5 Critical Facts: Why Geolocation Technology Is the Next Advance in Clinical Trials

By | Clinical Trials

Geofencing as the Next Advancement in Clinical Trials

The good news today is that applying consumer technologies to health studies offers attractive solutions to some of the biggest challenges in real-world use and clinical trials – including unreported and undetected participant data.

Unfortunately, false perceptions commonly pervade some of the most promising technologies currently on offer. And ignoring the facts can mean missed opportunities. That is certainly the case with geolocation.

Geolocation can significantly reduce the risk of missing critical health events, while also improving the experience of patients, in a clinical trial for a new therapy. Geolocation, or more specifically, “geofencing”, allows study sponsors to identify and “fence” healthcare facilities within a participant’s range of activity. An app, downloaded to the participant’s own smartphone, uses cell tower triangulation, WiFi, and telemetric data to alert the participant and clinical sites whenever the participant enters a geofenced location. A critical read-time symptom survey is sent as the participant leaves the clinic and that information is automatically logged into a safety case tracking system. Sites can follow up with the participant to obtain additional information that might be relevant to the trial, or to provide useful insights about the disease under study.

Most important, the participant – who might well be experiencing an adverse event – feels the information that he or she is providing is useful and timely and that someone is looking out for their care. In short, geolocation technology is a promising solution to the chronic issue of under-reporting of significant health events in clinical trials and health-related studies.

Yet, despite its potential to improve the data quality of clinical trials, misconceptions abound. Let’s take a look at five of the most common.

 

The Five Misconceptions

 

Misconception #1

Geolocation technology cannot be used to run a study in pharmaceuticals because of data privacy issues.

Fact: Use of the app is agreed upon by both patient and sponsor during the consent process; participants opt-in, just as they would when using a consumer app involving location services. Further, use of geofencing in clinical trials will be approved by the IRB.

 

Misconception #2

Personal data about an individual’s movement can be shared and exploited.

Fact: Detailed location information identifying the geographic locations of hospitals, doctors’ offices, homes, or other healthcare facilities are loaded into the app and stored on the phone.  Participant interactions with multiple locations can occur while keeping the location data on the device. This is very similar to the Apple privacy model whereby key information is kept only on the phone. Continuous longitude and latitude is not uploaded to the cloud. Only geofence breach information is used to issue new symptom surveys.

 

Misconception #3

Patients will not consent to any use of geolocation, even if their privacy is assured.

Fact: Anyone who has used a smartphone to get directions from a certain point, hail a ride on Lyft, or download coupons when close to a favorite coffee shop has consented to sharing their location with a commercial entity. Just as consumer app users have shown a willingness to share personal information if they feel they’re benefitting in some way, studies indicate that patients are also open to location tracking if they believe it is for a good purpose.  Indeed, large pharmaceutical companies are already successfully utilizing this technology in their studies.

 

Misconception #4

The location data is not accurate and will be marred by inaccurate timing of when surveys are received.

Fact: Depending on the study’s needs, several complementary approaches can be deployed to ensure that false readings are kept to an absolute minimum.

To avoid an event being logged and an alert triggered when a participant is simply passing through a geofenced location, a minimum time duration threshold can be imposed. For example, the participant must be in the area for longer than ten minutes to trigger a logged event.

 

Misconception #5

This technology is not relevant to most studies.

Fact: In cardiovascular trials, important patient outcomes – including death – were reported only 23% of the time¹. A recent survey of 413 clinical trials found that 70% were missing crucial outcome data, largely as a result of underreporting adverse events.

And while the most obvious use of geofencing relates to participants’ activities outside the home, what about detecting when a participant is less frequently leaving the home? This could indicate an unreported illness, or in the case of depression, this could objectively indicate fatigue.²

In truth, the accurate detection of critical events, such as illnesses and hospitalizations, presents an ongoing challenge for sponsors of clinical trials and other health-related studies. The limitations of self-reported patient information, which suffers from low reliability and low accuracy, can lead to the ultimate failure of the study­.

Sophisticated solutions using advanced digital technology add another exciting dimension to automating patient-reported outcomes – and ultimately, can help reduce study costs and speed time to market for new therapies.

Send questions: david@datacubed.com

 

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1 Heneghan C, Goldacre B, and Mahtani KR, Why clinical trial outcomes fail to translate into benefits for patients, Trials. 2017; 18: 122. doi: 10.1186/s13063-017-1870-2

2 Swindle R, Kroenke K, Braun LA (2001). Energy and improved workplace productivity in depression. In: Sorkin A, Summers K, Farquhar I (Eds.), Investing in Health: The Social and Economic Benefits of Health Care Innovation (vol. 14, pp. 323–341).

