While the breakneck pace of technological innovation has affected nearly every facet of modern life, the opportunities it has created in clinical research have been game-changing. This has been particularly true for patients managing conditions that impede their ability to take part in traditional clinical trials, like those suffering from Parkinson’s disease.
In many diseases — including Parkinson’s disease — obtaining consistent, reliable, high-quality clinical research data from in-clinic trial measures can be challenging, time-consuming, and inefficient, limiting R&D efforts and slowing the pace of therapeutic innovation. However, as digital biomarker measurement capabilities continue to expand, researchers are increasingly empowered to better understand Parkinson’s disease and hopefully provide patients with transformative new therapies faster and more effectively.
Rethinking Parkinson’s disease research
Digital biomarkers will prove particularly beneficial for empowering and accelerating future Parkinson’s disease clinical trials. Along with the inherent physical difficulties faced by patients, these clinical trials have also historically had problems due to the periodic “point-in-time” and subjective nature of existing clinical measures. Traditional trials are challenging for both patients and clinicians, leading to limited and insensitive data, slower and less effective research, and ultimately, unrealized improvements in Parkinson’s disease care. And yet, patients are waiting for new therapies. Digital biomarker development eases clinical research participation burdens for patients and clinicians alike, helping researchers overcome in-clinic study conduct challenges while improving the quality of insights and speed future Parkinson’s disease trials provide.
Patients
Traditional trials gather data in a clinical setting, which is time-consuming and can be problematic for patients with mobility issues — an unfortunate reality among many Parkinson’s disease patients. Travel for these individuals can increase pain or anxiety, and the “single snapshot” nature of this burdensome evaluation process gives only a small window into symptoms and progression while missing the larger day-to-day picture of disease management.
Digital biomarker measures, in contrast, are collected remotely using electronic devices and wearables, like a cellphone or a watch. As a result, Parkinson’s disease digital biomarkers assessment testing can be done quickly and conveniently from the patient’s home, removing the burden of travel. Since in-clinic testing no longer limits the time frame during which data can be collected, the use of digital biomarkers also provides a continuous stream of quality data — more like a video than a snapshot — giving researchers a faster, more complete, and likely better indication of disease progression and management in everyday life.
This in-home testing environment makes participating in clinical trials a more practical and far less daunting possibility for patients, allowing a greater number of people to contribute to Parkinson’s disease research, while ongoing data collection enables measurement of more data points, which could decrease the number of patients required for a quality trial. Digital biomarkers hold the promise of addressing historical participation challenges while providing a more realistic and accurate understanding of Parkinson’s disease.
Researchers
Researchers also face a lengthy list of obstacles in traditional Parkinson’s disease trials, from patient enrollment challenges to the potential for human error. Some of their challenges even mirror those that patients experience.
From the start, the unique challenges inherent to Parkinson’s disease clinical trials mean sites face a heavy workload and require significant on-site monitoring resources, a costly need compounded by specialized clinician training or certification that is routinely required. The subjective, “snapshot” nature of these assessments also limits the statistical power of Parkinson’s disease clinical trials. As a result, Parkinson’s disease research often requires large numbers of patients to enroll and in-clinic assessments to be conducted over a long duration. This is especially challenging for Parkinson’s disease R&D and can potentially even be cost-prohibitive for therapies targeting rare genetic variants.
Beyond logistical issues, in-clinic testing for Parkinson’s disease suffers in part because of its subjective nature. During an in-person evaluation, a researcher might conduct tests designed to evaluate four main disease characteristics: bradykinesia, rigidity, tremors, and gait and balance. Data related to these characteristics can be challenging to capture in an objective and consistent way across all participants and all data points — particularly when researchers must attempt to distill these complex, multifaceted disease aspects into simple, Likert-style scales. How accurately quantified can the severity of a patient’s tremors or the state of their balance truly be when using such measures? These ambiguities and nuances leave a great deal of room for clinician bias or error to skew data.
By incorporating digital biomarkers, these testing issues are significantly remediated, potentially reducing risk, time, and cost for researchers. Since patients utilize wearables and other electronic equipment to consistently collect data points, human error and overall researcher responsibility are lessened. This allows clinicians to better prioritize their efforts and attention, devoting more time to the patients and the research while receiving the comprehensive high-quality data necessary for better, more accurate insights.
A more informed future
Digital biomarkers have transformative potential for the future of Parkinson’s disease clinical trials, enhancing the speed and accuracy of effect detection while providing a clearer look at the progression of the condition and the effectiveness of medicines, management techniques, and therapies. They represent a revolutionary step in advancing how research is conducted, and the ongoing development and validation of digital biomarkers holds great promise for improving Parkinson’s disease data collection methods and data quality, enabling researchers to accelerate timelines and improve R&D decision-making.
Koneksa is at the vanguard of this evolving field, enhancing early disease detection with novel digital biomarkers tailored to Parkinson’s research and enhanced by advanced algorithms. Our device-agnostic platform conforms to each individual trial’s requirements, ensuring the right fit for better compliance and higher-quality data that enable faster, more informed decisions.
Get in touch to discover how Koneksa’s digital biomarkers can revolutionize your Parkinson’s disease trial.