Clinical Data Gap Analysis ­Uncovering Hidden Opportunities

Contributed by:

David Fishman, MBA President, Snowfish LLC

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

David Fishman, MBA President
Snowfish LLC

The practice of medicine relies on clinical evidence. From a product’s conception through approval, launch, and post-launch activities, clinical evidence is the rationale for a product’s overall existence. Clinical data is critical for differentiation and ultimately, market acceptance. A solid grasp of the clinical data for a product and its competitors can open up new opportunities and markets.

The starting point to assessing the market opportunity, setting product direction, recommending clinical trials, and building differentiation is systematic analysis of the available data. This may be accomplished through a process known as clinical data gap analysis.

Gaining a solid grasp of the clinical data can be a significant challenge. For a given therapeutic class or disease state, there are often hundreds and, in some cases, thousands of clinical trials.

Furthermore, individual studies will likely measure a number of heterogeneous trial elements such as study population, multiple primary and secondary endpoints, product claims, and attributes. There is clearly a significant amount of data to capture, organize, and analyze.

Why Perform a Clinical Data Gap Analysis?

Clinical data impacts a whole range of activities across multiple departments in a pharmaceutical or medical device company. Clinical data gap analysis provides a systematic review of a product’s data, compares it with that of its competitors, and then assesses how uncovered gaps fit within contemporary clinical practice. Undergoing this systematic review helps to set a product’s course and uncover hidden opportunities.

A clinical data gap analysis is typically used by various areas within life sciences companies including: » New Product Development

» Medical Affairs
» Marketing
» Research & Development

The clinical data gap analysis is most often used for:

» Clinical trial planning
» Product development
» Brand positioning
» Product planning

What is the Process of Clinical Data Gap Analysis?

Our approach to performing a clinical data gap analysis captures all the available clinical information on a given disease state utilizing information from multiple disparate sources and compares the available data for a particular product with that of its competitors. These “data gaps” are identified through the review of hundreds to thousands of published and unpublished clinical studies. Not all of the identified gaps are worth pursuing. To maximize efficiency the top clinical gaps are tested with clinical stakeholders. To facilitate decision-making, the gaps are placed into an overall analytic framework to further refine the analysis and determine the impact of a particular direction.

The strength of clinical data gap analysis is that all relevant information is captured, analyzed, and tested. The value of clinical data gap analysis is in evaluating the individual gaps and determining their relative weighting based on individual company circumstances and resources. These weightings provide insight on the areas with the highest potential to impact a product’s commercial success.

Benefits of a Clinical Data Gap Analysis

Through clinical data gap analysis, a company can determine if it is truly necessary to follow the common paths being taken by the competition, jump on the next important clinical use, and uncover very useful data that already exists and can be instrumental to further product growth.

Clinical data gap analysis is an integral tool for life sciences companies to maximize the market opportunities for their products. This type of analysis allows companies to make the soundest decisions in planning for their products and use their precious resources most wisely.

For more information on uncovering hidden opportunities for your product(s), access the complete white paper below.

 

Snowfish LLC provides strategic market analysis and insights to healthcare, life-­sciences, and biotechnology companies. To contact Mr. Fishman directly, please call 1-800-Too-Snow-Guy (866-766-9489).

For more information, visit snowfish.net The Power of Clinical Data Gap Analysis Provided by: Snowfish

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