In the world of clinical trials, technology is transforming the way pharmaceutical companies conduct research and develop life-saving therapies. In response to the pandemic, where traditional methods of conducting clinical trials faced challenges due to restrictions on physical contact, the industry has seen a 50% increase in trials involving digital technologies such as wearables from 2019 to 2021. In this article, we will explore how technologies like wearables, AI and Big Data, and blockchain are disrupting the way clinical trials are conducted.
While clinical trials are often plagued by low success rates, incomplete patient enrollment, and lengthy processes, the use of innovative technologies offers a new perspective: They enable researchers to collect more accurate and reliable data, make trials more accessible to participants and sponsors, and potentially enhance transparency and security. Here are three selected key technology trends that pharma companies are starting to embrace to address industry challenges.
Remote patient monitoring
Wearable devices and sensors can capture physiological data such as blood pressure, heart and sleep rate in real time. Unlike data traditionally collected in a clinic, wearables enable richer data monitoring 24 hours a day in patient-centered settings. This reduces the need for patients to travel to research centers. Moreover, remote monitoring combined with mobile health platforms has the potential to improve compliance and safety: They can help detect safety signals or patients who are deviating from the protocol early-on. This allows researchers to adjust medication or intervene before data need to be excluded.
Many start-ups have emerged to develop wearable devices that aim at reinventing patient monitoring. Current Health, a Best Buy-owned start-up based in Edinburgh, UK, offers a wearable device that continuously monitors a patients’ vital signs, including heart rate, blood pressure, and temperature. The device can be used for both in-hospital and remote patient monitoring.
AI and Big Data analytics
AI has enormous potential to automate many aspects of the trial process. Already at study start-up, AI algorithms can help streamline the protocol development process by analyzing vast amounts of data and identifying patterns and insights. Traditionally, study start-up can take months or even years, as researchers must navigate complex regulatory requirements and obtain approvals from various stakeholders. With big data analytics, one application is for algorithms to screen regulatory documents and find potential issues that could delay approval.
For protocol development, the technology can identify patient populations, suggest appropriate endpoints, and even help design adaptive trials that can adjust the protocol based on data analysis. This can reduce staff workload, errors and costs.
One of the biggest challenges in clinical trials is patient enrolment and retention. Many trials struggle to recruit enough patients, and once enrolled, many patients drop out of the study before completion. Trial data management systems powered by AI integrate information collected from remote monitoring devices for trial recruitment. The tools can also help keep patients more engaged by allowing them to send feedback or share information with researchers.
U.S.-based start-up Biofourmis, for example, has built a clinical research platform that provides continuous monitoring, predictive analytics, and personalized care plans to improve patient outcomes and reduce costs.
In a nutshell, Blockchain is an electronic ledger that allows for decentralized transactions without intermediaries, giving it the potential to record virtually any information of value. Thanks to the audit trails built into each transaction, the original source is always verifiable and data cannot be altered without trace. In clinical trials, collaboration between the pharma companies, regulators and patients is critical. Blockchain ensures the privacy of participants even when their data is exchanged with collaborators. At the same time, it allows trials to be conducted in a transparent and secure manner, addressing data accessibility and intellectual property concerns for stakeholders.
Blockchain is still in its infancy, and there are some technical challenges to overcome. Nevertheless, the technology has the potential to become a disruptive tool for various aspects of studies, including data management and analysis, as well as patient recruitment. One example of a start-up developing blockchain for clinical trials is ClinTex. The company is developing a clinical trial ecosystem based on blockchain to address the pain points of these trials. ClinTex aims to enable workflow management and allow researchers to share data while meeting FDA regulatory and IP protection requirements.