Your 5 Questions About Enrollment Assistants Answered

Enrollment AssistantsTM are the heart of WCG’s recruitment and enrollment services. If you’ve spent more than 10 minutes with me, you’ve likely heard me sing their praises. They recruit and screen potential study volunteers, conduct patient chart reviews, field and evaluate referrals, conduct community outreach, describe trial protocols to patients, explain consent and guide qualified candidates to enrollment. They ease site burden and increase patient engagement. I could go on.

As my colleagues and I talk to sponsors, site staff, and Investigators about the use of on-the-ground recruitment support, we run into some very good, and common questions. I'd like to answer a few here.

Q1: How can a person from outside the study team legally work at a site?

Mark Summers: This is probably the most common question we hear. Let me start by answering the unasked question: WCG ThreeWire has provided thousands of Enrollment Assistants (EAs) at sites all over the globe, and we've never had a compliance or regulatory issue. 

Now, to the actual question. Let’s begin in the U.S. Because WCG enters into a HIPAA business associate agreement with each site, EAs can access patient records and site portals, and work directly with patients. On the delegation-of-authority log, the EA is under the direction of the Principal Investigator.

Elsewhere, we have country-specific agreements. For instance, in the EU, we enter GDPR-compliant data-privacy agreements that govern how we capture, store, use and transmit data. Each agreement is customized, of course, but all of them allow EAs to be fully engaged members of the team

Q2: How accepting are sites of EAs--especially sites that have never worked with one?

Mark Summers: We find sites generally very accepting. They love the idea of having the sponsor provide the resource. Think about it: Because the sponsor pays for EAs, sites lose nothing by accepting EA support. And we customize our services to the needs of a site and a study. We’re giving them an extra staff member, fully integrated into their team and solely devoted to the study. So we don’t get much resistance.

Q3: Are EAs trained onsite or by WCG ThreeWire?

Mark Summers: Both. There are three components to the training. First, there’s the training WCG ThreeWire provides all EAs. And then there is protocol-specific training. We often provide that, but sometimes, the sponsor or CRO does.

The third element involves the workings of the individual site. EAs don’t need to be trained on the EMR/EHR system--they’ve seen them all. But each site has its own its processes, procedures and systems, and typically, the site will provide that aspect of the training. That’s crucial, because the EA needs to be an extension of the team that’s already in place at the clinical research site.

Q4: Would an Enrollment Assistant be more beneficial to, say, a large academic center than to a small standalone research site?

Mark Summers: Not really. The Enrollment Assistant’s job description is tailored to each site and each study. The size of the research facility wouldn’t be an issue; it would simply be a matter of figuring how many hours the EA would need to spend at the site and how to set that up in a way to maximize efficiency.

Q5: How do you keep track of your enrollment performance metrics?

Mark Summers: We do that through MyPatient.com, a workflow management system. Each patient enrolled through the EA’s efforts is entered into MyPatient.com. We’re able to track where that patient came from and then we follow them through to enrollment so we know how many incremental enrollments were produced by the Enrollment Assistant. We are then able to calculate the cost per subject enrolled.

Sponsors, CROs and sites all have log-in credentials and see the data in MyPatient.com. We like to say accountability is baked in.

Other questions?

My colleagues and I are happy to answer any questions you have. Our experience shows the more Sponsors, CROs and sites know about Enrollment Assistants, the more they want to work with one. So ask us anything at info@wcgclinical.com

About the Author

Mark Summers | President of Patient Engagement, WCG

Mark is widely recognized as a veteran entrepreneur and thought leader in the area of accelerating clinical trial patient enrollment, with more than thirty years of experience in pharmaceutical and medical device clinical research. His clinical trial experience at both WCG ThreeWire and sponsors covers a wide range of therapeutic indications and patient populations in over forty countries. Prior to founding WCG ThreeWire, Mark held executive leadership positions at two early stage medical device firms where he produced more than $100 million in global growth following completion of extensive clinical trials.

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