2009, TTC,llc E-Newsletter Issue 3

Introducing...

Standard of Care, TTC's New Database

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.

back to the top

Special Codes for Patient Visits to Physicians

other than Principal Investigator

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.

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.

back to the top

What Bothers Clinical Investigators?

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

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.

back to the top

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.

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.

back to the top

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

"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."