Crisis of the Clinical Trials Staff Attrition After the COVID-19 Pandemic

Abstract

A survey of clinical research professionals @SWOG indicate that 80% of clinical trial offices are understaffed. Addressing this is critical so progress for people with cancer continues. Read more about lessons learned in the #COVID19 pandemic and how it informs a path forward.

It has been over 2 years since the WHO declared COVID-19 a pandemic, but the oncology clinical trials enterprise globally continues to bow under its impact. Arguably, the COVID-19 pandemic both added to and revealed the unsustainable stressors that underlie this infrastructure. The challenges in both the recruitment and the retention of qualified clinical research members have been anecdotally discussed among institutional leadership and at national cooperative groups, including SWOG Cancer Research Network (SWOG). However, there has been little published on this topic. In response, we conducted a nationwide survey of SWOG-affiliated oncology research professionals to better understand the scope of just how the COVID-19 pandemic has affected clinical research processes and staffing.¹ Notably, 80% of leadership reported that their institution experienced personnel shortage due to the COVID-19 pandemic and virtually all aspects of clinical trials experienced negative impact during the COVID-19 pandemic because of staff attrition. In light of this crisis, there are lessons learned that provide potential solutions moving forward.

Prior research and our experience highlight three important themes that we deem actionable. First, high staff turnover has created additional pressure on those who remain, contributing to increased stress and burnout. Second, there is a lack of opportunity for promotion and professional growth in the current research environment, which the COVID-19 pandemic further exposed, leading some to question the future of their role as clinical research professional (CRP). Third, there is a perceived lack of engagement institutionally and among clinical research and institutional leadership, and this has had a negative impact on morale. Below, we interrogate each of these themes and summarize areas for improvement.

Multiple stressors contributed to high staff turnover and burnout during the COVID-19 pandemic. The SWOG survey identified these clinical trials activities as those most affected by the COVID-19 pandemic: (1) accrual of participants, (2) audit procedures, and (3) sponsor-related activities such as sponsor visits and transfer of data. These findings are consistent with that seen across the oncology clinical trials community, in which the COVID-19 pandemic is associated with a significant decrease in enrollment in National Cancer Institute (NCI)–sponsored trials,^2-5 especially in areas most affected by the COVID-19 pandemic. Additionally, delays were prevalent across all trial activities,⁵ which are likely multifactorial, resulting from a combination of governing bodies redeploying existing oncology resources toward COVID-19 studies,^6,7 sponsor decisions,⁸ and patients' hesitation.^5,9 Multiple protocol requirements could not be met as a result of medical visit cancellations, reduced availability of ancillary and other specialty staff,⁵ and more.¹⁰ Activities that were previously held on site and in person were modified. One study reported the following COVID-19 pandemic–driven outcomes¹¹: a large number of protocol deviations, patients lost to follow-up, and increased subject anxiety, but these were balanced by the flexibility of express delivery of study drugs directly to patient's homes.

The traditional rigidity of protocols and regulation was starkly exposed during the height of the COVID-19 pandemic, and this mobilized federal agencies and research institutions to collaborate in an attempt to reduce regulatory burdens.¹² To adapt to constraints, the NCI and governing bodies relaxed protocols,³ which included suspending audits or conducting them virtually, delaying data submission deadlines, remote monitoring including remote site initiation visits,¹³ special consent procedures, and increased accommodation for diagnostic studies to be performed in one's own community.⁵

Changes implemented as a result of the COVID-19 pandemic should be seen as the foundation for a new model of clinical trials research and regulation. Integrating modern technology could provide study volunteers greater independence from their treatment sites including remote monitoring, digital audits, greater adoption of remote consent, delivery of oral medications directly to their home, and limiting diagnostic test requirements for the primary study center. Although the impact of these adaptations on staff has not been formally studied, we hypothesize that greater use of health information technological advances would have lasting value, including to increase employee satisfaction and retention.

