Some of the most significant trends in global clinical trial costs are occurring in the area of reimbursement for completed patients/subjects. Over the last five years, in phase II and III studies, reimbursement has increased globally by 30%. France and Germany show the highest percent increase, at 50% and 41% respectively. Conversely, compensation has decreased in South and Central America by 14%. Costs are on the Rise Procedure costs, however, continue to fluctuate across the globe. A routine electrocardiogram typically hovers near $107 in North America, while in South and Central America, it is reimbursed at $71 and in Europe the rate drops to $48. Yet, consider the dramatic increase in informed consent in North America, once typically covered under standard salary costs paid for during an initial visit in a clinical trial. In 2005, the cost paid for an informed consent, regardless of therapy area, was $74. In 2007, it rose to $80 and in 2009 it reached $86. Calculating protocol complexity also reveals interesting data. A numerical value is assigned for each procedure in a protocol, based on the staff experience required to perform the procedure, the time the procedure typically takes, and the level of difficulty for the task. Those values are totaled for each of the blinded industry protocols, and through these totals or “site work effort," a similar pattern to what is shown in the cost per patient/subject compensation emerges. In the last five years there has been an average global increase in protocol work effort by 28%. Protocols placed in Western Europe have shown the highest level of increase at 61%, Eastern Europe follows at 54%, Asia-Pacific at 26%, and North America has shown a smaller increase of 6%. Interestingly enough, only protocols placed at sites in South and Central America have decreased in work effort by 9%. Site Proficiencies When examining work effort required by the site and in procedures tolerated by patients by therapeutic area, the most difficult study designs occur in oncology, with studies focused on the central nervous system and on anti-infective agents ranked second and third. While complex oncology trials are evenly distributed across the globe, the most complex central nervous system trials tend to be placed outside of North America and Europe, indicating a growing need for highly capable sites in those areas as sponsors cast a wider net in an effort to find appropriate patients for their trials as well as maintain their clinical trial budgets. The most complex anti-infective trials are placed in South and Central America, and the least complex therapeutic areas, as calculated by site work effort, are respiratory, cardiovascular, and hematology. Trials in these therapy areas tend to be conducted evenly across all geographies. Trial Procedures on the Rise The sheer numbers of procedures performed in a trial are increasing as well. In the last five years, genitourinary studies have seen the largest growth with the number of unique procedures increasing by 49%. These studies have shown a procedure volume increase of 52%, indicating not only more procedures are required by the protocol, but more visits are in the design as well. The site work effort for genitourinary studies has increased by 26%; more procedures and visits in this case are increasing overall work effort, but not at the same rate. This indicates the added procedures are of a more routine type and are not adding complexity at the same rate as they are adding bulk. The past five years have also shown a steady downtrend in the unique procedures of gastrointestinal and dermatology studies, with a drop of 15% and 13% respectively. The volume of procedures has decreased by 19% in GI and 17% in dermatology, and the site work effort has dropped 22% in GI and 16% in dermatology studies, indicating more complicated procedures are being removed in gastrointestinal studies. The rate of compensation globally is increasing at almost the same rate as the work effort required by the study designs. Certain geographies are showing a more dramatic increase as a direct result of the industry’s search for patients and capable sites. The overarching need to stay within budget remains, yet it will be important to be aware that the cost of executing clinical trials is definitely on the rise. n The overarching need to stay within budget remains, yet it will be important to be aware that the cost of executing clinical trials is definitely on the rise. Medidata Solutions Worldwide Lori Shields Vice President, Data Operations Rafael Campo Manager, Data Quality and Analytics Medidata SolutionS Worldwide is a global provider of hosted clinical development solutions that enhance the efficiency of clinical development processes and optimize research and development investments by streamlining the design, planning, and management of key aspects of the clinical development process. For more information, visit mdsol.com.

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