A Phase 1 Study to Evaluate Intratumoral Doxorubicin Exposure Following Administration of Aldoxorubicin or Doxorubicin

Feasibility assessed

Can this study realistically enroll — sites, patients, timeline?

Protocol drafted & medically reviewed

A protocol synopsis exists, has been linted against SPIRIT, and is through medical review.

Sites activation-ready

Every site's contract, activation and first-patient timeline is within benchmark.

Recruitment funnel and screening plan

Enrollment funnel, accrual pace and eligibility yield computed; candidates to screen proposed per site (import is human-gated).

Sites risk-scored

Per-site KRIs z-scored across the study; statistical outliers get a proposed on-site visit.

Data cleaned

18 edit checks swept AE, DM, SV, EX and LB; deterministic queries auto-closed.

Safety reports triaged

Every reported adverse event triaged with an E2A clock; serious ones with a physician.

Dropout risk scored

Active patients scored; at-risk cohort proposed for outreach.

Termination risk watched

Accrual curve, literature risk profile and registry comparators surveilled; termination itself stays a human decision.

Drug supply forecast

Kits required over the horizon from observed dosing, accrual and discontinuation (partner IRT).

TLFs generated & validated

ICH E3 Section 14 tables from live data (disposition, demographics, exposure, AEs, Kaplan-Meier efficacy), pending double-programming validation.

CSR drafted & signed off

ICH E3 clinical study report assembled from study data; medical sign-off required.

TMF inspection-ready

Trial master file audited against the DIA TMF Reference Model; gaps filed as QA findings.