September, 2014 Clinical Trial Office: Support service for clinical trials performed using BMC clinical infrastructure A new clinical research support service is being launched to provide a central and comprehensive framework of financial
"September, 2014 Clinical Trial Office: Support" is the property of its rightful owner. Permission is granted to
download and print the materials on this website for personal, non-commercial use only, and to display it
on your personal computer provided you do not modify the materials and that you retain all copyright
notices contained in the materials. By downloading content from our website, you accept the terms of this
agreement.
Presentation Transcript
01
September, 2014 Clinical Trial Office:
Support service for clinical trials performed using BMC clinical infrastructure<br>
02
A new clinical research support service is being launched to provide a central and comprehensive framework of financial and administrative support and oversight for clinical trials performed using BMC clinical infrastructure.
The objectives of the service are to:
Increase the support for clinical trials through expanded institutional involvement and continued investments in the clinical research infrastructure
Improve cost recovery by expanding on our ability to budget and bill industry-sponsored clinical research for professional fees and hospital service costs
Enhance clinical research billing processes by educating the clinical research community on national best practices; and implementing policies, procedures and systems
The Clinical Trial Office is a major component of this new environment and will be involved with awards for both BU and BMC.
This presentation will outline why changes are necessary, what’s new (focus on the Clinical Trial Office), what has been done so far, and next steps. 2 Executive Summary<br>
03
Why is Change Necessary? The National landscape consists of tighter regulations and increased scrutiny of research costs. Noncompliance with federal regulations can lead to stringent corrective action plans and financial implications. A few examples:
University of Alabama at Birmingham (2005) $3.4M
Unlawfully billed Medicare for clinical research trials that were also billed to the sponsor of research grants (double billing).
Rush University Medical Center in Chicago (2005) $1.0M
Inappropriate clinical trials charges submitted to Medicare and Medicaid
Beth Israel Deaconess Medical Center (2002) $ 3.2M
Improper billing of experimental cardiac devices to Medicare
The following examples at BMC were identified in the recent past:
Clinical Trial participants received bills in error due to incorrect registration
Potential misappropriation of clinical trial expenses resulting in return of funds
A Clinical Trial requiring Research MRI’s did not follow standard practice and could have resulted in research charges being charged incorrectly
An independent assessment of 5 clinical trials in 2012 found that 89% of expected professional charges related to participant study visits were potentially unbilled. 3<br>
04
4 Membership:
Chief Medical Officer (Ravin Davidoff, MD),
Chief Financial Officer (Richard Silveria),
Vice President, Finance (John Lindstedt),
Medical Director, Research (Recruiting),
Exec. Director, Research (Michael Collins) Being formed and will include senior faculty across BMC participating in research Membership: A mix of BMC departmental administrators and clinical research coordinators, as well as representation from Patient Financial Services, Revenue Integrity, Investigational Pharmacy, and Radiology Being recruited to support the strategic direction of clinical research at BMC and provide clinical and scientific support to Principal Investigators and the central service functions that support clinical research Hired to bring management to the various Research Operation Functions Supports clinical research by managing the financial, legal and administrative components of clinical trials in conjunction with Principal Investigators and Study Teams Institutional Commitment to Clinical Research: Creating a Clinical Research Identity<br>
05
BU Charles River Campus Boston Medical Center Human Research Protection Program (IRB): BUMC Office of Research Compliance: CRC Intellectual Property and Commercial Ventures: CRC Clinical and Translational Science Award: BUMC Clinical Trial Office: BMC
Effective: 2014 Investigational Pharmacy Service: BMC Laboratory for Animal Science Center: BUMC BU Medical Campus Note: Excludes research operations
managed separately A New Value Added Service for Research 5 MANAGE | USE<br>
06
Clinical Trial Office Support Services The Clinical Trial Office (CTO) will support clinical research by managing the financial, legal and administrative components of clinical trials in conjunction with Principal Investigators (PIs) and Study Teams.
The CTO is involved in the following functions:
Study Initiation
Medicare Coverage Analysis (MCA)
Budget Development (comprehensive negotiation support)
Negotiation of Contract Terms and Conditions
Financial and Billing Management
Reporting and Auditing
Account Reconciliation and Closeout
The new program leverages best practices from peer institutions, including Partners Healthcare, Beth Israel Deaconess Medical Center, Tufts Medical Center, and Children’s Hospital. In addition to the local peer review; Jim Moran, Executive Director, Healthcare Advisory Services at Ernst & Young (formerly of Washington University) and Erika Stevens, Senior Manager (formerly of Dartmouth Hitchcock Medical Center and Columbia University Medical Center) are contributing insight to ensure that the CTO is consistent with standard practices. 6<br>
07
7 Benefits of CTO Support Service<br>
08
8 PI Engagement is Important for Success! Although the CTO will strive to minimize additional administrative burdens on Principal Investigators, increased participation is needed to ensure the continued success of the institution’s clinical research program.<br>
09
9 CTO Recruitment Director, Clinical Trial Office: Selvin Ohene
Formerly Administrative Director of Cancer Center, Tufts Medical Center
Senior Clinical Trial Financial Analyst: Dean Robinson
Formerly Clinical Trial Financial Analyst, Massachusetts General Hospital (CCPO)
Senior Clinical Trial Financial Analyst: Allisson Dugan
Formerly Senior Research Administrator, Beth Israel Deaconess Medical Center
VelosCT 10 Boston Medical Center has made a capital investment ($600K+) to implement a fully functional clinical trial management system (Velos eResearch) that will assist with:
Participant recruitment and accrual
Scheduling, follow-up, retention and management
Financial management
Reporting for all clinical trials
The implementation will be staged in three main phases, involve stakeholders with various cross-functioning subject matter expertise, and external support and is expected to be complete May, 2015 .
Phase I: System setup, configuration and onboarding new trials
Phase II: Data migration of selected existing studies
Phase III: Additional interfaces created and integrated over next three years
Executive Sponsor: Michael Collins: Executive Director, Research
Project Manager: Garo Stone-DerHagopian: Associate Director, Research Business Intelligence<br>
13 Policies and Procedures (Ernst & Young Engagement) E&Y Advisory Services reviewed 35 policies and procedures (some in draft). Minimal or no edits were suggested for 27 policies with proposed edits to 8 policies. E&Y drafted an additional 20 policies to support research operations.<br>
14
The CTO will work in collaboration with the Associate Director, Research Operations to provide the clinical research community with opportunities for training and education.
There will be multiple channels available to PIs and their study teams to receive training:
Live group training sessions (available in Fall, 2014)
Targeted online training (via Healthstream) (TBA)
Seminar series (TBA)
The following training sessions will be required for Investigators/study teams involved in clinical research: 14 Training and Educational Opportunities Time commitment is expected to be 1 hour per topic area.<br>
