Phase IV Studies: Some Insights, Clarifications, And Issues.

CONCLUSIONS: Critical remarks are raised against the pure commercial perspective in the proposal of PASS and PAES and on the design of registries which should be mainly based on the objectives and the planned analyses, as it has reported in the study protocol. Finally, a particular focus is also placed on the work of the Ethical Committees regarding the approval of the observational studies on the safety and the efficacy of the drugs in their pragmatic clinical use. PMID: 29651962 [PubMed - as supplied by publisher]
Source: Current Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Curr Clin Pharmacol Source Type: research