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Saying hello to a new year has got us thinking about what’s in store for the clinical research industry in 2022. In the past two years, we have seen quick and substantial pivots in the way clinical trials are conducted. Every aspect of a trial has been reshaped, repackaged, or completely transformed. Obviously, the pandemic spurred major shifts in remote participation and support of clinical trials. Ubiquitous technologies like Zoom and / or specialized telehealth solutions have replaced in-person meetings, site visits, and healthcare appointments with video calls. Early in the pandemic, clinical trial sponsors reported the need to amend protocols with telehealth visits, remote data collection and remote monitoring procedures. Delays were quickly addressed with a combination of new technologies and procedures. Many of these solutions were tools some research teams were already beginning to explore prior to 2020, but the pandemic exponentially increased the demand and pushed teams to adopt these technologies more rapidly than they planned.  

As we look to 2022, we see… more of the same. The pace may not be as rigorous, but the industry has accomplished a great deal to provide a strong foundation for significant growth in three key areas: 

  • Increase in hybrid trials 
  • Use of remote tools 
  • Continued focus on diversity, equity, and inclusion 

Hybrid Clinical Trials 

Though the idea of decentralized trials is setting the stage for the future, hybrid trials offer some interesting benefits sponsors will likely take advantage of in 2022. Hybrid trials enable clinical research teams to dip their toes in the water and begin to understand the implications of partially remote tasks and activities before committing to a fully decentralized model. Some clinical studies aren’t necessarily suited for the decentralized model. Hybrid trials enable clinical trial teams to customize the trial and mix traditional and virtual designs in a unique way that can offer better outcomes, increase participation and retention, and potentially, improve the patient experience.   

Mature Remote Tools 

In the past two years, the use of a variety of remote tools to help research teams communicate with study participants and enable them to remotely track and share data about their health and wellness have become increasingly important. We expect remote patient assessment, engagement and data collection tools to benefit substantially from the experiences of the past two years and continue to increase in usage. As patients participate in hybrid or decentralized clinical trials, tools designed to capture data directly from patients, such as wearable devices and apps, have significant potential to add value to the patient experience, while improving study participation and retention.  

Barriers to participation in clinical trials, such as distance to a clinical trial site, have always challenged recruiting efforts. Technology presents an opportunity to mitigate some of these barriers; however, it is imperative the technology used and / or associated tasks do not create a new set of challenges. As the use of these technologies increases, we are learning more about the participant experience and the patient burden. These learnings will be incorporated into simple, easily understood interfaces, artificial intelligence (AI) and natural language processing (NLP) solutions that guide and educate patients to maintain compliance with the trial protocol.  

Focus on Diversity, Equity & Inclusion  

In February 2021, the “Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials” was published on the JAMA Network Open website1 finding that Black or African American, American Indian or Alaska Native, Hispanic or Latino, and older adults were underrepresented compared with the US population.  

This finding was particularly relevant to the COVID-19 pandemic where minority communities were particularly hard hit by the virus. Equitable inclusion in clinical trials ensures efficacy in broader populations but also introduces and engages these populations with the larger research community. Furthermore, as medicine becomes more targeted and specialized, the importance of heterogeneous populations in the study who are representative of intended populations cannot be understated. 

As understanding and awareness of health disparities continues to grow, awareness of representation in clinical research will also increase. New technologies and hybrid or remote trial designs present an opportunity to address these challenges and increase participation in underrepresented populations.  

Takeaways for 2022 

The past two years in the pandemic taught us the importance of flexibility. Being able to react quickly to changes will be a high priority going into the new year. Maturing patient devices and remote tools will improve the patient experience, but these new data sources and data types must be managed efficiently. More and more varied data are likely. As companies increase the number of hybrid trials, new trial designs, workflows and automations will be required.   

Flexible technologies like iMednet enable teams to swiftly adapt to the rapidly evolving requirements of clinical research and efficiently manage data for a wide range of study designs and formats. To learn more about the iMednet platform and how Mednet is adapting to the future of clinical trials, contact us.