Table 3.

Proposed Components of Research Consortia by Their Longitudinal Experience and Research Resources

Level	I	II	III	IV
Longitudinal experience	Young consortium	Young-experienced consortium	Experienced consortium	Maximally experienced consortium
Research resources	Lower resource setting	Medium resource setting	High resource setting	Maximal resource setting
Clinical trial type	Single-arm intervention study for common and highly curable disease (ALL, BL, WT) or target disease (OS, ES)	Single-arm intervention studies for most childhood cancers Biology studies for banking or focused etiologic research	Incorporation of randomized clinical trials Few single- or multi-arm trials for relapse disease Biologic studies for expanded etiologic research	Predominance of randomized clinical trials Focus on relapsed disease, phase I/II clinical trials, and effectiveness trials Biology studies for identification of new markers
No. of studies/trials	Few (1-5)	Several (> 5)	Multiple (> 10)	Multiple (> 20)
Research infrastructure	Strong emphasis on building local capacity by: Training data managers Establishing processes for data collection, quality, safety, and analysis Nurturing local researchers Establishing ethics committees	Additional emphasis on: Increasing data quality checks, research staff, and oversight proportional to higher volume Support for development of secondary analysis and local projects	Clinicians have dedicated time to be site-specific principal investigators Clinical research staff is more experienced and independent Stable financial support has been achieved	Dedicated staff, time, and support has been secured Full set of research staff is available (CRC, CRA, CRN) Statistics core available Research has close ties to drug development and pharmaceutical companies (bench to bedside)
Informed consent	Relatively simple because studies likely reflect standard of care	Relatively simple because studies likely reflect standard of care	Increasing complexity	Increased complexity
Health systems	Intentional strengthening of health systems through: Drug procurement Access to care Quality checks Outcome assessment	Additional emphasis on: Expanding the formulary (treatment and supportive) Improving early referral Building research teams	Culture of research, quality, and safety has been achieved Clinical research is part of subspecialty training Nursing research	Clinical research is embedded within health care systems Consortium influences health care policies
Health care delivery	Intentionally improving: Standardization of care for specific diseases Evaluation of barriers to implementation Monitoring of compliance	Additional emphasis on: Standardization of care Processes and/or quality Integration and/or incorporation of subspecialists Increased access to expert care	Care teams are supported by research teams Care is multidisciplinary and interdisciplinary More supportive staff allows for more outpatient care	Cost-effective care Maximizing outpatient care Limiting impact on quality of life Accountability is high

Abbreviations: ALL, acute lymphoblastic leukemia; BL, Burkitt lymphoma; CRA, clinical research assistant; CRC, clinical research coordinator; CRN, clinical research nurse; ES, Ewing sarcoma; OS, osteosarcoma; WT, Wilms tumor.