Are you maximizing the drive to data with your clinical trial?
Clinical trials are the backbone of advancing therapeutics. The investment made in financial and human capital are tremendous. The trials themselves represent true hope to those who can benefit from them the most, clinically. Sometimes even a last hope. Success can be life changing. And failure can shutter companies and their pursuit of making a difference. As the clinical trial process is just that – a process – more and more data is acquired and greater confidence garnered as therapeutic candidates clear hurdles. In addition to funding the trial itself, companies are wise to invest in building a communication foundation that can be leveraged in both the short- and long-term.
When your clinical trial’s design is established and approved, you know the outcomes you aspire to achieve. The direction is clear. It may be to treat a condition that previously had no indicated therapy. It may be to overcome hurdles with existing therapeutic options. Or it may be to achieve even greater efficacy or durability. Whatever the clinical objectives, they form the earliest seeds of brand differentiation and value.
Influencing the market requires time, effort and an enduring commitment. This is why communicating to relevant audiences at the launch and throughout a clinical trial is so important. Here are five things to keep in mind as you move forward.
Define or Redefine the Disease State
It is critical to position the disease state in a manner that highlights the clinical challenges you hope to overcome with the therapy being studied. Healthcare professionals, patients, payers and even regulatory bodies may all have preexisting perceptions of the disease state and approaches to management or treatment. These perceptions may be accurate or inaccurate, but it is essential for the drug candidate to have a reason to be and this starts with the presentation of the clinical challenge. It is important to be clear, consistent, compelling and, moreover, credible when making this argument.
Identify and Communicate Meaningful Differentiation
It could be a new class of drug, or its mechanism of action. It could be method of delivery or formulation. Whatever sets the drug candidate apart in a meaningful manner should be clearly communicated in the context of existing and potential treatments. This core attribute is also inextricably tied to the clinical trial. Explain the approach being taken, how it is different and why it matters (how it’s clinically relevant).
The clinical trial is the one period of time where aspirational statements are not only permissible from a regulatory perspective, but expected as part of the trial’s reason to be. Aspirational language needs to be credible. It needs to capture what you hope to accomplish with the clinical trial. As these are clearly aspirational statements, they do not share the same burden of clinical evidence as the product claims that will eventually emerge is the trial is successful. Clinical trials provide real opportunities for practitioners and patients to make a difference. Communicating in an aspirational manner can help not only with recruitment, but also establishing interest and positive awareness.
Start Building Relationships
Whether it be with potential key opinion leaders, advocacy organizations or patients themselves, clinical trial communication is an effective way to begin identifying constituents and forming relationships. It is vital to remember that in building these relationships there needs to be mutual benefit. Stakeholders must be valued and their participation viewed as partnership. Relationships take time to form and strengthen. Trust takes time to establish. All the more reason to begin this process early and not during a time of urgent necessity.
Seed the Market
Time prior to drug approval can be instrumental to preparing the market for a product launch. Far too often, this time is squandered. Utilizing this time to communicate the disease state and clinical trial aspirations can help identify potential patients for treatment and build demand for the product prior to its launch. In certain instances, this can even delay treatment decisions until your product enters the market. Seeding the market can facilitate competitive advantage and amplify a launch’s success.
How you conduct your clinical trial also says a lot about your company. How you communicate during this period of time can also directly shape perceptions of your potential treatment as well as organization. So as you embark on your clinical trial program, be prepared to communicate. Be transparent with your learning along the way. Be inspirational to those who you want to affect. Be deliberate with your messaging. And take advantage of this very narrow, yet critical window of time.
by Jonathan D. Katz