Getting Traction in Clinical Research

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Getting Traction in Clinical Research

Sam Zamarripa

Traction in the clinical trials market: Our technology addresses more than the opioid crisis

Mention the term opioid crisis and you get attention. From members of the media, who don’t hesitate to devote space or air time to another story on the national epidemic. From lawmakers, who are under public pressure to do something about it. From healthcare professionals, teachers, employers—anyone who sees the epidemic’s ravaging effects on those they work with.

Helping solve the opioid crisis is something most people want to hear about. It’s the reason our company was founded, after all. The reason we developed our system for monitoring and managing prescription drugs. But helping people avoid the path to addiction is not the only use for our solution. We are gaining traction in other areas, too—especially in clinical trials, where a system like ours is sorely needed.

An end to the costs of adherence guesswork

Clinical trial administrators face a constant challenge with participant adherence—or the lack of it. Traditionally, trials have had no effective means of monitoring and managing in real time the way participants take their medication. Administrators must rely on participant notes or diaries submitted after the study is over—hardly a reliable way to trace adherence.

In fact, studies have shown that, even though medication adherence in clinical trials is generally reported as greater than 90% when based on subject self-reporting and pill count, the percentage is much lower when adherence is evaluated by periodic sampling of drugs in plasma or urine. While non-adherence can affect patient safety and ruin a trial, it is also costly. It has been estimated that it takes only 30% of participants who are less than fully adherent to require doubling the number of participants necessary to produce an equally significant study.

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Source: Shiovitz TM, Bain EE, McCann DJ, Skolnick P, Laughren T, Hanina A, Burch D. Mitigating the effects of nonadherence in clinical trials, Journal of Clinical Pharmacology, J Clin Pharmacol. 2016 Sep; 56(9): 1151–1164.

The costs are mind-boggling

The clinical trials patient recruitment firm Praxis has some eye-opening data about the cost of clinical trial delays. The company estimates the average cost of enrolling one patient in a trial is $15,700 for Phase 1, $19,300 for Phase 2, $26,000 for Phase 3 and $26,000 for Phase 4. These were the costs reported in July 2017. Other alarming stats from Praxis

The average dropout rate across all clinical trials is 30%.

The loss in revenue opportunity for niche drugs when a timeline is delayed is $600K per day.

The loss in revenue opportunity for blockbuster drugs when a timeline is delayed is $8M per day.

Almost 80% of all clinical trials fail to finish on time. 20% of those are delayed for six months or longer.

We deliver three key benefits to clinical trials

With stats like these, you can quickly see why pharmaceutical companies are showing strong interest in our solution. With tadTM collecting usage data from the moment the participants receive the drugs until they turn them in for reconciliation, clinical trial administrators get a precise accounting of adherence across the board.

Our system delivers:

·         Early detection of non-adherents. Administrators can quickly spot non-adherent participants and remove them from the trial before they have a chance to ruin the data and drive up the costs. With this early detection system, administrators are far less likely to reach a point where they need to expand the participant field.

·         Ongoing tracking of bona fide participants. For participants who stay in the trial, tad provides a clear picture of how well they are following the proper dosage pattern. It’s evidence that backs up administrators when they need to intervene or provide counseling to the participants about the importance of staying the course. No more notebooks. No more diaries. No more manual recording of dosage times and dates.

·         Accurate and speedy accounting. When a participant is kicked out for non-adherence, the drugs that were not taken must be returned and accounted for. The same goes for the conclusion of a trial—all the participants’ remaining drugs must be reconciled with the dosage diaries they kept. It’s a costly headache, and it can be eliminated with the tad system, which keeps a running real-time total of the pills that have been taken by each participant.

Many advantages over smart caps

There are many other advantages. Unlike smart pill bottle caps, another technology used in clinical trials, not just anyone can open the tad dispenser. tad’s biometric recognition system controls who has access to the drug and dispenses only the right dose at the right time to the right person. In addition, smart caps are easy to lose and, for patients with arthritis, difficult to remove and put back on. That’s not a problem with tad, which is the size of a smartphone and requires only the touch of a finger on the biometric keypad to dispense the correct dosage.

