Post Marketing Clinical Research

For those who thought Clinical Research is all about recruiting volunteers/patients for early stage studies, there's lot more happening at the other end of the spectrum. With increasing focus on safety in the CRO industry by health authorities and regulators, Pharma companies & CROs are concentrating on the late phase trials in a big way.Phase IIIb/Phase IV are the fastest growing drug development phases in terms of company R&D spend.Initial post marketing research, undertaken following successful market approval, can be used to justify market entry and establish the target patient population.An increase in post-approval clinical trials will result in increased costs (and hence budgetary pressures) and fuel growth in regulatory activities and legal affairs for pharma and biotech companies.

So what is driving the growth in this area- product differentiation or product efficacy for acceptance by patients and physicians alike ?

Where phase IIIa trials are considered insufficient to position the product appropriately on the market from a public health perspective, regulatory authorities may request phase IIIb research be undertaken before full market approval is granted. As part of product lifecycle management, phase IIIb studies can be used to supplement sales through indication expansion and the building of a product franchise.Mandatory trial conduct will then come at a further cost to the sponsor company.Later phase IV trial data is used to successfully manage product positioning in light of changes in the market environment. This is done in order to secure maximal sales revenue from the marketed product whilst it remains under patent protection.

Phase IV trials for market development

*Phase IV trials are strategically used by companies to address product positioning and encourage differentiation in increasingly competitive markets.

*Short term solutions for effective phase IV trial conduct will require a more networked model for both operational management and sponsorship, taking advantage of funding from other interested stakeholders and outsourcing where internal expertise or economies of scale are limited.

*Phase IV trial use is increasingly important when determining the timing of indication expansion and leverage of an in-market brand to build market share by taking advantage of existing prescriber support.

*Newly initiated Risk Evaluation and Mitigation strategies (REMS) and product labeling changes have the potential to hinder a drug’s market penetration and potential for expanded indication usage.


*Conducting mandatory PMC trials will not necessarily follow where disease indications are considered public health priorities. However, public health priorities will remain a driver for fast track status and accelerated approval nomination, under which PMC conduct is mandatory.

*For orphan drugs, postmarketing trials would only be required to satisfy regulators and payors concerning the risk-benefit profile of the drug.Using phase IIIb/IV trials to provide evidence of drug performance in extended patient populations would be of particular benefit for companies wishing to maximize revenues from orphan drug products through indication expansion strategies.