Clinical Trial Protocol Complexity Calculator — Free | Hive Prospect
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Free Protocol Preflight

Could your trial be harder or more expensive than it needs to be?

Answer 10 simple questions. We will show you where the design may create extra cost, slow enrollment, or force amendments later. No account. No sales call.

How to answer: choose Yes when the statement sounds like your planned study. If you are not sure, choose the closest answer. This is only a first-pass warning light, not a scientific judgment.
1. Will a typical participant come to the study site more than 8 times?
What does this mean?

In child-speak: does one patient have to keep coming back again and again? More visits usually mean more staff time, travel, scheduling and drop-out risk.

2. Will the study run in more than 3 countries?
What does this mean?

In child-speak: are you planning to open the same study in 4 or more different countries? Each extra country can add regulators, contracts, languages, vendors and startup work. This does NOT mean 3 countries is always better than 4.

3. Are you planning to open more than 20 study sites?
What does this mean?

In child-speak: will more than 20 hospitals, clinics or research centers recruit patients? More sites can help enrollment, but every site also needs startup, contracts, training, monitoring and closeout.

4. Will participants have several invasive or specialist procedures?
What does this mean?

Examples: biopsies, lumbar punctures, endoscopy, complex imaging, infusions, specialist examinations or other procedures that are harder than a routine blood draw.

5. Does the study depend on central imaging, specialist labs or complicated biomarker shipping?
What does this mean?

In child-speak: do samples or scans have to travel to special places, be handled in special ways, or arrive on a tight clock? That creates logistics and failure points.

6. Will the main answer take a long time to appear, or require experts to judge it?
What does this mean?

In child-speak: after you treat a patient, do you have to wait a long time before knowing whether it worked, or do people need to debate/grade the result?

7. Do you expect more than 3 out of every 10 screened patients to fail screening?
What does this mean?

In child-speak: if 10 people volunteer, do you expect 4 or more to be rejected before joining? High screen failure can make recruitment much more expensive.

8. Is taking part burdensome for patients or caregivers?
What does this mean?

Examples: long drives, hotel stays, frequent fasting, missed work, childcare, a caregiver who must attend, painful procedures, or very long visits.

9. Are your enrollment forecasts based mostly on guesses rather than protocol-specific site evidence?
What does this mean?

In child-speak: have the actual sites shown that they really have enough eligible patients for THIS exact protocol, rather than simply saying enrollment should be fine?

10. Does the protocol include tests or visits that you cannot clearly connect to safety, the main endpoint, or a decision you will make?
What does this mean?

In child-speak: are you collecting anything mainly because 'trials usually do this'? Every extra procedure costs money and can burden patients and sites.