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.

Indian Clinical Research Industry

An insider's perspective of how emerging economies particularly India is posing challenges to western companies in the clinical research industry.

India is rapidly becoming preferred destination for clinical trials because of large heterogeneous patient population and English-speaking physicians. It also has built reputation for meeting regulatory requirements and providing well accepted, good quality, auditable data. With low recruitment cost, developing infrastructure, better regulatory framework, Indian CRO industry is expected to grow to $1b by 2010.

· Indian CRO industry provides opportunities for western firms in terms of growing market, increasing efficiencies through faster cycles and resources.

· Threats are increasing from Indian CRO firms, who are giving tough competition both in global markets as well as home turf, are learning technical know how and gaining competitive advantage.

Outsourcing of drug research and development to contract research organizations (CROs) is a well established practice in the pharmaceutical industry and continues to be driven by financial and technological imperatives. The R&D services most commonly outsourced are clinical monitoring for Phase II-IV trials, clinical trial project management and data management. Overall, CROs are able to shorten clinical testing times by as much as 30%.

In the last decade, India has emerged as an important clinical trials destination for global pharmaceutical and contract research organisations (CROs). In 2005, the global market for contract research was dominated by the US and Western Europe; Eastern Europe comprised 10.7% while India accounted for 0.7% and China made up 0.5%. By 2010, however, Eastern Europe will comprise 13.3%, India will account for 2.4% and China will represent 1.1%. [1]

The face of the industry is changing rapidly with large multinational CROs partnering with local Indian CROs to put their dot on the South Asian map.

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[1] PHARMACEUTICAL OUTSOURCING STRATEGIES: Market expansion, offshoring and

strategic management in the CRO and CMO marketplace: Alison Sahoo