• by Neil Weisman , January 24, 2012

As a healthcare marketing professional, you must understand how medications are used to treat patients in order to develop innovative and effective communication strategies. But how much do you know about how these products are brought to market? No doubt you've heard of clinical trials, but our guess is, like most, your knowledge beyond that is limited. Understanding the clinical development process will give you a deeper understanding of the products and services you are promoting, which, in turn, will make you a more successful marketer.

How Understanding Clinical Development Benefits You

There is a good reason why you're probably not familiar with clinical development. There is an imaginary wall separating clinical development (pre-approval) and marketing (post-approval). Any hint of promotion prior to approval could compromise the data submitted to the FDA. However, as a marketing professional, there is valuable information you can learn from clinical operations for the following reasons:

1. We talk with your patients first.

2. We talk with your prescribing physicians first.

3. We know what products you will be marketing tomorrow.

Before exploring these, here's a quick overview of the clinical development process and the challenges facing the industry. There is a wealth of information online if you're interested in learning more. CenterWatch.com and CSCRIP.org are terrific references.

Clinical Trials 101: A brief overview

The process of securing approval for a new compound is long and costly. It can take 12-17 years and cost upwards of $1 billion for a compound to make it all the way through the clinical development process. And many don’t make it that far. It is estimated that for every 5,000-10,000 compounds developed in the lab, only about 10 will qualify for human testing, and only 21.5% of these will be FDA approved, according to Medical Marketing and Media. With drug patents lasting only 20 years, time is of the essence for pharma to complete clinical trials as quickly as possible.

There are three phases of clinical trials. Phase 1 looks at safety, usually in healthy volunteers. This is the first time the drug is introduced in humans. Phase 2 looks at the effectiveness and safety of the drug, and is the first time the drug is taken by people with the condition. Phase 3 tests a larger population of people to determine scalability. Each phase can take several months to several years. Once all three phases have been completed, the pharmaceutical company can submit to the FDA for approval.

How to Recruit Patients for Clinical Trials

Clinical trials are conducted at physicians’ offices, often called investigative sites. Frequently, sites will be chosen to participate in a trial because they already have practice patients who may be eligible to participate.

If a pharmaceutical company wants to accelerate enrollment, or if the trial requirements are very challenging, they may hire a marketing company that specializes in patient recruitment, like Blue Chip, to supplement the sites’ efforts. The patient recruitment company develops a direct-to- consumer campaign using a variety of tactics. When pharma hires a marketing company, a wealth of research, benchmarks, and other tracking metrics are captured, dramatically increasing the opportunity for learning for commercialization and brand.

We Talk to Your Patients First

The strategy developed for a patient recruitment program is the first marketing campaign targeting your potential customers. Like in post-approval marketing, we research their lifestyle, attitudes, media consumption, etc. We also integrate historical response patterns, which tactics were most effective, and levels of patient commitment. We believe that a parallel exists between research participation and taking a marketed medication, in that participants represent early adopters.

We Have a Relationship with Prescribing Physicians

In addition to patients, clinical trials engage the physicians who will eventually prescribe your product. Experience has shown that these physicians will become your brand ambassadors once the product is approved. You can continue to build on the relationship that your company established on the clinical side. You can also gain feedback on physicians’ and participants’ experience with the medication, as well as questions or concerns they had.

We Know What Products You Will Market Tomorrow

It’s always good to know what is coming down the pipeline for your marketing projects. The face of pharmaceuticals is changing rapidly. The era of big blockbuster medications is evolving to personalized and tailored therapies. The FDA is requiring more data and more trials than ever before, resulting in lengthier and more expensive drug development.

While we cannot tear down the walls between clinical and marketing, we can share notes, particularly when clinical trials are completed. Imagine there’s a whole team of people you’ve never met who are just as passionate and committed to successfully developing the same product you’re launching. So when the time is right, make contact—there’s plenty to learn from each other.