Announcing Phase 3 Data: A Defining Moment

By Kevin Bruns

Years of pre-clinical and clinical research are about to conclude and your Phase 3 data set is ready. You may be unsure of the outcome, but regardless of whether the data are positive, negative or neutral you know this is a defining moment for your company.

You also know you’ll need to communicate the findings to key stakeholders including investors, payers, physicians and patients. But, how?

SmithSolve partners with clients throughout the process to anticipate risk, position the data, and manage timelines with a single goal in mind: a clear, balanced assessment of the data and their implications. Clinical trial results can define the trajectory of a company. For smaller companies in particular, this event determines share price and may set the stage for commercial success or failure.

SmithSolve understands the stakes are high and has a tried-and-true method for guiding clients through Phase 3 data announcements using a four-step process:

  1. Prepare Scenarios. Plan for the various outcomes your data set may yield by drafting a news release for each scenario. The two most likely are positive and negative, but we always recommend preparing for the pesky neutral or “not statistically significant” scenario as well.
  1. Build Support. Identify and prepare spokespeople who can clearly and concisely articulate the importance of the data as well as the potential impact the data may have on the patient community and/or the larger healthcare landscape. Keep in mind, a spokesperson will be a reflection of your company with the media and other audiences. Investigators often make excellent spokespeople, because they have a high degree of familiarity with the compound or device as well as the trial protocol and data. Regardless of the spokesperson’s credentials or familiarity with the subject matter, always provide media training ahead of any interviews to maximize successful message delivery.
  1. Break Through the Noise. Define clear, credible and concise messages that will differentiate your compound or device from competitors. It’s imperative to deliver these messages with clarity and impact, so they resonate with all audiences. Visuals and multimedia materials have high impact, are easily sharable, and enhance any announcement. “A picture is worth a thousand words” rings true when you produce the right multimedia content.
  1. Sustain Momentum. Before disclosing the data, make sure your organization is prepared to field and prioritize media inquiries to align spokespeople with priority outlets and reporters. You’ll also need a sound protocol for monitoring and reporting of media coverage to address inaccuracies or misperceptions. Lastly, keep the big picture in mind; how will you keep the momentum going through future milestones, such as regulatory filings with the U.S. Food and Drug Administration.

To learn more about how SmithSolve can help you maximize upcoming data release communications, please drop us a note or give us a call.