Beyond Lead Counts: What Sponsors Should Measure From Referral to Randomization
Most patient recruitment reports open with lead counts. They're easy to produce and easy to compare, and they say very little about whether a clinical trial will enroll on time.
A sponsor needs to know how many referred patients reach randomization. Lead counts can't show that, because a lead only records interest. Eligibility, confirmation, clinical site follow-up and site screening all come later, and each step loses patients for different reasons.
High patient interest does not mean high eligibility
Antidote’s feasibility tests show how far apart the two can be. In a Parkinson’s disease test with a narrow device-history requirement, 9 of 214 respondents met the survey criteria, and six of those nine said they were very interested. Across the five tests below, the share of respondents who met the initial criteria ranged from 3.2% to 43.1%, depending on the criteria and the type of study.
A report of 214 leads for the Parkinson’s study would look healthy. Nine patients meeting the initial criteria is a more useful starting point for sizing the patient pool than response volume alone, though phone confirmation, clinical site screening and randomization still determine actual enrollment.
The metrics to track from pre-screening to randomization
Questions to ask a recruitment partner
- Can you report weekly volume and conversion at every step, from survey response and qualified patient to confirmed referral, clinical site screening and randomization?
- Which criteria do you confirm by phone before a referral reaches the clinical site?
- How do you track a referral after handoff, and how will we see where it stalls?
- Can you test the protocol before launch, so we know whether low numbers mean weak interest or narrow criteria?
Frequently asked questions
What is a good qualified lead rate for a clinical trial?
It depends on the protocol. Narrow treatment-history or device-history criteria can cut the qualified rate to a few percent even when interest is strong, so the rate is most useful compared against a feasibility test of the same protocol.
What is a referral-to-randomization rate?
It's the share of referred patients who go on to be randomized. It shows whether recruitment brings patients who fit the protocol and complete the process.
Why test before launch if the protocol is final?
A short feasibility test estimates how restrictive the protocol-based pre-screening criteria are and shows where clearer, patient-friendly explanations could improve the quality of responses. It cannot prove the final enrollment timeline or replace eligibility confirmation at the clinical site, but it gives patient recruitment planning a starting point based on real patient responses rather than estimates.
Know the numbers before enrollment starts
Antidote runs short feasibility tests that check protocol-based screening questions and draft patient-facing messages with relevant patient populations before launch. Before clinical sites take on the work, sponsors receive:
- The share of respondents who meet the initial criteria
- Which criteria screen out the most patients
- How interested eligible patients are in taking part
- Which messages motivate, confuse or deter patients
Before committing your recruitment plan to response targets, test how many patients are likely to meet the initial criteria.
