What’s on the Horizon for Clinical Trials in 2023?
Technology that enables clinical trials is rapidly evolving. As a result, researchers have been able to upturn the traditional methods for carrying out clinical research. Results are in, and the reviews are trending positive: clinical studies are becoming more fast-paced, complex and targeted, but there's always room for improvement. Seeking an expert perspective, we asked Phylloceuticals and Nile AI representatives for their predictions on the biggest trends in clinical trials in 2023 and what still needs to change.
Rethinking clinical trial structure
Let's look back at where we've come from to set the scene. Historically, clinical researchers primarily conducted their clinical trials at large, central hospitals. That was where the hospital staff was and where doctors could reliably administer tests assessing the effects of a new therapy. For months or even years, patients had to travel to the site to undergo tests on a regular basis, and clinicians would also ask them to submit data they had recorded at home every day.
For logistical reasons, many clinical trials still use this centralized structure; however, the approach comes with some issues. Centralized clinical trials tend to include less diversity in patient cohorts. Due to accessibility issues, only people close enough to the trial site with time and the ability to travel there regularly can partake in the trial. Therefore by default, this structure excludes patients who cannot afford to take off work and those too sick to travel periodically. As a result, the drugs assessed in these trials have not been thoroughly vetted in large swaths of the population. Therefore, there is a push toward running decentralized or hybrid trials that use remote patient monitoring technology and apps that patients can access from home to enable more people to participate, thereby holding drug candidates to a higher standard.
Teresa Prego, chief commercial officer at Nile AI, remarked, "Based on our learnings from recent vaccine testing and the high potential for lack of diversity in clinical trials, 2023 trial activities and trends will include utilizing distributed access to participants to include members of populations traditionally less able to access clinical trials. The potential to include greater at-risk or difficult-to-access trial participants will be an essential element as we work to provide therapies and solutions for the broader audiences impacted by health issues, chronic conditions, and rare diseases."
Bill Brydges, CEO of Phylloceuticals, added, "Decentralized clinical trials will continue to dominate the conversation. But right behind that will be a significant uptick in the ability to get clinical-grade materials into the hands of trial participants speedily.”
A new take on drug manufacturing
Biologics – drugs made from the components of living organisms – are taking the world of medicine by storm and are being used for an ever-increasing number of therapeutic purposes. However, manufacturing biologics cannot occur by inorganic means; drug manufacturers must use live cells to produce the drug in question and then purify it and package it for use. A common way to manufacture biologic drugs is using mammalian cell lines. Still, the process has a flaw: engineering mammalian cells to produce large amounts of a biological drug leads them to produce proteins that are toxic to the cells, inhibiting their ability to make the biologic and slowing down overall production.
"The use of plant-based platforms to quickly manufacture clinical-grade materials will begin to shift the balance from mammalian cell platforms, which can often take a few months to produce target clinical-grade material," emphasized Bill Brydges. "Plant-based platforms can produce the same, less toxic proteins in a matter of weeks, allowing for multiple targets to be tested simultaneously and allowing clinical trials to get moving more quickly."
An uptick in data sharing
With high-grade reagents, researchers and clinicians can confidently carry out their studies and analyze results to inform new treatment best practices. But now, instead of using well-trodden computer software and spreadsheets, doctors can assess the effects using artificial intelligence (AI) and advanced data analytics to gain deeper insight. However, to maximize these platforms' potential, science and medicine must work together on a scale never achieved before.
"Much of the valuable data that can be utilized to enable AI and data analytic tools creates a significant need to improve and encourage the ability to share information and data collectively to create more powerful solutions for patients," explained Teresa Prego. "While integrating data silos may provide incredible insights into disease management and the efficacy of therapies and care, data currently lives in silos of measurement tool-based or trial-based aggregation. A healthy first start toward a more powerful integration of data is a willingness to collaborate and share by industry partners at large."
While none of the concepts discussed here are unheard of in the clinical realm, a great deal of conversation must be had and work done to implement each into the clinical practice in a broad and sustained way. Only then can strategies to improve diversity in clinical trials, accelerate drug manufacturing and amplify data analysis have the most significant benefit on the field. If appropriately implemented, new approaches to clinical development stand to speed up the process while resulting in higher-quality drugs that will have a massive impact on human health and well-being for years to come.