Clinical Trial Liaisons to the Rescue
Clinical trials are the most expensive part of drug development. A 2014 study published by the Department of Health and Human Services’ Assistant Secretary of Planning and Evaluation (ASPE) found that the average cost per study across all therapeutic areas amounted to $13 Million for Phase II and $20 Million for Phase III trials. Since the publication of this report, clinical trials haven’t gotten any cheaper.
Another sobering statistic for everybody working in drug development is the percentage of successful clinical trials: only 14% of drugs in clinical trials will be approved by the FDA according to a recent study by MIT.
Attrition, of course, is expected. Clinical trials are, by nature, research and research is unpredictable, uncertain and can fail regardless of how well the researchers prepare and how diligently they work. Clinical trials can also fail for “bad” reasons, that is, not because the drug candidate didn’t show efficacy or had too many side effects but because the clinical trial planning and implementation suffered from avoidable issues. Recruiting the wrong or too few patients, selecting the wrong study sites, underfunding the study, or failing to communicate complicated medical and scientific concepts are possible reasons for failure.
Clinical Trial Liaisons to the Rescue
Clinical Trial Liaisons (CTLs) are the pharmaceutical companies’ response to these challenges. Modeled after the role of Medical Science Liaisons (MSLs), CTLs are also point persons and experts for all aspects of their drug, however, they exclusively focus on engaging sites participating in clinical trials. The responsibilities of CTLs are similar to those of MSLs but instead of engaging Key Opinion Leaders and healthcare providers, CTLs serve as the sponsor’s point person for the Principal Investigators (PIs) and their staff. As opposed to MSLs, who are generally responsible for an entire therapy area, CTLs tend to work on a single study.
Clinical Trial Liaisons are typically tasked with:
· Discussing the scientific rationale for the study with PIs and the site staff.
· Educating the site teams about the study protocol, patient eligibility criteria, and study procedures both before the start of the trials and during the trials, as needed.
· Supporting patient enrollment through referrals.
· Collecting PI feedback and relaying it to the internal study teams.
· Keeping the PI and staff informed of any new information about the drug that becomes available while the trial is ongoing.
· Meeting with sub-investigators, e.g. physician assistants and nurse practitioners to help maintain focus on the study’s overall design, rationale and eligibility criteria.
· Supporting research staff with developing pre-screening procedures for patient enrollment.
· Identifying new sites for consideration and coordinating communication between the sites.
· Maintaining open communication with the clinical monitors.
The role of a CTL is distinct from that of a clinical monitor, though there can be some overlap. The main responsibility of a clinical monitor is quality control during the course of the trial whereas CTLs work closely with the investigational team on patient recruitment and to resolve any issues and challenges that might come up during the trial. Especially in cases were a CRO is hired to oversee the clinical trials, the CTL serves as the representative of the sponsor.
For the sponsor, the CTL’s value lies in making sure that all sites are fully engaged throughout the trial, patient recruitment targets are met, and costly and time-consuming amendments to the study plans are kept to a minimum.
For the clinical investigator and their staff, CTLs tend to make life easier. In the CTL they have a competent point person with the scientific background and expertise to answer questions about the study quickly and someone with the ability to work with both the investigational and, if needed, the sponsors’ study team on a peer-to-peer level to solve problems.
The role of a Clinical Trial Liaison is gaining more traction in the pharmaceutical industry because of their ability to assure that the expensive clinical trials run as smoothly as possible from initiation through completion.