By: Colin Weller, VP, Product Management
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.
As stewards of clinical research, our vision is to help change the world by bringing more effective treatments to patients faster. We’re working hard to achieve this vision and have made significant strides in shortening clinical trial timelines.
For many indications, a drug development program consists of up to 15 individual studies, each with its own study start-up. This means deployment takes three to six months for each trial, causing considerable windows during which no participants are being recruited and no new data are being generated. At Medable, we've effectively cut startup times in half using new technology and processes.
Progress exemplified Take, for example, a recent oncology study in NSCLC with a top-10 pharma. Here, the client was able to utilize the automation capabilities in our eCOA+ offering. As a result, they were able to launch their eCOA prior to the launch of electronic data capture (EDC) and other systems. This effectively took eCOA off the critical path and shaved weeks off the trial deployment timeline,.
Similarly, by utilizing automated protocol configuration and validation tools, Medable has reduced eCOA deployment timelines by 50% for several of our top pharmaceutical clients.
The digital data revolution Thankfully, Medable isn’t the only one using technology to improve trial timelines drastically. Many of our peers in clinical research are spearheading efforts to use digital technologies to improve trial timelines vastly.
Over the past five years, there has been a significant surge in the adoption of digital health technologies (DHT), resulting in a remarkable 97% increase in usage, according to PwC . This is good news, as case studies from across the industry demonstrate the transformative impact of digital measures.
For instance, a top 10 pharmaceutical company achieved an impressive 80% reduction in the number of participants required to detect disease progression in Huntington’s Disease, thanks to the sensitivity of digital biomarkers.
Similarly, collaboration with a major pharmaceutical company showcased enhanced safety monitoring and digital biomarker development utilizing electronic-patient reported outcomes (ePRO) combined with sensor-collected performance outcome (PerfO) data. Digital biomarkers now consistently enable smaller sample sizes (such as 70% reduction) through more precise digital measurements.
80% fewer participants required for dection of disease progression in Huntington's Disease 74-85% of trial data could be collected remotely using clinically validated devices FDA agreed to the use of a digital endpoint as the Ph3 registrational primary endpoint 70% reduction in sample size via more "precise digital" measurement
Real progress requires a proper foundation A holistic platform approach is required to fully realize the potential of DHTs, digital measures, AI, and automation innovations. One that fully realizes these technologies across the entire clinical development lifecycle, not just trial startup or single studies.
This involves expanding where measurements can be taken (e.g., patients' homes, community clinics, retail pharmacies), increasing the precision and granularity of measurements (such as sleep or gait as endpoints), and combining multiple data types (PRO, sensor data, and EHR data) to enable new trial designs and smaller sample sizes.
Medable's single-system solution, encompassing digital experiences (Total Consent, TeleVisit, eCOA+), intelligent automation, digital measures, and digital data from sensors and wearables, is well poised to drive this evolution. The future envisions a platform integrating lab, sensor, imaging, and EHR data, enabling more profound evidence generation and cross-study/program data referencing.
As the biopharmaceutical industry embraces digital innovation, we inch closer to a future where clinical trials are faster, more efficient, and better equipped to deliver life-changing therapies to needy patients.
A step on the path to one-year trials While achieving clinical trials within a single year may seem like a far-fetched goal, the pharmaceutical industry is undoubtedly on the right track. Significant strides are being made to streamline clinical trial processes and reduce timelines at Medable and across our wider research sphere.
Ultimately, the objective measure of success is the tangible impact on people's lives. By embracing digital innovation with a logical platform foundation, we can help improve millions of lives globally.
