If you find yourself in the position where you need additional patients to meet your enrollment targets (or if you’re already facing a rescue scenario), there are three key factors to consider when determining how to close the enrollment gap and meet your recruitment targets: time, quality, and engagement support.
Horario
The average time it takes to identify, recruit, screen, and enroll a patient varies based on target population, protocol complexity, site capacity, and recruitment methodology. In a scenario where a study isn’t meeting enrollment timelines, how does your patient recruitment partner / central recruitment vendor measure up with:
- Study startup timeline
- How quickly can your patient recruitment partner launch a program to begin targeting patients that could participate in your clinical trial?
- Engagement and identification of potential participants
- How is your vendor identifying potential patients, and how interested are they in clinical trial participation?
A significant benefit to direct-to-patient digital advertising is that your potential participant is already interested in the clinical trial as a method of treatment. In other approaches, like mining EMR data or relying on site databases and physician referrals, there’s still a hurdle to overcome in terms of interest in participation (more about this in an earlier blog post).
Quality
Finding interested participants is the first hurdle. Finding interested participants who are a good potential match for your study is the second. In the scenario where you need to amplify recruitment to meet your enrollment targets, first you need to understand why the enrollment target has been challenging. Is it a lack of potential participants early on, is it higher than expected screen fail rates, is it challenging inclusion/exclusion criteria? Regardless of the driver, your patient recruitment vendor should have the expertise and resources to overcome the quality challenge. Challenge your patient recruitment partner about:
- Methodology of adding potential patients into the recruitment funnel
- Is your partner relying on a database of individuals who showed interest in a generic study at some point in the past, or are they delivering potential patients to you who are interested in your study, now?
- Validating self-reported medical information
- How is your patient recruitment vendor validating self-reported data, and how much of an additional burden is it on the site or the patient?
One of the challenges in direct-to-patient digital recruitment is the initial reliance on self-reported medical history. While this is a great place to start, there’s additional burden (because there are more participants) on sites to collect consent and screen for the I/E criteria.
AutoCruitment’s integrated Electronic Medical Record (EMR) solution captures consent, queries the Health Information Exchange (HIE), and automatically delivers the patient’s medical record into the patient management portal. The AI-powered EMR solution helps sites screen and prioritize patients who are eligible for the clinical trial.
Engagement Support
After you’ve solved targeting, initial recruitment, and early screening challenges, you need to ensure that your sites and patients are supported throughout the enrollment process. It is no question that sites are overburdened due to staffing and retention challenges, and with increased complexity in trial protocol and challenges in patient access, the burden and pressures are increasing. How can you ensure that your sites are supported so the enrollment challenges don’t continue with an increased volume of patients?
- Dedicated engagement support for both patients and site staff:
- What level of support is your patient recruitment vendor providing to already overwhelmed sites?
- Technology enabled engagement and real-time reporting on the patient funnel
- How is your vendor using technology to help the sites and engagement services team to manage patient volume and meet the enrollment targets?
Conclusión
When a biopharma organization is facing a supplemental patient or rescue scenario, they need to ensure they’re choosing a partner with a proven track record of quickly identifying and enrolling eligible participant by leveraging sophisticated recruitment strategies and integrating technology to streamline the process. With the right partner in place, biopharma companies can close the enrollment gap and bring important treatments to market on time and on budget.