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Introducing...
Standard
of Care, TTC's New Database
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Standard of Care, TTC's new
database that provides current trends on what is
considered to be standard of care procedures. Standard of Care delivers value
to Study Sponsors and CROs by:
- Providing substantial cost savings.
- Avoiding payments for procedures
ordinarily covered bythird party payers.
- Eliminating the need to gather
standard of care information from sites and other sources.
- Expediting grant negotiation.
- Accessing the most current
data updated everysix months.
Easily accessible via
the Web, the Standard of
Care tool allows the user to identify standard of care savings
for procedures performed within the time frame of the protocol's visit
schedule in just one click. Rather than depend on sites to provide
information on standard of care, this new database provides objective
data on how sites actually treat patients within the standard of care.
The Standard of Care database is
derived from de-identified U.S. medical records and third party claims.
Data include claims across various third-party payer types, including
commercial insurance, Medicare and Medicaid, covering more than
70% of reimbursed care in the U.S. The data are collected from the following source:
·
Medical diagnostic data from CMS 1500 medical claims - completed
for patients seen in physician offices. Greater than 650 million
claims per year submitted by more than 355,000 physicians are
received. These data are available in near real-time and is the
largest ongoing tracking program of outpatient office visit data.
· UB-04
Hospital Claims - submitted for hospital/facility charges,
approximately 90 million claims per year. The UB-04 claims
represent charges submitted from approximately 2,000 facilities,
including 1,200 hospitals.
The Standard of Care
database sorts the insurance claims data by the specific indication
group or/and distinct diagnostic code. Data consist of more than 200
indication groups and thousands of distinct diagnostic
codes. The Standard
of Care tool provides the visits, list of procedures and the
average time each procedure was performed per patient during a 12 month
period. A critical feature is a presentation of time between visits so
that the creator of the clinical grant can evaluate which of the
protocol's visits and procedures are within the standard of care
claims.
For more information about Standard of Care,
please contact help@ttc-llc.com.
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Special
Codes for Patient Visits to Physicians
other
than Principal Investigator
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Over the past two years we have seen an increasing
number of grants in which the study and flow chart includes patient
visits to physicians other than the principal investigator for example a
neurologist or an ophthalmologist. These visits are conducted to
track adverse events and to substantiate the drug's safety. Although the
visit is performed by a physician other than the principal investigator,
it involves a series of procedures that are very similar to those
included in a regular initial neurological or ophthalmological visit.
However, the secondary investigator must take certain protocol specifics
into account, as well as complete detailed CRFs referring to safety and
adverse effects of the drug.
To ensure precise forecasting and benchmarking for
this type of visit, GrantPlan® now includes code T0901. The value
of this new code is the accurate accounting of the costs for a visit in
situations where the protocol requires a specialist other than the PI to
examine the study patient.
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As always, please send any budgeting, forecasting, or
technical questions you may have to our help desk: help@ttc-llc.com.
Please Note: Slovakia recently
changed its national currency to the Euro. GrantPlan® and CRO
CostPro have been updated accordingly. Current studies in this
country will not be affected unless the "Update Exchange Rates"
button is used on the Countries Tab.
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What
Bothers Clinical Investigators?
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Finance Matters
We know that next to
the desire to participate in medically innovative research, financial
remuneration is the most important reason these physicians take
part in clinical research.1
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Drug Safety Reporting Is A Worry
The uneasiness among
investigators about the reporting systems associated with SAE is
especially noteworthy. More than one-quarter of the clinical
investigators are troubled by the SAE reporting systems in clinical
trials, although far fewer have an issue with the follow-up activities
of reported SAEs. The issue of drug safety has received significant
attention in the last few years, possibly highlighted by the Vioxx
controversy. Investigators may be more sensitive to the
general drug safety issue because medical professionals, public
officials, and the general public have given the topic such
attention. For example, the FDA has recently reorganized to
provide more safety surveillance of marketed drugs, and a widely
read Institute of Medicine report highlights the difficulty of
anticipating possible drug safety issues with marketed drugs
based upon the relatively small number of patients taking part in
clinical research studies.2 Whatever impact this
increased attention on drug safety may have had among drug development
professionals, U.S. clinical investigators are concerned about SAE
reporting.
An experienced clinical
investigator commented: "I worry about how we report adverse
events. The issue has become more and more important for everyone. If I
can't be sure if these reports get to the right people quickly enough,
I am going to be careful which trials I accept."
1. Glass, H.
"The Importance of Medical Innovation in an Investigator's
Decision to Take Part in Clinical Trials', Drug Information Journal,
42(6), pp537-543, 2008.
2. Institute of
Medicine. 'The Future of Drug Safety: Promoting and Protecting the
Health of the Public', National Academic Press, September 22,
2006.
For more information about Bid Grids, CRO Selection &
Management, and/or utilizing cost benchmarks to more accurately
forecast the cost of outsourcing clinical trials, please contact help@ttc-llc.com.
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Mastering
the Business of Clinical Research
Budget
Management for Clinical Trials
Plan and create a successful budget for your
clinical trial
Course Outline #1
- Introduction
to Overview
- What
does a Clinical Trial Budget Include
- The
Feasibility Process and its Impact on Cost
- Investigator
Grant Costs
- Group
Exercise: Develop an Investigator Grant Budget
Course Outline #2
- CRO
Costs
- Third
Party Vendors
- Internal
Pharma Costs
- Group
Exercise: Budget Negotiation
All courses are designed, developed and
delivered on-site for your organization's specific needs.
Additional topics have been identified by sponsor organizations and CROs
participating in research conducted by Dr. Harold Glass and the
University of the Sciences in Philadelphia.
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For more information
about Mastering the Business of Clinical Research or other budgeting and
negotiating courses offered by TTC, please contact help@ttc-llc.com.
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4548 Market Street, Suite
M-20 / Philadelphia, PA, 19139, US / 215.243.4103 (tel),
215-895-4001 (fax)
136 Delaware
Road / London W9 2LL UK / 44 7792 145 831
www.ttc-llc.com
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"Our help desk is available whenever you
have a question or need assistance with GrantPlan®. Simply
email an inquiry to help@ttc-llc.com
and one of our client service professionals will respond to you in a timely
manner."
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