LAPS Grant Update Anthony Elias, MD PI 2/12/15. Background of Grant Much of SOC determined by NCTN trials Reconfiguring of NCTN by NCI due to declining.

Slides:

Advertisements

Similar presentations

The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.

Advertisements

Central IRBs An IRB Infoshort June Working Definition  A central IRB is one that serves as IRB of record for all of the sites engaged in a research.

PLENARY SESSION Fall Group Meeting Miami, FL November 13, 2010.

Guideline for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Clinical Trials Support Unit (CTSU) Lore Lagrone Program.

Bringing Technology to the Rural Hospital Rural Telecon ‘07 October 17, 2007.

Managing Sponsorship Research Services University of Oxford.

YALE MASTER SLIDE HERE Clinical Research Management – Is not just a handshake deal? Jamie Caldwell, MBA Director Office of Research Services for the Health.

Todays Clinical Trials. Tomorrow’s Cures. Robert L. Comis, MD 1 National Coalition for Cancer Research “Cancer 101” Congressional Briefing 09/10/14.

October 19, 2010 Steven Hirschfeld, MD, PhD Julia Slutsman, PhD

Public Health and Healthcare in Ontario A Made in Ontario Solution for Public Health and Healthcare Andrew Papadopoulos Director, School of Occupational.

Clinical Trials with SARC We’re here to help.. What can SARC do for you? Provide help developing a research idea Provide help with contacting pharma Provide.

Why companies saying or should say “YES” to India for Studies.

Research Policy and Procedure Task Force Report to RAF Jean S. Kutner, MD, MSPH Chief Medical Officer, University of Colorado Hospital February 12, 2015.

Diabetes Clinical and Translational Research: Rewards and Challenges Ruth S. Weinstock MD PhD Medical Director, Joslin Diabetes Center and Clinical Research.

Caveats We are interpreting the guidelines along with you We may have some limited additional insight due to participation during the course of planning.

Barriers and Facilitators to Clinical Trial Research in Australia Google images Michael Friedlander.

Annual Meeting 2011 Clinical Trial Development Clinical Trial Development: OEWG, RA’s Role, and Activating Trials on Deadline Martha Heckel Protocol Associate.

System Director, Oncology Service Line

1 Targeted Strategies to Improve Physician and Patient Access to Cancer Clinical Research An Overview of Coalition Programs and Services Ruth Lambersky.

2011 ACRIN Annual Meeting ACRIN ACCELERATED ACCRUAL DEMONSTRATION PROJECT Department of Radiology The University of Iowa Carol Mertens, Ph.D., CFLE, LMHC.

Developing Relationships: Cooperative Group Networking Developing Relationships: Cooperative Group Networking Kandie Dempsey, MS, RN, OCN, CCRP Delaware.

Liz Bankert Director, Committee for the Protection of Human Subjects Dartmouth College Robert “Skip” Nelson, MD Associate Professor of Anesthesia and Pediatrics.

2011 ACRIN Annual Meeting The ACRIN Accrual Project at University of Washington Constance Lehman, MD. PhD David Mankoff, MD. PhD Tiffany Wong, MS.

Research: Intramural and Extramural Jacquelyn Goldberg, JD CIRB Review Board Administrator Clinical Investigations Branch, CTEP Division of Cancer Treatment.

DCB New Grantee Workshop: Post-Award Administration of Grants Brett Hodgkins Team Leader National Cancer Institute Office of Grants Administration.

SARC: Participation and Protocol / Concept Review Robert Maki, MD PhD Memorial Sloan-Kettering Cancer Center.

UC DAVIS OFFICE OF RESEARCH Overview of Good Clinical Practices (GCP) Investigator and Study Team Responsibilities Miles McFann IRB Administration Training.

The Value of a Healthcare Community Network Early Implementation Experience Rick MacCornack, Ph.D. Director of Quality Improvement Northwest Physicians.

DCB New Grantee Workshop: Post-Award Administration of Grants Brett Hodgkins Team Leader National Cancer Institute Office of Grants Administration.

The NCI Central IRB Initiative Third Annual Medical Research Summit Washington, D.C. March 2003.

Site Management Organization (SMO) Making Clinical Trials More Efficient.

Improving Total System Performance & Public-private Partnership Dr. FUNG Hong Hospital Authority May 2001.

1 Clinical trials with stem cells Bernard Lo, M.D. February 12, 2009.

Yadvindera (Bobby) Bains MD Director of Radiation Oncology, Laredo Medical Center Adjunct Associate Professor, Dept of Radiation Oncology, University of.

Research Orientation to SCCA. What is the SCCA? The SCCA brings together the outstanding adult and pediatric oncology patient care services of three world-

Evaluation Plan Steven Clauser, PhD Chief, Outcomes Research Branch Applied Research Program Division of Cancer Control and Population Sciences NCCCP Launch.

The NCI Central IRB Initiative Jacquelyn L. Goldberg, J.D. VA IRB Chair Training April 8, 2004.

