Clinical trial innovation must be patient-centered, inclusive, and tech-enabled.
The Reuters Pharma Clinical 2022 virtual conference, held May 17-19, featured more than 20 presentations but one predominant theme: that "accelerated technology adoption in clinical trials … has neglected patient needs." The conference included 40-plus speakers, largely from the life sciences industry.
The event spanned traditional topics (trial design, engagement, and participation) while highlighting the need for greater inclusivity so that the following tech advancements do not come at the expense of patients:
- Standardizing trial data and digital health developments
- Expanding clinical trial virtual options post pandemic
- Using AI and machine learning to enroll more diverse participants faster
These topics were presented against the backdrop of the conference’s stated mission: "We must establish new industry-wide benchmarks now, leverage recent digital innovations, and ensure permanent cultural change toward patient-centric trials. If we do not act immediately, we risk losing this opportunity to rebuild patient trust."
Additional conference presentations emphasized the importance of patient-reported outcomes, pipeline strategies that please both regulators and investors, and partnerships with advocacy groups to aid participant engagement.
Data standardization
The Reuters conference emphasized that data standardization in clinical trials is necessary to achieve a common healthcare industry objective: scale and efficiency. One panel (“Faster trials need unified data standards across healthcare”) highlighted the need for:
- Specific performance indicators for data collection
- Real-world data (RWD) to identify trial participants
- Data standards that also speed automation and quality outcomes "across tools, sites, and … measures"
Data standardization has also become central to health equity, specifically the collection and use of race, ethnicity, and language (REAL) data. Beyond the world of clinical trials, multiple CMS regulations and initiatives will require this data—a focus stakeholders generally support while raising concerns about the lack of existing guardrails.
Breakthrough technologies, decentralization, and real-world data
The Reuters panelists also addressed trials involving digital therapeutics (DTx) and the growing role of decentralized clinical trials (DCT) during and post-COVID-19.
DCTs use telemedicine to conduct trials remotely and virtually. Meanwhile, DTx trials must increasingly use RWD and real-world evidence as patients, providers, and payers look beyond the pill for treatment. This is critical as drug costs rise—particularly for emerging one-time, curative, and gene/cell therapies.
Laura Beerman is a contributing writer for HealthLeaders.
KEY TAKEAWAYS
The Reuters Pharma Clinical 2022 conference featured the dual themes of patient and tech-centricity.
Standardization was a recurring theme in clinical trial design and data collection.
Additional tech topics included the expansion of virtual trials during the pandemic and the importance of real-world data.