Scenario Analysis Planning for Phase III Results

3 Scenarios, 2 Months, 1 Message

321

 

Phase III data lock in sight? Your internal scenario analysis starts now. That’s three scenarios, two months in advance, one unified message. The three scenarios may be overwhelming efficacy, modest efficacy and insufficient efficacy. Each scenario analysis should consider the primary endpoint data, preliminary views, interpretation of the possible results and an explanation of next steps. Considerations include statistical significance, patient results, regulatory implications and commercial relevance.

3 Scenario Analyses Your internal scenario analysis begins with the statistical boundaries that frame the three levels of efficacy – overwhelming, modest and insufficient. Outcomes include the goal of the study, number of patients, FDA protocol, primary endpoints and statistical methodology. Below this top-line overview are the bullet points specific to each outcome – the statistical results, the interpretation and implications for the study. Under message development, the points are the words that will be used to convey the results. Is this a “new treatment option” for which you now have “the confidence to proceed”?  Or maybe the trial “did not meet its primary end point” and there are “additional analyses” and “realignment of resources” needed.

2 Months in Advance With data lock in sight, evaluate the statistical boundaries that frame the three levels of efficacy – overwhelming, modest and insufficient. Each of these levels will need appropriate interpretation for all stakeholders. This is also the time to identify impacted audiences – patients, caregivers and advocacy groups; employees and partners; KOLs and investigators; scientific and medical media; investors and financial media. The message development must include key proof points that support the overarching message pillars and channels of communication for each. What parts of the website need updating and who will be responsible? Is there print collateral that should be developed, presentations to create and/or refine?

1 Unified Message It’s critical to begin an integrated communications plan with a well-developed methodology. This ensures message development across all possible outcomes and communicated to all stakeholders. The announcement of top-line data results is too important to leave to chance. Start early and plan thoroughly for high efficacy message impact.

LaVoieHealthScience is all-in for biotech and pharma with 15 years’ experience delivering strategic communications for life science companies. Contact us today to learn more about how we help our clients ensure appropriate communication of Phase III results.