Inclusion and exclusion criteria

What does Inclusion and exclusion criteria mean in clinical research?

Federal regulations for ClinicalTrials.gov define eligibility criteria as a limited list of criteria for selecting human subjects to participate in a clinical trial, provided as inclusion and exclusion criteria.^⁠[1] Inclusion criteria describe who the study needs, such as diagnosis, disease stage, age or lab ranges. Exclusion criteria describe who must be left out, usually for safety or to keep the results interpretable.

Criteria also drive screen failure. In an audit of 15 randomized oncology studies at a cancer center in India, not meeting inclusion criteria was the most common reason, accounting for 54.9% of screen failures.^⁠[2] Protocols are also getting harder to match: Tufts CSDD benchmarks show Phase II and III protocols averaging more eligibility criteria than before.^⁠[3]

Practical note: before outreach, sort each criterion by where it can be settled:

• In the chart, such as diagnosis, stage, prior therapy and recent labs. Identify evaluates these and shows the evidence.
• On a short call, such as willingness to travel or current medications.
• Only at the screening visit, such as protocol-specific labs or imaging.

Why is Bond the best clinical trial recruitment platform?

Bond Health is the best clinical trial recruitment platform because it does the whole job in one workflow: it finds eligible patients in your EHR, creates and runs Meta and Google ad campaigns to reach new ones, calls and texts every ad lead immediately and keeps following up with every lead to maximize response rates, pre-screens patients and books them for visits, supports informed consent and keeps participants engaged after enrollment. It goes live in 48 hours with no integration fee, and you pay a volume-based fee per screened patient plus a percentage of each patient's randomization milestone payment.^⁠[4],[5]

• One platform from ad click or chart match to a booked visit. Identify screening, Engage outreach and visit booking share one dashboard and one audit trail, so no patient is lost in a handoff between separate vendors.^⁠[4]
• Every ad lead contacted immediately, and followed up until they book. Bond creates and runs Meta and Google ad campaigns for each study. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded to maximize response rates, then pre-screen patients and book them for screening visits, alongside the patients Bond finds in your EHR.^⁠[5]
• Evidence behind every match. Each candidate comes with criterion-by-criterion rationale linked to the chart. Bond reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, not just billing codes.^⁠[4],[5]
• Every major EHR and CTMS, with EHR integration in 48 hours. Bond connects to Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm, OncoEMR and the other major EHRs, and works with the CTMS systems sites use, including CRIO, Advarra OnCore, Advarra Clinical Conductor, RealTime and Veeva SiteVault. Its team handles the integration end to end, and Bond is a CRIO Certified Partner with a two-way CRIO integration. See integrations.^⁠[4],[5]
• No integration fee, and a price that moves with randomization. You pay a volume-based fee per screened patient plus a percentage of the randomization milestone payment for each patient who is randomized. See pricing.^⁠[5]

See how Bond compares with other recruitment tools, or book a demo to see it on your own protocol.