Can Patient Engagement Improve Protocol Compliance?

Posted by Jim Lane on Feb 21, 2017 3:13:58 PM

Protocol non-compliance at clinical research sites is a well-recognized problem. Sponsors spend a lot of time, effort, and money finding deviations, implementing corrective and preventive actions, and cleaning data. The combined cost of CRA resources, sophisticated centralized analytics, and data clean-up activities can be enormous. More critically, a proliferation of protocol deviations can fatally undermine study results, thereby nullifying years of effort and dedication.

Given the scale of the challenge, study managers might understandably think that if site staff were to “walk a mile in their shoes” they would appreciate how frustrating it is and try a bit harder!

However, we shouldn't be too quick to pass judgement. After all, clinical trials are complex exercises and rely on site staff scattered across the globe, who don’t work for the sponsor, and whose primary job isn’t the trial. Problems are bound to arise!

Before handing over their shoes, study managers should consider the underlying dependencies faced by site staff. The reality is that sites do experience the same frustrations, but for them it’s often even greater. While study teams are dependent on site staff to implement complex protocols, site staff are equally dependent on patients! Like the study team/site relationship, patients don’t work for sites (quite the opposite!), have no medical training, only see a site staff member for a few hours over the duration of the study and, paradoxically, are also the most important people in the entire project. All of this is compounded by the fact that patients, by their nature, are notoriously non-compliant.

Protocol Compliance Alert.pngNon-compliant behaviour by patients (i.e., you, me, our families and friends etc.) is pervasive in normal clinical care and there’s plenty of research that confirms this. As patients:

  • We fail to keep appointments

  • We fail to have diagnostic testing or consultation as recommended

  • We fail to comply with medication therapy

  • We fail to follow medication monitoring recommendations

 An FDA study determined that:Protocol compliance drug reconciliation.png

  • 14 to 21% of patients never fulfil their original prescription

  • 60% cannot name all of the medications they’re taking

  • 30 to 50% fail to follow the instructions for taking a medication

Other research concludes that:

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In focus groups conducted by Longboat with site staff, we heard directly how this behaviour carries over into clinical trials. Examples given about patient non-compliance in real-world scenarios included patients:Site Staff Focus Group.png

  • Not fasting before a visit, resulting in the visit needing to be rescheduled for lipid profile, blood glucose tests etc

  • Forgetting to take investigational medicinal product on the morning of the visit, resulting in the site not being able to complete pharmacokinetic analysis

  • Forgetting to bring unused medication, resulting in the site not being able to carry out a compliance check

  • Forgetting to complete PRO questionnaires, diet diaries etc. at a specified time before the visit

  • Taking prohibited medication between visits, resulting in potential safety risks as well as potentially assigning causality to investigational medicinal product versus the prohibited medication

Again, this shouldn’t come as a shock. If patients struggle to be compliant in normal clinical care, the situation is hardly likely to improve when we layer on a bundle of non-instinctive activities typical of clinical trials. Add Fitbits, Jawbones, tablets etc., as patient-driven data collection becomes more commonplace, and we’re adding more to the list. If the patient was non-compliant before, now we have really raised the bar!

Patients are playing an increasingly important role in ensuring protocol compliance and data quality in clinical trials and this trend is likely to continue. However, the research indicates that those same patients are ill-equipped and often unreliable to play this critical role.

Patient centricity initiatives frequently focus on trial awareness, protocol design, advocacy reach-out, and communication of study results. The fundamental issue of non-compliant patient behaviour and its mitigation, through such measures as continuous trial support, encouragement, and patient engagement, must feature prominently and be part of core trial activities to help ensure patients have the tools they need to be compliant!

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