CTMB Guidelines (Rev. October 2006) Section 5: Conducting the Quality Assurance Audit.

Understanding Clinical Trials – Part 2 Georgianne Arnold, MD Professor of Pediatrics University of Pittsburgh Medical Center Pittsburgh Children’s Hospital.

Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine.

The TJU Human Research Protection Program (HRPP): Part I – Which Entities/Offices are Involved ? J. Bruce Smith, MD, CIP.

NCCCP Pilot – Clinical Trials Ann O’Mara, PhD, RN, FAAN Program Director Community Clinical Oncology Program Division of Cancer Prevention June 26, 2007.

1 Office Interactions with Physicians’ Offices Physician Offices.

Pharmacy & The IRB Linda Sailor, BS, PharmD Rania Sadaka, BS, PharmD May 2015.

VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs September.

NCI Clinical Trials Reporting Program CTRP User Meeting May 4, 2011.

11 Radiation Therapy Oncology Group Clinical Trials Administration Sharon Hartson Stine, Director Group Administrator.

Making Clinical Trials More Efficient Site Management Organization (SMO)

Starting Medication Abortion Services in a FQHC Residency Clinic: You Can Do It! Lealah Pollock, MD, MS Isabel Lee, MD UCSF Family and Community Medicine.

Multi-site Research - Central/Single IRBs - Data sharing questions P. Pearl O’Rourke, MD Partners HealthCare October 26, 2015.

Participating in NCTN Studies NCI codes, Rosters, and Roles

London (South) Comprehensive Local Research Network

National Cancer Institute

Workforce Development Domain Task Force

AACR Genomics In Clinical Medicine Think Tank

Patricia M. Alt, Ph.D. Dept. of Health Science Towson University

How to Navigate the NCTN and Participate in Imaging Research

Trial Innovation Network Uncovering Grand Opportunities

S1400 Lung Master Protocol SWOG Spring meeting May 01, 2015

Rare Diseases Research: From Study Budgets to Patient Recruitment

Claire McKinley, PMP, CCRP

Clinical and Translational Science Awards Program

Director, Risk and Compliance

Cindy Murray NP Princess Margaret Cancer Centre

Consent and eligibility for Clinical Trials: Learning Burst 4

Clinical Trial Development: RA’s Role, OEWG, and IRB Submissions Martha Heckel Protocol Associate, ACRIN Dept. of Protocol Development & Regulatory.

NRG Oncology Biospecimen Bank Report NRG Semiannual meeting

Patient Choice Act ….for those you love.

Patient Engagement through Social Media for Clinical Trials

Presentation transcript:

LAPS Grant Update Anthony Elias, MD PI 2/12/15

Background of Grant Much of SOC determined by NCTN trials Reconfiguring of NCTN by NCI due to declining budgets 30 LAPS institutions funded by NCI U10 – NCI considers LAPS to be the mark of an elite institution – LAPS institutions will get priority for phase II contract Had to restructure elements of main member and affiliates Included UCH, PVHS, and MHS as clinical sites of the main member

LAPS/Cooperative Group Trial Activations

Cause of Delays in Protocol Activation 3/1/14-6/30/14: activating CIRB; consent boilerplate approvals RSS: evolving and increasing regulations and requirements; opaqueness Care plan construction in EPIC Baton passing: a myriad of steps; not uniformly identified Insufficient integration within UCHS – Hospital reviews – Pharmacy – Eventually G&C (not a significant barrier for NCTN trials)

Consequences Data

Monthly NCTN Accrual

LAPS/NCTN Accrual Goals

NCTN Accrual

Why UCHS and not just UCH? Successes Development of processes across system Greater knowledge of the people across the system – everyone is trying hard Uniform pricing structure CIRB Common EMR Development of faculty/community disease committees Enhanced patient referrals in both directions

Why UCHS and not just UCH? Threats Deadly slow activation of trials Processes so bogged down that each protocol handled individually Increased frustration of North and South with Central Devastation to accrual (68% of prior years) Few protocols – worst record of the 30 LAPS institutions Tremendous toll on CCTO financially Loss of accruals leads to loss of authorship and leadership LAPS grant cut for year 2 Jeopardizes ability to get phase II grant Have not fundamentally worked out institutional agreements between UC and UCHS – Bypass of University by retaining IRB and trial organization within UCHS Cannot yet proceed with pharma trials

Why UCHS and not just UCH? Solutions Common goals Increase patient access to clinical trials across system Increase accrual to clinical trials Integrate clinical research with clinical care These lead to BETTER PATIENT CARE We are all on the same side – ONE TEAM Need integration of pharmacies Need full system-wide buyin with trust Would be great for the University/SOM to have the same relationship with UCHS as is developing with UCH

Thank you

NCTN Accrual by Disease

NCTN Accrual ACRIN 4 NRG SWOG

NCTN Accrual

NCTN Accrual Anticipated