Patient Centricity in Clinical Trials

By | Clinical Trials

What is Patient Centricity and Why Does it Matter?

Patient centricity is the concept of designing and executing clinical trials in a manner that accommodates the patients’ perspectives and reduces burden on patients. Patient centricity has rapidly gained momentum within the pharmaceutical industry and has become a regulatory focus in recent years, underscoring its importance for current and future drug development. Over the past decade the FDA has held several dozen patient-focused drug development (PFDD) workshops and developed relationships with patient advocacy groups,¹ and has even released an industry guidance document on PFDD.²

 

What’s in it for Sponsors? 

Besides being the right thing to do, patient centricity offers benefits for study teams, especially in achieving study- and program-level development goals. In one analysis, patient-centric trials were found to take nearly half as much time to recruit patients; additionally, drugs developed through patient-centric trials were more likely to be launched than drugs that were not.³ This means delivering a study ahead of planned timelines (and within budget) and receiving topline results to read outs sooner. Both of which can provide a competitive advantage in registration timelines and product commercialization.

 

Major Gaps and Solutions in Patient Centricity

 

Gap: Communication Between Sponsors and Patients
Aside from consent forms, patients are not often provided with additional material or information from the sponsor that was intentionally developed to be patient-facing. Conversely, patients in clinical trials lack a means by which they can share feedback about their individual study experiences directly with study teams.

Solution: Study teams can develop informational material describing the study design, objectives, and treatments that sites can use when recruiting prospective patients. For patients who enroll in a trial, educational materials (eg, videos, newsletters, etc) about study assessments can help patients anticipate what to expect and understand why those data are needed. At the end of the study, all patients should be informed of the study results and thanked for their participation. Patients should also always have a mechanism to share feedback, questions, and concerns directly with the sponsor. Educational materials and two-way communication can ideally be managed through an electronic platform, as this is convenient for  patients and allows feedback to reach study teams in real time.

 

Gap: Visit Schedule and Assessments
Protocols may often require frequent and/or long site visits, a large number of assessments at each visit, or more frequent invasive assessments (eg, biopsies or other sample collection) than might otherwise be required per standard of care. In-person study visits can be very disruptive to patients’ lives, requiring missed time from work, school, or other commitments. 

Solution: During the study planning stages, patients can provide valuable input on the quantity and types of visits and assessments that would be acceptable for patients; this information would help the study team to strike a balance between collecting the minimum amount of medically necessary data and still making the study appealing to prospective participants.

Study teams can also explore technology solutions to minimize patient burden. For example, a “Bring Your Own Device” model allows patients to complete study assessments and enter study data (eg, PROs, dosing diaries, etc) directly into their smartphones. Another useful technology solution is to replace in-person study visits with remote telemedicine visits. Both of these approaches are convenient for patients and can help alleviate the burden of study visits.

 

The Bottom Line

Dedicating the time, budget, and resources to design and implement a patient-centric clinical trial may be a new venture for many study teams, but has the potential to yield tangible benefits for patients and study teams alike. Technology solutions offer an appealing way to communicate more effectively with patients and decrease patient burden.

 

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

 

¹ US Food and Drug Administration. (2017). Enhancing FDA’s Approach to Patient Engagement. Available from: https://www.fda.gov/media/109891/download.

² US Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input – Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. (2018). Available from: https://www.fda.gov/media/113653/download.

³ The Economist Intelligence Unit. (2018). The Innovation Imperative – The Future of Drug Development, Part I: Research Methods and Findings.

Creating Patient Engagement in Clinical Trials

By | 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)

¹”Estimated Costs of Pivotal Trials for Novel Therapeutic Agents ….” 24 Sep. 2018, https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2702287. Accessed 9 Jan. 2020.

² “Global Public Attitudes About Clinical ….” 5 Oct. 2018, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2705849. Accessed 9 Jan. 2020.

³”D3 Conference poster_rd3 – Datacubed Health.” https://www.datacubed.com/wp-content/uploads/2019/10/ISPOR_Poster_Datacubed_Health.pdf. Accessed 9 Jan. 2020.

Slash Costs in Clinical Trials with Your Own BYOD Calculator

By | Clinical Trials

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 :  https://www.datacubed.com/contact-us/  

Send questions: david@datacubed.com

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

By | Clinical Trials

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.

Send questions: david@datacubed.com

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