Collaborative Research Networks
Download as PPT, PDF1 like312 views
The document discusses the benefits and challenges of collaborative research in pediatric clinical research networks (PCRNs), emphasizing the need for larger sample sizes, improved funding, and effective management. Key findings highlight the significance of strong investigator commitment, the importance of mentorship, and the necessity of overcoming bureaucratic hurdles to enhance network productivity. Future strategies focus on enhancing virtual collaborative capabilities and fostering partnerships to expand research opportunities and efficacy.
Collaborative Research Networks
- 1. POISE Network Webinar October 25, 2010 Charles G Macias MD, MPH Baylor College of Medicine- Texas Children’s 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 network’s budget
- 25. Key findings • Establishing buy-in for network research – A network’s 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
- 34. Active research collaboratives Study Collaborative Number of Investigators Number of Institutions Number of patients Number of publications Additional substudies Meningitis 24 20 3295 4+1 4+1 SBI in infants 11 8 1248 4 5 UTI 30 19 2477 3 abstracts 3 planned Appendicitis 19 10 ? (2000 in Dec) of 2500 Data collection closed April 2 planned MgS04 asthma survey 10 8 324 1 abstract 1 submission 0 POISE 25 25 527 (interns) 0 Network H1N1 PERN Study 99 99 ? 1 0
- 35. Challenges • Permanent infrastructures and infrastructure funding – Iterative process of self-definition based upon: • Skills sets of members • Industry • Growth of PECARN and maturing of federal recognition for PEM research • Availability of funding • Strength of the AAP: people and money • Young investigators, mentorship for longevity of the network • 3 year leadership roles- building institutional memory
- 36. Network: support • Limited administrative support – Monthly teleconferences for each study collaborative-AAP – AAP supports venues for biannual meetings but individuals participate with their own resources – No permanent infrastructure for patient enrollment or chart review: no research coordinator support – Research collaboratives bring their own funding where necessary • Data center – Data processing and data quality support centralized – Contributed personnel support (informatician, biostatistician) – Projects » UTI collaborative » Appendicitis collaborative » H1N1 PERN study
- 37. Administrative achievements • Productivity based upon volunteerism – Strength of the drive of PEM researchers – Evolution of efficiencies and expertise in research • Development of an increased number of mentors for support » PECARN researchers/mentors » EMSC/NEDARC partnership- young investigator grant writing scholarship • Evolving partnership with pharmaceutical industry • Formalization of a survey review mechanism separate from study review process
- 38. The future • Enhancements of virtual collaboratives – www.pemcrc.org – Migrating the AAP SOEM network to www.pemnetwork.com – Enhancement of the network will allow subsites for www.pemcrc.org to create • Wikified sites for active protocol development for each collaborative • Multi-media for virtual training • Shared compliance document libraries • Web/pod casts
- 39. Key messages for collaborative research • Support the networking of people with a shared vision/mission – Expand the talents of stakeholders with expertise in study design through education and mentorship – Identify champions at each site (may not be the investigator) and assure effective communication strategies are in place – Encourage new participants in effective and meaningful way • Centralize administrative functions as much as possible (DUAs, protocols) – Clear governance descriptions • Standardize – Consider reuse of tools to maximize familiarity (SOPs) – Develop strategies for effective use of EMR
- 40. Key messages for collaborative research • Provide sharing of models for protected time • Create and enpower workgroups with enough structure and timeline guidance to be effective – Include grant writing groups for projects and for core infrastructure support – Staff training module development • Encourage well-defined links to professional societies, organizations and industry • Develop mechanisms for transparency in enrollment • Create detailed dissemination strategies and consider expansion into knowledge translation research • Collaborate with other networks for economies of scale
- 41. Collaboration among networks -H1N1 Case control study 99 centers worldwide
- 42. References • IECRN (Inventory and Evaluation of Clinical Research Networks), Complete Project Report, 2006 • Pediatric Clinical Research Networks: Optimizing Effectiveness through Cooperation, Proceeding notes, 2009 • Klassen TP, Ackworth J, Bialy L, et al. Pediatric Emergency Research Networks: a global initiative in pediatric emergency medicine. Pediatr Emerg Care. 2010; 26(8):541-3.