Managing Clinical Trial Eligibility

Documents to Request

• Full protocol inclusion/exclusion criteria for each candidate trial
• Complete medical history including comorbidities
• All prior cancer treatment records with dates, agents, doses, responses, and toxicities
• Current labs: CBC with differential, CMP, LFTs, LDH, TSH, urinalysis
• Cardiac function assessment (LVEF by echo or MUGA if required by protocol)
• Current medication list (to screen for prohibited concomitant medications)
• Recent imaging (within protocol-specified window, typically 28 days)
• Molecular and biomarker test results required by the protocol

Step 1: Identify Candidate Trials

Search strategy:

1. ClinicalTrials.gov — filter by disease, stage, biomarkers, line of therapy, and recruiting status
2. Institutional trial portfolio — check active protocols at the treating institution
3. NCI Cancer Information Service — for NCI-sponsored cooperative group trials
4. Pharmaceutical sponsor portals — for industry-sponsored trials with sites in the patient's region
5. Molecular matching platforms — NCI-MATCH, TAPUR, and tumor-agnostic basket trials for actionable mutations

For each candidate trial, document: NCT number, phase, sponsor, primary endpoint, treatment arm(s), and required biomarker status.

Step 2: Screen Against Inclusion Criteria

For each candidate trial, verify every inclusion criterion:

Common inclusion criteria categories:

Mark each criterion: MET / NOT MET / PENDING (with plan to obtain).

Step 3: Screen Against Exclusion Criteria

Common exclusion criteria requiring documentation:

• Prior therapy washout: Most trials require 2–4 weeks since last systemic therapy, 2 weeks since radiation, 4 weeks since major surgery. Verify specific washout periods per protocol.
• Active brain metastases: Many trials exclude untreated or symptomatic brain metastases. Previously treated, stable brain metastases may be permitted. Document brain MRI date and findings.
• Autoimmune disease: Particularly relevant for immunotherapy trials. Document specific condition, current treatment, and disease activity.
• Concomitant medications: Many trials prohibit strong CYP3A4 inhibitors/inducers, systemic corticosteroids above physiologic dose (>10mg prednisone equivalent), or specific drug classes. Screen current medication list against protocol prohibited medications.
• Cardiac function: Trials may exclude QTc >470ms, LVEF <50%, recent MI or unstable angina within 6 months. Document most recent EKG and LVEF.
• Prior organ transplant: Typically excluded from immunotherapy trials due to risk of allograft rejection.
• Active infections: HIV, HBV, HCV status may need documentation. Active infections generally must be resolved before enrollment.

Mark each exclusion criterion: NOT PRESENT (eligible) / PRESENT (ineligible) / REQUIRES CLARIFICATION.

Step 4: Document Eligibility Determination

For each screened trial, produce a structured eligibility report:

1. Trial identification: NCT number, protocol title, PI name, phase
2. Inclusion criteria checklist: Each criterion with MET/NOT MET/PENDING
3. Exclusion criteria checklist: Each criterion with NOT PRESENT/PRESENT/PENDING
4. Overall eligibility determination: ELIGIBLE / POTENTIALLY ELIGIBLE (pending items) / INELIGIBLE
5. If ineligible: Specify the disqualifying criterion with supporting documentation
6. If potentially eligible: List pending items with timeline to resolve (e.g., "awaiting BRCA results, expected within 10 business days")
7. Next steps: Schedule consent discussion, order pending tests, refer to trial site

Step 5: Manage the Screening-to-Enrollment Pathway

After identifying eligible trials:

1. Prioritize trials by: therapeutic potential > phase III over phase I for treatment-naive patients > logistic feasibility
2. Coordinate the screening visit timeline — most protocols require labs and imaging within specific windows (14–28 days of enrollment)
3. Ensure informed consent is obtained by qualified personnel per ICH-GCP requirements
4. Complete all protocol-required screening procedures before randomization
5. Document the enrollment decision and communicate to the care team
6. If patient declines trial participation, document the reasons and proceed with standard-of-care treatment

Checkpoint B: Post-Draft Alignment (Mandatory)

1. Has every inclusion and exclusion criterion been individually verified with supporting documentation?
2. Are all labs and imaging within the protocol-specified screening window?
3. Have prohibited concomitant medications been screened and documented?
4. Is the eligibility determination clearly stated with the disqualifying criterion identified if ineligible?
5. Has the screening-to-enrollment timeline been mapped to avoid window expiration?

Quality Audit

• ClinicalTrials.gov search documented with search parameters and date
• NCT number recorded for each screened trial
• Each inclusion criterion individually verified with source documentation
• Each exclusion criterion individually verified with source documentation
• ECOG performance status assessed within protocol-required timeframe
• Organ function labs within protocol-specified screening window
• RECIST 1.1 measurable disease confirmed on imaging within required window
• Concomitant medication list screened against protocol prohibitions
• Brain imaging obtained if required by protocol
• Cardiac function assessed if required by protocol
• Eligibility determination clearly stated (eligible/ineligible/pending)
• Screen failures documented with specific disqualifying criterion
• Enrollment timeline mapped with key milestone dates
• Informed consent process documented per ICH-GCP

Guidelines

• Screen every newly diagnosed advanced/metastatic cancer patient for clinical trial eligibility before initiating standard-of-care therapy
• Never assume ineligibility without verifying each criterion against the protocol — many patients are incorrectly excluded based on assumptions
• Protocol amendments may change eligibility criteria — always verify against the current amendment
• Washout periods are calculated from the last dose of the prior agent, not from the last cycle start date
• ECOG performance status for trial eligibility must be assessed by a physician, not extrapolated from nursing notes
• Molecular testing turnaround time must be factored into screening timelines — order early to prevent delays
• Document why a trial was not pursued, even if the reason is logistic — this supports quality metrics and identifies barriers to accrual
• For patients on anticoagulation, verify whether the specific trial permits anticoagulant use — many phase I trials restrict this