Experts Urge It's Time to Integrate Digital Health into Clinical Trials

Recently, Dr. David Lee Scher authored an article analyzing the current trend of leveraging internet technologies in clinical trials and outlined five key reasons why this trend has become unstoppable. Dr. David Lee Scher is a pioneer in the application of remote patient monitoring and electronic health record data integration, and serves as Chair of the Roadmap Task Force of the mHIMSS Advisory Committee. VCBeat has compiled and translated this article to provide insights into how this pioneer and advocate of digital health perceives the development of internet technologies in the field of clinical trials.

Today, recruiting patient participants via social media has not only become feasible but has also emerged as a topic of discussion in numerous forums, including mainstream medical journals. Undoubtedly, online patient support groups warrant special consideration, given the regulatory issues involved in this domain. However, in the new era of digital and internet-based clinical trials, it is essential to establish a new regulatory framework that accounts for advancements in technology and the evolving patient population. More specifically, internet technologies offer unique approaches to problem-solving. Several years ago, crowdsourced clinical research was recognized as an emerging branch of clinical research. Even in medical research, methods for raising funds from the general public have been developed. Regardless of how trial paradigms shift, patient safety must remain a primary concern for study planners and researchers. Health literacy is critically important today; it is a key determinant of patient engagement and a crucial factor in the labeling of pharmaceuticals and medical devices, playing a vital role in the user experience of any health-related mobile application. Improving patient recruitment, retention, and data collection should be prioritized for any internet-based technology applied in this field.

So why can and must we adopt internet technology for clinical trials?

1. The GiantsPaving the way for it.Apple’s ResearchKit is a pioneering achievement that fulfills many objectives in this field. Although this product cannot currently cure cardiac tumors, it has the potential to halt tumor progression if healthcare providers and patients leverage it alongside other tools to maximize its efficacy. ResearchKit’s current contributions are twofold: significantly enhancing public awareness of and enthusiasm for digital health, and encouraging healthcare providers to participate in clinical trials. The apps currently offered through ResearchKit primarily monitor health via smartphone sensors; however, the sense of satisfaction and ensuing sense of purpose that patients derive from participating in research will serve as a powerful catalyst for future disease-oriented studies. Furthermore, its role in facilitating the broader application of internet technologies in health and healthcare should not be underestimated.

2. The technology has already arrived.Some may intuitively assume that internet-based apps for clinical trials are limited to data and symptom entry. However, the characteristics of activities and workflows across various stages of clinical trials enable this technology to effectively improve patient recruitment, engagement, and retention. Parallel 6 is a company that applies patented technologies to end-to-end internet-based clinical trials, dedicated to enhancing subject recruitment and retention in research studies. Furthermore, pharmaceutical companies are recognizing the power of crowdsourced research, as evidenced by the collaboration agreement between Genentech and 23andMe. Such partnerships, in turn, are driving the proliferation of internet-based clinical trials.

3. Traditional evidence-based medicine is no longer considered infallible.As previously reported, the foundations of evidence-based clinical trials have developed visible cracks. Some of these fissures may stem from overt gender bias during participant recruitment. Such biases have drawn the attention of the U.S. Food and Drug Administration (FDA) and have become a key focus in the recruitment of study subjects. As one source for recruiting research participants, social media warrants attention on several fronts. First, it can facilitate the recruitment of patients with rare diseases by connecting individuals scattered across different regions. One study found that patients who actively use social media to obtain health information are 60% more likely to participate in clinical trials than those who do not. Second, recruiting clinical trial participants through social media may help reduce gender bias and improve the comparability of baseline characteristics among trial subjects. Treatment Diaries, a large and successful online platform that aggregates interdisciplinary patient support groups, reports that 73% of its participants are women, according to Amy Ohm, the company’s CEO.

4. Traditional clinical trial research is becoming increasingly financially burdensome.The exorbitant costs of traditional clinical trials are deterring an increasing number of sponsors and healthcare companies. Even for medical devices that have already received marketing approval, the cost of conducting trials for new indications using traditional methods can amount to tens of millions of dollars. Apart from the most prestigious and well-funded entities, the nursing and coordination costs associated with traditional clinical research have discouraged most institutions. Although the majority of studies today are sponsor-supported, trial costs remain prohibitive for physician-led research conducted at smaller hospitals and institutions. Internet technology can help address this challenge. Currently, even Contract Research Organizations (CROs) are seeking ways to reduce costs and improve efficiency. In a recent report, the U.S. Department of Health and Human Services evaluated the potential cost reductions achievable through internet technology across various stages of clinical trials for multiple diseases: “In Phase I, the maximum expected cost savings through internet technology are $400,000 (for immunomodulation and respiratory systems); in Phase II, cost savings range from $500,000 (cardiovascular) to $2.4 million (hematology); in Phase III, up to $6.1 million can be saved (pain and anesthesia); finally, in Phase IV, savings range from $700,000 (genitourinary system) to $6.7 million (respiratory system).”

5. In clinical workflows, internet technology can enhance the safety and efficiency of trials.Internet technology can collect more real-time data, improve trial efficiency, and theoretically enhance patient satisfaction and subject retention. Furthermore, it enables earlier reporting of adverse events, potentially leading to safer treatments and better clinical outcomes for patients. I sincerely hope that pharmaceutical and medical device companies, clinical research organizations, insurance providers, and healthcare institutions will leverage internet technologies to achieve the aforementioned cost savings, allocate resources more effectively, and thereby advance the development of healthcare.