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Strong shift to DCTs, regulatory changes, and increased focus on diversity among main industry talking points in 2022.
As burdens from the pandemic began to lessen, many clinical operations staff rethought their clinical trial approaches, making 2022 an interesting year for clinical research. Changes in clinical trial quality assurance, pharmacy involvement in clinical trials, decentralized clinical trials, and diversity inclusion were highlighted. I’ll summarize my 2022 findings in this article.
In 2022, clinical trial quality has changed due to the increased emphasis on the evolving concepts of quality management. The definition of quality is shifting away from perfection to an organizational culture of quality. This shift, according to CDER, is the result of both profound experiences with quality and the desire to design reproducible processes and outcomes. Sponsors are adhering to new regulatory guidance regarding the development of a culture of quality, and auditors are focusing on events and their underlying causes. Quality is not solely the responsibility of QA; according to industry leaders, activities conducted by other teams are essential in this space. The concept of “inspection readiness,” which means that sponsors and organizations are prepared for an audit at any time, has grown in popularity with these recent changes. Also of interest is data integration, as sponsors now have access to their data in near real-time. Aggregated data access reveals novel methods for overseeing clinical trials, enabling sponsors to address potential issues before they arise. Connecting the dots early has proven effective in programs that run and scale rapidly.
CVS Health launched clinical trial services and is utilizing its existing infrastructure to bring clinical trials closer to patients’ homes. Pharmacies are evolving from a place of product distribution to a healthcare destination, as more than 85% of the US population lives within 10 miles of one of CVS’s nearly 10,000 locations, which allows them to bring clinical trials to patients directly in their communities. CVS is focusing initially on vaccines, infectious diseases, cardiovascular, pulmonology, dermatology, oncology, neurology, and immunology/autoimmune disorders. CVS is also leveraging its telemedicine and in-home nursing capabilities to support decentralized clinical trials. Additionally, pharmacies leverage their real-world data model (RWD) to gather deeper insights that may not be found in medical records, such as data on social determinants of health, to supplement the clinical data. Additionally, RWD modeling can be advantageous for identifying appropriate patients and site placement for clinical trials, as CVS has enrolled 18,000 patients in trials utilizing strategies derived from this data.
The concept of decentralized clinical trials (DCT) is still in its infancy in the industry, although the pandemic has facilitated its adoption, and regulators are discussing the concept. Regulators agree that DCT is an ecosystem and that sponsor engagement with regulators is essential, and they emphasize the importance of study oversight in DCTs. There is a rise in digital endpoints, which benefits researchers since they can obtain more comprehensive information about patients’ outcomes through high-frequency data collection. However, DCT challenges include the introduction of data fragmentation and inconsistency (due to the many technology systems and vendors being used), which could increase study risks. Hence, data centralization and infrastructures for patient supervision must be designed. EMA expects to issue guidance on DCTs soon, but FDA has yet to commit to a date for releasing guidance.
Minority patients are less likely to participate in clinical trials because they do not trust the medical community. However, biopharmaceutical enterprises are building centers of excellence, focusing on building bridges between clinical trials and minority communities. To elaborate, during the COVID-19 pandemic, the discussion amongst the biopharmaceutical community centered on patients of minority groups not wanting to participate in vaccine trials, and FDA noted the lack of diversity and inclusion of patients. Initiatives like the Beacon of Hope will fund 360 scholarships for African American and Hispanic medical students over ten years to train them to become investigators. Over time, clinical trial conduct amongst these investigators would bridge the trust gap between minority patients and investigators. Biopharmaceutical enterprises are also investigating how they can make patient participation easier and promote technology, such as electronic informed consent and wearables. Additionally, biopharma is evaluating forums of community physicians, nurses, caregivers, and patients to speak about clinical trials, especially those with diverse backgrounds.
In summary, (1) emerging clinical quality trends in clinical trials, such as inspection readiness and data integration, are empowering sponsors to be better prepared for audits and leverage data to ensure their programs run smoothly, (2) pharmacies are enabling accelerated access to clinical trials for pharmaceutical companies and patients by leveraging their telemedicine and in-home nursing capabilities to support DCTs, (3) DCTs have the potential to enable more efficient, effective, and reliable clinical trials, and (4) biopharmaceutical enterprises are exploring ways to make it easier for patients to participate in clinical trials, such as by providing electronic informed consent and investing in initiatives to raise awareness of clinical trials amongst minorities.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.
For more information on these 2022 trends from Applied Clinical Trials, follow the links below: