Adjusting to the changing dynamics of the clinical research associate role.
The role of the clinical research associate (CRA) is fundamentally important to the success of clinical trials. However, this role is undergoing significant transformation due to the changing dynamics within the clinical research industry. In this article, we explore the recent shifts in demand for CRAs, the evolution of the CRA role, and strategies to prepare and support future CRA talent.
To better understand the evolving CRA role, it’s helpful to reflect on the shifts in demand for CRAs in recent years. Over the last two decades, the demand for CRAs has consistently outpaced supply. Why? The development of more complicated scientific assets and/or targeted therapies has led to a rise in the volume and complexity of clinical trial data. We have also seen a significant increase in the number of sites and patients, in part due to the increase in trial patient sizes since the early 1990s. This requires more monitoring time, despite efforts to move from source data verification (SDV) to source data review (SDR).
CRA sourcing models are also a factor. Large pharma sponsors often use embedded sourcing models to enable a variable workforce, involving multiple suppliers. This can result in simultaneous requests for CRAs from multiple suppliers, amplifying the demand significantly.
Finally, while the COVID-19 pandemic exacerbated the CRA shortage, the primary challenge today is the need for experienced CRAs, particularly as trials shift from vaccine indications toward more complex indications in oncology and rare diseases.
The role of the CRA is fundamentally changing as trials move toward a decentralized approach where data is collected remotely. This future CRA may need to incorporate elements of a data monitor, data analyst, and risk analyst, among other roles. This requires a different skillset, with the ability to analyze and interpret high volumes of data, and to differentiate between data that is relevant versus what is “nice to have.”
The traditional “road-warrior” model, where the CRA’s key productivity metric is days spent on-site may be replaced by one with metrics related to risks mitigated or data queries closed.
Another, perhaps parallel opportunity for the evolution of the CRA role is to become the site “owner.” While CRAs may have been perceived as such in the past, their travel schedules and resulting lack of availability made this difficult. However, if the future CRA travels less, that time can be redeployed to address site questions, management, and ownership. CRAs would become experts in site processes and SOPs. They would understand the patient flow and pathways to enrolment. They will have close relationships with all site staff, allowing their outreach (calls, email, texts, etc.) to be prioritized and acted upon; and they will retain oversight over site health in terms of productivity and quality metrics.
In this evolving landscape, where the role of the CRA may diverge from where it is currently, how we respond will be critical. A concerted focus on hiring, training, and development is essential.
It is quality of experience, not quantity of tenure, which counts.
Firstly, aligning to the therapeutic needs of sponsors and the evolving requirements of the role must guide our efforts in both the recruitment and training of our CRA talent.
The focus should be on attracting candidates who can quickly evolve to a CRA role from a variety of backgrounds and disciplines, and ensuring they receive training and support tailored to their circumstances, the needs of sponsors, and to the stage of their career.
At ICON, we’ve found it hugely constructive to run dedicated CRA training programs that are specifically tailored to each CRA in question and their respective backgrounds. These programs offer a comprehensive curriculum, including online and instructor-led training workshops to lay the foundational knowledge of clinical research. Importantly, these also include hands-on experience in the form of accompanied site visits, mock visits, simulation visits, and individually tailored coaching, mentoring, and skills development, including in specific areas of high focus.
It’s also important to consider risk management, analytics and IT skills that CRAs increasingly need. Our dedicated training programs now include an oncology academy, where experienced CRAs focus on learning solid tumor and then hematology indications. These also follow the path of instructor and online learning with co-visits to sites with oncology-experienced CRAs, followed by signoffs to ensure adequate competencies to monitor independently in the required complex indication.
Secondly, “phenotyping” CRAs with sites and customers can lead to enhanced productivity. Established customer relationships may provide blueprints for the characteristics that contribute to successful collaborations at site or customer levels. Or if a CRA is expected to be a site owner, interpersonal and influencing skills will be key to a successful relationship.
Hence, hiring may consider not just therapeutic and hard skills, but also softer skills and traits that may make CRAs good candidates for a specific customer or site.
In this way, CRAs develop technical expertise, and build the critical soft skills that are needed to establish and maintain strong relationships with sites. The “mock” part of the training allows for an objective assessment of progress, along with targeted identification of development needs. The coaching and mentoring part of the curriculum, while subjective, is particularly important to foster skills that build strong relationships across all levels of staff at sites.
A further benefit is the focus on providing hands-on, real-world experience. In this way, we are shifting the perception that length of tenure in a CRA role should be used as a benchmark for competence. We’re seeing competency levels accelerate, which ultimately is building the supply of experienced CRAs.
Technology and digitization have transformed clinical trials, offering new ways for CRAs to perform their role more efficiently.Using technology applications allows for the collection of digitized data from patients in a faster and effective manner; but it also may give CRAs remote access to data.
One example at ICON is the implementation of remote CRA hubs, which we use regularly to support sponsors. Our key objective is to provide access to experienced and specialized CRAs in a cost-efficient way.
We have several off-shored hubs in lower-cost locations, chosen based on availability of clinical-research experienced CRAs, along with the availability of infrastructure to support a remote team. Hub CRAs work closely with in-country traveling CRAs, and the role of a hub CRA stretches from data reviewer to site manager. Language abilities are key to this remote role.
There are many benefits to these hubs. Sponsors get greater access to experienced CRAs with knowledge of complex indications, often in more cost-efficient geographical locations. The hub model allows for monitoring to occur at many sites for extended periods beyond a standard working day in the country where the trial is physically conducted. Due to the remote nature of their role, hub CRAs do not travel, and as such, overall job satisfaction for non-traveling hub CRAs is higher, resulting in better retention.
The role of the CRA is rapidly evolving in response to changes in clinical trials. There is real opportunity for the industry to invest in CRA talent and apply new thinking to critical areas, including site-performance management, risk management, remote monitoring, and remote data collection.
By focusing on hiring adaptable candidates, tailoring training and developing programs to individual needs, and leveraging innovation for more efficient operations, the industry can ensure that CRAs remain at the forefront of driving successful clinical research.
The evolving CRA role promises to be varied, interesting, and fulfilling, and as we look ahead, it will become even more so.
Helen Yeardley, Senior Vice President, Global Clinical Operations, ICON plc