Data
The Future of decentralized clinical trials: Opportunities and adaptations for Medable
Traditionally, clinical trials have relied heavily on centralized sites and face-to-face interactions between researchers and participants. However, the limitations of this model have become increasingly apparent, especially during the COVID-19 pandemic, which prompted an unprecedented emergence of decentralized clinical trials (DCTs), whose characteristics of remote patient engagement, virtual assessments, and mobile health technologies allowed the healthcare industry to continue drug development (albeit at a slower pace). As the healthcare landscape continues to evolve, DCTs are emerging as a vital component of the clinical research ecosystem. By leveraging technology and data to streamline processes and the need to enroll a greater diverse patient population, DCTs promise enhanced patient engagement, improved data quality, and accelerated study timelines. As with everything in life, nothing is always that simple. In this blog, we will explore the future of decentralized clinical trials and look at the challenges faced by sponsors, sites, and patients when planning, implementing, and running a DCT. We will also discuss how Medable is continuously adapting its platform and software capabilities to reduce risks and provide solutions that allow the benefits of DCTs listed above to be fully realized.
How platforms solved clinical trials’ disparate data problem
Our world is drowning in data.
Humanity generates a staggering 402.74 million terabytes of information every day. From the countless videos we stream to the endless social media scrolling, our global digital footprint is growing exponentially. This data deluge is reshaping industries, influencing our lives, and posing unprecedented challenges.
Within clinical trials, rapidly evolving technologies are enabling researchers to capture new data points as trials grow more complex. However, this poses new challenges in managing clinical trial data.
Evidence generation evolved
The pharmaceutical industry faces a daunting challenge: it takes an average of 12 years and $3 billion to bring a new drug to patients, with the FDA approving an average of 50 new therapies yearly.
This pace is inadequate to address humanity's needs and our own future goal of helping the industry produce ten times the number of treatments it does today.
A significant bottleneck is the lengthy clinical trial process, where Phase 3 studies alone can span three years or more. However, a critical factor compounding these timelines is the difficulty in recruiting sufficient patients for these crucial studies, often adding up to 2 years to the already protracted journey.
Medable enables >90% eCOA adherence in vaccine trial
A leading biotech company came to Medable looking to conduct a vaccine trial. They were concerned that their trial’s participant population of persons aged 50+ years may be hesitant to use the sponsors’ chosen eCOAtrial technology, would not be engaged in the study, and therefore may not provide consistent trial data.
Learn how we drove success for them, including >90% eCOA adherence.
Medable’s Patient Caregiver Network improves post-seizure trial data
A pharmaceutical contract research organization (CRO) expressed concerns about the timing and availability of seizure diaries for patients enrolled in their rare disease study.
They wanted to understand when patients should be prompted to complete the diaries and how they could improve the process to better accommodate caregivers' and patients' needs to produce better trial data.
DCT Digital Week: Creating the Digital Foundation for Scale in Clinical Development
Learn how sponsors and CROs can improve their clinical trial conduct by developing new strategies that create sustainable, repeatable, and effective clinical conduct.
Back to basics: What are electronic clinical outcome assessments (COAs/eCOAs)?
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.
Connecting in new ways: Our partnership with Withings Health Solutions
In June, Medable announced a partnership with Withings Health Solutions with the goal of reducing the burden on sponsors and sites while empowering patients to participate in trials from home.
What does the new European Medicine Regulatory Network recommendation paper on decentralized elements in clinical trials tell us?
Learn what impacts the new European Medicine Regulatory Network recommendations paper means to your clinical trial operations.
New EU Regulatory Recommendations for Decentralized Trials Keep Focus on Patients and Sites
As clinical trials rapidly modernize, government regulators work to evolve even as the same core principles apply. Still, decentralized clinical trials are – simply – clinical trials, as all research today is decentralized in some way, yet we lack global harmonization of regulations.
Patient perspectives: A year of pharma webinars showcase what’s working and what needs work
Learn what industry topics, trends, and focuses are being well received by patients and caregivers with this blog.
Clinician Reported Outcomes (CROs): A universal approach
Get the basics on ClinROs, why they are important, the industry governance around them, and how their electronic versions can benefit clinical trials.
Designing patient-friendly ePRO instruments
This blog explores why patient-centric ePRO instrument design is critical to driving study success, provides tips on how to make instruments more patient-centric, and offers resources for additional ePRO design guidance.