Personalized Information at the Right Time: Four strategies to elevate patient experience in clinical trials (Part 2)





In this four-part series, we will identify major gaps in patient experience in clinical trials, and we will explore ways to address them to reduce patient dropouts and bring life-saving drugs to market faster. In Part 1 we talked about the difficulties of access to critical information for patients in clinical trials, and how always-on smart chatbots can fill that void.

Today, in Part 2, we will explore the daily burdens of clinical trials for patients and ways to alleviate them.

Remember our patient Jane from the previous post?

Jane is one week into her 3-year clinical trial. She has about 30 study tasks a week. She will need to prepare for her first site visit in about three weeks. She will have 36 full-day site visits in the course of the trial, for which she will need to take time off work. 
Every day, she has two medication dosages — one at noon after lunch and one in the evening after dinner. She also has to fill out a daily diary before going to bed, and measure her blood pressure using the supplied study device.

Jane is already overwhelmed with the number of study tasks every day. She has every intention to remain in the study, but her life is extremely busy with three children and a full-time job. Remembering to do all of her study tasks at the exact right time simply gets lost in her hectic life.

Patient non-adherence is a real issue in clinical trials

Jane is not alone. On average 40% of patients in clinical trials stop taking their medication after only 5 months1. For sponsors, this translates to $12 million dollars in additional capital needed for a Phase III trial, to enroll roughly 100% more patients in order to maintain equivalent statistical power2.

The reasons for patient non-adherence are numerous and complex and can vary greatly by person. Topping the list, however, is forgetfulness, with 50%-62% of patients in multiple studies reporting it as a major cause of their unintentional non-adherence3, 4.

What if we can help patients remember their multiple daily tasks at the exact time mandated by strict clinical trials?

Each Patient is Unique

We instinctively know that each person around us is unique and different from us in many ways. We don’t expect everyone to be an early-riser just like us, or love the same food that we love, or leave work at the exact same hour that we leave. Then why do we send the same email reminder to all patients at the same time, and expect them to react to it the same way?

Let’s think about Jane — she has to take her medication after lunch when she will be at work. We send a reminder to all patients promptly at 12pm to take their medication. But, in the rush of the morning to get her three children to school she completely forgot to grab her pillbox. Now she has no choice but to miss her medication and become non-adherent.

Personalized Information at the Right Time and Right Place

What if we knew Jane’s schedule, needs, and preferences, and could eliminate her burden of remembering the tens of new tasks from her voluntary participation in the clinical trial?

Artificial intelligence has the power to adaptively learn about each unique patient’s needs and preferences over time, within the constraints of regulatory and privacy frameworks. The resulting patient profile can inform various strategies to alleviate each unique patient’s burden, including forgetfulness.

With artificial intelligence, we will now be able to send Jane a reminder at exactly 8:35am, right when she is about to leave home, to remember to carry her pillbox with her so she can take her medication after lunch.

A small 1% improvement in patient adherence, can result in over $300,000 in cost savings for a Phase III trial2. Artificial intelligence can save sponsors millions of dollars by seamlessly eliminating the major cause of patient non-adherence while enhancing the patient experience in the process.



In Part 3, we will explore the power of education in engaging patients in clinical trials.

Brite Health Co. develops data-driven patient-first technology solutions for improving engagement and adherence in clinical trials. More at www.britehealth.co

References

  1. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Blaschke TF1, Osterberg L, Vrijens B, Urquhart J., Annu Rev Pharmacol Toxicol. 2012 
  2. Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost http://www.appliedclinicaltrialsonline.com/non-adherence-direct-influence-clinical-trial-duration-and-cost
  3. Unintentional non-adherence to chronic prescription medications: How unintentional is it really? Abhijit S Gadkari, Colleen A McHorney. 2012 
  4. Patient Medication Adherence: Measures in Daily Practice. Beena Jimmy, Jimmy Jose. 2011

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