The promise of EDC was faster access to the sponsor’s data. It’s the only reason we can have adaptive trials –data is available in near real-time. Only, it’s really not. Instead, we find that sites are entering data only in time for monitoring and often only enough to justify the monitoring visit. The promise of EDC is not being realized.
You can’t blame the sites. They don’t have any incentive to enter the data — until that point where they will get into “trouble” if the data is not available. They’re following the same approach that many of us have to live by – hit the deadline.
If we really want to realize the promise of EDC – near real-time access to clinical data – then we need to change the rules of the game. Instead of offering a disincentive for late entry – getting in “trouble” with the monitor – we need to offer an incentive. And a great incentive to offer that will cost nothing is direct payment on entry.
With new payment automation systems, we can directly link payments with entry in EDC. So at the end of every week, we can pay directly on what has been entered. If there is concern about keeping the site engaged through data review, we can always hold back a certain percentage until after successful monitoring – probably between 10% and 25%. By paying directly on entry, the work is being rewarded by avoiding the #1 site complaint of sponsors – delayed payments.
In the past, offering this type of support would have been impossible, since the effort needed to compute a payment can be significant. But now that we can fully automate the payment process, the only real cost is the need to approve the batches – tiny compared to the old approach. Payment automation solutions like ClinPay FLS offer the opportunity to totally change the dynamic of EDC data entry.