Phase IV

Phase IV studies are required post market approval. These might be single country marketing studies through to large global observational trial studies. Clinical monitoring is done for the safety related aspects as well as data integrity validation of clinical trials by pharmaceutical companies. Technologies, such as EDC and e-PRO, are utilized and offer expertise when developing the trial and defining patient and visit numbers to ensure statistical relevance. CRO’s not only provide complete range of clinical study management and biometrics for typical Phase IV post approval studies. Retrospective/ prospective chart reviews (single/ multi centre), patient satisfaction surveys, PRO validation, Proof of concept studies are some of the angles in Phase IV studies to validate a product’s performance against a valid competitor in the market. Companies venture into post marketing studies to improve the potential of their product and this has been the fastest growing segment in the area of clinical research. Phase IV studies helps in finding data for new entrants in therapeutic segments and new markets for which the drug was not initially approved. These studies are randomised to improve and maximise the informational value. The Phase IV research environment is driven by the varying regulatory environment, increasing safety concerns of new medicines, and the need for real-world data on the marketed drugs. Phase IV studies have become a key component in the pharmaceutical industry’s product life cycle. This emerging area of clinical research is essential for the pharmaceutical firms to provide initiatives and assistance in areas such as client approvals, company expansion; marketing, New indication studies/labeling expansion, Product/ disease registries, Health-related quality of life, patient-reported outcomes via IVRS, Post-marketing surveillance, Retrospective chart reviews, Managed-care studies, Pharmacoeconomics. Late Phase solution is uniquely positioned to address key areas like Post-authorization safety studies (PASS) / Post-authorization efficacy studies (PAES), Phase IV trials — approved product, same indications (interventional), Registries — disease, product and safety (observational), Community-based and naturalistic studies.Literature-based meta-analysis, Post-market patient registry study and Randomized-controlled, multi-centre clinical trial are some of the major aspects of Phase IV studies. Real world outcomes like Health economic & outcomes research, pragmatic trials, patient reported outcomes, epidemiology data, lactation/placental transfer studies, consumer health studies are also subsets of post approval trials.