As more and more trials opt to include electronic patient reported outcomes (ePRO), sponsors must consider whether they will provision devices or use a bring-your-own-device (BYOD) model. In some cases, they may choose a hybrid option that allows some participants to use BYOD and others to receive provisioned devices. This article explores some key factors to consider when deciding on a device model for ePRO.

Participant Preference

It is important to consider participants’ preferences, particularly in trials where recruitment is challenging. Many participants like the convenience of using a single device that a BYOD model offers since they do not have to keep track of a separate device to use for the trial. For trials where there may be some stigma attached to participation, completing assessments on their personal device may be more comfortable for participants because they do not have to explain the presence of an additional device. On the other hand, some participants may be hesitant to download an app to their own devices. They also may be reluctant to use cellular data for a study and prefer a provisioned device to ensure they are not paying for data they are using for the study. Although this does not appear to be a widespread concern, provisioning a device can alleviate that worry. A hybrid model accounts for each individual participant’s preferences.

Regulatory Compliance and Security

One advantage of provisioned devices is that sponsors can have greater control over the device. Sponsors have greater oversight over security measures and assurance that each device configuration is adequately tested. At one time, there was some concern that without these measures, regulators would be hesitant to accept ePRO data collected in a BYOD model. Several of the large COVID-19 vaccine trials used to support authorizations with many major global regulatory agencies utilized BYOD ePRO data. This precedent is providing sponsors with greater confidence in using BYOD.

An additional advantage of BYOD is that devices are more likely to be charged regularly and less likely to be lost of misplaced.

Patient Accessibility and Burden

For some patient populations, requiring participants to have a smartphone that meets the requirements of many ePRO solutions could be a barrier to participation. This is particularly true in older populations, in populations that contain significant numbers of socioeconomically disadvantaged groups, and global trials that have sites in areas with lower rates of smartphone use. A hybrid solution that provides devices to participants upon request can alleviate this burden. Even in populations where this may not be a barrier to recruitment, an option to provide devices can increase the diversity of trial participants.

Tablets

When most people think of ePRO, they envision diaries and assessments completed on a smartphone. However, assessments that require participants to manipulate objects on a screen, such as the Trail Making Test, may work better on the larger screens on tablets. When tablets are utilized in a trial, it may be necessary to use either a fully provisioned or hybrid device model. Comparatively fewer people will have a tablet that meets the requirements for most ePRO solutions. Requiring participants to have a tablet would be a significant burden to place on participants and would inevitably create enrollment challenges.

Support

When selecting a device model, it is important to consider the impact on technical support needs. Provisioned devices typically arrive at sites completely configured, but sites may need additional training and support to assist patients in the set-up of BYOD devices. Additional training and documentation also may be needed for technical support staff to enable support for a wider range of device types.

Pathway ePRO can be successfully deployed using any of these device models. Learn more about the advantages of Pathway ePRO.

WCG today announced the acquisition of VeraSci, a global provider of specialty scientific expertise and eClinical software to support the design and execution of clinical trials focused on central nervous system (CNS) disorders. The addition of VeraSci, based in Durham, North Carolina, deepens WCG’s scientific and patient engagement capabilities, and complements its CNS offerings, including those available via the Company’s MedAvante, ProPhase and Analgesic Solutions businesses. With this expansion, WCG is addressing the growing demand for proven scientific and technology solutions to power remote data capture, hybrid virtual studies and fully decentralized clinical trials in key CNS therapeutic areas.

“WCG’s acquisition of VeraSci represents a natural next step and an exciting growth opportunity,” said Donald A. Deieso, Ph.D., Executive Chairman and CEO of WCG. “On behalf of WCG, I’m proud to welcome VeraSci, an organization that shares our dedication to improving the clinical trial experience for patients and sites, commitment to scientific rigor and passion for bringing novel technologies into clinical trial processes. This is a marriage of two premier global teams with a common vision.”

VeraSci provides clients around the world with innovative solutions that improve data quality in clinical trials, including endpoint and assessment services, rater training and certification, language and translation support, and eCOA and ePRO technologies. With its Pathway technology platform, which can be easily configured to meet the needs of any study across the globe, VeraSci enables the collection of high-quality data that can be used to assess symptoms, cognition and functional capacity in a wide range of therapeutic indications.

