Quality by Design: Better data using participant insights
Quality is not an afterthought within clinical trials. Instead, it is a required and integral part of the entire process beginning at the start of protocol design. While clinical trials will always encounter challenges in driving quality experiences and data, there exists one approach that’s backed by regulatory agencies and proven to lead to better outcomes.
This is a “quality by design” strategy that’s informed and driven by all stakeholders, including those most affected by your trial’s protocols - your participants, and sites.
Key Insights from the FDA's DHT Guidance
On December 23, 2023, the FDA released guidance for the industry on how digital health technologies (DHTs) should be used in clinical trials.
DHTs, which the FDA defined in their “Framework for the Use of DHTs in Clinical Trials,” are “technologies such as wearable, implantable, ingestible, and environmental sensors and software applications on mobile phones, among others.”
DHTs can be used to collect data from clinical trial participants more efficiently and objectively than traditional methods. For example, DHTs can collect data on participants' activity levels, sleep patterns, and medication adherence. This data can be collected electronically, which can reduce the burden on participants and improve the accuracy of the data
Trends, insights, and news from SCOPE 2024
With over 3,300 attendees across 850 companies, the 16th annual Summit for Clinical Operations Executives (SCOPE) was a huge success. As previous years have shown, what’s big at SCOPE tends to be big for our industry. Thus, we’re summarizing some key takeaways from this year’s conference to understand where the industry may be headed next.
Defining “evidence generation” within modern clinical trials
Medable has always been, at its core, a platform that enables clinical trial sponsors to collect data and generate evidence to answer scientific questions.
But from the start, Medable has done things differently. Today, the flexibility, purpose, and build of Medable’s evidence-collection platform is what sets us apart from others in our space.
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.
Medable platform speeds diabetes study startup by 50%
A top 10 pharmaceutical company approached Medable seeking support for their PhaseIII diabetes study in the highly competitive weight loss market. Their primary goal was toreduce the client’s average study build timelines from 16-20 weeks, down to just 8 weeks,a reduction of more than 50%.
See how Medable was able to meet the customer's goal with this case study.
Record-breaking enrollment achieved in weight-loss study
A top 10 pharmaceutical company approached Medable seeking support for their Phase III diabetes study. Their primary goal was to reduce the participant enrollment phase timeline to get the study underway as quickly as possible.
Amplifying Evidence with Unified Clinical Trial Data Collection
Join us for a discussion about how combining a unified clinical trial data collection platform with intelligent automation can revolutionize drug development and why the current status quo is no longer sufficient. With novel capabilities, the industry can now explore new possibilities, such as incorporating additional sensors to identify surrogate or alternative endpoints, rethinking adaptive trial designs, and quickly responding to emerging data.
Keeping up with ClinOps: Why and how to improve delivery
Medable is joined by Join GSK and Lightship for a panel discussion on how a trial platform as a service can enhance, expedite, and improve the day-to-day operations of clinical operations across the life cycle of a study.
Optimizing Evidence and Design Using the Patient’s Lens
Uncover how to work with patients to shape everything from protocols to data collection.
Assessing the financial value of decentralized clinical trials
Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted
Development of a mobile health app (TOGETHERCare) to reduce cancer care partner burden: Product design study
Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.
How AI and ML can transform clinical trial conduct
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.
Back to basics: What are wearables and how are they powering diversity and efficiency
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.
Back to Basics: What is a decentralized clinical trial?
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.