The biopharmaceutical industry was already adapting to enormous change before COVID hit but, as shutdowns began to impact clinical trial sites, a whole new challenge emerged in the incredibly complex dance that is drug development. Without functioning clinical sites with patients, there are no drug trials. Without new drug trials, there are no new drugs. This stark reality is illustrated by some unsettling statistics—new patients entering clinical trial sites dropped by 20%,1 and 41% of clinical trials were delayed or put on hold indefinitely.2
This has put a tremendous strain on pharmaceutical and biotechnology companies to get new drugs to market in a timely fashion, and even worse, deprived patients of potentially life-saving therapies.
Based on these challenges, three emerging developments are paving the way for the next revolution in the pharma and biotech industry:
1. Decentralized virtual clinical trials. Up to 65% of life sciences companies plan to run clinical trials remotely after the pandemic.3 Pharma, biotech, and medical device manufacturers as well as their CRO partners need to be prepared for this new paradigm with technology that captures physiological and behavioral data from patients at home versus physical clinical trial sites.
2. Scalable enterprise infrastructure. Life sciences companies must prepare to enable digital scalability across the enterprise with the proper infrastructure. They can’t approach digital medicine on a one-off basis anymore. They need platform technology that allows them to leverage and replicate proven methods of continuous remote patient monitoring (cRPM) and data capture across multiple therapeutic areas, not just designed for data streams available today, but one that is “future proof” and architected to accommodate novel data streams from new devices that will inevitably come online.
3. Analytics, artificial intelligence (AI), and digital biomarkers. Simply collecting data on drug safety and efficacy in patients as momentary point measurements is no longer enough. R&D leaders have a once-a-decade opportunity to establish a durable competitive advantage by embracing and capitalizing on continuous, real-time data captured from wearable biosensors to understand and characterize health of their patients in the real world. The leaders who recognize and seize this moment will position their organizations for outsized competitive advantages related to speed to market and demonstrated value for patients, providers, and payers.
Just as the last decade saw electronic data capture (EDC) and electronic clinical outcome assessment (eCOA) solutions become the standard across all clinical studies, the massive push to decentralized trials and regulatory focus on quality-of-life (QoL) markers have established biosensor data as the new “must have” data set to evaluate safety and efficacy of pharmacotherapies.
Three Tips to Embrace and Advance Change
To excel in the race toward clinical research that utilizes more virtual, scalable, and analytic-based solutions, pharma leaders must do three things:
1. Meet patients where they’re at (often at home). This means finding innovative ways to monitor patients with biosensors that fit seamlessly into their everyday lives and provide an accurate window into the safety and efficacy of an investigational therapy. In many ways, this is a more realistic measure because digital biomarker data is being captured continuously in a patient’s natural environment versus sporadically in a clinical setting. The ability to obtain real-word evidence via RPM is vital to evaluating and quantifying the therapeutic safety and efficacy of new products.
2. Move away from device-centric approaches. Instead, pharma leaders must embrace technology that allows them to continuously capture and analyze digital biomarkers regardless of the type of wearable used. This “device-agnostic” approach enables greater flexibility in the wearable chosen rather than being tied to a particular type. Different clinical use cases and conditions often necessitate several types of devices, whether that be a patch biosensor, smartwatch, or other type of wearable. Just as every clinical trial has a unique set of endpoints, there should not be a “one-size-fits-all” approach to device selection and use.
3. Plan for future enterprise scalability and think long-term across multiple therapeutic areas and disease states, or risk adopting infrastructure that cannot flex and evolve to support a rapidly evolving set of new technologies. A pharma company should choose a platform that aligns with its vision of growth. With the forethought that it will expand into other potential patient populations with drug candidates that address a broader portfolio of conditions, it’s wise to invest in technology that is not only able to serve the needs of today but is able to pivot toward future expansion. That means serving more patients with more therapies that save more lives—faster.
More than ever, pharma leaders must put patients at the center of research and development, using tools and designing experiences that fit into patients’ lives. Doing so need not be a trade-off between patient-centricity and clinical insight. Rather, the right tools, collecting the right data, and delivered in the right way offer the opportunity for more actionable insight than ever. Biopharma leaders that embrace this opportunity for innovation and adopt digital infrastructure to scale across the enterprise will not only position their organizations for success, but better realize their mission of bringing novel therapies to patients.
1. COVID-19 and Clinical Trials: The Medidata Perspective (9/21/20).
2. TMF Futures 2021 Report, Arkvium (as reported by FierceBiotech, 8/9/21).
3. TMF Futures 2021 Report, Arkvium (as reported by FierceBiotech, 8/9/21).