In most clinical trials, the patient recruitment phase has a huge impact on the overall timelines for delivery. The importance of site selection, accurate and realistic recruitment rates, and proactive analysis of planned vs actual metrics is well proven. Data is the single biggest tool available to those charged with study planning.
Some crucial pieces of information are often not made available to the sponsor, however. For example:
- Why are patients who are evaluated by the site not progressing to screening?
- What are the reasons for ineligibility?
- Is the patient (or their family) not comfortable with clinical trials?
- Is there some particular aspect of the study that makes it unattractive?
- Where are the patients coming from?
- Site’s own database
- Referral from another site
- Patient recruitment website
Of course, the intent is that this data is collected and made available to sponsors. Study teams provide their sites with the tools considered necessary to provide this information, traditionally a paper Pre-Screening Log. Inherent in this process is the expectation that the investigator, or more likely the study coordinator, will sit down in a quiet room with their patient notes and carefully compare the details of each potential patient against the eligibility criteria in the protocol. They’ll record all this information in the log and remember to send this to the monitor on a regular basis for analysis.
The reality, however, is that site staff struggle to find time to carry out this process. While the busy study coordinator rushes to meet another patient, visit the lab, or call the courier, they just might think of a patient that could be eligible for one of their studies. They will do a mental cross-check of that patient against the criteria they can remember, and at the first reason for non-eligibility, they will stop and dismiss that patient from their mind. The study monitor will call some weeks later and request to view the Pre-Screening Log. The coordinator will scramble to remember some of the details of some of the patients that were previously considered and scribble down a number sufficient to hopefully keep the monitor happy.
The tools we provide must change to match the reality of working at clinical sites and facilitate collection of this critical data. We know that unless there is a compelling reason for the sites to do something and a really quick way of doing it, site workload means compliance will be low. Sites will not do anything they do not “have” to do.
So Longboat developed a solution that addresses this critical data shortfall and can plug into our broader site and patient engagement platforms. We’ve developed Pre-Screen Navigator, a form that allow sites to pre-screen patients ‘on-the-go’ using their phones, tablets, laptops, or desktop computers. The data is recorded and immediately made available to other staff within the site, the site monitor, and crucially, to the study team. This removes the uncertainty over recruitment activity and also provides the insights sponsors need when making important decisions about their studies and programs.
Initial results from early deployments have been hugely successful. While the dataset is not yet sufficient to draw any significant outcomes, the reception has been positive. As sites become more familiar with the criteria, the time for completion of the form is as little as 5 seconds. We’ll keep you posted!