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How to check for gaps

Clinical trial gap analysis can elicit unique and well supported marketing messages

Gone are the days when the marketing department received a registered product coupled with a few publications outlining the bare bones of its characteristics from R&D. In a highly competitive market, with a plethora of me-too drugs, and high expectations for every product, planning how to differentiate your product from the competition needs to be built into phase II and III trials, not just phase IIIb-IV.

Performing a clinical trial gap analysis enables all departments to see which key messages can be gleaned from existing trials, and which ones are missing but need to be incorporated to strengthen communication.

So how does a clinical trial gap analysis work?
Clinical trial gap analysis is the identification of gaps in a particular clinical trial programme compared with competitor products, desired outcomes and disease messages. It requires the pharmaceutical company to plan very early in the process what it would like to communicate about its product, and how it should be placed in the marketplace relative to competitor products. A gap analysis can also help to identify areas of disease communication that need to be strengthened, better understood, or communicated differently to reach a new target audience. All of the vital points for a successful launch and product life cycle can then be addressed through further clinical trials, peer reviewed publications, or public relations campaigns.

Identifying market needs
Generally, products are developed by companies in order to meet a need in the marketplace. However, as more drugs enter already crowded therapy areas, it becomes essential to identify a need and firmly establish your product as the one to meet that need. It is also essential to maintain a successful position in the market with a well designed life cycle management plan that addresses the needs of clinical, regulatory, marketing, sales and health economics. So how do we ensure that everyone's needs are met? By establishing a working group matrix involving key members of the various departments to design a life cycle management plan.

This plan needs to state the trial endpoints and how they can be communicated; sub analyses that will provide additional messages; dosing regimen; comparators; and health economics data. These points should then be compared with the key messages that the matrix group has developed and any gaps should be noted and addressed through the clinical trial plan. Key messages that simply cannot be met should be reconsidered. Another important step is to ensure not only that all the key messages are addressed, but that there is sufficient data to support these messages.

Gap analysis can also be performed to compare competitors' messages with your own, and to ensure differentiation between some of your benefits and key messages and those of the competitors. If your product is a late entrant into an already established marketplace, your strategy may be to create a niche market for the product. A gap analysis looking at competitors and the needs of the marketplace will enable you to identify where gaps in the market exist for your product. Clinical trials can then be planned and designed to ensure you have a strong clinical registry and marketing strategy.

Obtaining all the information necessary to conduct a successful gap analysis is vital to the outcome. Competitor information needs to be obtained not just from marketing campaign material but from a variety of sources. A thorough literature analysis over a time span will provide an insight into the key messages for specific target audiences, how messages have evolved and changed, as well as the direction the competitor is headed. Talking to key opinion leaders will reveal how they perceive competitors' positioning and what they believe the gaps are in the market. Congresses are another important source of information. Company satellite symposia, oral presentations, posters, abstracts, and exhibition booths allow a vast amount of information to be gathered in a relatively short period of time. Don't just collect your competitors' information; analyse it to identify their strong messages, weaker ones and to what extent their data work (or don't work) to support their messages. This can be an extremely useful aid to understanding how your product can be differentiated.

Suitable for all phases
A clinical trial gap analysis is not only essential for a product that is still in phase II development, but is an important tool for products at different stages of their life cycle, in particular if a product is already established, growth has slowed and competitors are pulling away.

The analysis will allow you to identify additional indications that your product could pursue to allow you to differentiate from your competitors. It can also help to identify where you are losing market share to competitors and what strategies you can implement to overcome this gap in your marketing strategy. Finally it can help you to reposition and potentially re-launch the product to boost growth.

It is never too early or too late in a product's life cycle to conduct a gap analysis, and it is essential to update and re-assess the analysis on a regular basis. This will ensure you stay on track and adapt rapidly as marketplace dynamics shift. It will also provide your product with a stream of clinical data for continual communication opportunities.

In summary, it is useful to conduct a clinical trial gap analysis when you have:

  • Products in development - this allows you to plan the life cycle of the product, ensuring that all your key messages and differentiating benefits will be incorporated into a range of clinical trials and can be communicated in a timely fashion through publications and congresses

  • Products entering a competitive marketplace - a gap analysis will allow you to benchmark your product against the competitors to determine the product's key strengths and opportunities in the market

  • Established products - in order to reposition your product or to identify competitive advantages.

A set of key messages
The outcome of a gap analysis, no matter what stage your product is at in its life cycle, is a well defined set of key messages, and the identification of clinical trials that will support those messages. Messages can be ranked in order of the strength of support, importance to key opinion leaders, and differentiation against competitors. This should be supported by a publication plan that outlines when and where the messages will be published and which target audience will be reached. The clinical development plan should meet the needs of all parties who have invested in the development of the gap analysis. This means that marketing and sales are happy that they can sell the product, regulatory has ensured the trial will meet the European Medicines Agency (EMEA) requirements and health economics will obtain the data they need to support the targeted price.

So before you set about updating your next marketing plan, consider conducting a clinical trial gap analysis to see what opportunities there are in the marketplace and how you can develop a plan that makes the most of your product.

A hypothetical case study
Hyper Pharmaceuticals has a new angiotensin II receptor blocker (ARB) in the pipeline. Phase II trials indicate that the compound has a dose-dependent blood pressure response. This has led the company to believe that it could be plausible to enter the already crowded marketplace almost 10 years after the first ARB was launched.

Hyper Pharmaceuticals created a matrix working group consisting of members from R&D, marketing, pricing, regulatory and representatives from the local operating company. The group determined what key messages and marketing strategy would provide them with the best opportunity for a successful launch. This was then compared with the messages and strategy that the current clinical programme would provide.

Gaps were identified and strategies developed to fill the gaps. New clinical trials were proposed in line with R&D and regulatory to ensure feasibility and registration likelihood. Timelines were developed to map out when key messages would be available for communication, enabling the team to determine which trials would not meet the desired launch timelines and whether alternative trials could be developed to provide similar messages.

Simultaneously, the group analysed the competitors in the marketplace to assess current positioning and future trends. The group was able to determine that some ARBs were chasing heart failure indications, others end organ protection, and some were satisfied claiming 24-hour blood pressure control.

An analysis of the literature enabled the group to determine whether there was a need in the marketplace for an antihypertensive providing dose-dependent blood pressure reduction. It highlighted that there was definitely a need in the marketplace; however, there was no recent literature and the majority of the articles focused on the importance of end organ protection. To counteract this, the group developed an awareness publication plan in order to create `noise' in the market surrounding the number of people with uncontrolled hypertension and the inadequacies of the current medications in lowering blood pressure satisfactorily.

A publication plan for the new compound was developed ensuring a flow of communication to all target audiences over the life cycle of the product. Key messages were mapped out, highlighting the number of times every message would be repeated as well as noting where gaps in message communication existed. Target journals were selected, including possible secondary publications.

The end result of the clinical trial gap analysis was a communication plan that matched the marketing strategy and, most importantly, was going to be supported by a stream of clinical evidence.

The Author
Effie Baoutis is director of, and Mandi Robertson is consultant at, The Remedy, Fleishman-Hillard (www.fleishman.com)

8th March 2007

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