Creating Patient Engagement in Clinical Trials

The environment for clinical research is tougher than ever. According to one study, the median cost per patient now stands at $41,117¹. As the cost per patient continues to increase, finding ways to improve patient retention and compliance becomes critical. It is against this backdrop that study teams are recognizing the value of patient engagement in clinical trials.


patient engagement in clinical trialsWhat is Patient Engagement?

Patient engagement is the holistic approach of treating patients as collaborators in the process of conducting research. Patient engagement leverages their insights to inform study design with the goal of obtaining meaningful, high-quality data. Most importantly, patient engagement provides study participants with transparent information about their role and offers them tools to stay informed and compliant with the study protocol.


How Do We Create Patient Engagement?

Patient engagement starts with the very basic design elements of a clinical trial. When possible, study teams should reach out to patient advocacy groups to help understand the unique needs of their community. What are some of the challenges patients may face in participating in this study? How can we better accommodate and address these issues to create an environment where participation is easy? 

This may include things like –

  • Offering transportation or flexible scheduling options 
  • Communicating the value of research in a clear and understandable way
  • Providing tools that make completing study tasks easy
  • Developing a study roadmap to keep patients informed

Site location and disruption of daily routine are two of the most common reasons patients cite for not being able to participate in clinical studies². If a patient works, has children, or both, finding time to come into the clinic can be challenging. Offering weekend appointments, providing transportation or offering remote telehealth visits (when appropriate) are all opportunities for study teams to improve patient engagement. 

Crafting a message around the study can also help, particularly during the recruitment phase of the study. Be clear about the study’s goals and how this research can play a positive role in the lives of those living with the disease. While this may seem obvious for oncology research it may be less so for other diseases. Share information such as the number of people impacted by the disease and what current treatment options lack. 

In addition to addressing logistical concerns and communicating value, providing tools and information to patients is critical in the execution of any patient engagement strategy. Once a study is underway, the various study tasks and instruments will need to be interwoven into the patient’s normal life. Providing tools to make participation easier can have a huge impact on a patient’s capacity to stay engaged with the study over a long period of time³.

For studies utilizing outcomes, diaries, journals or other patient-generated data, the use of a mobile app to capture information may be an easy way to foster engagement during the course of the trial. Apps allow patients to easily see what they need to complete and enables them to enter data wherever they are. This not only improves engagement but can reduce the risk of recall bias. 

Offering a study roadmap is another patient engagement strategy to consider. Give patients reference materials that make it easy to understand what tasks and activities they will need to complete. How often will they need to complete their patient diary? When is their next visit? How long is the study? What happens after that? These are all questions patients will have and providing documentation, either digitally through an app or on paper, can make the experience much easier.


The Bottom Line

Patient engagement is the process of reducing barriers, enhancing patient knowledge and making study participation easy. With R&D expenses now at $2.7 billion per approval, the need to weave patient engagement into study design is critical to the advancement of new medications. 


Related Content: Reaching for 99% Compliance and Engagement in Trials Webinar (Prerecorded)

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¹”Estimated Costs of Pivotal Trials for Novel Therapeutic Agents ….” 24 Sep. 2018, Accessed 9 Jan. 2020.

² “Global Public Attitudes About Clinical ….” 5 Oct. 2018, Accessed 9 Jan. 2020.

³”D3 Conference poster_rd3 – Datacubed Health.” Accessed 9 Jan. 2020.

Slash Costs in Clinical Trials with Your Own BYOD Calculator

By David Kiger, Chief Commercial Officer, Datacubed Health

We received such positive feedback on my last blog about the benefits of a bring-your-own-device (BYOD) approach to patient connectivity in clinical trials that I decided to offer additional thinking on the subject. If the last article exploded technical myths, here we’ll explore something else many people haven’t fully considered: the costs savings.

Aiming for Perfect Trial Execution

Let’s start by playing out a scenario. You’re in Phase 3 of a high-profile study that your team has been working on for years. You are determined that it be perfectly executed as you move into the regulatory stage.

Let’s say your company has provisioned devices to your study subjects or caregivers the way you’ve always done it: acquiring them from a vendor, loading the software, carefully packaging each one, shipping them out, verifying delivery. Say that this phase of the study involves 500 people.

Grappling with an Unforeseen Protocol Amendment

Then midway through the trial, you learn that amendments are required to the protocol design. Given the growing prevalence of innovations like adaptive trial design, that’s not an unlikely situation.

Now what? Your IT team has to lock down the devices and recall them all to install the update or administer updates through remote device management. But of course, the IT team is not really equipped for this task; they haven’t planned for it, and if your company is like most, they are already short on resources.

Chances are quite high that every study subject will not return the device at the first request, and will have to be chased … at least once. Some of them may be traveling and off the grid, or experience limited wireless connectivity. Some may never return the device at all.

Needless to say, you have a full-blown logistical headache on your hands. Now factor in the costs of packaging and freight both for return and replacement, and substantial labor costs for the recall and update – not to mention the original expense of provisioning.

Avoiding Risk with the BYOD Alternative

What a monumental hassle. But it’s one that could have been completely avoided if the subjects or caregivers had been able to use their own familiar smartphone or tablet to enter health-outcome data. With the BYOD alternative, you simply provide your subjects with a user-friendly app at the outset. In the event of a protocol change, the app can simply be updated through electronic transmission, then deleted at the end of the trial.

Since it’s their own device, a study subject is far more likely to keep it close at hand and make sure it’s charged, which results in better response and easier and more streamlined communications on your end. And it’s simply logical that allowing participants to use their own devices can boost retention and compliance.

