In recent years, the clinical research sector has witnessed an exciting evolution in technology, aimed at enhancing patient recruitment and retention. This wave of innovation offers promising solutions to streamline operations for sponsors, sites, and patients. Sites are increasingly faced with the challenge of adopting new systems and integrating them into their existing workflows—a task that becomes even more daunting against the backdrop of current workforce challenges. However, as more trials become available and continue to increase in complexity, there is a need for automated systems to ease the added stressors on CRCs and recruitment teams. Despite the potential cost of tech, and the complexities of implementation, it’s crucial to find a technology vendor that can meet your current needs and can scale with your organization. Most of these tools support reducing barriers of entry into clinical research for patients and physicians alike, expanding access to a greater population of research-friendly candidates.
EMR-Based Patient-Trial Matching
In the last few years, the industry has seen a significant increase in new patient-trial matching solutions, particularly technology platforms that directly integrate with EMR/EHR systems. These tools allow sites to search within their own databases, identifying patients that match specific I/E criteria for a trial. Typically, these systems will support various filter criteria, like age ranges, sex, and BMI, as well as form fields for both inclusion & exclusion criteria that support real word identifiers. When exploring potential patient-trial matching technology vendors, consider the following factors:
Benefits to EMR-Based Patient-Trial Matching Software
- Using Data You Already Have – A good platform will match I/E criteria to patients within your current EMR or database, based on key terms found in their health record
- Speed – Most generate nearly instant match lists for the recruitment teams, reducing communication with unqualified patients and recruitment team’s time
- Beyond Just an EMR Search – Most platforms allow for semantic (real word) searches beyond just EMR ICD10 codes and use automated reasoning to infer other matches
- Feasibility Projections & Demographics – Some offer population overviews and rapid feasibility analyses based on the site’s connected population to save sites time and avoid the trials that their population may not support
Limitations of EMR-Based Patient-Trial Matching Software
- Change Management Required – Many sites do not currently have a process for robust, outbound recruitment based on limited workforce
- Research-Naive Patients – Outreached patients may not be research-interested just because they match trial criteria
- Data Quality – Software accuracy is limited to the thoroughness of the data within the EMR (bad data = bad results) and some manual chart review is required by the team
- Cost – Sponsors still have to be convinced to cover new technology, which could expose financial risks to the site, but some vendors may offer results-based pricing models
AI-Enhanced External Advertising Vendors for Patient Recruitment
In contrast to the “internal search & outbound outreach” model supported by patient-trial matching software, external vendor campaigns follow the traditional recruitment model of aggregating and supplying patients to sites for outreach. Some of these vendors are implementing new technology to refine messaging, images, and targeting to find more qualified patients for sites.
Benefits to AI-Enhanced External Advertising Vendors
- Ease of Use – Most sites are already set up for this type of patient recruitment
- Patient Focused – Focus is on research-friendly, inbound patients routed directly to the recruitment team
- Reimbursable – Typically covered in sponsor budgets for site advertising or within a broad, central campaign
- Optimized – Is often monitored by a dedicated team for optimization based on site feedback about the screen fail or did not qualify rates
Limitations of AI-Enhanced External Advertising Vendors
- Lack of Site Oversight – Site loses oversight and control on messaging, targeting, & quality control, relying exclusively on the methods of the vendor
- Lack of Resources – Site may not have a dedicated recruitment team to immediately respond to inquiries and potentially losing interested patients
- Inaccurate Data – Reliance on accurate, self-reported medical conditions with no insight into medical records to qualify patients
- Mismatch in Outcome – Does not directly support feasibility projections
Site-Patient Retention & Support
As most in the industry can attest, patient retention is as significant as recruiting for a trial. In scenarios where patients don’t complete a study, sites lose potential revenue, and sponsors are unhappy and risk their ability to meet the goals for a study. With the current study failure rate, many have released new tools and apps to further support patient journeys from screening visits to close-out visits. The diverse array of software solutions offers various features that support greater physician and patient interaction.
Benefits of Site-Patient Retention and Support
- Simplification – Simplifies study oversight for sites by digitizing eConsent etc. and allows for an overarching view of participant activity within a trial
- Patient Empowerment – Gives more control to the patient through an app or website for online scheduling and filling out questionnaires and may support telehealth or video appointments
- Increased Reach – Some support engaging more healthcare providers to get their patients involved in research
- Increased Automations – Many support automations like appointment & medication reminders, direct messaging, and patient payments
Limitations of Site-Patient Retention and Support
- Too Much Technology – The site has yet another independent platform to manage unless otherwise integrated with other systems like an EMR or CTMS
- Patient Limitations – Many require patients to own and use a smart phone to interact with the platform, which may exclude certain populations based on access
- Data Accuracy – Dependent on a patient accurately self-reporting progress, without in-person clinical support to visually confirm
- Post-Enrollment – May only support healthcare partnership and patient journey once enrolled within a study
Determine Your Site’s Needs with Patient Recruitment Technologies
There is a vast landscape of technologies, each claiming to expand your patient database and increase patient engagement. However, these tools vary significantly in effectiveness and suitability. How can a site choose the best option(s) for their investments?
- Identify gaps or inefficiencies in your current recruitment and retention efforts. How would your site prioritize these challenges in regard to your site’s goals?
- Evaluate the influence of adopting new technologies on your team’s operational capacity and your site’s financial health. What impact does new technology have on your team’s workload? Is the ROI measurable?
- Envision your ideal technology ecosystem. What kind of features would you consider a requirement to help support your recruitment & retention workflows? What new types of technology may align with your growth?
Best Practices for Engaging with New Technology Vendors
- Interview multiple vendors that tout the same capabilities and compare them to determine which supports the priority of your goals.
- Consider how to best implement the available tools across your workflows that will maximize your investment. Ask about timelines and the burden on your team.
- Certain organizations will repurpose your deidentified data and sell it. Explicitly ask your vendor about how they will be using your data outside of the scope of the technology. Be aware of your local privacy laws and the necessity for HIPAA compliance.
- Request the financials early in the conversation determining your total investment, inclusive of upfront costs and recurring costs.
- Try not to let one bad vendor ruin your experience. If it doesn’t work for your site, find something else that will!
Research sites might be hesitant to adopt new tools and technologies, but the recent advancements made in the industry are here to stay. This is only confirmed by the increasing complexing of research protocols, leading to high failure and study drop out rights. A well-implemented solution can help a research site increase patient recruitment and retention, and therefore, lead to financial and site growth.
Originally posted by the Society for Clinical Research Sites: April 2024