Table 1.

Conditions for trial informativeness [49–52] with Rockefeller additions of “Return of Research Results,” “Data Sharing,” and “Representative Enrollment” (column 1), Rockefeller University Center for Clinical and Translational Science (CCTS) Departments and cores (column 2) processes to support attaining the goals (column 3), metrics for assessing the outcomes (column 4) and selected performance indicators (column 5)

Conditions for trial informativeness	Departments and cores	Processes	Metrics	Performance
1. Importance: Trial hypothesis is likely to inform an important scientific, medical, or policy decision [53–58]	Research Facilitation Office Biostatistics design consultation Community engagement	TRN Required Public Health Impact Statement Epidemiology course ACCTS review CAB review	TRN Time in TRN until submission Number of protocols terminated in TRN Time from IRB submission to approval ACCTS Percent fully approved Percent approved with stipulations Number of stipulations Percent tabled IRB Time to approval Percent approved in < 30 days	TRN (2022) Median 16 days (mean 48 days) TRN terminated 6 protocols* Median 5 days (Mean 26 days) ACCTS (2018–2022) 75% fully approved 20% approved with stipulations Median: 3 4% tabled IRB (2018–2022) All protocols: mean 20 days and 80% <30 days Full review, mean 32 days and 67% <30 days
2. Design: Trial methods are likely to provide meaningful evidence related to study hypothesis [59–63]	Biostatistics Rockefeller Scientific Resource Centers TSE experts relevant to specific design	TRN R3 lectures and resources ACCTS Review
3. Feasibility: The trial is likely to be feasible [64–67]	Research Facilitation Office Community engagement Comprehensive Recruitment consultation and ongoing support	TRN ACCTS Review CAB review
4. Integrity: Trial is conducted and analyzed in a scientifically valid manner that is faithful to design [68,69]	Research Nursing Research Pharmacy Hospitalist Research coordinators Research Bionutrition Biostatistics/Bioinformatics IT oversight of data security and management Database management Clinical Research Support Office Research Facilitation Office Research Participant Advocate Good Clinical Practices Workgroup	Accrual Index CCTS early audit program Internal monitoring Real-time sharing of reported protocol deviations to TSEs IRB Continuing Review ACCTS Continuing Review
5. Reporting: Systems are in place to ensure timely, complete and accurate reporting [70,71]	Clinical Research Support Office Biostatistics Bioinformatics	Regulatory support for ClinicalTrials.gov reporting IT Database management and data queries DSMP review	Number of Problem Records on ClinicalTrials.gov register	0 records with problem status in 2023
6. Return of Results (RoR): Investigators are counseled on appropriate return of aggregate and individual results, including actionable genetic information	Clinical Research Support Office Research Facilitation Office	IRB application requires plan for return of results ICF includes return of results CRSO templates and assistance RU Informed Consent Materials for DNA sequencing research studies	RoR plan part of IRB review RoR in ICF part of IRB review	Required for IRB approval Required for IRB approval
7. Data Sharing	Biostatistics Bioinformatics IT Scientific Resources Center support	TRN – plan for good data management and reporting R3 lectures and resources ACCTS review	Study design, analysis plan required element of TRN	Required for ACCTS approval
8. Representative Enrollment	Clinical Research Support Office Research Facilitation Office Partnerships with Community-Based Organizations and Patient Advocacy Groups	TRN Recruitment consultation and support IRB review ACCTS review	Recruitment Number of consults Percent of protocols with substantive recruitment stipulations Representative enrollment	Recruitment Consults part of TRN Tracking just begun For representative enrollment data, see Table 4.

ACCTS, advisory committee for clinical and translational science; IRB, institutional review board; TSE, translational science expert/educator; CAB, community advisory board; DSMB, data safety and monitoring board; IT, information technology; TRN, translational research navigation program; R³, research rigor, reproducibility, and reporting program; DSMP, data safety moniroting plan; ICF, informed consent form; CRSO, clinical research support office; RU, Rockefeller University