JP Kappelle

For the life science industry, 2021 proved to be a year of introspection, assessment and analysis. We took a hard look back at the lessons learned from the COVID-19 pandemic to determine what worked and what didn’t, and what we can apply to the clinical trials of tomorrow.

While patients and sponsors continue to push for faster, more responsive and more inclusive drug development, new technologies and solutions have emerged to help meet those expectations. New remote and virtual trial designs are being adopted by a much broader selection of sponsors, sites, and patients, resulting in improved trial access and participation. Improved data collection and integration resulted in huge leaps in trial efficiency and speed.

There is no doubt that this spirit of collaboration and innovation will continue in 2022. Still, many challenges remain, particularly in light of the continued uncertainty around the pandemic. With new variants continuing to emerge and spread, cutting-edge life science and clinical trials remain crucial to public health, and it’s critical that the industry continues to adapt to the new reality.

Here are some of our top predictions and expectations for the major trends that will shape clinical trial design in 2022:

DCT trial designs will continue to expand:

 Decentralized Clinical Trials (DCT) have been around for decades but haven't really grown in application until recently. Access to patients further from investigational sites, diversified patient populations, providing patients choices (patient centricity) and accelerating enrolment are key advantages of DCT trial designs. With a rapid increase in Direct-to-Patient (DtP) drug shipments and remote solutions to support patients at home, clarifying regulatory guidance, best-in-class integrated technology platforms and successful use-cases, the adoption of DCT trial designs will continue to accelerate in 2022.

 Questions such as “Where is my drug”, “What’s the drug status”, “When do I need to produce or ship” often require supply chain experts to consult multiple systems, are time consuming and mostly single study centric. A year of continued supply chain snarls, manufacturing capacity constraints and increased clinical supplies costs from new drug innovations drive the need to focus on integral and balanced cost-risk management approaches. Smart supply strategies such as drug-pooling, free-picking and just-in-time packaging/labeling are already being applied, more fully integrated supply chain management solutions will be needed to really move the needle in 2022.

Smart packaging concepts will be more attractive:

 When an investigational drug requires self-administration, patients typically register the date and time of the drug intake in diaries. Recently, regulators started questioning the accuracy of this registration and related drug adherence and validity of study data. Technology and smart packaging concepts can be used to remove the human element and digitize drug adherence registration. We expect to see increased adoption of these concepts in 2022. 

: While Cell and Gene Therapy (C&GT) has continued to expand through 2021, it requires further acceleration of technology solutions and special conditioned resource capacities in the entire value chain, not only for clinical research but even more for commercial growth. The logistical and scheduling requirements of C&GT trials are complex - the success of scaling these trials and treatment opportunities will depend on technological advancements replacing the current manual processes. In 2022, fully integrated technology platforms will be able to seamlessly automate the C&GT value chain, allowing for the scaling required to support the wide-spread availability of personalized medicine.

Real-time drug tracking will become standard:

 Hardware and communication technology advancements have seen significant improvements in recent years, which will begin to drive expectations far beyond the industry standards of the past. Tracking solution companies can now offer real-time tracking solutions, including multimodal tracking capabilities, reliable and appropriate battery life, and advanced communication capabilities. This makes real-time tracking for clinical trial shipments a reality. The adoption of real-time tracking will inevitably lead to additional regulatory expectations for both shipment tracking and site storage, providing further opportunity for technological advancements by best-in-class integrated technology platforms. The resulting oversight opportunities will help ensure drug efficacy and patient safety in 2022 and beyond.

These shifts have already begun to impact the clinical trial ecosystem. DCT and hybrid trials require different types of business and operational acumen, technology, and workforce skill sets to thrive, and the industry is still in a transitional stage. But DCTs and hybrid approaches are here to stay.

Patients have quickly gotten used to the conveniences of remote trials and won’t want to surrender them easily. As a result, service providers will continue to offer new, increasingly high-tech solutions to better support remote clinical trial operations. Of course, all of this must be done without reducing compliance and most importantly, without impacting the safety of trial participants.

Taken together, we believe these factors will continue to bring more innovation, responsiveness, and inclusiveness into clinical research, ultimately resulting in better, faster and more successful product development in 2022 and beyond.

is the Director of Strategy; both of 4G Clinical

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Top predictions for the major trends that will shape clinical trial design in 2022.

JP Kappelle

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