As site costs continue to increase in the more traditional areas for clinical research, a growing number of CRO's and sponsors are using sites in areas such as Latin America, Asia, and Eastern Europe according to GrantPlan. The demand for less expensive markets have increased as sponsors and CRO's reach toward less expensive regions in which to conduct clinical trials. Lower costs will never be the decisive consideration in selecting a site, however, substantial cost differences are becoming more important in the decision making process. 

TTC, now a part of IMS, continues to provide annual current global data on the relative costs of clinical grants around the world using the GrantPlan database. The aggregate GrantPlan subscribers conduct nearly 80% of all commercial clinical trials around the world, with each sponsor company and CRO contributing the current costs of each clinical trial.  

 Mean cost per visit in Phase II-III clinical trials.

This year, the data shows the United States and the United Kingdom continues to be the most expensive countries for clinical grants. With low single digit growth in the established geographies, grant costs seem to have stabilized. Despite the increased demand, the newer geographies have experienced a slight decrease in the costs per visit of approximately 6% in Asia and a minimal increase in Latin America.  

—TTC (for more information, please contact 

Articles

Revisiting Clinical Grant Expenditures

Clinical grants are growing increasingly sophisticated. Consquently, investigator site startup costs have become increasingly complex as well. Clinical sites are charging for a greater amount of site-cost line items. In addition, sites are charging more for those line items.  

TTC's GrantPlan database contains grants from 76% of global clinical trials. GrantPlan tracks all the site-cost line items from clinical grants. The most common site costs are general site startup administrative fees, advertising, IRB fees, and pharmacy fees. 

In 2010 the average number of line items included in global clinical grant site costs was 2.9 line items. That number increased to 3.0 in 2011, and is currently approaching 3.1 line items in 2012. Advertising fees are most responsible for the additional line items. 

Additionally, sites are charging more for individual line items. The single most common site cost is the general administrative site startup fee. Between 2010 and 2011 the average site startup administrative fee increased 8%. Halfway through 2012, the average startup administrative fee has increased 3%. 

Site-Cost Line Item Charges on the Rise

TTC estimates that nearly $1.5 billion of US clinical grant spending should be covered as part of standard of care treatment (SOC) by third parties for their patients' participation in clinical trials.  

SOC payment in oncology trials has been a common industry practice for a number of years. Sponsor pharmaceutical companies realize that the practice can be extended to other therapeutic areas as well. Additionally, large number of states specifically require that SOC procedures in clinical trials be covered by third party payers. 

Clinical sites are accustomed to billing insurance claims for their patients in general. A survey of 512 investigator sites in the United States on their current third party payers billing practices found that two thirds of sites regularly bill third party payers for their patients participating in clinical trials. When broken out by therapeutic area, billing is regularly done for oncology trials (84% of sites), dropping to 30% of sites participating in digestive system trials. 

The most mentioned reason by sites for not billing third party payers is simply that the sponsor did not ask them to. 

—TTC (for more information, please contact

Standard of Care Billing More Widespread

Only one in 10 self-originated drugs targeting diseases of the central nervous system (CNS) that entered clinical testing between 2002 and 2007 were approved. As such, CNS drugs have a success rate that is half that of the overall clinical approval success rate. Drug developers face numerous challenges in developing treatments targeting complex chronic illnesses in CNS including very demanding protocol designs and substantially longer development and regulatory review times. The clinical phase through approval duration for CNS drugs, for example, was 32 months longer than that of non-CNS drugs. Mean clinical phase duration for CNS drugs was 40% longer and the regulatory review and approval duration was 13% longer. CNS drugs are also far less likely to receive priority review status: between 1996 and 2010, non-CNS drugs were two-and-a-half times more likely to receive a priority review rating from the US Food and Drug Administration. The CNS new product pipeline, however, is among the richest, accounting for 11% of all drug development projects worldwide and growing by 6% annually.  

Phase transition probabilities for self-originated CNS drugs and the benchmark for all TAs (2002-2007). 

—Tufts Center for the Study of Drug Development, 

CNS Drugs Have a Low Approval Rate

Improved study completion times represents one of the most critical areas for clinical development organizations. Previous TTC research has demonstrated that paying sites more on a cost per patient basis does not improve study completions times.  

Other variables, such as study and protocol design, or whether a CRO or sponsor directly runs the fieldwork may be important. According to 

, TTC subscribers conduct over 76% of all commercial trials around the world. A detailed analysis of study completion results for over 2,500 Phase III studies demonstrates that whether a CRO or sponsor company runs the study has no bearing on study completion times. It might be hypothesized that CRO-run studies would be slightly slower to complete because of the added information step between sponsor company and CRO embedded in outsourced studies from study start to study completion.  

Still, study design factors such as  the number of countries in a study, had clear affects on completion times. There is, however, no difference whether a CRO or sponsor company manages the study. 

Improved study completion times represents one of the most critical areas for clinical development organizations. Previous TTC research has demonstrated that paying sites more on a cost per patient basis does not improve study completions times.

Study Completion Times

Clinical grant expenditures represent a major portion of the budget for later phase clinical trials. Although not the ultimate reason for picking a site or region to conduct clinical trials, the relative cost of conducting a clinical trial can play an important role in the decision.  

TTC provides annual current global data on the relative costs of clinical grants around the world using data pulled from the GrantPlan® database. The sponsor company and CRO subscribers to this database conduct over 76 percent of all commercial clinical trials.  

Mean Costs per Subject in Phase II-III Trials			

This year, the data shows that the United States remains the most expensive country for clinical grants, often by a large margin, followed by the United Kingdom. Newer geographies such as Eastern Europe, Latin America, and Asia are distinctly less expensive for clinical research.  

While less expensive, these areas show more rapid increases in clinical research spending than in North America or Europe. The United States and Western Europe (excluding the United Kingdom) have been averaging 3 percent to 4 percent annual increases. In contrast, clinical grants in the new geographies are increasing at rates over 14 percent.—TTC (for more information, please contact 

Clinical grant expenditures represent a major portion of the budget for later phase clinical trials.