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BASICS << Gap analysis
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Gap analysis
Published 8 August 2008, written by Christine Gardner
What is gap analysis?
Gap analysis identifies any relevant topics or ideas that are not adequately covered.
Gap analyses can be conducted for both a product and selected competitors, and can cover areas such as volume of publications (including abstracts and other communications), target audiences, journal and congress selection, types of articles, etc. Unmet needs in the target indication should also be considered and competitor claims should be reviewed to ensure that the product can match the competition in terms of basic requirements and, if possible, that it will be able to adopt a superior position.
However, this article will concentrate on the use of gap analysis in the development of a product’s key messages.
What is the aim of gap analysis?
The aim of the gap analysis is to ensure that all the draft (desired) key messages can potentially be supported by data derived from the planned clinical development programme.
Where does it fit into the communications strategy?
Gap analysis is one of the key steps in the development of a product’s communication strategy. It is an essential part of ensuring that the strategy covers everything that you want to say about the product.
However, various other aspects of the communication strategy need to be in place before the gap analysis can be conducted. These include the development of the target product profile and draft key messages. If you do not know what you want to say about the product, then you cannot identify the gaps!
When should it be performed?
There is no set time for this. However, ideally a first gap analysis should be done before proof of concept, i.e. before phase II results are known. This will ensure that any gaps identified can be addressed at the planning stage of phase III studies rather than after these studies have been completed.
What is the process?
Each planned endpoint in the planned phase III programme should be evaluated to determine whether it will provide relevant data to support any of the draft key messages.
It is important that when an endpoint is evaluated this takes into account the precise patient population being studied and the time over which the data will be collected, to ensure that it will be relevant to the target patient population. Although the target product profile will detail this for most draft key messages, this may not be the case for unmet needs or competitor claims, and such criteria will have to be developed. This is best done in collaboration with the pharma company’s medical function.
Once all the planned endpoints have been evaluated versus the draft key messages this will show how well, or not, each draft key message could be supported by phase III data, provided, of course, the studies actually provide the results hoped for.
How can gaps be addressed?
Once any gaps have been identified, different approaches can then be used to address these. The best solution would be the inclusion of additional relevant endpoints in the planned phase III clinical programme. Where this is not possible it may be feasible to include hypotheses that could then be tested in phase IIIa/b studies for potential inclusion in later studies. Another approach would be to conduct an entirely new study to answer specific gaps. Or it might even be decided that it is not be possible to address a specific gap(s) in the clinical development programme.
In summary, a gap analysis can be extremely valuable in identifying any immediate issues that need to be addressed before proof of concept, while any remaining gaps can be revisited after this.
What happens after gap analysis?
Once a gap analysis has been conducted the next step in the development of the product’s communication strategy would be to confirm the key messages, gain input from key opinion leaders on the product’s messaging and then decide how the key messages will be communicated to the key target audiences, i.e. the development of a detailed publication plan.
Is that it then?
The generation of a product’s communications strategy and publications plan is not a finite process and both need to be re-evaluated regularly, particularly at key milestones in the product’s development or when new competitor data or other relevant information becomes available. For example, if the initial gap analysis was performed before phase II results were known, then another gap analysis should be conducted to re-evaluate how well the key messages are being supported.
Thus, there will be many opportunities for further gap analyses in a product’s progress to market and beyond.
About the author:
Christine Gardner (E: gardner29@btinternet.com) has over 30 years’ experience working in and around the pharmaceutical industry and communication agencies.
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Feedback: Do you have any comments about this article? Contact the Editor, Mary Greenacre.
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