In India, local offices build investigator grant budgets, which traditionally have been based on intangibles such as experience and gut feelings. Most contracts are two-party arrangements between the investigator and the hospital. Most clinical grants in India have four main components: procedures, professional fees, site costs, and overhead.

Procedures. Procedures are activities done to or on a patient. Common procedures in most clinical grants are electrocardiograms (ECG), informed consent, and chest x-rays. Procedure costs are 21% of the U.S. costs. Some specific cost differences can be seen in Table 1.

Professional fees. Wages, salaries, drug preparation, and facility fees are examples of professional fees. Contracts do not include pharmacy fees, and the cost for dispensing the investigational product is already included in the principal investigator's salary. India does not include subject reimbursement in the initial budget, but this cost may be added to ensure that the study retains subjects.

One of the cultural differences when negotiating site budgets in India is subject reimbursement. Oftentimes, a family member will have to accompany the patient to each visit; therefore, additional reimbursements may be included. This is not typically included in the initial budget presented to the site, but may be added in order to accommodate the sensitive needs of this population and their families.

Site costs. Site costs tend to be one-time fees, such as advertising, Institutional Review Board or Ethics Committee fees. India's enormous patient pool and the country's 13 official languages make an advertising campaign impractical. Rather, hospitals recruit patients directly, with each site determining its fees for this service. Health Authority & Ethics committee fees are also predetermined.

Overhead. Overhead in India runs between 10% and 20%, which is applied for both procedures and professional fees. Some have questioned whether the overheads varied between public and private hospitals. Based on our analysis and survey results, the cost difference is not significant enough to warrant a comparison.

Once sponsors create a budget they believe represents market conditions, they submit it to the site for approval. At this point, a site may choose to negotiate certain aspects of the budget to reflect its own requirements.

Investigator grant negotiation

Negotiating contracts in India always takes place directly with the principal investigator. Contracts are usually in English and the negotiating currency is in dollars; at times, the currency may be in euros or pounds.

A smaller amount is paid at the initial visit to encourage investigators to retain patients. Typically, payments are made on a per visit schedule (i.e., cost per visit times total number of patients). Monthly site payments are used to provide wages and salaries for support staff.

When we consider all of the aforementioned costs, the total investigator grant on average ranges from 30% to 40% of the cost in the United States. The information in Table 1 is provided from the GrantPlan® Database,⁴ which is a large database of current international clinical grant costs in the world. Most major pharmaceutical companies contribute data to, and access, GrantPlan® for clinical grant data.

Clinical research in China

As with India, China represents a vast new marketplace for the clinical research community. The country offers:

• The largest urban, treatment-naïve patient population in the world
• More than 18,000 hospitals
• More than 1.5 million physicians, almost 2 million physician's assistants, and more than 1.6 million well-trained registered nurses and technicians, all working at significantly lower salaries.⁵

Some key clinical trials underway in China are primarily for lung cancer and infectious diseases. Beijing, Shanghai, and Guangzhou are three of the major clinical research cities. The Beijing Tong Ren Hospital and Peking Union Medical College Hospital are two examples.