The Part of Competitive Assessment About Clinical Trials

If you’re interested in evaluating a therapeutic product, your own or a potential competitor’s, and are new to why we do clinical trials and how they are organized, have a look at clinical trials at NIH and follow a few links for a high level overview. In particular, check out this page with a host of disease-related registries, through which patients and their families can find and share additional information and think about participating in clinical trials.

Thoughtful, Thinking

When I’m undertaking a competitive assessment for a client, I usually spend some time on another website operated by NIH, which catalogs all of the clinical trials in the US. It’s called “clinicaltrials.gov.” You’ll find it helpful to look at the guide to searching and do some of the sample searches further down on this page. For practice, I suggest that you choose a disease like “malaria” or a disease and a population, for instance “hepatitis” AND “children”. Or search the term “genomic” with any second medical term of interest. Then click through a few of the clinical trials that pop up, and get a sense for the kind of information that is available about the trials, particularly who is sponsoring the study and what “active pharmaceutical ingredient (“API”) is being evaluated.

To get more proficient with this data gathering tool, try searching for any other API or disease that is relevant to your own research or other interests! Then when you need to evaluate the competitive landscape for a disease of company or product, you’ll have have some “muscle memory.” These sites are some of the best sources of information about potential products in clinical development.

Innovation Strategy — It’s More Than Moving A Product From Point A to Point B

An effective strategy takes you from where you are now to a predetermined goal. The planning process requires a candid assessment of what’s at both ends of the path so you know where you’re starting, where you’re going, and how to get there! In business, the assessment is usually fairly detailed and iterative.

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In contrast, when your objective is part of a personal strategy for achieving self improvement, for instance, working mindfulness meditation into your daily life, success is mostly under your control as long as the universe cooperates.For instance, finding the time to make something a new habit is often a mission critical component of implementing a “personal” strategic plan. Yet even this can be a challenge, and we all know that. My most recent success was actually doing 108 days in a row of yoga, with inspiration fromTravis Elliott, the ultimate yogi (available on DVD), and thanks to my cat, Raven, for keeping me company on some late night workouts! There are plenty of great self-help guides. One of my current favorites is “Better Than Before: Mastering the Habits of Our Everyday Lives” by Gretchen Rubin (2015).

In the technology innovation context, however, simply being intentional about getting from “point A” to “point B” isn’t enough. For instance, a competitor might get there first. Witness the epic patent infringement battles between Apple and Samsung. Or if the goal is developing an effective pharmaceutical product, it may not be worth the effort (and cost) involved if the therapeutic space is too crowded when you arrive. Your product has to be better enough than the alternatives so that the health care system will pay for it. Here’s a news story about states that won’t pay for a blockbuster drug to treat hepatitis C.And that’s just the developed countries’ perspective — how to make a given product available globally often adds a seemingly confounding layer of strategic and financial complexity to the process.

Successful strategic planning thus requires knowing way more than just the location of “point B” and heading in that general. One also needs to evaluate the lay of the land at “point A” and to understand the hurdles likely to be encountered and plan for them — including obtaining financing, hiring and retaining the right people with the right intellectual capital and effective teamwork skills, gathering research materials, securing patents, avoiding the infringement of patents owned by others, navigating the regulatory system and qualifying for reimbursement by third-party payers.

This integrated kind of evaluation is referred to variously as landscape analysis, competitive assessment, due diligence and is also known by a few other labels. It can be quite complex, and is done best with a multidisciplinary approach and team.

This is one if a series of posts that will dig into various aspects of that “competitive assessment” process. It’s intended to be provide some basic “how-to” guidance in evaluating the translational potential of a given research product and offer some useful tools in assessing the commercial potential of a developmental product.