Clinical Trials Designed for the Patient: How Remote Technologies Improve Engagement
Elisa Sung • September 19, 2023
Patient data is the backbone of all clinical trials. However, trial subject recruitment, engagement and data collection are very costly activities. According to the Deloitte Center for Health, roughly a third of a clinical trial’s total costs go toward patient recruitment alone. The rise of remote monitoring tools in the post pandemic era, such as smart packaging, wearables, and other technology, can help focus and contain trial efforts for individual patients, while reducing costs, and diversifying trial patient samples for more effective drug development.
In Part 1 of HITLAB’s IMC Webinar Series on Technology in Clinical Trials, leaders in clinical trial management discussed how remote technology allows for a patient-centric approach to clinical trials, leading to better patient recruitment, engagement, and retention rates.
Panelist Joanne Watters, Managing Director of Customer Relations at IMC, discussed how technology such as remote monitoring tools and smart packaging creates a patient-centric approach to clinical trials. All the data is brought to a central place, benefitting accessibility and ensuring accurate, effective analysis across clinic staff and researchers. As an example, IMC’s smart pill bottles track the location of a drug from the store to the patient’s home and when the patient takes a pill. Previously, this data could not be collected, resulting in cases of ambiguity around when a patient took the drug and whether it was the correct dosage. With remote technology, real-time objective data on adherence and patient behavior provides all stakeholders with touch points to track patients’ progress.
Panelist Divya Yerraguntla, Senior Vice President of Demand Generation at Syneos Health, also spoke to the patient-centered perspective in the era of remote technologies. Technology, such as wearables and remote monitoring tools have enabled clinics to gather detailed, personalized patient data, while decreasing costs for trial sites and sponsors. This has given researchers greater decision confidence regarding the success of a drug while increasing efficiency of shared information. In a 2020-2021 Mayo Clinic study, 5,796 Covid-19 patients at risk for severe disease were enrolled into a remote monitoring program (RPM), which consisted of a tablet with an app and Bluetooth medical devices. Patients who engaged with the RPM program for 30 days had a 0.5% mortality rate, whereas it was 1.7% for those who did not engage. Patients who were engaged in the technology also saw a significant decrease in rate of hospitalization, length of hospitalization, and ICU admissions, lowering cost of care. This result may be because the real-time data collected through the RPM program alerted healthcare staff to any adverse health symptoms, allowing them to quickly intervene.Furthermore, remote monitoring has also integrated healthcare into patients’ daily lives instead of requiring them to go out of their way to walk to a clinic or remember to record dose ingestion times in a journal. On the trial site side, these technologies and platforms have allowed for simulation of drug variants as well as mapping of how different combinations of ingredients in a drug may affect patients without having to physically implement separate trials.
Decentralization of clinical trials, which remote technologies make possible, will continue to make implementation more cost effective and efficient. However, regulatory hurdles are another important consideration and differ between jurisdictions. Yerraguntla pointed out that Syneos Health has been able to model trials with regulatory pathways as well unique patient preferences in place. By doing so, trial sponsors and sites can target additional resources or interventions to ensure protocol compliance. For example, teenage patients moving away from home for the first time to attend college may forget to take the drug as instructed due to the absence of parental reminders. However, remote technologies are widely used amongst this demographic and therefore could be utilized as an interface to provide reminders.
Remote and distributed technologies are already transforming the clinical trial space, increasing enrollment rates above target levels and streamlining procedures, leading to quicker evaluation and verification for drug development. Wearables and smart packaging provide clinics with objective data to inform trial design, while keeping patient information secure through de-identification techniques. According to McKinsey & Company, telehealth use increased by 38x in 2021 compared to the pre-pandemic years. Insider Intelligence predicts almost 61 million patients in the US — more than 1 in 5 individuals — will use remote monitoring tools by 2024. This growing market of remote access and distributed data gathering capabilities benefits patients, healthcare professionals, and other stakeholders.
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