Validating pharmaceutical product claims: Questions a formulary committee should ask

Claims, justifying the acceptance and placement of new products on health system formularies, are all too often presented in terms that are either unverifiable or only verifiable in a timeframe that is of no practical benefit to formulary committees. One solution is for formulary committees to request that (i) all predictive claims made should be capable of empirical testing and (ii) manufacturers in making submissions should be asked to submit a protocol that details how their claims are to be assessed. Evaluation of claims can provide not only a significant input to ongoing disease area and therapeutic reviews, but can also provide a needed link to comparative effectiveness research and value-based healthcare. This paper presents a set of protocol standards (PROST) together will questions that should be addressed in a protocol review.