Intent Solutions

Traction in the Clinical Trials Market

By Sam Zamarripa

Mention the term opioid crisis and you get attention. From members of the media, who don’t hesitate to devote space or airtime 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. However, potentially 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 and hepatitis C intervention programs, where a system like ours is sorely needed. In this blog, we’ll take a look at the role our system can play in clinical trials.

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 near real time the way participants take their medication. Administrators must rely on participant notes or diaries submitted after the fact—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.

Nonadherence can increase variance, reduce study power, and decrease the magnitude of treatment effects. 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.

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 tad 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.

A system “with legs”

tad has 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. It 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, specific timeframe.