Of all the barriers to success in clinical trials, recruitment is arguably the biggest. Clinical trial recruitment is expensive, making up to one-third of the total cost of trial costs. Clinical recruitment is also slow and inefficient; and when you consider the importance of ensuring a diverse patient base for clinical research, that hurdle gets even higher.
Data is an invaluable tool in the clinical trial toolbox—especially when it comes to tracking and showcasing your site’s recruitment and retention results. Accurate and current data demonstrates to potential and current sponsors that your organization is capable of effectively organizing and running a successful trial to deliver the results they need. Key metrics for recruitment and retention include patients available, screened, enrolled, completed, failed screenings, and dropped out along with overall enrollment and retention rates.
If you offer potential sponsors current and thorough recruitment and retention data about your trials, you’re already ahead of the field. Only about half of US clinical trial outfits actually use a CTMS, and it’s likely that less than 5% of sites track and maintain timing and performance metrics. A lack of recruitment and retention statistics equals uncertainty, and sponsors likely will choose sites that back promises of future performance with evidence that they’ve performed in the past.
Pinpointing Patient Data Points With AI
AI extracts symptoms, diagnoses, treatments, genomics, lifestyle, demographics, and thousands of other data points from medical files and sorts the fragments into patient profiles, all while protecting private identifying information. As sponsors increasingly demand diversity metrics as part of the RFP process, recruiting a wide range of patients also directly affects sites’ win-rate and trial feasibility. AI effectively identifies the right mix of patients eligible for a specific study and allows sites to show sponsors that their databases align with study needs. The result is a larger and more tailored pool of potential volunteers delivered exponentially faster.
Managing Recruitment Data
Recruiting with a CTMS allows you to track your metrics and base decisions on what’s working and what’s not. It also helps manage and nurture subjects, allowing organizations to manage participants in one centralized location. You can also use a CTMS to create milestone enrollment goals and check enrollment progress for all studies at your site. This allows you to focus on and prioritize recruitment efforts. Tracking your recruitment efforts and outcomes can play a strategic role in deciding how to recruit for future trials.
Successful retention begins with nurturing your subject and making them feel like a patient. Create personal notes and comments in your CTMS, like “[patient name] loves talking about his dog, Otis.” When you communicate with your subjects, either as a visit reminder or thanking them for attending, refer to your comments and notes in your data management software. This helps build and nurture your relationship.
Improving Retention Data Quality
72% of patients that don’t complete the study are a result of refusal to comply or misunderstood patient expectations; digital consent software helps mitigate these issues resulting in better retention and study data quality. Through earlier and more comprehensive patient engagement, the risk of dropout decreases, ensuring higher retention rates to deliver to sponsors.
eConsent can assist with site data quality and can result in better retention metrics. At its core, eConsent helps digitize and streamline the entire consent process, allowing for greater data quality and reliability. Digitizing the process of obtaining informed consent avoids the risk of inadvertently introducing error, or ending up with incomplete data.
Here are some ways to increase your site’s retention through digital consent deployment:
- Deploy Protocol Gates. Ensure that patients cannot move along in the process if personal information, digital signatures or other crucial components of the form are not filled in.
- Ensure Data Completion. Maximize the number of trial participants for whom a site has complete data by engaging them earlier in the process with tools that are easy to use and make the trial more clear every step of the way.
- Scale Data Intake. Using the same data fields for every study doesn’t make sense; often studies need different pieces of data on patients, protocols, or other data points. Make sure site managers understand the scalability of eConsent to adjust the to fit the study needs and the patient group’s capabilities to comply. This will ensure only the consent data needed for the study is tracked and make the process more comprehensive for site staff.
- Build in Data Improvement Measures. Leverage the analytic tools inherently available through digitized consent systems to demonstrate improvements to sponsors through data trends over time. Increasingly, sponsors want to be ensured that trial metrics are being monitored and reported upon accurately. Providing sponsors with predictability and reliability makes a site more valuable for current and future trials.
- Encourage Remote Data Entry. eConsent systems are especially critical when patients never physically enter a site. Direct entry increases the accuracy and completeness of information. Remember to still ensure that data isn’t missing any elements and have staff reach out to remote patients early in the trial to explain the importance of reliable data entry on their end.