Clinical Research Networks

Clinical Research Networks Doin’ the Thizzle Dance Pediatric GI/Hep Research Conference

Topic Choices Prevalence  Impact on QOL  Funding likelihood  Patient/parent “investment”  Possible geography/site differences  Health disparities  Knowledge deficits  Technology advances  Uniformity in approach feasible/ethical 

Center Selection Expertise and willingness  Innovation and writing ability/leadership  Availability of subjects  Geographic distribution  Interaction of principals  Availability of center infrastructure  Track record/delivery on promises  Unique quality  Reputation and integrity 

Research Network Advantages 

Diversity – – –

Geographic Ethnic/racial Age/socioeconomic/cultural

Enrollment completed faster  Diversity of study questions  Broader expertise  Rare disease study opportunities 

Network Disadvantages Cumbersome administration/approvals  Need for consensus protocol  Regulatory delays  Authorship/attribution  Center “investment” and disparate ability  Communication/travel 

Regulatory Hurdles DCC and CC IRBs  FDA for IND  CRADA contracts  Data and Safety Monitoring Boards  External advisory boards  DCC site visits and audits  CRC/CTRI oversight committees  Trial registration (eg clinicaltrials.gov) 

General Study Questions        

Epidemiology Natural History Etiopathogenesis Genetics Noninvasive predictors (imaging, proteomics) QOL/standardized questionnaires Treatment trial Tissue/lab/clinical correlates

Network Centers/Roles 

Clinical Centers – – – – – – – – – – – – – –

Protocol design Study objectives Consent Screening Registration Data acquisition Data entry CRFs/internal QA Protocol execution AE/SAE management Budgeting Drug dispensation Tissue procurement Manuscript preparation

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Data Coordination – – – – – – – – – – – – –

Website development Form development Biostatistical analyses Enrollment power Network QA Data checks Compliance Data repository Audits Brochures DSMB reports Information distribution Meeting preparation

Network roles cont’d 

Sponsor(s) – – – – – – – – –

Selection of centers Funding Budgets Oversight of DCC Oversight of CCs Dispute resolution Biorepository CRADA selection Ancillary studies

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DSMB – – – – – –

External review Data quality Safety oversight Protocol/consent suggestions/approval Interim stopping Oversight of SAE management

Budgeting Considerations Capitated  Non-capitated  Capitated with secondary performance basis  Budgets for patient care, PI/investigator time, coordinators, supplies, equipment, travel, data entry, research pharmacy, IRB?, GCRC?, ancillary studies, indirect costs 

Network Committees           

Steering Executive Database Treatment Trial Pathology Radiology Standard of Care Ancillary studies Imaging (radiology) Publications and Presentations Exemption/Exception

Publication Attribution Conventional  Corporate 

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Appendix with writing group (with principal), Network members

Modified Corporate