“Since our inception, we have invested in expanding VeraSci’s expertise and capabilities to include a variety of clinical and regulatory endpoints covering a range of diseases and disorders. We have also pioneered technological advances that are changing the way subjective endpoint assessments are conducted in clinical research,” said Rich Keefe, Ph.D., CEO and Co-Founder of VeraSci. “Now, as part of WCG, we are positioned to be the go-to research partner around the globe. We can scale and further strengthen our offerings, including our industry-leading CNS services and solutions.”

Dr. Keefe added: “For all of us at VeraSci, it’s truly an honor to join WCG and a thrill to work alongside colleagues who are just as committed to enabling well-designed, science-focused processes and technologies to drive more effective, efficient and patient-centric clinical trials.”

Caren Gadigian, President and Co-founder of VeraSci remarked, “Dr. Keefe and I have worked tirelessly for 16 years to develop VeraSci to where it is now. We look forward to maintaining our commitment to science and to the benefit of patients in need through our new partner.”

As an industry leader in neurocognitive measurement and with its deep therapeutic and technical expertise in psychiatric disorders, VeraSci also enriches WCG’s capabilities designed to solve the overarching challenges of CNS clinical study planning and execution. VeraSci’s experience encompasses all phases of development, from single-site, phase I studies to global phase III trials, with hundreds of raters and thousands of patients.

“Whether we’re discussing stroke or migraine, epilepsy or multiple sclerosis, or Alzheimer’s or Parkinson’s disease, on average, developing drugs to treat CNS disorders takes 20% longer than drugs for other indications and 38% longer to secure regulatory approvals. These challenges are largely due to limitations in understanding the underlying disease, as well as in identifying and measuring appropriate clinical endpoints,” said Lindsay McNair, MD, Chief Medical Officer of WCG. “The VeraSci team is composed of highly-respected scientists, industry thought leaders and operational experts, including Dr. Keefe and Dr. Luca Pani, VeraSci’s Vice President of Regulatory Strategy and Market Access Innovation, who is also the former Director General of the Italian Medicines Agency. Their combined experience and expertise in clinical psychology, neuroscience, clinical pharmacology and regulatory science, with particular emphasis on technology-enabled, remote endpoint assessments, will be extremely valuable to clients and, more broadly, our industry, as we work together to enable advances in CNS treatments, which improvements in the clinical trial process have tremendous potential to accelerate.”

Emmanuel Olart, WCG’s Chief Applications Officer, noted: “Since our founding in 2012, WCG has been preparing for what we have seen coming as the future of clinical research, working hand-in-hand with sponsors, CROs and sites, and providing them with innovative technologies and solutions to improve clinical trial efficiency and effectiveness. Acquiring VeraSci is part of that ongoing effort, bringing clinical trials closer to patients, reducing the burden of participating and making the experience better for them via solutions that enable remote data capture, hybrid virtual studies and fully decentralized clinical trials.”

Moving forward, VeraSci will be known as WCG VeraSci. The organization will retain its leadership structure and continue to operate from its headquarters in North Carolina.

About VeraSci
VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies. Learn more at www.verasci.com.

About WCG
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two segments, Ethical Review and Clinical Trials Solutions (CTS), WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection. For more information, please visit www.wcgirb.com, www.wcgclinical.com or follow us on Twitter @WCGClinical or LinkedIn.

The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a new Innovative Medicines Initiative (IMI) funded project to find an ethical and GDPR compliant framework for returning clinical trial data to study participants, a key step in reconciling the promise of avoiding useless repetitions of studies with privacy rights of individuals. VeraSci will serve on the Medical and Technical Expert Decision Committee for the project. Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci will serve as the Project Coordinator in his role as Professor Pharmacology and Clinical Pharmacology at the University of Modena and Reggio Emilia in Italy.