Our device can also be set up for windowed dispensation, meaning the pills will only dispense within a certain timeframe, as well as for dose titration, prescription tapering and remote prescription changes by the pharmacist per physician’s orders. Should there be an adverse event during the trial, the device can be locked so participants no longer have access to a drug. Smart caps offer no help in such a scenario.

A system “with legs”

There was a funny Business Insider article a few years back about products that were originally intended for a completely different purpose than the one they are known for today. The Slinky was developed to stabilize naval equipment on rough seas. Frisbees were pie containers. Play-Doh was a wallpaper cleaner. I’m certainly not putting tad in the same category as these products, but it is gratifying to see other uses for our system beyond the one that triggered the initial invention brainstorm.

To us at Intent Solutions, tad’s ability to solve many challenges in clinical trials is further proof that we have created a system that is going places. Helping patients. Helping companies. With the strength to bring significant change—and greater control—to any setting where people take prescription drugs.

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Data makes the difference: Telling the life story of every prescription

Sam Zamarripa


Tangible objects are easy to talk about. “Do you like my new car?” “What kind of smartphone do you have?” “This tomato came from my own backyard.”

It’s the reason we usually lead with our device when we talk about what we do at Intent Solutions. It’s just easier to talk about tadTM and its abilities as a smart, automated prescription drug dispenser than it is to talk about our other solution: the data that tad generates.

Granted, it’s not as tangible as tad, but in the long run the data offers the real value to healthcare providers and clinical trial administrators. And it’s the reason I’m devoting this blog to describing its benefits.

tad can generate data and present it in a concise dashboard that provides every detail about what happens to a drug once it is prescribed to a patient. It tracks every time the drug is dispensed and by whom (through tad’s fingerprint recognition system), and it dispenses medication only as the prescription requires. It works like a Fitbit, tracking not footsteps but the minute-by-minute history of a prescription—all in a user-friendly app on a smartphone or computer.

 

In hospice care, tad’s data can solve diversion problems

In the case of hospice patients, for example, tad alerts hospice officials of any diversion attempt by unauthorized individuals to take or redistribute the drugs, or any attempt by anyone, authorized or unauthorized, to take more of the drugs and take them more frequently than the prescription requires. Problems are avoided quickly, with concrete evidence provided.

Should a prescription need to be changed or at the time of the patient’s death, tad provides a secure way for caregivers to return the remaining medications to the hospice organization for final accounting and disposal, and the data trail it provides is invaluable in helping the hospice reconcile the remaining medications with what was originally prescribed.

In hospice care, this is a very big deal. 

Whenever drug diversion is suspected in hospice care, it often boils down to a contest of wills or veracity between the professional caregivers and the family, and it’s left up to the hospice organization to decide if the drugs have been misused, abused or diverted to other uses. Not a good position to be in, especially with no precise record of how the drugs were administered after they were picked up or delivered from the pharmacy to the home. tad—and the data it generates—provides that record.

Current methods for preventing diversion—pill counts, lockboxes, limiting each prescription to only a few pills at a time, employee training—are costly and labor-intensive. No matter how carefully they are managed, they are only baby steps in the quest to solve a giant problem.

 

In clinical trials, tad makes adherence tracking an exact science

In another important market for Intent Solutions, clinical trials face a different challenge from hospice care. They struggle with accurately tracking whether participants in a clinical trial are taking their drugs as prescribed. 

Traditionally, trials have had no effective means of monitoring and managing in real time the way participants take their medication. Administrators must rely on participant notes or diaries submitted after the study is over, and then the number of participants may need to be expanded to account for uncertainties in adherence rates—increasing costs and slowing time to market.

tad reminds participants when it is time to take their medication, but it goes a step further. It also provides clinical trial administrators with a dashboard that keeps them up to date—in real time—with a clear view of usage data at every step of the trial’s progress. If adherence is a problem, administrators can spot it quickly and expand the field if necessary. If the trial is offering incentives to participants, administrators have solid documentation demonstrating the participants’ performance, and can intervene at any time to change the field.

