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has been described as a piggy-back strategy because the primary driver for such studies is to achieve regulatory approval. The pharmacoeconomics case for a new medicine in a setting more typical of the product in use is better demonstrated in phase 3b studies sometimes termed naturalistic trials. Although, presently, pricing and reimbursement decisions are predominantly driven by nonpharmaco-economic reasons (e.g., competitive pricing, local reimbursement rules), decision makers are increasingly looking for such data to provide a reference range. |
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With the increasing requirement to justify cost effectiveness, there needs to be continuing investment in pharmacoeconomic studies to sustain justification of product use and pricing. Information technology will facilitate the generation of outcome data from larger population groups in the years following product introduction, enabling recognition of the real product value earlier than previously been possible. |
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2.
Registration and Launch Strategy |
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The indication selected for first registration and launch of a new product may be one of several that could have been registered. Several factors will generally have been considered in deciding the first registration and launch strategy. These include speed to market, opportunity to set satisfactory pricing in the market, the value of the indication, and coherence with strategy to bring other indications to market at a later stage (Fig. 4). The lead indications for a new drug are generally selected early in development. It is not easy to reengineer filing strategy at a late development stage but development data may necessitate this (e.g., strength of clinical data in different indications). A thorough understanding of regulatory requirements is needed to ensure that trials are designed appropriately to support commercially desired labeling. Where possible, this involves dialogue with regulatory agencies to discuss specific plans. It involves review of relevant guidelines and, for the U.S., review of relevant competitor Summary Basis Of Approval (SBOA) documents. It also requires understanding the attitude of agencies toward particular types of products gained by attending key Advisory Committee meetings. In a number of pioneering areas, regulators and their advisors are struggling to make sense of clinical science just as much as academic and industry specialists. It is essential to be closely attuned to current thinking in such areas and, indeed, for the industry to actively contribute to the debate. |
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The clinical trial strategy should be reviewed by leading clinical specialists in the major markets in time to ensure that the trials conducted are relevant to the markets and to ensure that opinion leaders are fully familiar |
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