Clinical Trial Enrollment Challenges

Clinical Trial Educators

We talk a lot about Medical Science Liaisons (MSLs) and Key Opinion Leaders (KOLs) and their roles and responsibilities. We also dedicated a blog to the emerging role of Health Outcomes Liaisons (HOLs) – but the list doesn’t end there: Clinical Trial Educators (CTEs) are also part of the growing list of specialized jobs in pharmaceutical companies. Here is an overview of a CTE’s roles and responsibilities.

Clinical Trial Enrollment Challenges: Patient Recruitment

Saying that clinical trials are expensive is about as novel and surprising as saying “the sky is blue” or “a lot of people like ice cream.” Hard numbers, however, are not that easy to find and estimates for actual cost vary widely depending on the indication, the number of patients enrolled in the trial and other factors such as whether the trial compares a new treatment to an existing one or not. A study published in JAMA Internal Medicine looked at 2015 and 2016 pivotal trials (generally Phase III trials intended to provide evidence for a drug marketing approval by the FDA) and found a huge range: from $2M price tag for a four person trial for a rare disease to a whopping $347M for a large study.

Patient recruitment is a key step in the process. Not only is a significant portion of the cost of clinical trials associated with recruiting patients, but the success of a clinical trial is highly dependent on the company’s ability to sign up a sufficient number of participants. Studies show that patient recruitment is challenging at best, e.g., a 2015 analysis of registered trials revealed that 19% had to be closed or terminated early because not enough study participants could be identified. Recruiting challenges can also delay trials which is not only costly for pharmaceutical companies but also delay patients’ access to novel treatments.

Pharma companies invest heavily in patient recruitment as well as retention – another challenge as attrition rates can reach 30% to 40% if patients don’t see the effect they had hoped for, experience side effects, or adherence to the treatment protocol is difficult or inconvenient.

Identifying and Retaining Study Participants

This is where CTEs come in. CTEs are highly trained professionals, often registered nurses or physicians, pharmacists or certified therapist. Since the role of a clinical trial educator is still fairly new, the responsibilities can vary but generally the primary focus of a CTE is to accelerate patient recruitment and enrollment. CTEs achieve this by working closely with the hospitals that participate as trial sites, they visit the sites to help the staff with enrollment of patients either directly or by working with off-site partners contracted to support patient enrollment.

Experienced CTEs can also draw on their network of professional contacts to identify additional facilities and physicians that might treat eligible patients. Many healthcare providers do not refer their patients to clinical trials because they either don’t know about them or they are reluctant to suggest it to their patients because they don’t know the investigator. A CTE can lower this bar and get both the HCP and the patients the information they need to make an informed decision about participation.

CTEs also support and train study coordinators to help them achieve enrollment goals.

Working closely with study sites also makes CTEs valuable resources when it comes to selecting site for a new study: drawing on their personal contacts they can proactively approach qualified sites about a planned clinical study and help them lay the groundwork for a successful enrollment phase.

But a CTE’s educational role doesn’t end there: they are also tasked with interacting with patients and their caregivers. This is especially relevant in trials that involve a complex drug treatment protocol. A trained professional who serves as instructor, coach and educator can make the difference between enrolling a patient or not and between them remaining in the study and adhering to the protocol vs. dropping out or failing to follow the protocol.

As trusted and valuable resources to the investigator and their team, CTEs can also expand the MSL’s access to the investigator and key team members.

Value Added by CTEs

CTEs are expensive resources and add to the already sky-high price tag for clinical trials which is why pharmaceutical companies might shy away from engaging them. More data and experience are needed to better understand the economic value CTEs add to a trial. However, some studies exploring the value added by CTEs already exist. They show that trials deploying CTEs to support study sites with patient enrollment fare better than those without. One study evaluated the CTE program for a cardiovascular trial (abbreviated TRA•CER) and found:

“(…) a significant positive association between CTE site visits and the assessed recruitment-related study milestones in the TRA•CER trial, and enrollment finished ahead of plan.”

A case study published by QuintilesIMS reported an increase in monthly patient enrollment by up to 85% when CTEs supported the clinical trial sites.

CTEs are the new kids on the block but with patient recruitment and representation continuing to be a major challenge we might soon see more companies engaging them in the hopes of streamlining patient enrollment, increasing adherence, bolstering retention and overall reducing the duration and cost of their clinical trials.