Of the many new drug treatments that appear on the market each year (including new chemical entities, new licensed uses for existing drugs, and new formulations or methods of administration of existing drugs), only a few offer a real benefit to patients over existing treatments.1,2 Promotional claims for these new products can make it difficult for health professionals to distinguish those that offer real benefits from those that are no better, or sometimes worse, than what is already available. By publishing reviews of new drugs, bulletins have an important role in helping their readers recognise the products that really are an advance and which deserve to be included in the list of drugs they use.
This chapter outlines the principles of how to evaluate a new drug. It is mainly for editors from established bulletins looking to develop their working practices on evaluating drugs that are new in their country. See Chapter 7 for the more general aspects of planning, writing and editing an article.
Many independent bulletins publish their own evaluation of new medicines. It is a task that demands significant and specialised resources, including the ability to access relevant data, and editors skilled in critically appraising the data. Because of the time and energy involved in reviewing a new drug, bulletin editors could think of collaborating with each other or sharing information, rather than different groups repeating the same work again and again. Even if a bulletin reuses the evaluation of another, there is still a need to take account of local circumstances (e.g. local spectrum of morbidity and mortality, inter-racial variation in the activity of metabolising enzymes, availability of services, local cost, etc.) in making a recommendation about the value of a drug (see Section 8.5.1 of this chapter for more about this).
Some bulletins have become experienced and expert at certain aspects of evaluation. For example, the group producing the Japanese bulletins Informed Prescriber and Kusuri-no-Check routinely appraise preclinical and animal data in their evaluations, in particular looking for signals of harm associated with long-term use of drugs. This particular aspect is dealt with in the annexe to this chapter.