Phase IV Studies, What is New at TTC, and Wisdom from the Help Desk.

June 2011- Philadelphia, PA

Phase IV Studies

Newsletter Article by H.E. Glass, Ph.D.

Several factors are propelling an increase in the number of phase 4 prospective studies being done in geographies around the globe. As new drug productivity declines and major drugs come off patent, pharmaceutical companies are looking for ways to maximize the effectiveness of their marketing efforts for their current drugs. In addition, regulatory authorities are requiring more attention to post approval drug safety issues. The FDA for instance is being more assertive in requiring the completion of extended safety studies for drugs as part of the new drug's approval. The FDA has often required these studies in the past as part of a new drug approval, but the new FDA reorganization and safety mandate have prompted them to become more aggressive to insure that the studies are actually completed.

In addition, pharmaceutical companies are aware of the heightened visibility of drug safety issues for many publics in the United States, Europe, and elsewhere.

An analysis of Clinicaltrials.gov and the GrantPlan databases demonstrates that much of the work in phase 4 is concentrated in several therapeutic areas.

Percentage of Phase 4 Studies in the Top Six Therapeutic Areas
Rank	Therapeutic Area	2008	2009	2010
1	Endocrine, Nutritional and Metabolic Diseases, and Immunity Disorders	8%	18%	22%
2	Central Nervous System	10%	18%	17%
	Mental Disorders	6%	8%	8%
3	Cardiovascular System	21%	15%	11%
4	Musculoskeletal System and Connective Tissue	3%	8%	8%
5	Respiratory System	20%	8%	6%
6	Genitourinary System	6%	10%	6%

GrantPlan data indicate that the costs per patient and per visit of phase 4 studies are distinctly lower than for phase 2 and 3 clinical trials. Prospective phase 4 studies, while not necessarily as complex as phase 2 and 3 studies in terms of the number of medical procedures involved, can still be quite expensive. Often these studies involve many patients, for extended periods of time. The final study costs then may be significant, even if the per patient costs may be lower than for earlier phase research.

Mean Global Costs Per Patient and Per Visit by Phase
Phase	CPP_US$	CPV_US$
2	15,465	997
3	13,884	861
4	6,646	590

What's New at TTC?

TTC's Late Phase Advantage™ A product for Medical Affairs

Late Phase Advantage™ a product designed for Medical Affairs, powered by a comprehensive and current database of payments to physicians for phase 3b and phase 4 studies. These include payments for medical procedures and non-medical activities performed by clinical investigators in the conduct of late phase observational and interventional clinical studies.
Used by sponsor companies and CROs to forecast, budget and manage late phase studies, Late Phase Advantage™ assists with cost containment and ensures compliance with Fair Market Value payments to physicians and institutions. This database provides fee information for both corporate sponsored studies as well as Investigator Initiated Studies (IIS).
The Online Negotiation feature reduces time to budget agreement between study investigator and study manager. This also provides easy version tracking and facilitates a manageable transfer of cost data to internal management systems.

In addition, Late Phase Advantage™ provides users the ability to identify those medical procedures incorporated in the study that are considered Standard of Care and should be paid by 3rd. party payers, saving the study sponsor as much as 20% of the costs involved in the study.

This all-inclusive product gives late phase study managers the capability to compare the costs of activities and services proposed by various CROs. It also supplies industry benchmarks for these activities to support the CRO Selection decision. It is also used to evaluate whether to outsource or manage the study internally.

Companies subscribing to this product can access all modules or customize by selecting only the modules suited for their needs.

To participate in the TTC Preferred Pilot Program created for our newest product, Late Phase Advantage™, contact:

Laurence G. Poli PhD
TTC, llc
215-243-4103
lpoli@ttc-llc.com

Essentials for Pharma and CROs, LIve Webinar July 12th at 11:30EST

Professor Harold E. Glass, research professor and TTC's President and CEO, will be hosting a live webinar at 11:30am EST on July 12th. Attendees of this session will learn important facts regarding how sponsor companies and CROs integrate standard of care consideration in their clinical grant agreements. Current regulations will be discussed in addition with current practices. Other topics discussed include actual cost savings, Fair Market Value, and using appropriate Standard of Care data. People from clinical budgeting, financing, operations, purchasing/procurement, compliance, CROs business, development, and site start-ups should pay special attention to this webinar. If you would like to register for this event, please email pr@ttc-llc.com with the subject 'Pharma and CRO Webinar' and your Company Name, First and Last Name and the Webinar information will be forwarded to you.

From The Help Desk

June 2011

In an effort to assure the latest information is consistently available in GrantPlan, we update our codes along with the CPT updates yearly. We would like to remind our clients that this takes place around the end of July of each year.

When codes are taken out of the CPT system, we update the description of this code with the words 'obsolete code' as the first words of the line which immediately draws attention to the fact that this code is no longer viable. At the end of the description we insert 'please use code X', which is the CPT (Current Procedural Terminology) replacement code. All clients using GrantPlan®'s Online Negotiation module know that in the US sites like to have the corresponding CPT code when working with a budget.

After two A-IB updates in which this particular code is not updated with new benchmarks, we delete the old code. Your budgets using this code will not be affected and will remain the same using the obsolete code. This ensures all studies currently using the old code and being negotiated online remain untouched.

Should the description of the new code be exactly the same as the obsolete code, we use the current two year industry benchmarks and populate these to the new code. This allows users to continue using the same procedure with robust industry benchmarks.

Phase IV Studies, What is New at TTC, and Wisdom from the Help Desk.

Clinical Trials