A Less Focused Approach to Increasing the Pool of Research Participants: All Volunteers All the Time
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Presented by Nariman Nasser, Director of CTSI's Participant Recruitment Service, at the SCOPE (Summit for Clinical Ops Executives) Conference in Miami, Feb 2012.
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Presentation by Erik Wieland, Applications Manager at UCSF IT, as part of the "UCSF Profiles & LinkedIn Bootcamp for Researchers, Faculty, Staff" on 2/9/2015.
Improving the Health of San Francisco
The document discusses the San Francisco Health Improvement Partnership (SF HIP) initiative, which is a collaboration between UCSF, San Francisco government agencies, community clinics, schools, and community organizations. The goal of SF HIP is to use research from UCSF to improve population health in San Francisco and reduce health disparities. SF HIP focuses on priority health issues like physical activity, hepatitis B, alcohol, and mental health. For each issue, partnerships identify target populations, desired outcomes, interventions, and metrics to evaluate the interventions. Examples provided include a project using data to identify high users of multiple services related to alcohol and a quality improvement collaborative around hepatitis B care.
UCSF International Research and the Connection to the HIV Community
UCSF conducts extensive international HIV research. [1] Over 200 faculty conduct research in over 100 countries, with over $77 million in awards. [2] Coordination efforts include the AIDS Research Institute and Center for AIDS Research. [3] More coordination is needed across departments and standardization of practices. [4] Early antiretroviral therapy reduces HIV transmission and provides individual health benefits, though challenges remain in implementation.
UC BRAID UC-ReX
The document summarizes the UC Research eXchange (UC-ReX) program, which aims to improve collaborative research across University of California campuses by enhancing access to clinical data. Key points:
- UC-ReX was initiated in 2011-2012 with initial funding to advance UC collaborative research capabilities.
- Its goals for Year 1 were to enable cross-campus cohort identification by developing governance, selecting a technical infrastructure, harmonizing data, and enabling access/support.
- The Year 1 budget outlined costs for management, technology strategy, implementation, data alignment, and support workgroups totaling over $1 million.
- An executive committee with members from multiple UC campuses governs UC
UCSF CER - Intro to Stakeholder-Engaged Research (Symposium 2013)
This document provides an introduction to stakeholder-engaged research. It discusses promoting outcomes that are important to patients, ensuring stakeholders have relevant information to make medical decisions, and getting all stakeholders working toward common goals. It notes initiatives like the NIH Roadmap and Affordable Care Act that promote stakeholder engagement. It identifies interested organizations like PCORI, AHRQ, CMS Innovation Center, and foundations. It outlines funding opportunities for stakeholder-engaged research through these organizations, totaling billions of dollars through 2019.
CTSI – An Evolving Organization
The document discusses the 2012 annual retreat of the Clinical and Translational Science Institute (CTSI) at the University of California, San Francisco. It notes that over 260 people attended the retreat, including many campus leaders and panelists. The retreat had a fun agenda aimed at helping CTSI continue its trajectory. It also discusses key questions around how CTSI knows it is meeting its mission and how it can better serve its "customers". CTSI faces drivers for change like reduced funding but aims to preserve its core mission overseen by NCATS.
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UCSF International Research and the Connection to the HIV Community
UCSF International Research and the Connection to the HIV Community
UCSF CER - Intro to Stakeholder-Engaged Research (Symposium 2013)
UCSF CER - Intro to Stakeholder-Engaged Research (Symposium 2013)
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UCSF Participant Recruitment Service: Preparing for Launch!
The Participant Recruitment Service at UCSF is preparing for launch with a soft launch phase involving developing recruitment materials, piloting recruitment services for 4 studies, creating a participant registry database, and conducting passive recruitment from the Integrated Data Repository database. The PRS aims to centralize recruitment efforts and address challenges like limited coordinator time, uncoordinated multi-site efforts, and lack of diversity in clinical trials. The soft launch will test recruitment materials, registry, and services to help enroll more research participants.
Best Practices in Clinical Study Recruitment
This document discusses best practices in clinical study recruitment and retention. It covers:
1) Recruitment practices such as performing initial analyses of study design and site-specific factors, planning and budgeting for screen failures and protocol changes, and implementing a staged communication plan.
2) Retention practices like ensuring participants are well-informed, understanding their needs, and keeping communication open.
3) A proposed Participant Recruitment Service at UCSF to centralize recruitment efforts through activities like recruitment analysis, direct mailings to patient cohorts, and developing recruitment materials and resources.
Secondary Data Analysis
This document discusses secondary data analysis and provides examples of large federal health surveys that can be used for secondary analysis, including NHANES and NHIS. It outlines strengths and limitations of secondary data analysis. Complex survey design must be accounted for, including statistical weighting, clustering, and stratification. Several statistical software programs are designed for analyzing complex survey data. The document concludes with a hypothetical case study using NHIS and EPA air pollution exposure data to study the relationship between acrolein levels and childhood asthma episodes.