About FACILITATE

There has been growing concern that the EU General Data Protection Regulation (GDPR) safeguards will make Europe non-competitive in the innovative drug development space. Here are a few ways GDPR may complicate clinical trials in drug development:

  • The principle of data minimization may preclude machine learning
  • Privacy by default and design may preclude predictive analytics
  • Clinical data reutilization requires access to enough “detailed information,” which GDPR restrictions could make difficult or impossible

In addition to creating an ethical and GDPR compliant framework to return clinical trial data to study participants, FACILITATE seeks to:

  • Find legally robust and ethically forward-looking ways to allow patients’ data to be accessed, used, and re-used
  • Generate a partnership where patients are at the center of data governance
  • Show how a patient-centered data-driven approach can make the entire drug development and approval process better
  • Avoid storing clinical data in siloed systems where there is no possibility to use them beyond their original (and often single-sided) purpose

 

Like clinical trials in adult populations, pediatric clinical trials increasingly incorporate electronic patient-reported outcome (ePRO) systems to gather data directly from patients. One challenge unique to pediatric trials is that many trials also seek to gather information from one or more caregivers, known as informants. The chosen informant is often a parent, but depending on the individual child’s family situation, multiple people may fulfill this role—mothers and fathers in separate households, grandparents, or stepparents. In some instances, a patient and their parent may share a device. In others, the patient and each parent may have separate devices.

These varied situations mean that pediatric trials utilizing informants need maximum flexibility in an ePRO solution—all while maintaining the same level of data security, traceability, and regulatory compliance (FDA 21CFR Part 11 and GDPR). The ePRO solution should allow multiple informants to enter data across multiple devices and device types, each with a unique username and password. Ideally, informants should be able to access the system on mobile devices (Android and iOS) and online through a desktop computer.

Sponsors considering ePRO in pediatric trials may also want to consider a hybrid approach that allows for both bring-your-own-device (BYOD) and provisioned devices. Many parents and caregivers will prefer the convenience of accessing diaries and questionnaires from their phones. Some caregivers, including grandparents, may not have access to a smartphone and are more likely to participate if given a provisioned device. Additionally, provisioned devices can also be used to capture data from pediatric patients when they are not with a parent or caregiver whose device they usually use. If provisioned devices will not be used, it is vital to ensure that patients can access the system across multiple devices. This is particularly true in shared custody situations where routinely getting access to the same device may be prohibitive to participating in a trial.

Learn how Pathway can provide the features you need to support your next pediatric clinical trial.

View Pathway ePRO Demo

Adolescent oncology patients can be vulnerable to a great deal of emotional and behavioral challenges. But which young people are most susceptible is very difficult to predict. An article recently published in Frontiers in Oncology discusses how digital phenotyping and dynamic monitoring present an opportunity to understand and predict which patients are at the most significant risk.

The article, “Digital phenotyping and dynamic monitoring of adolescents treated for cancer to guide intervention: embracing a new era” was co-authored by Dr. Luca Pani, VP of Regulatory Strategy and Market Access Innovation at VeraSci.Adolescence is an important period for physical, social, and emotional development. It is also the time when many mental illnesses first emerge. For adolescents with cancer, general vulnerability to mental illness is compounded by physical and psychological symptoms associated with treatment and interruptions in relationships with their peers. While some adolescents can develop great emotional and mental resilience during the course of their cancer treatment, it is often difficult to distinguish the resilient from the vulnerable, which can prevent timely intervention. Digital phenotyping captures ongoing objective measurements in patients’ daily lives, provides a continuous stream of information, and uses real-time algorithms to detect any pattern changes that may be cause for alarm.

Read the full article to learn more.

The journal Clinical Drug Investigation recently published the article “New Models for the Evaluation of Specialized Medicinal Products: Beyond Conventional Health Technology Assessment and Pricing” which was co-authored by Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci. As the number of advanced therapy medicinal products (ATMPs), such as gene therapies, increases, it becomes clear that the existing health technology assessment (HTA) process is not sufficient anymore to give the right value to such treatments. The objectives of this article are to discuss why the current HTA process is inadequate for evaluating these new therapies, how evidence should be continuously generated and presented to regulators and payers to support their use, and to propose new approaches to pricing models. Without new approaches or adaptation of existing frameworks, certain ATMPs may not reach patients in some or all countries or be at risk of withdrawal from the market.

Read more