Blog posts
Building a “gold standard” clinical trial experience in Japan
When talking to customers conducting their first multi-country trial, we sometimes liken clinical trials to spider webs. Just as a garden spider’s web differs from a black widow’s, clinical trials follow unique patterns in every region. Each country comes with its own set of rules, ethical standards, approval processes, and data privacy laws. Cultural factors also play a crucial role in how patients are recruited and understand Clinical trials, requiring sensitive communication and a deep respect for participants’ needs.
In Japan, these regulatory and cultural intricacies form a complex ‘web,’ with anchor points and structural requirements that, when understood and implemented correctly, create a framework for success. However, conducting Clinical trials in Japan has historically posed challenges for Sponsors and Contract Research Organizations (CROs). When we first entered the region, one Sponsor consistently cited issues with eCOA solutions and site and patient support, not fully adapting to Japan’s unique requirements. This feedback, combined with our own experiences on the ground, revealed a clear need for improvement.
Today, we can proudly say that the solutions we put in place have transformed Japan’s Clinical trial landscape, and what was once a challenge has now become the “gold standard” for supporting Clinical trials in the region.
Creating success with digital measures
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.
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.
What happened at ASCO 2024
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.
Evolving Total Consent: Introducing digitally-enabled biosample consent storage
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.
Ahead of ASCO: Opportunities for A More Modern, Equitable Oncology Enterprise
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.
Email: The gold standard for clinical trials
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.
Simply digital: Trial technologies help reduce oncology’s burden
With the share of oncology trials continuing to increase, the case for using digital tools in these trials grows with it.
Today, cancer trials are the most commonly researched of all diseases, with their share of clinical trials growing each year. According to research from Tufts CSDD, the number of cancer drugs “has nearly quadrupled since 2000, to 1,489 trials in 2021, up from 421 two decades earlier.”
Tufts CSDD notes that this growth comes as “oncology drug developers are increasingly shifting toward precision medicine, embracing new molecular targets and improvements in genetic sequencing technologies”
How partnership ensured a successful first digital trial
Since our inception in 2015, Medable has conducted over 300+ digital and decentralized trials using eCOA, eConsent, telehealth, and more. However, just as a bell curve shows, adoption rates for new technologies can wildly vary across our industry. While some organizations quickly implement new technologies, others take a more cautious approach.
Together, this team, which included Mihai Viisan, a Solution Design SME, Luka Ajduk, a Product Implementation Lead, and Ted Meyer, the Supply Chain Coordinator, built a trusting working relationship in which Medable led study implementation.
Experts discuss AI’s future in pharma
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.
No delays: How Medable achieves a 99% device shipment rate
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.
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.