The adoption of connected devices in clinical trials has experienced a significant surge since 2020.  Driven by the need for more efficient and accurate data collection, sponsors and CROs have begun investing heavily in devices that can help with remote monitoring capabilities and improved patient engagement. These devices, which include wearables, sensors, and mobile apps, are revolutionizing the way clinical trials are conducted, enabling researchers to gather real-time data and gain deeper insights into patient behavior and treatment outcomes.

According to a report by Grand View Research, the global connected device analytics market for the healthcare industry is projected to grow at a staggering compound annual growth rate (CAGR) of 28.9% from 2022 to 2030. This remarkable growth can be attributed to the increasing demand for real-world evidence, the need for remote patient monitoring, and the growing emphasis on value-based care models.

‍

Modern clinical trials employ various digital-based tools and technologies designed to increase the speed, accuracy, and ease of conducting clinical trials. In the best-case scenario, these tools are housed in the same experience or a  “clinical trial platform.” 

Clinical trial platforms are software-based, web-based, and/or cloud-based solutions that facilitate clinical trial research throughout its entire lifecycle. They offer a complete technology ecosystem that connects patients, research sites, and trial sponsors from patient recruitment to close out and data submission. Users of clinical trial platforms can access and operationalize all of their digital-based tools through this connected platform. Platforms can prevent users from accessing parts of the platform not permitted for them. For instance, participants can not view other participants' data or gain access to tools meant for sites. Other users, like sponsors’ study teams, have access to the full suite of tools as needed based on their roles.

There’s little doubt that 2023 will be remembered as the breakout year for generative artificial intelligence (AI) and machine learning (ML) within both tech and pharma. Much like the surge in digital and decentralized trials in 2020, AI and ML have sparked a paradigm shift in what is possible in the development of drugs and treatments. 

With the FDA’s recent publications providing a future framework, sponsors and CROs everywhere are researching how best to bolster drug development. With all these advancements happening at an unprecedented pace, we’re providing an overview of the uses of AI and ML in clinical conduct below.

‍

Mobile health technology, like medical-grade wearabledevices, can transform patient monitoring by enabling the collection of newtypes of data and better accuracy of patient responses. This tech can increaseaccessibility of trials for patients and even increase diversity and reducepatient burden by removing geographical and travel barriers.

As a result of these myriad benefits, we’ve seen theincreasing inclusion and acceptance of wearable devices throughout clinicaltrials. Here, we’ll dive into the specifics of these helpful tools and theirimpact on the future of medicine.

‍

In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary. 

‍

Patient recruitment is one of the most critical elements of a clinical trial. Without sufficient participation, studies will lack the power to demonstrate the statistical significance and efficacy of new treatments. Ultimately, poor patient enrollment will delay or prevent new therapies from reaching the market. Not only do such delays cost millions of dollars, but they also deprive patients of effective, potentially life-changing treatments. 

‍

Patient screening, a vital step in the clinical trial recruitment process, is when interested participants are assessed for their eligibility for a given trial using select inclusion/exclusion criteria. These criteria help characterize the target patient profile to ensure patient safety, better efficacy, and optimized signal detection. 

Traditionally, patient screening was done in person at a clinical trial site. Due to the current digital revolution in healthcare, which has recently accelerated in response to global health events, the ability to use cloud-based software and digital qualification steps to optimize patient screening and enrollment brings innovation, convenience, and sophistication to this process. 

‍

While informed consent form (ICF) signatures traditionally have been collected on paper at a physical site, today’s digital approach — electronic consent (eConsent) — offers more than high-tech signature collection. It provides an upgrade to patient education and communication as well, empowering participants in new ways. Moreover, eConsent can democratize clinical trial access, allowing researchers to recruit broader and more diverse participant groups through entirely remote consenting processes. This broader and less burdensome access also can increase the speed of recruitment and reduce drop-out rates.

‍

COAs (called eCOAs when captured electronically) are essential to understanding whether a drug is reducing symptoms, improving patients’ quality of life, and improving patients’ ability to perform activities they care about. COAs enable a well-rounded understanding of how a drug is working, its side effects, its impact on patients’ lives, and more. Perhaps most notably, PROs/ePROs allow for the patient’s voice to be heard. Capturing the patient’s voice is particularly important because the clinician may not always see or express the patient’s experience in the same way.

‍

Clinical trials require volunteers to assess medical products like devices, vaccines, or medications for efficacy and safety. For health equity to be achieved, it’s imperative that clinical trials include people from diverse backgrounds so as to represent the global population of patients using the products.

‍

The advancement of decentralized clinical trials (DCTs) allows patients to participate without having to travel to a trial site, removing many barriers that may have hindered people of diverse backgrounds from participating.

‍

‍