Collaborative Research Networks
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- 1. POISE Network Webinar October 25, 2010 Charles G Macias MD, MPH Baylor College of Medicine- Texas Childrens Hospital Houston, Texas Past Chairman, PEMCRC
2. Objectives To discuss the benefits to collaborative research through research networks To describe barriers to effective performance of research networks To discuss obstacles and solutions noted in critical analyses: Pediatric Clinical Research Networks (PCRNs) Inventory and Evaluation of Clinical Research Networks (IECRN) To summarize translation of key points through practice examples in the Pediatric Emergency Medicine Collaborative Research Committee (PEMCRC) 3. Challenges of pediatric research Low mortality, low morbidity Larger sample sizes Pediatric under-representation in literature Fewer valid and reliable tools Timeliness and efficiency barriers with single institutions Limited funding 4. Benefits of collaborative research Increases opportunities to achieve sample sizes in shorter time frames Allows for diversity in representation of populations (generalizability) Geographic areas Etiologies of infectious diseases Mix of ethnicity and race Successes of PECARN and PEMCRC 5. Pediatric Clinical Research Networks AAP/PROS assessment Internet search 21 interviews with network leaders Survey of 43 AAP leaders 67 PCRNs 40% are specialty networks Specialty: more publishable, primary-care most adept at launching 6. What works well? Well-developed base of expertise in study design, feasibility assessment, protocol review, and feedback on applying protocols to specific populations Importance of shared vision and defined mission Core infrastructure (human resources, funding, information technology) and affiliations with larger professional associations or institutions Sense of research culture and core values within a subspecialty Expertise located in data coordinating centers 7. What works poorly? Network management/project management Setting research priorities Sustaining network infrastructure with limited funding Maintaining site interest and enthusiasm over time Managing change and growth Finding ways to partner with other networks and disciplines Finding ways to support face to face meetings 8. Project management concerns Protocol complexity, time for patient accrual and staff effort tasks Disconnects between budgets and site demands/workloads Logistics in coordination of IRB approvals, contracts, business agreements and regulatory compliance Paucity of qualified research assistance and rate of turnover Efficient data management and quality check systems lacking 9. Role of Clinical and Translational Science Award Limited role of pediatric demands for CTSA involvement PCRNs are challenged to influence national politics of the CTSA program National Center for Research Resources (NCRR) could aim pediatric strategies at PCRNs 10. Data collection Forms: Paper/pencil Hardcopy worksheets to electronic Electronic options: Teleform Registries Web: Access Variability of EMR/EHR: Extraction vs systems reporting Embedding protocols Data center mechanisms for feedback to sites within a network for integrity of quality 11. Best practices Sharing of best practices is itself a best practice Connecting special interests Sharing structures with other PCRNs Governance models Industry relationships Communication strategies Data collection methodologies Training strategies Face to face conferences for sharing (QI) 12. Societies and organizations Support and recognize network researchers Facilitate network research resources locally Promote research networks for AAP guideline development Link PRCN research to ABP Maintenance of Certification 13. PCRNs key issues Creating a learning system Regulatory efforts Awareness of current climate of cost-shifting and cross-subsidization (resources) Lack of a business model Challenges of EMRs and EHRs Lack of clarity in the CTSA role 14. Assessment and strategic planning What is currently being done? What could reasonably be done with resources? What could be done to expand resources? What strategies could be helped by interaction with other networks? Wikified utility for resources among networks 15. Inventory and Evaluation of Clinical Research Networks (IECRN) Commissioned by the NIH Roadmap for Medical Research in the 21st Century Overall goal of translating basic sciences into more usable clinical activities by making clinical networks more efficient and effective 16. IECRN objectives The four major objectives of IECRN were to: Develop an inventory and database of clinical research networks Conduct a survey of a subset of clinical research networks to provide a detailed description of current practices used by networks to accomplish their goals, as well as barriers and facilitators to their success Identify networks that have had particular successes and study the practices that have contributed to that success Conduct a National Leadership Forum to present and discuss the practices that are identified as possible best practices for network achievement 17. Core survey: qualitative component 262 research networks met core methodology definition for inclusion 95% response rate to survey Network age range: 6-50 months (median of 6 yrs) NIH funded networks conducted a greater percentage of clinical trials 18. Key findings A network must have strong and committed investigators Expertise and involvement Clarity of scientific focus Practice based network participants must have commitment to be open to new knowledge Sponsor commitment and vision if relevant 19. Key findings Openness to new participants Prevents the network from becoming stagnant New ideas and new energy Invite outside scientists (build inter-organizational relationships) Young participants require mentoring and support 20. Key findings Importance of time Reduced grant writing time vs increased participation time Lack of protected time (developing vs enrolling) Lack of time set aside by networks for analysis and writing of manuscripts 21. Key findings Lack of funding Limits scope of activity Chronologic decision-making: setting an agenda and searching for funding afterwards Lack of flexibility in how money can be spent: multiple sites increases complexity of budgets Support of existing or expanding infrastructure Strategies to adapt to limited funds: ex simplicity rather than complex assessment methods or data collection methods vs searching for external infrastructure support (ex. pharmaceutical) 22. Key findings Uncertainty of core support Need for certainty of core infrastructure is critical to appeasing the need to enhance organizational capability of individual sites Lack of funding for core support staff 23. Key findings Tension between collaboration and competition Need leadership in young investigators Need opportunities for young investigators to become first authors on network projects Process to ensure effective communication Regularly scheduled communication venues Conferences to enhance skill sets Structure of guidelines, processes, and timelines 24. Key findings Incentives for cross network collaborations Commonality of interests with other networks/investigators Build on existing foundations, partnerships, or societies This strategy is rarely within a networks budget 25. Key findings Establishing buy-in for network research A networks productivity is dependent on buy-in from its stakeholders Level of engagement for agenda setting Level of engagement for voting/prioritizing/strategic planning Feasibility of studies: are there subgroups to assess? (ex. PECARN, Community advisory groups) Staff buy-in for training 26. Key findings Bureaucratic and regulatory hurdles Variations in IRB functioning Understanding of regulatory activities (ex. data transfer) Reviews by sponsors who may not understand the network goals Operating procedures for the network and the site Manuals of operations Policies and procedures 27. Key findings Well-trained and appropriate staff Administrative support for network Selection of centralized tasks for network Ex. data quality assessments Staff turnover and strategies to assure longevity Minimize variation in training Training and professional development of staff Strength in academically affiliated institutions 28. Key findings Use of information technology Need well integrated systems compatible across the network Focus on modular tools that are not system dependent Centralization of software as a strategy Standardization of protocols/data elements within systems Webcast tools/learning systems and communication Electronic data capture to minimize human effort Appropriate use: avoid using technology for technology sake 29. Key findings Value of standardization Using protocol templates Extensive and robust SOPs within manuals Barriers to standardization are time related: coming to consensus 30. Key findings Access to participant populations Careful site evaluation and selection Retention of participants: sharing best strategies Transparency: monitoring of recruitment and retention Blinded report cards Healthy competition among sites 31. Key findings Dissemination of key results Top down approach: publication of results by academic centers with passive uptake Bottom up approach: directly influence practitioners Access large institutional providers with a single organizational structure for multiple entities (ex. VA research networks) 32. PEMCRC Network: stakeholders A network of volunteer researchers affiliated through membership in the American Academy of Pediatrics 159 active members Represent 52 academic institutions 20 institutions have infrastructures to potentiate implementation of almost all PEMCRC studies 33.