How to improve clinical trial recruitment
Clinical trials are necessary for medical research. Producing new medicines to the market depends on the strength of research organizations and drug companies to test and verify their work vigorously through their Clinical Trials, but finding people willing to participate is notoriously tricky.
Big data, RWE and AI in Clinical Trials made simple
Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands the desire to make clinical trials more patient centric.
In all of this, even though some of the technologies have yet to mature enough to meet the high quality standards necessary, it is important to know them and begin imagining the promise they hold for clinical trials.
Global Clinical Trials: Best Practices & Common Pitfalls
This document discusses best practices and common pitfalls to avoid when planning and conducting global clinical trials. It identifies key factors to consider such as study feasibility, regulatory requirements, site selection, and patient recruitment. Specific pitfalls addressed include unrealistic protocol design, poor planning, incomplete feasibility data, lack of customized recruitment strategies, and inadequate consideration of local regulatory, cultural and logistical factors. The importance of leveraging local expertise and collecting metrics to guide a data-driven approach is emphasized. A case study example illustrates how challenges can reshape a study's scope and timeline.
Solving the operational challenges of oncology clinical trials
This executive briefing explores new strategies for solving your oncology clinical operations challenges. It also features valuable insights into how you can enrich your site selection, speed up your start-up times and maximize patient recruitment opportunities here in North America.
NI Electronic Care Record - Des O'Loan
The document discusses the development and findings of a pilot Electronic Care Record (ECR) project in Northern Ireland. The key points are:
1) The pilot integrated clinical information from 16 existing health systems and allowed clinicians to access patient data via a single login.
2) Evaluation found the ECR improved clinical outcomes and decision making. 97% of users were satisfied with ease of use and found it useful.
3) The pilot demonstrated that a regional ECR is achievable and could help improve patient safety, quality of care and reduce costs across Northern Ireland.
Preliminary results from a survey on the use of metrics and evaluation strate...
Preliminary results from a survey on the use of metrics and evaluation strategies among mHealth projects
Patricia Mechael, Nadi Kaonga
Center for Global Health and Economic Development at the Earth Institute, Columbia University
CORE Group Spring Meeting, April 30, 2010
Clinical trial recruitment overview
- Patient recruitment for clinical trials is a major challenge, estimated to be a $1.2-1.8 billion market. Recruitment costs average 6% of trial costs and are a primary factor in delays.
- Less than 5% of patients are aware of clinical trials, and only 2-3% actually enroll. However, over 90% of participants have a positive experience and would participate again.
- There is significant opportunity to improve recruitment through more patient-centric approaches leveraging data, technology, and analytics to identify more eligible patients and improve the recruitment process. However, this will require changes to traditional models.
Top 5 Warning Signs Your Clinical Trial Is Off Track
This document discusses risk management in clinical trials. It outlines a four-step process for risk management: risk assessment and analysis, risk mitigation, risk measurement, and risk management. It provides examples of early warning signs to look for during study start-up and operations, how to measure those risks, and how to address risks that become issues. Some potential risks discussed include slower than expected enrollment, poor site compliance, and breakdown of sponsor-CRO relationships.
Study Design to Support Reimbursement
The document discusses strategies for developing a reimbursement case for molecular diagnostic tests early in development. It emphasizes designing analytic and clinical validity studies to demonstrate test accuracy and association with clinical conditions. Clinical utility studies should show how test results impact patient management, outcomes, and healthcare costs. Randomized controlled trials provide the strongest evidence but alternative study designs like prospective observational studies and decision modeling may also support reimbursement. The goal is to generate evidence of a test's medical necessity and value to payers from an early stage.
Developing the Reimbursement Story 2016-03-10
The document discusses strategies for developing a reimbursement case for molecular diagnostic tests early in development. It emphasizes designing analytic and clinical validity studies to demonstrate test accuracy and association with clinical conditions. Clinical utility studies should show how test results impact patient management, outcomes, and healthcare costs. Randomized controlled trials provide the strongest evidence but alternative study designs like prospective observational studies and decision modeling may also support reimbursement. The goal is to generate evidence of a test's medical necessity from the intended patient population to achieve coverage and payment.
Tools to Drive Enrollment OCT Arena-Boston-2015
The 4th Annual Clinical Operations in Oncology Trials East Coast was an amazing hit. Over 25 speakers challenged the 200 attendees on how- "WE" as an industry can use new tools and strategies to better our Clinical Trial Execution and Patient Enrollment.
With only 3% of the patients in the USA participating in Cancer Trials- we have to do a better job finding ways to educate them about the benefits of clinical studies.
The following tools are some of the new enhancements for better site and physician selection which can help find better results.
