By Dr. Armand Czaplinski and Kevin Duffy, KPS Life
The COVID-19 pandemic has impacted every industry in a variety of ways. For biopharmaceutical companies, this impact has been as comprehensive as it has been intense, affecting everything from the supply chains for active pharmaceutical ingredients (APIs), clinical packaging, labor shortages and monitoring resources, and everything in between. But perhaps most important is their respective ability to conduct and deliver their research and development programs directly or through their selected vendor partners. The well-documented labor shortage has been driven by an increase in market turnover and poor retention of key personnel. Part of this dynamic can be attributed to shifting expectations regarding in-person work, coupled with a redistribution of talent to other sectors and an inherent dip in the labor pool, creating a hurdle that many are struggling to overcome.
This downturn has proven particularly challenging for full-service contract research organizations (CROs), some of which may try to address the shortage by overextending their existing labor force, stretching the geographic reach of site visits, and assigning multiple protocols to team members. This tactic may create additional churn for these organizations, with some experiencing turnover rates of as much as 100 percent within a clinical project conducted for a sponsor. In turn, many CROs may be tempted to fill workforce gaps with inexperienced personnel tasked with a workload that far outstrips their expertise and bandwidth, further exacerbating the issue.
Personnel shortages and expertise gaps across the biopharmaceutical research and development paradigm have widespread implications for the time and expense associated with the drug discovery phase, already beset with competing challenges and an ever-evolving regulatory landscape. These factors have likewise compelled many sponsors to explore decentralized clinical trials (DCTs) as a solution to the rigors of conventional on-site trials and their commensurate workforce needs. But this approach is also not without its pitfalls: for many, DCTs require an aggressive technology transformation plan to include an overhaul of their systems, network size and workflows, which can be further complicated depending on the country or region of the world where the trial is being conducted.
All of these factors serve to create a challenging landscape for the global labor market in life sciences. Biopharmaceutical companies can employ several strategic approaches to mitigate risk in this regard, addressing the evolving demographics of the global workforce and ultimately transforming their own paradigms to ensure their programs succeed. Functional service providers (FSPs) can offer sponsors a more cost-effective alternative providing a complementary and/or supplemental partner to their existing outsourcing strategy. This can afford them access to tailored expertise, experienced clinical monitors, FSO oversight monitoring and global project management without any appreciable change in their existing workflows.
Responding To Workforce Gaps With Flexible Support
More clinical trials were launched in Q4 of 2021 than ever before with 1,015 initiations alone. This surge, driven by pent-up new projects, combined with the 23 percent of launched projects delayed by the pandemic, has created a huge demand for qualified employees to execute these trials. The widespread workforce gaps that have opened across Europe, Asia, and other regions have complicated the current state of the drug development industry.
To increase revenue, CROs may look to maximize some of their key clinical monitoring metrics – “the units” (most pharma contracts with contract research organizations are unit-based, with one on-site monitoring visit equating to one unit). This can most often be accomplished by assigning junior staff and very often to multiple projects as noted earlier.
DCTs have been implemented, in part, to alleviate this pressure, but often, the challenges created by this emerging methodology will require additional site support for which sponsors may not have budgeted. In addition, within the last decade, the span of control has been increasing, which leads to insufficient or suboptimal support resulting in demotivation, undue stress and disrupting the work/life balance we all seek.
These factors contribute to significant staff turnover for trials, which directly impacts the quality of drug development and can ultimately jeopardize outputs and the success of the study. The dearth of quality data that can result from mismanagement of on-site monitoring is one of the biggest threats to the success of a trial; mitigating this risk comes down to ensuring knowledgeable, consistent on-site oversight and reporting. This can prove particularly difficult in the current environment, where many junior site monitors have been promoted quickly to encourage retention, resulting in personnel without the experience and knowledge base to best support complex studies. The CRA-investigator relationships that were been forged during the life cycle of a clinical study and were fundamental to the successful delivery of a study at site level are now disappearing due to turnover and virtual/remote monitoring strategies.
Despite the rapid changes that have occurred across the industry because of the global pandemic, the ability and willingness of companies to change their perspective to respond is lacking. The rate at which DCTs were adopted across the market escalated precipitously in the wake of COVID-19, particularly in North America. This uptick in utilization has come with challenges for even the largest, most established biopharmaceutical companies, and those challenges have been further compounded for companies operating outside the U.S., where problems such as language barriers, institutional reluctance, or resource constraints can slow or stall the adoption of innovative technologies and processes.
Lastly, while DCTs have their place in the clinical trial space, it will be years before their full potential is realized for a broad range of studies. Currently, the majority of DCTs are employed in straightforward trials, where patient outcomes and data are easily captured. Multi-site, complex protocols occurring in multiple languages in disparate regions are still largely conducted traditionally. This reality serves to strain a global biopharmaceutical workforce, requiring near-term solutions that can help progress the unprecedented number of trials in the current research pipeline.
Evaluating An Outsourcing Model For Improved Outcomes
There are several advantages to employing a FSP model to support a clinical trial. FSPs are contracted to perform functions for a biopharma organization that typically retains control over the systems, processes, and data at the core of a clinical trial. The potential benefits of employing FSPs are far-reaching: increased quality, decreased costs, strategic control, and greater brand recognition can all be achieved with the right structure. This proven methodology can help sponsors simplify oversight and reduce their administrative burden by assuming responsibility for performance management, staff oversight, and administrative activities. Because the model is highly scalable, it affords sponsors the ability to increase or decrease the level of support for their trials in real time. This approach can also result in significant cost savings – many sponsors report cost savings more than 30+ percent due to improved resource forecasting, allocation, and redeployment.
Because FSPs typically operate on less aggressive margins than some CROs, these providers are often able to hire more tenured clinical research associates (CRAs). This approach, coupled with a focus on retention, creates a pool of curated and dedicated labor wherein many FSPs can maintain teams with decades more experience than a full-service organization. The added flexibility can make them an invaluable complementary resource for companies with established insourcing and outsourcing models beset with inefficiencies. Even large biopharmaceutical companies, which may have their own internal clinical trial team, as well as companies with long-standing CRO partnerships, can stand to benefit from the supplemental, tailored oversight and human capital FSPs offer.
More than half of clinical trials are outsourced. Historically, the sector has seen increasing reliance on full-service CROs. More recently, however, this paradigm has shifted to reflect recognition of the benefits of FSPs in supporting these studies. FSPs are defined by their flexibility, which extends to the various costing models available to sponsors. These include:
- Full-time equivalent (FTE)-based models, which are built around agreed rates codified in the contract for FTEs, invoiced regularly
- Time & materials models, for which rates are based in hours booked and invoiced regularly
- Unitized models, which are contracted based on the number of units required to finish project tasks
- Bridging models, wherein a sponsor contracts an FSP’s resources as dedicated FTEs that will eventually be transitioned into sponsor employees
- Lift & shift models, which contract out the management and execution of a study to an FSP but allow a sponsor to maintain strategic control
- Rebadge models, wherein individuals or teams transition into FSP FTEs while maintaining their existing roles with a sponsor.
Summary
Ultimately, engaging an FSP model can allow sponsors to retain strategic control and achieve greater flexibility as a result. Creating an outsourcing model wherein multiple handoffs occur between disparate systems and processes can directly and negatively impact the quality of the work performed. Addressing these challenges for a global market plagued by workforce retention issues will require creative solutions that are workable in the short-term and scalable in the long-term.