And even if this worst-case never happens, you’re still incurring unnecessary costs with the traditional method of provisioning devices: purchase, packaging, freight, labor costs.

Joining a Growing Trend

Indeed, the dramatic costs savings, along with improvements in patient retention, data integrity, and compliance, are spurring growing adoption of the BYOD approach. In fact, an estimated 20% of clinical trials will be run using BYOD in 2019. Datacubed Health is currently supporting several sponsors in moving their BYOD studies from either post-marketing research or large Phase 2 and Phase 3 pivotal studies. These sponsors will be able to realize the promise of continuous data in real-world evidence to provide a complete view of the patient’s interaction with the treatment.

There is no question that this is the future, just as digital technologies are enabling the industry to improve efficiencies in countless other ways. And let me add a parting thought: as the entire healthcare universe moves toward patient-centricity, using BYOD in your trials can help you take an important step in that direction. Join the evolution!

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Datacubed Health has created a calculator to help you with cost comparisons for traditional provisioning of devices vs. a BYOD approach. Please click here to request a BYOD calculator to see what type of savings your team can realize at :  

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6 Myths About Bring-Your-Own-Device (BYOD) Studies

By David Kiger, Chief Commercial Officer, Datacubed Health

While the pharmaceutical industry stands poised to plunge forward into patient connectivity – and thus begin to realize the enormous potential benefits for clinical trials – some decision-makers remain skeptical about bring-your-own-device (BYOD). There’s strong evidence that allowing participants in clinical trials to use their own smartphones to enter health outcome data can boost retention, enhance data integrity, and increase compliance. Yet today, BYOD is used in a small fraction of clinical trials. That’s enough to make you scratch your head.

The rate of compliance for studies with BYOD is estimated at 10-20% higher than for studies using a provisioned device, and the cost savings are huge. With BYOD, a user-friendly app is simply uploaded to the subject or caregiver’s phone and to the clinician’s tablet and deleted at the study’s conclusion.

As I see it, there is more to this reluctance than the traditional conservatism of the clinical industry stemming from the regulatory environment and patient safety concerns. Teams need to view business apps in the same way they do consumer apps. Let’s take a look at six myths that I believe are unnecessarily holding back innovation.

Myth #1: Devices are not secure and are vulnerable to malware.

Fact: Consumers use smartphones in countless secure transactions every day, in countries worldwide, from banking and online shopping to transportation. Remember: The first apps were introduced to the iPhone OS 2.0 back in 2008, more than 10 years ago. How many apps were you using in the last 10 years that had malware? With operating systems largely limited to iOS and Android, mobile devices are in fact highly robust, reliable, and secure. In the rare event something did happen, when data is sent to the cloud, the provider recognizes that elements and the schema have been manipulated.

Myth #2: Use of mobile devices is limited largely to a younger demographic.

Fact: The 55-and-over population actually represents the highest growth rate for mobile devices among all age groups today. In 2019, 8.2 million Americans age 55 and older will use a wearable device, up more than 15% over this year (cited by eMarketer, November 2018).

Myth #3: Mobile devices coupled with Bluetooth IoT devices can be used only for rudimentary data that is not relevant to clinical trials, such as vital signs like heartrate or rhythm.

Fact: The FDA supports the smart, secure, and safe interaction among different medical devices and information systems. Many people paid attention to the Apple Watch Series 4 implementation of electrocardiogram (ECG), but there have been several other examples of remote glucose monitoring devices, spirometry, blood phenylalanine, and dialysis devices used outside the clinic visit.

Myth #4: If we provision a single type of device to the patient, we control the screen size.

Fact: BYOD providers test out screen sizes used on a variety of standard smartphone and tablet devices. In the standard workplace, IT-department control of devices has largely gone away with the demise of BlackBerry. Patient scales such as the Visual Analog Scale (VAS) can be implemented in a variety of screen sizes that do not affect clinical data results.

Myth #5: Devices do not integrate seamlessly, do not have audit trails, and lose power quickly.

Fact: Service providers bring all device cloud data into 21CFR Part 11–compliant audit trails. Most devices do have the ability to repower and sync where they left off. BYOD providers typically can re-upload data when a patient hits a dead cell-phone zone. The majority of Bluetooth connections do work well, and providers have excellent help-desk supports in place to handle these rare occurrences.

Myth #6: Cool technologies like the collection of location data through BYOD pose HIPAA and privacy risks.

Fact: Consumer use of geolocation services through smartphones outside pharma is ubiquitous – from Google Maps to Starbucks, to wearable apps on Galaxy phones. Storing of personal data simply will not happen in the clinical trial, where purpose-built apps collect the data on a spontaneous, prescriptive basis for actionable insights, not for storage on cloud or repurposing. There are tremendous benefits for patients by leveraging phone geolocation including the following examples.

  • Using environmental sensors, an automatic alert is sent to the participant in a smoking-cessation treatment to avoid an area known for air-quality issues or a high population of smokers.
  • Notification is sent to the primary site when the participant visits an out-of-network emergency room not associated with the clinical study.
  • Alzheimer’s patients and those suffering from dementia need to have the ability to alert caregivers when they have left a designated area, or a patient is showing decreased movement outside of the home – an indicator of advanced disease progression.

In 2019, Datacubed Health will begin to support several sponsors in moving their BYOD studies from either post-marketing research or small studies into large pivotal studies. The cost of drug development can start to moderate and decrease. Continuous data can then truly be leveraged to provide the entire 360 degrees of a patient’s real-life or real-world evidence, and not just a snapshot of a clinic office visit. Let’s rally around the change.

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