The SWOG survey suggested that reasons for leaving the clinical trials industry include pursuit of better pay, better opportunity, and increased flexibility, which included the ability to work remotely from home. These trends are not exclusively a pandemic phenomenon as high turnover of CRPs was evident even before the COVID-19 pandemic. However, one industry-sponsored survey noted that CRP turnover rates in the United States reached a 5-year high of nearly 30%¹⁴ in 2020. High turnover is not only detrimental to oncology trials, but also costly. There is a steep learning curve^15,16 for a CRP to attain the necessary skill set. High turnover in CRP positions increases burden onto remaining staff who must delegate limited resources toward training new hires while fulfilling existing responsibilities. Existing data show that CRPs, including those in oncology, left their current positions for reasons related to better compensation, better career development options, better training or continuing education, and professional advancement.¹⁴ Finally, CRPs, especially those with the highest level of skill and years of experience, were found to be disproportionately undercompensated. Across the public and private sectors, including in academic centers, there has been little movement to address the salaries and benefits for those positions with the highest turnover. Furthermore, the rate of skill growth with every additional year spent working as a CRP for the same institution was determined to be disproportionate to the rate of salary growth.¹⁴

The desire for increased career development and professional advancement resonates across the country. Interestingly, in their study of empowering clinical research coordinators (CRC) at an academic medical center, Buchanan et al¹⁶ found that the role of the principal investigator (PI) significantly affected CRC retention. Greater respect, collaboration, and engagement from the PI were significantly associated with higher retention among CRCs. These observations should encourage leaders in the oncology clinical research enterprise to reconsider existing models of salary growth, workplace culture, and career mentorship.

In conclusion, there is an urgent need to direct resources toward clinical trials staff retention, training, and hiring practices in oncology with over 80% of SWOG-associated research sites reporting personnel shortages. No doubt the reasoning behind staff attrition in clinical research is multifactorial and based on individual motivations. Although studies evaluating those who resigned point largely to a lack of adequate compensation, limited career growth, and unsustainable job expectations in the setting of increasing trial complexity, these conditions were present before the COVID-19 pandemic.^1,14 It is evident that during the COVID-19 pandemic, the burden of research-related activities was left to dedicated professionals, who were already short-staffed, without mitigating existing frustrations. This situation remains as we move out of the critical public health crisis that was created by the COVID-19 pandemic.

Perhaps the changes implemented by necessity will introduce much needed modernization to the clinical trials enterprise.^17,18 The transition from in-person requirements to remote operations should allow for greater flexibility for both staff and patients, and this may ultimately increase job satisfaction. Although the opportunity for exploring more pragmatic and simplified protocol designs is critical, the work setting has evolved and more complex clinical trial protocol designs are likely to remain an important component of the portfolio. Ultimately, pressures on study site staff may continue to be a barrier to the opening of new clinical trials, particularly those seeking volunteers with rare cancers and perhaps at sites serving under-represented populations.

Research programs housed across the spectrum of academic, industry, and community-based practices must evaluate their compensation packages for highly skilled and committed research staff as the sense of being valued was an important theme brought forth in our survey. In addition, we must collectively find ways to show that research is a viable career pathway through opportunities for promotion and by allowing for the acquisition of new skills or higher education. Doing so may help address retention and improve job satisfaction among staff.

For clinical trials at all stages, leadership responsible for all clinical research organizations must evaluate the feasibility of remote operations across all research activities and allow this flexibility where it makes sense. As the NCI and governing bodies collaborated to mitigate pandemic challenges, it is warranted that leadership across academic institutions, pharmaceutical companies, regulatory agencies, and PIs collaborate to address these ongoing challenges by adopting the lessons we learned about what is possible because of the pandemic and continuing to work collaboratively on what still needs to be done. If it was not clear before, it should be starkly clear now: clinical trials require a community of dedicated specialists across disciplines and training. Unless we meet the challenges in staffing of research centers brought on by the COVID-19 pandemic head first, we run the risk of severely delaying, and in some cases, perhaps removing, the access to clinical trials, which in and of itself, would be a stark and preventable inequity for all with cancer.

AUTHOR CONTRIBUTIONS

Conception and design: Don S. Dizon, Daniel P. Petrylak, Dana B. Sparks, Catherine Tangen, Primo “Lucky” N. Lara, Ian M. Thompson, Charles David Blanke

Administrative support: Don S. Dizon, Charles David Blanke

Provision of study materials or patients: Primo “Lucky” N. Lara

Collection and assembly of data: Don S. Dizon, Catherine Tangen, Primo “Lucky” N. Lara

Data analysis and interpretation: Grace Sun, Don S. Dizon, Connie M. Szczepanek, Daniel P. Petrylak, Catherine Tangen, Primo “Lucky” N. Lara, Ian M. Thompson, Charles David Blanke

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Crisis of the Clinical Trials Staff Attrition After the COVID-19 Pandemic

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.

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