N-of-8 groups: elements of an impactful meeting

I really enjoyed working with Cindy B over the years to create impactful N-of-8 groups.

Here's some notes from the archives as we thought about the elements of one meeting.

N-of-8 success stories with KOLs

In many of my N-of-8 blog posts, I’ve shared success stories from working with Key Opinion Leaders a variety of markets. 

What they all have in common is a way to get the most from thought-leader interactions with a structured approach like N-of-8.

• Opinions can be applied to a change in practices.   
• Thoughtful questions can open up productive exchange.  
• Planned agendas should go beyond one-way presentations to gain meaningful insights and advice.   

Most of all, facilitated sessions with relevant exercises can move participants to want to stay active and work together to create something new and different.

5 kinds of case studies to understand and benchmark current clinical practice with N-of-8

With the array of information available now through journals, seminars, societies, textbooks, and online searches, to name just a few sources, it is understandably difficult to determine on your own what constitutes relevant current practice and what does not.

The first step in approaching this task may be to clarify the differences among basic research methodologies and to examine how different methodologies are designed to answer different types of practice questions.

Qualitative research is not typically designed or intended to yield causal conclusions. It is generally intended to describe or explain behavior and thus should not be used to make conclusions about motivation or influence.

That said, qualitative research contributes a great deal of essential information.

With the N-of-8 techniques I developed, you can explore attitudes, opinions, beliefs, perceptions, interactions, practice structure, and behaviors in various settings.

A case may be based on:

1. an individual customer, who has an established routine
2. a practicing group of physicians or researchers, who have created common protocols
3. a hospital, that uses a documented treatment algorithm or formulary
4. a professional society, which has published practice guidelines
5. an event, that exemplifies the experiences of the group

For example, I worked with a client with a treatment for a rare medical condition and collaborated with several research partners to report an analysis of eight cases of practices. Specifically, we collected observations of in-office activities, interviews with generalists and specialists, patient notes, videotapes of interactions, and other materials. The purpose of this study was to thoroughly examine the actual behaviors in these cases.

We gained valuable insight into the nature of diagnosis, patient communication, and most important, ideas for product packaging and training before the brand launch.

The major purpose of N-of-8 research is to understand current practice, product usage, and customer behavior.

Engaging “Opinion Leaders” that may be “Practice Influencers”

I've shared many examples of how N-of-8 can shift opinion to practice.

Another case was when I moderated a group of leading cardiologists to discuss eplerenone, the first agent designed to selectively block aldosterone for the treatment of high blood pressure.

The eight participants in this group included the chair of a major medical society, the client’s chief medical director, and six of world’s top hypertension specialists.  We were to discuss how aldosterone blockade reduces mortality and morbidity among patients with severe heart failure.  Simply put, eplerenone is used to treat high blood pressure by blocking aldosterone, which in turn lowers the amount of sodium and water the body retains. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Eplerenone is also used to treat congestive heart failure following a heart attack.

To say I felt intimidated would be an understatement.  As their facilitator, however, my job was not to go toe-to-toe on the science.  Instead, I was to help determine how emerging science could apply to practice.

The conversation turned to the difference between diastolic and systolic blood pressure.  And after several minutes, I asked the most innocent and naive question:  

“When you say systolic BP, 

what would that mean to 

the average family physician?”

Well, the question was apparently so elementary that my client almost had a cardiovascular event right there.  But then, one doctor responded, “You know, that’s a very provocative question and one that has created some controversy.”  This led to a lively, engaging, and fruitful debate – with more implications for practice than we expected.

Approximately 50 million, or one in four, adult Americans, have high blood pressure. Of those, 73 percent are not adequately controlled, and are at increased risk of heart attack, stroke, kidney failure, damage to the eyes, heart failure and atherosclerosis. Control of hypertension has remained inadequate despite the availability of several key classes of compounds.

"Hypertension is a complex disease with many factors contributing to the problem," said the advisors during our N-of-8.  "For patients and their health care providers who face unique challenges in achieving and maintaining control of their high blood pressure, eplerenone could represent an important new treatment option that goes beyond standard therapies in targeting the aldosterone pathway."

Preclinical and clinical studies had suggested that eplerenone works with relative selectivity to block aldosterone receptors, a key component within the RAAS (renin angiotensin aldosterone system).  This fact, the advisors said, plays a significant role in the body's regulation of the cardiovascular system.

In the discussion, they concluded that data showed the addition of eplerenone to optimize medical therapy could reduce morbidity and mortality among patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.

This all ultimately contributed to the company’s marketing strategy.  FDA initially approved eplerenone for the treatment of hypertension, but the brand team decided to wait another year for a second indication – the treatment of congestive heart failure (CHF) secondary to an acute myocardial infarction – a first for any drug in the class. 

Eplerenone was launched, and marketed by Pfizer, under the brand name Inspra.

4 principles of N-of-8® applied to “advisory boards”

I continue to promote the principles of N-of-8® to the ubiquitous tactic of “advisory boards.”  

That means demonstrating how the tool can be use to identify the right advisors, maintain a practice focus, create an agenda, and produce actionable results.

1. Advisor relationships are based on science, mutual collaboration, and engagement.  They tend to evolve over time.
2. When creating N-of-8 Advisory Boards, recruit both “opinion leaders” and “practice leaders.”
3. Instead of just asking for reaction, you should use N-of-8 to create a forum for insight and advice.
4. When facilitating an N-of-8, move from the “should do” to gain agreement on the “let’s do.”

The N-of-8 interaction process with thought leaders is different than the immediate, transactional tactics used on the commercial side of a company.  Instead, it builds on relationships based on science, mutual collaboration, and engagement.  These tend to evolve over longer periods of time than interactions with inline brands.

Because an N-of-8 advisory board is not a sales event, it must be assessed more like you’d assess a focus group—by number of positive reactions.  Yet, it can help a brand innovation team address the challenge of creating, maintaining, and leveraging those positive reactions  -- and still safely navigate regulatory hurdles.

Thought leaders will continue to be a critical component of a bio-pharma company’s professional marketing and medical strategy.  Therefore, we must maximize their impact in diffusing innovation and disseminating scientific information. 

Life science brand executives can rely on the N-of-8 tool for this goal.