Risks and Benefits of Global Drug Development: Resource Consideration

There are two major considerations in global drug development, the positive and negative factors of risk versus benefit and the use of resources. Outcome-oriented research may become a key to guiding future drug research efforts. Research aimed at reducing overall health care costs will be used in the future for formulary inclusion and reimbursement factors.

Successful global development demands improved design of clinical trials, using clinical input and statistical consideration. The sequence and timing of the registration process must be planned appropriately to take advantage of national or combined filings. The proper management of a product's life cycle may sometimes markedly expand product profitability.