Clinical trials budgets

This term is generally used to denote the administration file kept for each trial and each investigation centre. Box 7.1 lists some of the documents that need to be present before a clinical trial starts. (See ICH GCP Chapter 8 for the full list.) Once the study has started, other documents will be added, including completed CREs, ICFs and subjects medical records and other documents directly involved in the study. Some documents have to be kept specifically at the sponsor s office or the controlling centre. Separate files will contain financial and budget-related documents. 

Tarantowski R. Writing a clinical trial budget. Appl Clin Trials 1996 5 26-40. 

The federal government has had some insight into the need for a federal office to oversee dissemination of information on alternative medicine. Previously known as the Office of Alternative Medicine (established in 1992), the National Center for Complementary and Alternative Medicine (NCCAM) was established in 1998 as part of the National Institutes of Health. The mission of the NCCAM is to give the public reliable information on the safety and effectiveness of complementary and alternative medicine, with an emphasis on clinical trial sponsorship.The budget of the NCCAM has grown from 2 million in 1992 to almost 70 million in 2000, and almost half the budget is mandated to fund peer-reviewed grants. The NCCAM also helps to disseminate information to... 

Outsourcing is now a common practice of almost all pharmaceutical companies. For example, the use of CSOs to support some aspect of clinical trial research has grown from approximately 30% of the clinical studies conducted in 1993 to over 60% in 1997. The processes that a client uses to select a CSO and how a client interacts with the CSO ensure contracted research studies are monitored appropriately and completed on time and within budget. 

Gersch S, Cohen B, Hirshhom B. 2001. The seven basic components of clinical trials budgets. Clin. Trials Advisor 6(3) 5. 

Apart possibly from investigators fees, in-house costs represent the greatest single item in a clinical trials budget. Table 53.3 lists many of the subdivisions of costing that could be regarded as internal, the vast majority of which could be outsourced to CROs or similar organizations. 

To avoid these problems, it is recommended that the PI consult with internal support staff knowledgeable in budget design and institutional overhead. Most academic centers have a clinical trials office that can help construct a... 

The investigator must remember that most clinical trial budgets derived in academic settings must conform to the Health Care Finance Administration s corporate compliance regulations. The regulations state that federal health care payers are responsible for covering only those resources that are medically necessary for the care of a patient. Taxpayer dollars (e.g.. Medicare) cannot be used to subsidize purely research activities, or for experimental or unproven medical therapies. 

Clinical trials are major budget items in drug development. The total costs vary according to therapeutic area, indication, duration of the study, and numbers of subjects. Even for rapidly acting drugs in acute conditions (e.g. infections), the cost is unlikely to be below 50 million, while for a slow-acting drug for a chronic condition (e.g., osteoporosis), expenditure of 300 million is possible. 

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