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

Phases of clinical trials

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Found another link from University of Pittsburgh, which provides an excellent understanding of different phases of clinical trials:
http://www.clinicalresearch.pitt.edu/docs/comparison_of_clinical_trial_phases.pdf

Different types of clinical trials

Types of clinical trials:

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Winning strategies!!!

If you are a growing CRO, this is what you can do to smell the sweet taste of success faster!

· List companies in market you intend to penetrate and categorize them into primary and secondary accounts. Some clients are strategically significant for business, and hence deserve that extra special treatment-the key accounts. Key (high market share value) accounts will be defined based on profitability and large sales potential.

· Each key account will then go through a client profiling system which will be implemented by the Business Development Team . There will be three critical stages to qualify and implement sales plan for each & every account –Discovery, Planning & Implementation. The following section gives an overview of the procedures that will be followed to ensure revenues flow into the company.

1. Discovery-During this phase, the key account is profiled in the backdrop of the industry drivers and the client’s key products & differentiators are studied; any prior history in dealing with the account and competitive analysis conducted are mapped in this section. The Discovery phase sets the right foundation on which the key account can be approached and build successful business. With a better understanding of competitor’s products and services, CROs can provide appropriate services at more competitive prices.

2. Planning-Once discovery phase provides sufficient evidence of profitability of the account, it is suggested that one can move to the Planning stage. At this juncture, the author suggests that CROs can collate information on identifying key opportunities and setting goals specific to the client. A preliminary opportunity objective is established and important personnel within the organisation mapped to streamline the sales process. With tools such as opportunity analysis and value statement worksheet, the task is broken down further. The sales objective statement defines what each CRO is selling, at what price to be delivered and on a precise deadline. Delivery milestones and long objectives are set accordingly.

3. Implementation- This where it all narrows down to- converting the prospect into a client. An implementation plan is designed to ensure actual sales work begins, bearing in mind all the research done to capture the account and generate revenues. The best tactic is applied to establish value to meet the desired outcome by the due date. The plan is visited periodically to check progress and revaluate if changes are found necessary. The plan is tested by revisiting objectives and realigning with the company's overall business objectives.