Patients Qualified and Consented. Then 36% Never Reached Randomization.

Patients clear your eligibility criteria, ask to be contacted, then vanish before they enroll. So why does a trial full of willing patients still miss its enrollment number?

The answer sits in the steps between qualifying and enrolling, and those steps decide the number your forecast actually hits.

Where enrollment disappears

Qualification marks the start of enrollment. Most trial plans treat it as the finish. Between the two sits a sequence that stays off the forecast, and a willing patient can drop at any step in it:

• The records request.
  • Scenario: A patient qualifies, then learns the site wants two years of specialist notes from a clinic that charges for the release and takes weeks to send them.
• The washout period.
  •  Scenario: Enrolling means stopping a medication that works. The patient weighs weeks of worse symptoms against a trial that might not help.
•  The travel commitment.  
  
  • Scenario: The site sits 90 minutes out, and the protocol asks for six visits. The patient who said yes now measures that against a job and a fuel budget.
•  The caregiver's day off.  
  
  •  Scenario: Every visit needs a driver. The patient counts how many days a working daughter can take off before the answer turns to no. 
•  The consent form. 
  
  •  Scenario: A 20-page document written for regulators lands on a kitchen table, and interest shown online turns to hesitation on paper. 

Each step looks reasonable on its own. Stacked together, they push your real number below the qualified count you planned on, and the drop reads as weak patient interest even though the interest was there the whole time.

Why most trials anchor to the qualified count only 

The qualified count earns more trust than it deserves, for three reasons:

• It arrives first. The number lands early and looks certain, so sponsors build the forecast around it.
• The rest reads as execution. Sponsors file screening, consent, and logistics as detail to manage later, not as variables that move the enrollment number.
• It only sets a ceiling. The count shows the most patients you could enroll if reaching consent cost them zero effort. The burden of each step after qualification decides the real number.

That enrollment burden is measurable before you commit a budget to it.

Test the sequence before you fund it 

Of the patients who qualify for your study, how many will reach enrollment?

You can answer that before a clinical trial site opens.

A Market Feasibility Test (MFT) puts your protocol in front of real patients before trial sites open. Patients respond to the same eligibility criteria your study will use, and the data shows who qualifies and who steps forward.

 What 76 global trials revealed about screening 

The pattern is measurable, and it’s widening. Across 76 global Phase II and III trials, the average screen failure rate reached 36%. This means more than a third of patients who reached screening never made it through.

Antidote's own testing confirms the pattern. In a Parkinson's Market Feasibility Test, every patient who qualified requested contact and wanted to take part. The constraint sat further down the path, in the steps between qualifying and consenting.

The qualified count is where forecasting stops. The steps after it are where enrollment is won or lost, and most plans leave them unmeasured. Test them while the protocol still costs little to revise.