As one potential solution, ThreeWire – which WIRB-Copernicus Group (WCG) acquired in 2017 – has introduced enrollment assistants dedicated to tasks that are necessary, though often neglected due to time constraints.
To further discuss how the company is tackling patient enrollment challenges, Outsourcing-Pharma (OSP) spoke with Molly Hair (MH), account manager at WCG ThreeWire.
OSP: What are the main challenges to patient enrollment?
MH: The main challenges to patient enrollment are locating the right patients to participate in the first place and then ensuring they continue to participate throughout the study. When looking to locate potential patients there are two types generally: those that are known and those that are unknown. The site either has identified or will identify the known subjects through their records or networks.
Unknown patients are commonly identified through mass media outreach campaigns in either traditional or digital form. While mass media campaigns can drive significant numbers of interested participants to sites, the volume can actually overwhelm a site because of limited site resources.
An overwhelmed site doesn’t have the ability to respond to potential patient’s initial queries in a timely manner, or at all, which in turn could result in losing that patient before they are ever screened.
Principal investigators typically delegate the responsibility of responding to these calls, oftentimes to the site coordinator, who screens them based on a study’s inclusion/exclusion criteria, and then sets up visits to the site if they pass the preliminary phone screen.
The key drawback to this approach is that the coordinator’s main responsibility is conducting studies, usually several at once, so with intensely busy schedules, many potential study participants are never called back.
Not locating the right patients and then not keeping them is a key reason why research indicates that 68% of sites fail to meet their projected enrollment targets, and 11% fail to enroll a single subject. These statistics point to the sobering fact that clinical trial cycle time has remained unchanged in more than a decade.
OSP: How is the industry addressing these challenges?
MH: For media outreach efforts trying to locate unknown patients, many sites will use call centers to return referral calls. These call centers can be useful especially for processing referrals from large media campaigns.
Although call centers must stick to a scripted conversation approved by regulatory bodies, staff members can help provide responses efficiently. They can also ask screening questions before recommending someone for an office visit.
One disadvantage, however, is that many people who, ultimately, are unqualified make it through the preliminary screening.
OSP: In what ways do insufficient resources at the site contribute to enrollment difficulties?
MH: For starters, sites often cannot keep up with the referrals from marketing campaigns. As evidence, research suggests that one-third of referrals are never processed by the site. This means that people who may have qualified for the study may never move to the screening step, as they were not called. Moreover, if they are not called within 48 hours, they may lose interest, maybe permanently.
I worked as a recruiter on a trial that used massive media campaigns, and I experienced firsthand that there wasn’t enough time in a day to return all the resulting calls. We know that if it took a week or longer to call back a potential patient, it would often be too late.
It can take a lot of energy and courage for a potential subject to make that first call. If they do not receive a fast response, they are likely to change their mind.
I have read some studies that indicate those people who are not quickly followed up with will not only not participate in that trial, but any other trial. One bad experience can lose that patient for all future trials as well. This problem is particularly damaging for hard-to-recruit studies, such as those for serious or rare diseases.
When it comes to locating the known patients, the site also may not have time to actively find patients who have regular physician appointments. This could be the fastest and most inexpensive option for finding potential clinical trial participants. This extends to locating past or future patients and patients from referring physicians.
All of these sources streamline the process and cost of a fraction of TV, radio, or multi-media campaigns, yet a lack of resources, time, or process at the site level could mean these sources go untapped.
And there is a further complication. Some sites redirect referrals from one study to the next. This could take the form of a study coordinator is working on multiple studies and is actively trying to recruit them all simultaneously.
Thus, if they receive a response from an outreach campaign that may not qualify for Study A but would likely qualify for Study B, they may refer that patient to Study B despite the fact that Study A’s media outreach campaign was how the patient came to contact the site in the first place.
While not intentionally, this could result in one sponsor’s media budget benefiting another sponsor’s study.
OSP: In what ways is ThreeWire aiming to unclog this recruitment bottleneck?
MH: ThreeWire tackles the problem in multiple ways. ThreeWire will first develop an enrollment strategy that will help identify the known patients as effectively as possible. Additionally, where appropriate, ThreeWire will develop an outreach campaign to locate additional unknown patients.
Then, in order to make sure that all qualified patients are properly screened, and enrolled when appropriate, ThreeWire deploys its enrollment assistants to provide further support at the site where the critical actions take place.
WCG’s ThreeWire patient recruitment and retention services use enrollment assistants (EAs) to optimize the pre-consent enrollment process. EAs are individuals placed at sites who are dedicated to enrollment and pre-enrollment retention of one particular trial. They perform strict and customizable screening to make sure that referrals are high quality. They also have access to the site’s portals and protocols and can determine where exactly the trial needs help. This allows them to create a customized enrollment plan to meet those needs. The EA is available to the site for as many hours a week as needed for as long as necessary.
EAs are dedicated to tasks necessary for enrollment and the study, which are often neglected, such as conducting retrospective and prospective chart review to ensure every possible patient from the site’s own database is contacted.
When the study coordinator is busy with other responsibilities, such as conducting study visits, entering data, and administering protocol-related requirements, enrollment tasks can be moved down the priority list. When someone is dedicated to enrollment, we create a scenario in which every option to optimize enrollment is managed and completed by someone with expertise in doing so.
Right now, many sponsors are spending a hefty percentage of their budget on recruitment. This is a pivotal investment, but so is improving the quality of referrals and pre-enrollment retention. With EAs, sponsors can rein in their recruitment costs.
At one site, before working with ThreeWire, a global Phase III study enrolled 20 patients in 10 months. After engaging ThreeWire, they enrolled 70 patients in 7 months, a 5x increase in enrollment rate.
OSP: How is an enrollment assistant different from a traditional recruiter?
MH: The EA is focused exclusively on enrollment at one site on one study. Some sites may have staff dedicated solely to recruiting across multiple studies and other sites may designate a team members to participate in typical enrollment activities as an add on task. This means that they have other responsibilities which may take priority.
In some sites, the designated person may be working on more than a half-dozen programs simultaneously. Also, some study coordinators are not trained in recruiting and advertising, whereas an EA is.
EAs also hone in on screening for high-quality referrals, so sites are not wasting their time screening people who will clearly not qualify. Altogether, this high quality, high-touch service can create more engaged participants throughout the whole process.
At the core, the EAs bring patient centricity to the enrollment process. They return every call within 24 hours and schedule screening appointments for when it is most convenient for the individual. They serve as the point of contact throughout the entire enrollment process right up until the Investigator obtains informed consent.
OSP: What are some other new engagement strategies to find the right patients?
MH: Increasingly companies are working with active and vocal patient communities. This can be a great way to reach patients where they already are. We frequently work with the online patient community Inspire in this way and have found it to be very rewarding.
Another example is with genetic counseling services. In fact, WIRB-Copernicus Group (WCG), the owner of ThreeWire, has recently partnered with a genetic services company to provide just this type of patient-centric solution. If a participant tests positive for a particular genetic disease, the counselor may elect to open a pathway to that participate for potential clinical trials by explaining the implications for them and their family.
We are constantly learning more about how to improve the recruitment process. A particularly useful tool is the Online Resource for Recruitment Research in Clinical TriAls (ORCCA) project, a UK initiative that provides a searchable, online database of published recruitment information that sponsors can access to learn about new research and identify strategies for more effective recruitment.