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. 

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“No one knows their level of pain and how they feel or function better than the patient. Capturing the patient’s response to an electronic Patient Reported Outcome (ePRO) is always the best option.”

Since its inception, Medable has prioritized scientific integrity and rigor around various aspects of clinical trials. As part of its science team, Cindy Howry, VP of eCOA Science, plays a crucial role in ensuring that Medable’s clinical trial platform accurately captures electronic Clinical Outcome Assessments (eCOAs). Hired in 2023, Howry’s chief purpose at Medable is to ensure that the health economics and outcomes research (HEOR) science behind our technology is based on best practices and regulatory guidance.

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The rise of SaaS has transformed industries, including life sciences, by enabling new possibilities. For instance, Salesforce revolutionized how organizations managed their customers and future clients with its cloud-based software, enhancing accessibility and collaboration. Similarly, Canva made graphic design tools accessible to all, empowering professionals and casual users alike.

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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. 

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With the 14th annual DPHARM® wrapping up, we talked to our peers across the industry to find out what the big themes and takeaways were from this year’s conference.

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There’s no doubt that study launches come with extremely high stakes for sponsors. 

This period requires precise coordination over numerous critical activities across multiple stakeholders, including regulatory bodies, ethics committees, investigator sites, and internal teams. 

Any lapses here can significantly impact the entire study timeline, budget, and, in some cases, the study’s integrity. 

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The landscape of clinical trials is undergoing a significant transformation as digital measures and digital health technologies (DHTs) continue to evolve and prove their worth. 

As of December 2023, approximately 1,550 clinical trials worldwide utilized wearable devices, representing about 2% of all trials. While this percentage may seem small, it marks a steady increase since 2014, and the momentum is set to accelerate.

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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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In the lead-up to ASCO 2024 the oncology enterprise has much to celebrate. New drug approvals at FDA reached a three-decade high with anticancer drugs representing the largest percentage of new approvals. EHR vendors are making proactive commitments to cancer data standards to support scientific breakthroughs and more effective cancer treatment. And, for the first time ever, payers are offering a new reimbursable pathway for improved cancer outcomes via comprehensive supportive care. 

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Within clinical research, email is not just a compliant and valuable tool, it’s commonly the gold standard when communicating with participants. Read on to find out why.

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