The rapidly evolving clinical trial paradigm is prompting altered expectations of the traditional Clinical Research Associate (CRA). As a result of key developments in the industry, including new regulatory standards, innovative technologies, and more complex site and sponsor relationships, clinical sites must revise the CRA role.
With respect to regulatory developments, the introduction of risk-based monitoring in the latest revision to ICH GCP (ICH E6 R2) has driven a greater prevalence of risk-based approaches to monitoring clinical trials. For example, a strong majority (90%) of new studies at PAREXEL involve one or more risk-based strategies. Risk-based approaches focus CRA activities on the most critical data and processes. CRAs now have the ability to combine data from multiple sources and flag emerging risks in patient data across multiple sites or risks in site performance. Risks to the critical data or processes can be surfaced in near real time allowing CRAs to be better informed when engaging with site staff, maximizing efficiency.
However, many companies lack the technology or the capabilities to best leverage analytics and take appropriate action. CRAs now need the ability to grasp the significance of the data presented by the technology and take appropriate actions to reduce or eliminate the risk. This represents a new competency required of today’s CRAs. In addition, with more technologies evolving, trial sites have indicated they use an average of five to 15 systems per study. The ability of CRAs to stay up-to-date with these multiple systems and provide support to site staff presents a significant challenge.
CRA activities were once the domain of pharma and biotech companies as a core competency; but as technology evolved and budgets became tighter, the outsourcing of CRA activities increased via different models, such as functional service outsourcing, full-, or part-service outsourcing. As companies focused more on speed and costs, some functional benefits of CRAs’ delivery were lost, such as representation of the sponsor. To provide the most value possible, pharma and biotech organizations must seek to retain this important link with sites who are frequently customers of the sponsors.
As part of this effort, CRAs must take on a new form: Clinical Site Managers (CSMs). The CSM role builds on the core requirement of the CRA role but with five major additional components (1) enhanced site relationships, (2) patient enrollment consulting, (3) therapeutic area expertise, (4) technology literacy, and (5) total ownership.
Enhanced Site Relationships
Outdated standard: CRAs are not measured by site relationships and do not have time allocated to building relationships.
Present need: In order to build better relationships with the sites, CSMs must be measured by site relationships. CSMs need to dedicate time in their allocated hours to consciously build relationships with site personnel. In addition, CSMs need to have a better knowledge of the sponsor company that they represent and the purpose behind the drug and device they’re developing. Often, there is a greater picture behind a single study. With enhanced relationships, the communication between the CSM and sponsor is better, and ultimately the study delivery is better.
Patient Enrollment Consulting
Outdated standard: Sponsors often make the decision to act after the recruitment process has already fallen behind. Sponsors often hire additional resources to assist with recruitment and as such endure additional costs.
Present need: CSMs must be trained on useful tactics in the event recruitment is not meeting expectations. Often, many recruitment tactics are only deployed after a few booster visits and communication with the sponsors. Recommended best practice is to first agree with sponsors on the tactics that CSMs can use, limiting the need for extra communication and decision making after the process has already begun.
Therapeutic Area Expertise
Outdated standard: There has not been enough high-level training for specific therapeutic areas on how to navigate the complexity of the trial designs.
Present need: CSMs must be heavily trained for specific therapeutic areas. For example, for a lung cancer study, CSMs will not only have broad training in the area of oncology, but also in lung cancer specifically, and even niche training in PD-L1 studies. In the last decade, clinical trials have become smaller in sample size but much more multifaceted in design—CSMs need to be equipped to tackle this increasing complexity.
Outdated standard: CRAs have not been trained to manage or understand analytics, and as a result they often feel overwhelmed by the number of systems and data they need to review.
Present need: With multiple technologies in place for risk-based monitoring and site management, CSMs need to be trained to use these technologies to support their activities, enhance their productivity, and improve data quality. Additionally, in order to support site staff, CSMs must be trained to manage a variety of site-facing technology deployed across many clinical studies. Beyond that, CSMs must prepare for mobile technology, which is on the horizon for clinical sites.
Outdated standard: With so many moving parts within each trial, CRAs have been known to let other functions or vendors resolve the issue, distancing himself or herself from the situation.
Present need: CSMs must understand that they are accountable for everything that occurs at an investigational site, and that it is reflective of their performance. An experienced CSM should be able to recognize the indicators of a high performing sites vs. a low performing site. For example, knowing a site’s responsiveness during study start-up will certainly indicate their performance in the enrollment and maintenance phase.
CSMs also need to understand they are the single point of contact between CROs, sponsors, and the site. For any escalation or issues, CSMs will need to take the lead to resolve and address them head on. For instance, a CSM might not be responsible for handling an investigator payment, but if a delay was to occur, the CSM needs to take ownership and resolve within service provider or sponsor.
Having a greater accountability for the site performance and being the point of contact with the site represents a more fulfilling role than the traditional CRA role. Upskilling of CSMs in site relationships, patient enrollment strategies, technology literacy, and sense of ownership will result in greater success in site delivery and CSM job satisfaction.