Clinical Researcher—August 2022 (Volume 36, Issue 4)

GOOD MANAGEMENT PRACTICE

LaQuinta Jernigan

 

The so-called “Great Resignation” has compounded staffing challenges in the clinical trials space, hampering the sector’s ability to develop the life-changing new medicines patients are desperately waiting for.

The solution is taking as much pressure off sites as possible.

That means building a robust clinical trials ecosystem that provides consistent access to high-quality healthcare professionals and the most appropriate physical and technological infrastructure, while ensuring that every precious recruit stays engaged, on track, and on protocol throughout the lifecycle of the study.

Short Staffed

Over the last year, vast swathes of employees have resigned their positions in search of new opportunities and a greater work/life balance. In a trend compounded by the impact of the COVID-19 pandemic, millions have realigned their priorities, with a “if not now, when” attitude. Current figures show 4.5 million people in the United States and 391,000 in the United Kingdom quit their jobs in November 2021 alone.{1}

Dubbed the “Great Resignation” by commentators, the movement has affected all sectors, including clinical trial professionals. In fact, the 2022 Society for Clinical Research Sites Staff Turnover Survey found the current turnover of patient-facing staff had almost doubled, from up to 37% before the pandemic to up to 61% last year.

Of course, this is not wholly a new problem. As far back as 2016, a blog submitted to the Association of Clinical Research Professionals was pointing to a “bidding war” for monitors and clinical research associates (CRAs).

This matters to sponsors because staff shortages impact on site effectiveness. Not having the right people in place can delay study start, extend study timelines, and delay approvals. All this costs money and, more importantly, restricts patient access to new medicines.

As such, it makes both business and moral sense for sponsors and contract research organizations (CROs) to do everything in their power to support sites to support their programs.

Remote Challenges

The recent shift from wholly site-based studies to decentralized clinical trials (DCTs) and the hybrid (onsite/offsite) model has been mooted as a solution to many of researchers’ most pressing challenges.

By expanding the pool of eligible participants, the model can increase access and contribute to greater cohort diversity. In addition, by removing the need for frequent site visits, the model can reduce patient burden, boosting recruitment and retention.

For it to work effectively, however, the DCT/hybrid approach must be supported by the right infrastructure, including the right healthcare professionals (HCPs) for remote visits, the right backend systems, and the right patient support.

HCPs conducting home visits need the right skillset, not only in terms of therapy areas and examination experience, but also with regard to interpersonal skills. It is crucial, for example, that people are able to trust the professionals they invite into their homes. This trust then becomes the foundation for the strong rapport necessary to facilitate open and honest conversations about health and wellbeing.

However, high caliber HCPs are in high demand, and many companies are finding it challenging to recruit into the specialist roles needed to conduct clinical research.

It’s also important to note that the move from onsite to remote offices and trials is placing additional pressures on site staff.

Despite its many advantages, the DCT/hybrid model brings with it a multitude of additional administrative tasks, such as making payments, liaising with the remote HCPs, and coordinating everything from visits to equipment and supplies procurement and delivery. All this is happening at a time when sites are already short staffed, further contributing to burnout and increasing staff turnover.

The right patient support is also crucial to the success of remote or partially remote clinical trials. One of the oft-cited benefits of DCTs is that they reduce burden on patients, boosting recruitment and retention rates. However, they also have the potential to weaken the all-important relationship between participant and site, meaning sponsors and CROs have to look for alternative engagement strategies.

Ecosystem Approach

Luckily, many commentators and organizations are talking about these issues and high-quality solutions are becoming increasingly available.

In terms of staffing, for example, specialist HCP resourcing agencies can provide a bespoke, fully trained clinical team that meets the needs of the trial and the patient cohort at hand.

Specialist backend solutions can provide the physical and technical infrastructure needed to help reduce pressure on sites. Elements such as visit schedule systems and international distribution center networks, for instance, can make sites more efficient in how they conduct studies on behalf of their sponsor and CRO partners.

Further, we all know that dropouts delay the already lengthy drug development timelines, and that the re-recruitment process is as expensive as it is time-consuming and resource-hungry for site staff. The good news is that concierge-style patient support services, including taxis to and from site visits, automated expense payments, and convenient, tech-enabled communication with the clinical team, can bridge the gap between site and patient. This helps to drive up engagement, minimizing dropouts.

Yet while such approaches hold real efficiency-driving value, sponsors and CROs tend to implement them in a piecemeal fashion. This results in staff being asked to be trained on, and then switch between, multiple systems and interfaces, which only serves to increase pressure on already under resourced sites.

Instead, sponsors and CROs should be thinking systemwide. Using the same trusted partner for all elements of DCT support means all parts of the ecosystem can “talk” to each other. It allows, for example, remote HCPs to communicate directly with distribution centers, and for HCPs to act as a valued liaison between site and patients.

All of this eases burdens on sites, increasing job satisfaction and reducing the sense of being overwhelmed among staff, thus boosting staff retention and, ultimately, making clinical trials run as cost-efficiently as possible.

References

1. What’s Driving the Great Resignation? 2022. https://www.london.edu/think/whats-driving-the-great-resignation
2. Open Letter to Sponsor and CRO Colleagues Regarding the Workforce Retention and Inflationary Pressures Affecting Clinical Trial Sites. 2022. https://myscrs.org/workforce-challenges-letter/

LaQuinta Jernigan is Chief Operating Officer with mdgroup, a global digital and patient health services company that provides a patient-first approach to clinical trial recruitment, retention, diversity, and accessibility. She advocates both at work and outside work for diversity in clinical trials, and is passionate about addressing the many disparities that exist in healthcare for people of color. She previously wrote for Clinical Researcher in December 2021.