered using smartphones.

Besides being CEO of iRx Reminder, Dr. Sterns is faculty statistician and visiting associate professor for the Kent State University College of Nursing, and is adjunct associate professor for the City University of New York, School of Professional Studies. He has broad experience in research methodology, survey and instrument design, as well as advanced statistical analysis.

Dr. Sterns has been principal investigator and statistician for numerous completed healthcare, military, transportation, community agency and corporate research projects, as well as for surveys and technical reports. He has made more than 100 presentations before national and international audiences.

Prior to founding iRx Reminder in 2009, Dr. Sterns’ previous executive start-up experience includes having introduced six products for older adults, such as cognitive intervention therapy The Memory Magic, which is now in more than 1,600 facilities in seven countries.

Napoleon Monroe’s diversified background runs the gamut from developing and producing emergency pharmaceutical delivery systems to managing a Fortune 500 private brand, and building and managing the IP portfolio for a company that is now part of Pfizer.

His areas of expertise include product development, licensing, regulatory processes, risk management and international marketing, with experience managing business relationships in more than 30 countries.

As vice president of corporate brand development for global healthcare distribution and service company Henry Schein, Inc., where he held various positions from 1996 through 2008, Mr. Monroe was responsible for all aspects of the company’s private brands (annual sales were greater than $500 million). While there, he began filing medication management patents.

Before Henry Schein, Mr. Monroe spent more than 20 years at Survival Technology (now a part of Pfizer), where, as a corporate vice president, he was responsible for product development and systems strategy. While at Survival, he invented three medical devices that were patented and commercialized; two were for autoinjectors and one was for a transtelephonic, peak-flow monitoring device.

There, he also led teams that invented, prototyped, tested, commercialized and scaled up such other products as: the EpiPen, the leading product for treatment of anaphylactic shock; the Antidote Treatment Nerve Agent Auto-Injector delivery system, which still protects U.S. and allied military and civilian personnel; and products that supported the formation of Shahal Medical Services in Israel and Raytel (now part of Philips in the U.S.).

April Cashin-Garbutt

Written by

April Cashin-Garbutt

April graduated with a first-class honours degree in Natural Sciences from Pembroke College, University of Cambridge. During her time as Editor-in-Chief, News-Medical (2012-2017), she kickstarted the content production process and helped to grow the website readership to over 60 million visitors per year. Through interviewing global thought leaders in medicine and life sciences, including Nobel laureates, April developed a passion for neuroscience and now works at the Sainsbury Wellcome Centre for Neural Circuits and Behaviour, located within UCL.


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