Knowledge Center

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. 

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The annual American Society of Clinical Oncology (ASCO) meeting in Chicago highlighted the latest new molecules, methods of care, and innovation in cancer care. 

As the show closed out, we checked in with our associates to see what they thought were the biggest news and trends of the show. 

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Within biosample storage, a “nightmare scenario” exists that Medable and our clients discuss regularly.

Some years ago, a sponsor with tens of thousands of biosample specimens identified that they had lost the ability to link their biobank samples' documented consent for storage (and further research). The consent for these samples was taken on paper, but a system to collate and file the consent data attributed to each specimen was not implemented. When the organization couldn’t find the paper consent, they were forced to dispose of thousands of biospecimens, losing the ability to conduct valuable research and potentially millions of dollars of lost IP.

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A top-10 pharmaceutical company was looking to standardize the conduct of their diabetic polyneuropathy trials for future use.

Specifically, the client was looking to digitize their paper “body map” forms. These are used by participants to indicate the severity of pain on their bodies. 

Traditionally administered on paper, body map assessments had been a source of potential inefficiencies and errors. 

The client’s goal was to co-create and own their body maps, while simplifying and streamlining the process for future trials.

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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.

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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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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.

The adoption of connected devices in clinical trials has experienced a significant surge since 2020.  Driven by the need for more efficient and accurate data collection, sponsors and CROs have begun investing heavily in devices that can help with remote monitoring capabilities and improved patient engagement. These devices, which include wearables, sensors, and mobile apps, are revolutionizing the way clinical trials are conducted, enabling researchers to gather real-time data and gain deeper insights into patient behavior and treatment outcomes.

According to a report by Grand View Research, the global connected device analytics market for the healthcare industry is projected to grow at a staggering compound annual growth rate (CAGR) of 28.9% from 2022 to 2030. This remarkable growth can be attributed to the increasing demand for real-world evidence, the need for remote patient monitoring, and the growing emphasis on value-based care models.

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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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