Due Diligence Considerations as Part of Clinical Study Design

The Bracken Group

You have a great molecule and/or a great technology with amazing potential. But, there are many barriers between you and market success. Several can be managed by seeking due diligence input into the design of your clinical studies.

Start by Delving into the Competitive Landscape

While you’re in drug development, you need to spend time carefully analyzing your competitors and potential competitors:

Who else is working in your field? What are the drugs? Do they have a similar mechanism of actor or drug target? Who else has a similar indication? In the case of drugs not yet launched, when is it likely they will get to market? Will they beat you or follow you? What is their target product profile? How does your product compare? What benefits do other products offer? How is your product more or less attractive? Is it safer? Will it be more effective? Does it offer a different mechanism of action? Are there any challenges they are encountering as part of their regulatory review process?


Know that Marketing will Appreciate your Due Diligence

With a thorough understanding of the marketplace, you can support the distinguishing attributes for your product by building in these parameters into your clinical studies. That means marketing will have distinguishing attributes to talk about in your promotional materials down the road. So, make sure you measure the right clinical endpoints. You might even add secondary endpoints that will help you tell your story.

Remember that even though your product may be far superior to the competition, if you haven’t taken the time to make sure you capture your advantages in a prospective manner, you might never be able to talk about them.


Investors will Appreciate your Due Diligence, Too

Venture capitalists see a lot of companies. The ones that are the most buttoned up tend to interest them most. You’ll be in a stronger position with any potential investors if you can provide a detailed explanation of the marketplace in which you’ll compete and the considerations you’ve made to strengthen your position in it. Investors are always interested in the competitive landscape a key criteria when establishing a market valuation for your product or company

Can you demonstrate a thorough understanding of your competition today and down the road? Have you developed an approach to beating that competition? Is your clinical study designed to give you the ammunition you need? Investors want to hear “yes,” “yes,” and “yes.”


Due Diligence Prepares You for Global Opportunities

Will you be happy to market your product in the U.S., or do you have a global vision? If you foresee opportunities in Europe and/or Asia, you need to design a clinical trial that will meet the requirements of foreign regulatory authorities. They don’t always align with those of the FDA.

More than one company has found that what met FDA expectations did not necessarily meet those outside the U.S.

Understand the requirements before your trial is underway and enjoy a world of opportunity.

Once your study is completed adaptations are nearly impossible. Do all you can as soon as you can to make sure it’s done right, and it will serve your business well.


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