How To Optimize Your EDC Solution For Risk Based Monitoring
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
Clinical analytics–innovating to support clinical research
Clinical research informatics involves using informatics tools to support clinical research activities like managing clinical trials data and conducting secondary research using clinical data. It can help make clinical trials more efficient by facilitating study design, subject recruitment from electronic medical records and social media, data collection and management, and data analysis. National initiatives aim to develop informatics tools and networks to help researchers access data and accelerate clinical research.
Trial XL
Cognika's Trial XL uses machine learning to analyze clinical trial data and provide insights to improve trial operations. It profiles investigators and sites, evaluates criteria that impact recruitment and outcomes, and ranks investigators. Case studies showed it identified criteria impacting recruitment, better accrual estimates, and new investigators, helping reduce delays. Trial XL leverages all past learning, applies analytics to extract insights, and accelerates decision making for clinical trials.
Risk-based Monitoring Strategies for Improved Clinical Trial Performance
To address draft regulatory guidance for risk-based clinical trial monitoring, sponsors should consider strategies that utilize social, mobile, analytics and cloud technologies to create responsive methodologies that satisfy both the spirit and the letter of these new guidelines.
AlvarezButler_All-About-SSIs.ppt
This funding allowed Sentara Healthcare to take a systems approach to implementing NHSN surgical site infection (SSI) surveillance. They used $124,000 for information technology assistance to develop an electronic process for exporting surgical procedure data directly into NHSN. They also used $21,000 to train infection prevention and control staff as well as data auditors on SSI surveillance. This funding demonstrated how a large healthcare system can collaborate across departments like IT, infection prevention, and data auditors to efficiently implement NHSN reporting requirements.
Intelligent Clinical Supply Forecasting and Simulations through IRT-March02-2...
This document discusses using intelligent clinical supply forecasting and simulations through an interactive response technology (IRT) system. It highlights trends and challenges in clinical trials that increase pressure on sponsors and CROs. Simulation and forecasting tools that integrate with an IRT system can help optimize drug supply planning, reduce costs from overages, and improve efficiency. Real-time data from the IRT on enrollments, visits, and inventory levels allows frequent reforecasting to reduce supply chain risks and costs. The presentation provides an overview of how analytics and simulations using IRT data can help various stakeholders with challenges around forecasting demand, optimizing distribution, and efficient planning of drug supplies.
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UCSF Participant Recruitment Service: Preparing for Launch!
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This document discusses a project called EQUIP that aims to develop new methods for analyzing and displaying qualitative data in patient-centered outcomes research (PCOR). The project will draw on existing studies involving over 200 cancer patients to develop tools for extracting narratives from illness experiences. An "ethnoarray" approach is proposed to visually array patients' narratives based on domains like treatment decisions and social support. The goals are to engage stakeholders like researchers, providers, and patients to establish standards for using qualitative data in PCOR and assess new methods' feasibility in clinical practice. Challenges include bridging different disciplinary approaches, but the project sees opportunities to innovate at the intersection of qualitative and quantitative health research methods.
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On Sep 17th Catalyst brought a panel of academic and industry thought leaders for a lively discussion on the issue of data reproducibility in academic research. Moderated by Cathy Tralau-Stewart, head of the Therapeutics track of the Catalyst Awards, the panel explored causes and potential solutions for a problem that has been receiving national attention in both scientific and popular media.
Panelists included Keith Yamamoto, Vice Chancellor for Research at UCSF; Larry Tabak, Principle Deputy Director, NIH; John Ioannidis, Professor of Health Research Policy at Stanford School of Medicine; Elizabeth Iorns, Co-Founder, Science Exchange; Parker B. Antin, Board of Directors President, FASEB; Amanda Halford, MBA, VP of Research, Sigma-Aldrich.
http://ctsi.ucsf.edu/news/about-ctsi/data-reproducibility-preclinical-research-and-discovery
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A Less Focused Approach to Increasing the Pool of Research Participants: All Volunteers All the Time
- 1. A Less Focused Approach to Increasing the Pool of Research Participants: All Volunteers All the Time February 9, 2012 Nariman A. Nasser, Director
- 3. STRATEGY INCREASING THE POOL
- 5. INCREASE
- 10. Recruitment Trends by County UCSF Airway Clinical Research Center (ACRC) San Francisco 52% Alameda 16% San Mateo 11% Contra Costa 7% Santa Clara 4% Marin 3% Sonoma 2% Solano 1%
- 11. Age by Method of Contact UCSF Airway Clinical Research Center (ACRC)
- 12. VOLUNTEER REGISTRY CHALLENGES AND ADOPTION
- 16. NEXT STEPS
Editor's Notes
- Clinic patients – relying on the population who already is identified is fine but you must be realistic about how many of those will actually be interested, show up, meet remaining criteria, and enroll. Advertising to study demographics means spending lots of $$ for minimal return
- Referral networks – making strong, long-term partners of fewer referring practices, collaborative research networks, using navigators