Fred Ashbury, PhD, Susan Night JD LLM, VP Site Engagement & Network Strategy, TD2
Previously we wrote about the many benefits to patients, providers and practices of clinical trial participation. Despite these benefits, patient participation in clinical trials, especially in oncology clinical trials remains abysmally low. This poor clinical trial participation rate existed long before the global pandemic. However, since the pandemic the United States has witnessed an even more dramatic drop in clinical trial enrollment1.
Current Landscape in Oncology Clinical Trials
The clinical research industry, like many others in the US, is woefully understaffed as a result of the “Great Resignation” due to the global COVID-19 pandemic. In fact, much of the US is suffering from chronic Nothing Works Syndrome where workplace inefficiencies have been exacerbated by an absence of trained personnel. This situation is intensified by a corollary concern of Over-Expectation Syndrome, where many want to believe that we have recovered from the impacts of COVID-19 and all is back to normal. Both Syndromes are creating challenges in the oncology clinical research landscape.
Figure 1
Figure 2
At the same time, the number of physicians who are participating in clinical trials continues to trend downward, reducing the overall number of clinical research locations.
Clinical research programs are experiencing persistent staffing shortages creating a logjam of clinical trials ready for start-up or causing enrollments to be halted at research sites. To say this is an unprecedented period in clinical research would not be an overstatement.
Given the current oncology clinical trial landscape, there are some things that can be done to facilitate capacity for and capability to deliver clinical research in the community practice setting. These areas of focus are technology, relationship and organizational solutions.
Technology
Technology solutions must be designed to fit into the operational flow and processes of an active community oncology practice. In a recent survey, 39 percent of sites responded that technology has made their work slightly easier and more efficient3, particularly when the technology solutions are easy to implement and use. However, 30% of respondents also indicated that technology has made their work considerably or slightly more difficult or less efficient. Examples such as sponsor provided software and hardware such as ePROS, contribute to increased and improved data collection.
One outcome of the global COVID-19 pandemic was rapid adoption of technology in oncology clinical research leading to greater implementation of decentralized trials. There are ongoing efforts to make permanent these changes that were adopted during COVID-19 and to leverage technology that improves efficiencies through clinical research workflows4.
Leveraging relationships
The decrease in the number of potential investigators means that clinical research sites need to access patients from larger geographic areas, including rural/remote populations and specific populations who have been poorly engaged in studies. This can be accomplished by fostering relationships with other community oncology practices that do not offer clinical trial opportunities to their patients as a referral network for patient participants. Similar networks can be leveraged through relationships with referring urologists, gynecologists and other disease-specific physicians.
Increasingly, oncology practices are participating in site networks that are connected through various technology platforms. These may offer common electronic health records, clinical decision support systems or advanced analytics platforms that facilitate patient identification and trial matching for clinical research. The power of leveraging individual site data can therefore be aggregated through network relationships that is then curated, actionable and appropriately accessible to facilitate knowledge generation in a timelier manner.
Organizational restructuring
Community oncology practices must address staffing shortages by acknowledging and responding to the 2 main reasons workers quit their jobs: low pay and no advancement opportunities5.
One community oncology research site made a mid-year, market adjustment for their research staff to reflect the increasing compensation demand that has occurred in 2022 in addition to larger than ever end-of-year bonuses. By taking these steps, although it was a financial strain on the practice, they were able to contain staff turnover to a minimum, continuing research operations.
Figure 3
It will be a very long time before the US recovers from the Great Resignation and turnover in clinical research staffing will remain high for many years to come.
Clinical research sites should respond to increasing technology utilized in research by diversifying the demographics of the clinical research workforce6. Some sites are responding by creating new roles, such as patient engagement specialists, who have digital savvy and can support research teams and patients with incorporating technology into clinical trials.
Concluding Remarks
Demand for oncology patient participation in clinical trials remains high and will continue. There are many innovative treatments for cancer in the pipeline that will benefit all cancer patients in the future. Community oncology is the key to connecting patients to clinical trials and increasing diverse representation of trial participants. We must continue to identify solutions for staffing and other challenges in community oncology research programs that allow trials to move forward. In our next newsletter, we will take a deep look at resource challenges in the community practice setting.
References
1 Unger JM, Blanke CD, LeBlanc M, et al. Association of the Coronavirus Disease 2019 (COVID-19) Outbreak with Enrollment in Cancer Clinical Trials. JAMA Netw Open. 2020;3:e2010651.
2 Thompson, D. Air Travel Is a Disaster Right Now. Here’s Why. The U.S. Seems to Suffer from Chronic Nothing Works Syndrome. The Atlantic, June 26, 2022. https://www.theatlantic.com/newsletters/archive/2022/06/summer-air-travel-flights-cancelled/661385/
3 Bechtel, J & Vulcano D (2022 May 21) 2022 Global Oncology Micro-Landscape Survey. Society for Clinical Research Sites Oncology Site Summit, Austin, TX.
4 Pennell, NA, et al. American Society of Clinical Oncology Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care. J Clin Oncol 39:155-169, 2020. Specifically, recommendations of Goal 3a and Goal 3c.
5 Parker, K and Horowitz, JM. Majority of Workers Who Quit a Job in 2021 Cite Low Pay, No Opportunities for Advancement, Feeling Disrespected. March 9, 2022. https://www.pewresearch.org/fact-tank/2022/03/09/majority-of-workers-who-quit-a-job-in-2021-cite-low-pay-no-opportunities-for-advancement-feeling-disrespected/
6 Miessler, J. Workforce Demographics Unchanged, More Site Staff Diversity Needed, The CenterWatch Monthly, Volume 20, Issue 04, April 2022. A company that uses machine learning to analyze a database of millions of job profiles found the average age of clinical research coordinators (CRCs) and clinical research associates (CRAs) in the US is 44.
Fredrick D. Ashbury, PhD
Chief Scientific Officer, VieCure Professor (Adj), Department of Oncology University of Calgary Professor (Adj), DLSPH, University of Toronto
Susan Night, JD, LLM
VP Site Engagement & Network Strategy, TD2