Ideally, all appropriate new active substances to be used on an outpatient basis would be conditionally released, which, as stated previously, is estimated to be about 15 per year. This number still demands a substantial financial commitment to provide sufficient staff and resources to perform a proper follow-up process, although pharmaceutical companies are required to pay fees to have their drug applications reviewed, and this money could be used to fund the active monitoring of drugs during conditional release. However, particularly at the beginning, it may only be possible to evaluate a selection of new each year. Any such selection should be based on signals from the premarketing studies, novel chemistry or pharmacology, a close relationship with a class of products that have caused problems previously, or a good chance that the drug will be widely and inappropriately used.
The length of the follow-up period would depend on whether the treatment was short term or chronic, the seriousness of the disorder being treated, and the prevalence and incidence of the disorder. Some drugs for uncommon chronic conditions would probably have to be monitored for long periods to allow sufficient numbers of patients to accrue to be able to perform the evaluation. For safety evaluations, at least 10,000 patients would normally be required, with more being necessary in particular circumstances, and this number would be more than sufficient for an assessment of effectiveness. In some situations, the ability to detect an adverse risk of one in 1000 to one in 1500 may be adequate, which would reduce the required number of patients to 3000 to 5000. This number of patients would be sufficient to evaluate effectiveness and would reduce the estimated cost to $5 to $7 million per drug.