Unlike smart pill bottle caps, tad controls who has access to the drug and dispenses only the right dose at the right time to the right person.

(While caps with a Medication Event Monitoring System were shown in a  to slightly improve compliance among patients with schizophrenia, lost caps were costly, and the study concluded that patient compliance with such monitors was only estimated, because they only recorded the number of bottle openings and the date and time of each opening. A more recent  published in 2017 in the JAMA Internal Medicine journal reported pill bottles with digital caps reminding clinical trial participants to take their meds had no effect whatsoever on adherence rates.) 

 

Removing the guesswork

At Intent Solutions, we think tad and the data it provides are far superior to these smart cap/smart bottle systems. While some of them do track the weight in the bottle as a measure of whether a dose was taken when it should have been, they provide zero control over who is taking the medication or who has access to the bottle. 

And while diversion isn’t the issue in clinical trials that it is in the hospice setting, isn’t it better to know precisely who triggered each dose of a medication, and when?

Knowing. That’s the difference Intent Solutions’ data makes. Whatever the environment, we’re removing a lot of the guesswork that—until now—has played a significant role in monitoring and managing prescription drugs. Sure, data might be intangible, but the results it delivers are real. 

We’ll be sharing some of those results when we report in a future post on a current pilot project with tad in hospice care. 

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Setting the new standard for administering opioids and other prescription drugs

Sam Zamarripa


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Every successful business or product starts by answering a fundamental human need. Granted, some needs are more urgent than others. Antibiotics? Pretty urgent. Refrigerator door ice dispensers? Not so much. Driverless cars? The jury is still out on that one.

What about a solution to the opioid crisis? Bingo. Everyone—from physicians to government leaders, from Boomers to Millennials, from employers to teachers, from EMTs to medical examiners overloaded by the sheer number of overdose victims requiring autopsy—all agree that something must be done. The numbers are old news by now: The CDC and National Center for Health Statistics (NCHS) report that more than 115 people die in the U.S. every day after overdosing on opioids. Research shows that roughly 21-29% of patients who are prescribed opioids for chronic pain misuse them. 

Something must be done, indeed. That’s the reason Intent Solutions was founded. 

It’s not just the numbers that moved us. Two of our founders have a friend who struggled and recovered from opioid addiction after hip surgery. I discussed a little more detail about it in a recent interview with Crain’s Atlanta Newsletter. In addition, we knew that Georgia, our home state, has one of the highest numbers of prescription opioid overdose deaths in the U.S. But our company’s goal is more far-reaching than tackling the opioid crisis in Georgia.

Putting the control back in controlled substances

Our platform includes an automated dispensing device—tadTMfor “take as directed.” It controls prescription drug dosage and collects usage data that up to now has been unavailable—data that can prevent the misuse, abuses and diversion of opioids and other prescription drugs. Current methods for tracking prescription drug adherence rely on pharmacy refill rates, which provide an inexact picture of prescription compliance or non-compliance by patients and caregivers. Our mission at Intent Solutions is to change all that—to set a new standard for administering opioid and other prescription drugs, and to render current methods obsolete.

If you think about the evolution of the pill bottle—from a little cup, a little glass, an open vial, to plastic—the first major innovations with the pill bottle came with the Poison Prevention Packaging Act and then later with the Tylenol scare in 1982, when people died after taking Tylenol laced with potassium cyanide. Within a matter of months, every pill bottle cap in America was then not only child-proof, but it was also sealed. Those innovations were two of the last big innovations in how we manage the vile itself.

At Intent Solutions, we believe that technologies like ours have a big role to play in improving adherence, and it is heartening to see the interest from the U.S. Congress, the Centers for Disease Control (CDC) and a range of statewide organizations in how we can be part of a broad-based solution to the problem. We’ll be reporting our progress in future blog posts. 

The good news about prescription opioids is that they work. They can relieve pain in people that are suffering with chronic pain. Our device gives them a level of safety that didn’t exist before, and it gives their doctors the ability to monitor them more carefully. That, in our view, is a combination destined for success.