Monthly Archives: November 2022

Trusting Digital Health Technologies: Why Global Standards Are A Must

An editorial by Maria Palombini, director, healthcare and life sciences global practice lead, IEEE Standards Association, highlights that the clinical trials ‘industry’ needs to adopt the currently available and evolving digital tools that are integral to modernize and streamline the process of validating and discovering new treatment options and bring new drugs to market.

Clinical trials are not modernizing fast enough due, in part, to lagging global standards.

The need to digitally transformation the approach to patient recruitment and engagement, study design protocols, and overall trial management is mandatory. On a regular basis, shocking numbers are publicized as to the rising cost of evaluating and bringing a new drug to market, the declining rates of enrollment and patient retention, and the extended length of overall trials. “While these numbers often stir up emotions and debate, they are often undervalued as a symptom of the main problem: Clinical trials are not modernizing fast enough due, in part, to lagging global standards.”

Decentralized clinical trials (DCT) compels clinical operations to become more digitalized. 

Digitalization encompasses much more than electronic data capture and electronic data management systems. Digitalizing the entire process enables the use of the many exciting technologies in the digital health toolkit, including artificial intelligence (AI), machine learning (ML), blockchain/distributed ledger technologies (DLT), digital therapeutics, wearables, the Internet of Things (IoTs), biosensors, and many more. These following digital technologies present the opportunity to optimize the clinical trial management process from study design through review:

  • Wearables and sensors minimize, and potentially eliminate, the need for some patients to visit sites. Their continuous monitoring capability provides troves of data that can be further mined and used to improve clinical study design, protocols, recruitment, and more.
  • Digital therapeutics in the form of a smartphone app can be used to encourage patient adherence (i.e., medication reminders) or make participant feedback collections for eCOAs (electronic clinical outcome assessments) more efficient and effective.
  • Software as a Medical Device (SaMD) includes fixed or adaptive algorithms used for multiple purposes, including prescreening, screening, adjunctive clinical diagnosis, clinical diagnosis, medical monitoring for adverse events, and more.
  • AI/ML Artificial Intelligence and Machine Learning can be used throughout most steps of DCTs or modernized trials with the ability to predict patient retention rates, better analyze and implement participant feedback to reflect the patient’s perspective, better identify and target patient populations for recruitment, filter unstructured data from multiple patient record sources to gather insights, and more.

Can these technologies be trusted?

Some of these technologies are relatively new to a legacy process, which begs the inevitable question: Can they be trusted? How are they validated? Will they work the way they are intended? There are many technical and ethical considerations that clinical trial management teams need to understand and negotiate when applying these technologies to their processes while asking patients to use and trust them. This conundrum of trust in digital technologies can be the very obstacle to deciding whether a component or the entire trial will be decentralized.

Patients Are Ready, But Are Clinicians?

While trust can be the cornerstone of clinicians’ concerns, patients are seemingly ready to embrace more digital components.  A survey by Deloitte, reveal that 92% of clinical trial patients believe that improving experiences (such as through innovative technologies) should be a top priority for the healthcare industry. Patients are embracing digitalization quickly, and a great example is the growing wearables market: 

  • The number of connected wearable devices has increased dramatically since 2019.  The number of devices is forecast to reach more than 1 billion in 2022. (Statistica.com)
  • It is estimated that there are over 52,400 healthcare and medical apps currently available on the Apple App Store.
  • According to Statistica, we are now nearly a decade into the Zettabyte Era, with the amount of health care data and information created, captured, copied, and consumed worldwide in 2020 was 64.2 zettabytes and projected to be 120 zettabytes in 2023.

At this rate of use, it can be argued that patients are ready for it. The growing use of digital technologies such as wearables, digital therapeutics, and other biosensors by patients provide benefits that were never available before to patients to participate in their wellness/health process.

However, scientists and clinicians are not engineers or technical gurus.

Therefore, how do they effectively evaluate what and which technologies should be used and trusted? The answer is not so simple. The process will take some time to learn from trial and error. However, it also will require communities of multidisciplinary experts including clinical professionals and patients to get involved with development of global industry technical standards to address these uncertainties in the application and/or technology itself.

Looking at the world of health sensors and wearable devices, there has been more development in global technical standards to mitigate concerns of data transfer and portability and open sharing of mobile health. However, more development is still needed in the space of cybersecurity, patient privacy, data governance, validating algorithms, data integration, and more.

In addition, technical standards very important. “On any given day, internet users trust that a mobile device will connect to Wi-Fi. The global technical standard helps enable seamless connectivity anywhere in the world. Wouldn’t it be just as great to have the same approach when digital technology is integrated into the clinical research process?”

[Link]

[Reimagining clinical trials in the age of the digital patient (pdf)]

As Demand For Mental Health Care Continues: Technology May Be An Important Answer

Although the COVID-19 pandemic has eased, the demand for mental health care continues to persist.

A newly published 2022 COVID-19 Practitioner Impact survey by the American Psychological Association of U.S. psychologists reports that a growing demand for help with depression, anxiety and substance use issues means many psychologists across the United States are unable to take on new patients.

Over 2,200 licensed psychologists nationwide responded to the APA’s third annual practitioner survey in late September and early October. About 60% said they no longer can take on new patients and 72% said they have longer waitlists than before the pandemic. On average, psychologists said 15 people a week contact them seeking new care.

The survey reported that 79% said they have seen more patients with anxiety disorders since the pandemic began. approximately 66% have seen increased demand for depression treatment; 47% for substance use treatment, and 64% for trauma. About two-thirds of psychologists described the patients’ symptoms as being more severe this year.

Young people, especially 13- to 17-year-olds, represented the largest increases in seeking care. Many psychologists also saw a need for more care in children under 13 and among 18- to 25-year-olds.

Nearly half of psychologists reported a rising number of health care workers seeking treatment since the start of the pandemic. According to Arthur Evans Jr., chief executive officer of the APA, “Having timely access to psychological services is critical for addressing the needs of those diagnosed with behavioral health challenges,” Evans said in an association news release. “But we need to tackle this problem with a variety of solutions, beyond individual therapy.”

He cited the need to support and expand the psychologist workforce; to integrate behavioral health into primary care, and use technology and innovation to reach more patients.

About 11% of psychologists now see all patients in person, up from 4% in 2021. More than half (58%) see some patients remotely and some in person. About 31% see all patients via telehealth.

The APA noted that telehealth can expand access to care for patients from underserved communities, including those in rural areas and people of color. The APA continues to advocate for expanded coverage of telehealth by insurance companies.

With the high patient demand, about 45% of psychologists said they feel burned out. But 60% said they have sought peer consultation or support to manage it. About 77% said they were able to practice self-care and 63% said they have been able to maintain a positive work-life balance.

APA Survey Link