The use of technology in the healthcare space has created a plethora of opportunities for clinical trials to scale and obtain granular data points in the billions while providing a patient participation experience that is simplified, streamlined and satisfying. Where data collection was once an arduous task that required a significant time commitment on the part of the study participant, a major outlay of financial expense and on-ground professional expertise on the part of the Sponsor, CRO and/or site, the landscape has changed dramatically in the past decade. Digital wearable devices, algorithm development, machine learning and blockchain ledgers are all contributing to the transformation of clinical conduct and patient outcomes.
Patient monitoring tools relay data to researchers instantaneously by tracking RWE (real-world evidence) in real time via wearable devices, sensors and smart phones powered by artificial intelligence, big data and predictive analytics. 1. Myriad types of testing and monitoring can now be done remotely. Wearable devices that are similar in scope and design to commercial fitness trackers as well as skin sensors can collect data on heart rate, blood pressure, ECG (Electrocardiography), skin temperature, breathing rates and sleep cycles. (source: Wearable Devices in Clinical Trials: Hype and Hypothesis, Izmailova, Wanger and Perakslis) Patients being monitored while in the comfort of their own homes and maintaining their own routines means that the data is providing a complete picture of the patients’ lives and not just a limited time frame within the walls of a doctor’s office. Some of the data collection is passive, with no work required on the part of the patient. For other types of testing, patients must use a mobile phone, paired with the medical device, to send data points forward. This brings other important considerations to the forefront.
Wearable technology must be low burden and easy for patients to use while being impervious to environmental elements such as moisture and atmospheric conditions like pollution. Devices must be precisely calibrated to capture reliable data and they must be responsibly worn and reasonably monitored by the patient. The algorithms and machine learning structures that relay and compile the vast data sets are all for naught if a device is cumbersome and difficult for a patient to navigate. There are also generational differences to address. Patients in younger demographics may be more comfortable with mobile apps to track and report data while some patients in older demographics may be more aligned with using desktop or laptop computers connected to the internet. Clear communication between clinical research professionals and patients is key to making the determination if the adoption of a wearable device with remote monitoring is the best choice to meet the goals of the study and provide meaningful, patient-centric care.
Blockchain has become a broadband buzzword in healthcare and while bandied about, its actual meaning and origin are not always well understood. In its simplest description, blockchain is a transparent, shared, digital ledger of data, not entirely dis-similar to financial ledgers that have been used for hundreds of years. The affiliated data is tracked using encryption technologies, making it more secure from tampering because all data segments are linked and tracked together, based on the time-stamping of a prior link. The data is in “blocks” and strung together to make a “chain”. No one link, or block, in the chain can be modified without it being readily apparent, and tracked for all stakeholders to view. This provides particularly useful implications when it comes to patient data.
Blockchain is most often associated with the movement and exchange of rising cryptocurrencies in international circles; the technology is not, however, confined to the financial realm and is widely used in the healthcare sector. Due to its ability to process terabytes of data quickly and (fairly, by today’s standards) securely, it has become a way to manage medical records, pre-authorize payments, settle insurance claims and record other detailed transactions. Blockchain is efficient and can hold “the complete medical history for each patient, with multiple granularities of control by the patient, doctors, regulators, hospitals, insurers and so on, providing a secure mechanism to record and maintain comprehensive medical histories for every patient. (source Blockchain for Dummies® 2nd IBM Limited Edition by Manav Gupta, 2018) Patient privacy, as a practical, legal and ethical concern, is greatly assisted by the use of blockchain technology in data transfer and curation.
The rapid development and deployment of technology is swiftly changing the conduct of clinical trials and is providing a level of care that is becoming increasingly tailored to the needs of participants in clinical studies. In many cases, patients have the opportunity to participate in studies virtually through the use of low-burden, high-tech medical devices. The continuous transmission of granular data points provides clinical researchers with an unprecedented depth of data and in turn, this is providing greater ability to decode disease and provide effective therapies to patients more quickly.
The benefits of blockchain technology in healthcare extend beyond the patient experience. Blockchain also eliminates a problem that has long plagued the healthcare industry – that of sharing patient data. Insurance companies and physicians (both direct and referred healthcare providers) have long struggled with transferring and accessing patient data safely and efficiently, often with little success. Blockchain offers the perfect solution; rather than using multiple programs, storage locations, and languages, blockchain technology allows for one central place to house patient data. Due to the high level of security that blockchain provides, this data is secure and HIPPA compliant. It is also readily available for the individuals that need to see it and accurately tracked, which eliminates the double or late billing that so frequently happens in today’s healthcare landscape.
In summary, blockchain technology makes the process of navigating the healthcare system infinitely more manageable for patients, eases the burden of muddled communication for healthcare providers, and increases efficiency for all parties. Patient data can be accessed anytime, with guaranteed accuracy. With blockchain at the helm, the future of healthcare will be defined by efficiency and the cutting of costs.
https://www.ecnmag.com/article/2019/01/how-blockchain-technology-helping-healthcare-industry-evolve
1 https://www.iconplc.com/2018_ICON_Publication_Digital_Health_Whitepaper.pdf