Trends To Watch In 2022: RWD, DCTs, And Cell & Gene Trials
By Ed Miseta, Chief Editor, Clinical Leader
As we prepare to close out 2021 and look ahead to 2022, it’s a good time to think about the trends that will impact clinical trials in the new year. At this time of year, I receive numerous emails from companies outlining predictions for the coming year from some of their executives. Although I feel these insights are worth sharing, many discuss some of the same trends and topics. I will not attribute these predictions to specific companies or individuals, but I do appreciate the emails from Mobiquity, Veeva, 4G Clinical, Cognizant, and others who were kind enough to share their insights.
One prediction that came through loud and clear is that the move to decentralized and hybrid trials, which for many companies began in spring 2020 when the COVID-19 pandemic began to sweep the world, is not going to go away anytime soon. Almost every email I received mentioned the move to decentralized trials.
Most of the predictions I received noted decentralized and hybrid trial designs will continue to grow steadily. There are many factors that will continue to drive these trials, including gaining access to patients who are not near the study site, accessing a more diverse patient population, making trials more patient centric, and accelerating enrollment. Although the growth in these trials is expected to continue, the rapid increase in direct-to-patient drug shipments and the remote solutions that support patients in their homes is expected to return to the same levels as prior to the pandemic. One executive noted three factors will continue to accelerate the adoption of decentralized and hybrid trials. Those factors are best-in-class integrated technology platforms, successful use cases, and clarifying regulatory guidance.
In deciding where to best implement a decentralized approach, companies are generally not separating out portions of their portfolio by therapeutic area. One executive notes companies are taking the time to look at each protocol and evaluate what decentralized trial and digital endpoints are the most appropriate for a study given the drug profile, route of delivery, endpoints selected, countries involved, and patient input received.
One challenge that still exists and will need to be resolved relates to sites. Sponsors will need to ensure they are providing proper support for sites during implementation, but few have truly matured to integration. This may suggest they are allowing sites to use their own decentralized trial solutions and focusing on integrating with those platforms.
Another challenge is culture. Sponsors will need to invest in change management and support their colleagues on the change curve to embrace and support decentralized trials.
Supply Chains And Non-Traditional Players
Digitization of supply chains is another trend to watch. Supply chain experts must often consult multiple systems to determine the status or location of their drugs. Clinical supply chains will become more digitized with fully integrated supply chain management solutions.
Drug tracking will also transition from passive to real-time tracking. Advancements in hardware and communications technology will yield expectations that are beyond industry standards of the past. New real-time tracking solutions will include multi-modal tracking capabilities, reliable battery life, and advanced communication capabilities. Real-time tracking will lead to further technology enhancements by best-in-class technology platforms, further ensuring drug efficacy and safety.
Non-traditional players will continue to enter the clinical space and have an impact on drug discovery and trials. 23andMe is already having an impact, but the space will change even more dramatically with the entry of players that can have a substantial impact on clinical technology and the infrastructure on which those technologies reside. Those players will include Microsoft, Amazon, Apple, and Google. Companies like CVS and Walmart are expected to continue their expansion into primary care services and clinical trials.
In 2022 the industry will likely see drug companies attempt to leverage more diverse data sets to further define and segment patients in the development of therapies. With improved data sets and information derived from real-world data, diseases can be better segmented, and therapies will be targeted more specifically.
Cell and gene therapy research is expected to grow rapidly. However, that growth will require the acceleration of technology solutions and conditioned research capacities throughout the value chain. The most complex aspects of running cell and gene trials will continue to be the logistical and scheduling requirements. Scaling these trials will be contingent on technology advancements that support the processes, products, and patients and replacing current manual processes.
Finally, life science companies will move further into care delivery, driving a greater symbiosis between the life sciences and care providers.