In the past five years, ICON has reached its baseline recruitment milestone and helped sponsors bring nine new compounds to the market and two new indication approvals for already-approved medications with the support of CTLs. These successes show the significance of the fuction within clinical research.
Elizabeth Pash, PhD, Senior Director of Global Site Engagement Operations at ICON, spoke to leading pharmaceutical publication FirstWord about the CTL function, what this role is about, its value in developing and delivering optimal clinical trials and how it is expected to evolve in the future. She says, “ICON CTLs are doctorate-trained, clinical research professionals who engage in detailed scientific discussions with Principal Investigators and key site staff. CTLs are able to initiate these discussions at all stages of a clinical trial, supporting site identification, activation and recruitment.” According to Pash, CTLs are not only experts in their fields but they also impact recruitment, site engagement and partnerships with sponsors. With a substantial increase in clinical trials being conducted, professionals are needed who can identify the right sponsor for a clinical trial based on their domain knowledge. Medical Science Liaisons (MSLs) may be helpful in this area, but they might not know how clinical trials are conducted. That is where the CTLs’ come in. Their advanced educational qualifications in sciences and professional experience are an advantage because they have existing knowledge on clinical trials and trial sites, resulting in added impetus at supporting recruitment owing to their specialised knowledge and ability to identify appropriate professionals for a specific role.
Recruitment criteria also differ for centralised and decentralised clinical trials. Since decentralised trials do not follow the traditional mode of monitoring subjects in a central location and involve subjects commuting to sites, using telemedicine or availing services of local healthcare providers, personnel required to manage the recruitment of these trials also need to meet specific requirements. As Pash points out, “As more clinical trials begin to incorporate more decentralised approaches, the need for roles like CTLs is set to steadily increase in the industry, owing to the CTLs advanced knowledge of processes and technologies involved in decentralised trials to decide on the kind of personnel who should be employed in these environments.”
When asked how the CTLs differ from Clinical Research Associates (CRAs), Pash states that both are “protocol experts” but their roles with respect to sites are distinctly different. CRAs are required to know details of eligibility criteria and schedule of assessments to ensure proper conduct of trials and data monitoring during a recruitment drive, however CTLs know the scientific aspects of a protocol that will help with site engagement, indication investigation, determining the key eligibility criteria for a role, thereby ensuring trial success at participating sites. CRAs partner with study coordinators and supporting research staff whereas CTLs partner with principal investigators and site clinicians. Therefore, CTLs and CRAs need to work in tandem to ensure site staff are well-supported.
As Pash reiterates in her interview, the CTL’s role in site engagement and sponsor management is key to understanding the impact of the role in a clinical research environment when she says, “When sites are ready for activation, CTLs can support site training through discussion of the investigational product, review preclinical and early phase data, and provide the rationale for study design and key eligibility criteria.” Due to the unpredictable nature of research, unforeseeable issues may arise with planning, implementation or site selection for a clinical trial. With the CTLs existing knowledge in operationalisation of clinical trials at site level, they can provide valuable feedback to sponsors and study management teams on how to optimise recruitment at sites so that these issues can be avoided.
Data suggests that CTLs have benefitted ICON in increasing recruitment and introducing new drugs to the market since the introduction of the function in 2014. As observed, “Independent of therapeutic indication, ICON CTLs can contribute to a 20% average boost in the targeted recruitment rate and help approximately 70% of sites achieve their baseline recruitment goals.” When asked about the potential of this role beyond trials themselves, Pash suggests, the weekly meetings held during ongoing trials and the lessons that CTLs share during these discussions have helped ICON and sponsor operational teams to identify potential recruitment challenges and facilitate implementation of useful strategies to overcome them. In the end, Pash reinforces that ICON CTLs not only have the experience of supporting a number of clinical trials, but their engagement has allowed sponsors to adapt their study designs to “reflect how patients are presenting in the clinic and current treatment paradigms” leading to more engaged investigators and better recruitment.
Ultimately, CTLs help in accelerating the trial process. They identify and collaborate with sponsors much earlier, “support trial and protocol design, conduct targeted investigator interviews and apply relevant information in early stages of clinical development,” expediting clinical research and drug development.
Read the full interview