Vice President - Compliance and Quality, Advanced Clinical

Kimberly Wanick

There is no playbook for leading an organization out of a pandemic. Ongoing risk management (emphasized in ICH E6 R2) and Quality by Design (ICH E8) are traditionally applied in the pharmaceutical industry to ensure high quality clinical trials. Yet, with the current “great resignation”—in which the only sectors to lose more jobs than healthcare were accommodation and retail

—clinical research is suffering. This year alone, almost 1.7 million people have left healthcare jobs, according to U.S. Bureau of Labor statistics quoted by 

 “Burned out workers are pursuing flexibility and passion,” wrote the publication. This is “a development that can have significant downstream repercussions for research sites, industry sponsors, and ultimately patients, if not addressed head-on,” asserts 

Against this backdrop, arguably the greatest risk to the quality of clinical trials is the failure of stakeholders (research sites, sponsors, Contract Research Organizations (CROs), technology providers, industry vendors/suppliers) throughout the drug development process and supply chain to properly care for their employees, and respond to the employee burnout that is so widespread after more than two years of working under constraints and challenges of the multiple global social disruptions.

Historically, a laser focus on regulatory compliance has been the driving force in drug development. This involved protecting clinical trial participants while meeting regulatory requirements in the shortest possible time based on financial limitations and competition. Now, it is becoming clear that the individual care of stakeholder employees across the clinical trial ecosystem must also be a focus of attention. Virtually everyone has been traumatized to some extent by the pandemic and social disruptions – whether they work at investigator sites, sponsors, vendors, or CROs. The drug development ecosystem simply cannot afford to lose the invaluable skills and experience of these industry professionals if consistent, high quality work is to be maintained in clinical trials.

Technical and analytical expertise has typically been the operational focus of this industry with limited regard to employee wellbeing. Organizational culture needs to change, with executive-level support, to establish a new holistic employee wellness norm. The mental, emotional, physical, and spiritual wellbeing of each employee is vital, and should receive the same level of care as clinical trial participants, whose wellbeing is well enshrined in the clinical trial system.

Put simply, it is not an option to go back to pre-pandemic models where employee wellbeing was not a key organizational focus across the industry. To move ahead, it will be essential for organizations to intentionally apply the valuable learnings from the past two years into Quality by Design (QbD) initiatives that need to incorporate employee wellbeing in any or all of the three main components of their Quality Management System—processes, systems, and behavior. Changing organization behaviors is imperative to minimizing disruption to clinical trial quality.

With executive-level support, various solutions focused on employee wellbeing have been successful, both prior to and during the pandemic. These include:

Communicating transparently, frequently, and honestly

 via routine manager and employee one-on-one meetings based on principles such as situational leadership

 real time company email updates; monthly town hall meetings with unscripted forums for employee and management to talk about current topics and concerns; all-hands meetings with transparent business updates; and regular surveys on employee engagement and satisfaction coupled with leadership action plans based off of the survey results.

 including remote office, varied work schedules, less formality, job sharing, and employee-conceived solutions to meet individual employee needs while fulfilling job responsibilities.

based on going beyond delegation to true employee empowerment. Coined in the book, 

 this is based on using teamwork to accomplish more, develop employee experience and confidence, earn loyalty and create a culture of trust and support. This also encourages innovation and the creation of safe spaces in organizations. One of the book’s concepts is that there are multipliers and diminishers in almost every organization, and leaders need to understand both behaviors at work to avoid diminishing practices.

company sponsored mental health solutions

 offering varied resources including group sharing sessions; counseling for employees and their families; webinars on stress, burnout and other current topics in the workplace; and meditation sessions.

 and forums to encourage greater understanding of each employee’s uniqueness, and the importance of showing grace and sensitivity to all.

Encouraging continuing leadership skills education

 for all organizational leaders–as noted in the leadership podcast by Craig Groeschel, “Everyone wins when a leader gets better.”

These approaches can support employee wellness by developing a healthier, more balanced lifestyle and a general life perspective that translates into how they perform at work with other industry stakeholders.

From the CRO perspective, it can be helpful to provide customized support to investigator sites, lab partners/vendors, sponsors, and other stakeholders. This can include being more flexible and creative in working with investigator sites, conducting remote or hybrid audits with vendors, collaborating with vendors on quality issues, supporting sponsors with turnover or resource challenges, and working compassionately with local or global stakeholders who are experiencing social and political challenges. Specific examples that have proven helpful include:

For investigator sites with limited resources

 or time allowed on site by their office or institution, creative approaches ensure that trial activities are conducted in a timely manner by enabling more remote activities and/or providing more support than previously offered.

For vendors who have quality issues or are short staffed

, the CRO can collaborate with them to find mutually agreeable solutions to maintain compliance and fulfill clinical research deliverables.

, the CRO can take over additional trial activities or communicate more frequently to support newer sponsor employees, sometimes offering short term contract support.

All clinical trial stakeholders should collaborate on these types of efforts to help preserve talent, knowledge and expertise in the pharmaceutical industry. Losing employees to burnout can be avoided with commitment from executive leadership across all stakeholder organizations. By caring for our own employees as much as we care for research subjects, we can continue to run well-conducted clinical trials to improve human health, to the benefit of society as a whole. Consider the following metaphor for employee wellness from air travel that can be applied here. Travelers are instructed before take-off, “In an emergency, put your own oxygen mask on first, before helping others.” Caring for the employees of all stakeholders is the equivalent of putting on the employee masks first before being able to help our research subjects.

, Vice President - Compliance and Quality, Advanced Clinical

https://www.chiefhealthcareexecutive.com/view/don-t-let-the-great-resignation-stall-clinical-research-tom-kaminski

https://www.forbes.com/sites/debgordon/2022/05/17/amid-healthcares-great-resignation-burned-out-workers-are-pursuing-flexibility-and-passion/?sh=2ddefa297fda

https://www.bls.gov/news.release/jolts.t04.htm

Blanchard KH, Zigarmi D, Nelson RB. Situational Leadership® After 25 Years: A Retrospective. 

 page(s): 21-36. Issue published: November 1, 1993. https://journals.sagepub.com/doi/abs/10.1177/107179199300100104

Multipliers: How the Best Leaders Make Everyone Smarter, Liz Wiseman, 2017

https://open.life.church/training/108-leadership-podcast-it-s-about-time-part-1

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