Knowledge Center

In June of 2022, Open AI forever changed the world’s technological landscape with the release of ChatGPT 3.5. The explosion and proliferation of AI tools have become a focal point of interest and curiosity in almost every industry, with commentators in pharma wondering how AI can improve clinical research.

In January 2024, panelists from Syneos, Obvious Ventures, Sapphire Ventures, IDEA Pharma, and GSR Ventures joined Medable’s CEO, Dr. Michelle Longmire, to discuss the purpose, potential, and power this transformative technology offers. 

Here’s what they had to say.

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With BBC Research forecasting that “the global smartphone-based patient monitoring market should reach $21.5 billion by 2027,” it’s safe to say that smartphones, tablets, and other devices have become a cornerstone of modern clinical trials.

Today’s trials use smart devices to help facilitate several important trial activities, like informed consent, data collection, patient feedback, and more. As a result, ensuring device delivery logistics has become a crucial step in getting a trial started and keeping participants engaged throughout its duration.

At Medable, we often handle device shipping for our customers' clinical trials. The team responsible for providing this service, led by Carl Franzetti, SVP of Professional Global Services has a market-leading 99% device shipment rate, with the remaining 1% resulting from normal business operation limitations such as weather outages.

The result? Our customer’s trials start on time and their participants are better engaged. 

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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

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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.

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A top 10 pharmaceutical company approached Medable seeking support for their Phase III 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%.

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See how Medable was able to meet the customer's goal with this case 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.

The next level of clinical trial data capture is here. Gone are the days of paper, illegible handwriting, and data quality nightmares. eCOA, or electronic Clinical Outcome Assessments, and ePRO, or electronic Patient-Reported Outcomes, are revolutionizing the way clinical trials generate data. Both leverage digital tools to collect information electronically, offering a treasure trove of benefits. eCOA acts as the umbrella term, encompassing data from various sources like patients (ePRO), clinicians, observers, and even performance-based assessments. This holistic approach paints a more complete picture of a patient's experience. ePRO, as a subset, shines the spotlight directly on the patient's voice, capturing their symptoms, quality of life, and other critical self-reported measures.

Hear from industry leaders at this unique virtual event showcasing the eCOA/ePRO solutions of partners who are ready to help you with your clinical trial data capture needs.  Early registration is open via the form to your right.  

DCTs have transformed from a disruptive force challenging the norm to an integral concept, now widely embraced in the clinical trial landscape. Join us for this upcoming Clinical Leader Live session, where experts will explore the current landscape, highlighting the positive impact of DCTs and their transition from innovation to indispensable practice in the era of evidence generation and modern clinical trials.

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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

Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.

Modern clinical trials employ various digital-based tools and technologies designed to increase the speed, accuracy, and ease of conducting clinical trials. In the best-case scenario, these tools are housed in the same experience or a  “clinical trial platform.” 

Clinical trial platforms are software-based, web-based, and/or cloud-based solutions that facilitate clinical trial research throughout its entire lifecycle. They offer a complete technology ecosystem that connects patients, research sites, and trial sponsors from patient recruitment to close out and data submission. Users of clinical trial platforms can access and operationalize all of their digital-based tools through this connected platform. Platforms can prevent users from accessing parts of the platform not permitted for them. For instance, participants can not view other participants' data or gain access to tools meant for sites. Other users, like sponsors’ study teams, have access to the full suite of tools as needed based on their roles.

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.

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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.

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