Trends We Are Watching in 2022
As we approach our third year of the global COVID pandemic, we take a moment to reflect on the impact it’s had on health care in general and clinical research in particular. The last two years have laid bare the challenges of equity and access, as well as the importance of leveraging technologies to improve patient experiences and efficiencies.
While the pandemic has generated significant hardships, we believe it has precipitated some necessary advancements in the execution of clinical research. No one knows for sure when the pandemic will become endemic, or what “normal” will look like. However, we will be watching certain activities that we believe will continue.
Here are some trends that started in 2020 that we will watch over the next year.
Decentralized clinical trials
We expect the trend toward decentralized clinical trials, supported by increased use of telemedicine technologies, will continue. Even if administrative staff start returning to the office, many of the efficiencies of remote work are likely to continue in a flexible hybrid work environment.
Clinical trials will probably continue to leverage remote patient monitoring, using tracking devices or smartphones. Patient visits may occur via video conferencing rather than requiring them to come to a clinic or facility. This may allow researchers to expand their ability to recruit patients from further geographic distances. It will also require re-training of research staff to make the most of these technologies while ensuring patient privacy.
Diversity in clinical trial participants
In 2021, the public dialogue about diversity and inclusion in clinical trials increased. The FDA encouraged researchers and sponsors to develop and adopt mechanisms for increasing the participation of underrepresented groups in their clinical trials. This includes expanding eligibility criteria and adopting adaptive clinical trial design methodologies.
We anticipate hearing more this year about addressing the needs of specific populations, including ethnic groups, children, women, and LGBTQ communities.
Other industries have seen significant staffing impacts due to COVID. While media attention is focused on the so-called “Great Resignation,” much of the disruption has, in fact, been due to increases in the number of cases of COVID and isolation protocols for those who have been exposed.
Research organizations need to plan for this continued flux in their staffing levels in order to sustain projects and ensure continuity.
Accelerated Clinical Trials
The record-breaking speed by which COVID vaccines and treatments have been developed, reviewed, approved, and deployed have inspired researchers to consider how to translate the lessons learned to other clinical trials in other diseases. Some options may include simplifying protocols or leveraging observational research with “big data” mining.
Over the two years, we have seen increased attention on patient-focused approaches to clinical trials that take a variety of factors into account. The health care field has been at the fulcrum of the challenges wrought by COVID. But clinicians and their teams have also demonstrated enormous resilience and innovation. We will continue monitoring the landscape and identifying winning strategies that not only make clinical trials more efficient, but that also continue to protect human subjects.