Long-term follow ups in clinical trials can be as difficult as they are vital, revealing crucial insights into effectiveness over time, including delayed side-effects and enhanced long-term benefits.  

The challenge is: The longer a patient is asked to engage in study task completion, the more their burden increases, encouraging drop off rather than continued participation. In addition to outright burden, traditional follow-up methods (e.g. phone calls or paper questionnaires sent via mail) don’t entice engagement, and participant contact information is likely to change.  

But, there is one solution to these challenges that presents an effective avenue for addressing loss to follow-up (LTFU) and long-term drop-off: BYOD ePRO. By leveraging the ease and convenience of electronic patient-reported outcomes (ePRO), in combination with humans’ everyday interactions with their mobile devices, “bring your own device” (BYOD) ePRO models can help keep participants engaged longer and, in turn, advance the collection of high-quality patient data over time.  
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The Dangers of Loss to Follow-Up

There are any number of reasons why a patient may choose to drop out of a clinical trial: They may lose interest, experience adverse reactions, feel too burdened by study protocols, and so forth. Those reasons only compound as study duration increases. In fact, research published in Applied Clinical Trials magazine shows that loss to follow-up more than triples between 12 and 48 months after the beginning of a trial.  

The dangers of loss to follow-up can impact each touchpoint of the clinical trials process—from patients to sponsors. Data loss due to drop-outs produces incomplete study results, leading to biased data and compromised study validity, despite the efforts of study teams and sponsors. And, of course, any barrier to the progression of clinical research results in longer clinical trial periods and thus more monetary expenditures and headaches for sponsors and patients.
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Evolving Long-Term Data Capture Methods  

In this digital age, it’s no surprise that the traditional methods for conducting long-term follow-ups—site visits, paper questionnaires, and phone calls—are increasingly ineffective. In short: They’re burdensome for patients.  

When ePRO proliferated, data capture improved. And now, BYOD ePRO is changing the landscape even further by reimagining tasks as part of patients’ routine engagement with their mobile devices: Months after the conclusion of the initial study duration, a notification pops up on a re-consented patient’s phone from the app they downloaded at the beginning of the study. The patient quickly completes the task when they have a moment, and the study team has their data.    

By bringing follow-up tasks to the patients and allowing them to complete those tasks using their own smartphones, BYOD ePRO provides patients with the flexibility and agency they need to remain engaged—the most critical component of patient retention over time.  
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4 Key Benefits of BYOD ePRO Models for Long-Term Studies

BYOD ePRO models deliver a range of benefits to clinical trial stakeholders, including:

Increased Engagement  

The biggest advantage of BYOD ePRO is simple: Participants prefer it. By weaving the follow-up process into the flow of participants’ daily lives, subjects remain satisfied and engaged for longer. And, by leveraging patients’ own mobile devices as study tools, there’s no learning curve required for patients to understand a provisioned device. Research demonstrates that BYOD patients show greater engagement while using their own mobile phones than they do with provisioned devices and are more compliant with study protocols in BYOD models.  

Reduced Site Team Burden

Reducing participant burden isn’t the only concern in long-term clinical trials. Developing ways to make follow-up processes more seamless and convenient reduces study team and sponsor burden as well. BYOD ePRO inherently saves time and resources. It reduces, and even eliminates, much of the costs associated with traditional methods—as well as costs accrued as a result of loss to follow-up—while also removing the need to commission, ship, maintain, and train teams on new devices.  

Streamlined Safety Monitoring  

There is also the vital question of participant safety. In a BYOD model, study teams can increase the frequency of follow-ups without significantly increasing participant burden. In addition to allowing the study team to review the data in real time, this more frequent data stream expands contact with patients, improving the likelihood that any adverse events will be discovered and addressed quickly. What’s more, automating the monitoring of symptoms actually reduces the occurrence of adverse events as well as emergency department visits.

Better, More Accurate Data  

Not only does real-time data capture help with the monitoring of adverse events, it also increases the quality of the data collected. In a traditional study, if a patient goes on vacation or is navigating a busy week, the provisioned ePRO device is most likely ignored. But, most people carry their smartphones with them anywhere and everywhere they go. BYOD models leverage this everyday reality, allowing patients to input symptoms as they experience them. As a result, trial sponsors are gaining real-world, better, and more accurate data that boosts study legitimacy.  
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How BYOD ePRO Models Can Boost Long-Term Follow-Up Results

Whether a clinical trial is fully decentralized or hybrid, BYOD ePRO models have the potential to improve not just the patient experience and loss-to-follow-up rates, but also opportunities for teams and sponsors to conduct truly impactful research. Digital solutions to common challenges in clinical trials are no longer the future—they’re “business as usual.” And, the introduction of BYOD ePRO to long-term studies comes with the promise of a new and improved status quo. Read our related article, ePRO Solutions