For truly effective evidence planning, we bring together strategic thinking, in-depth knowledge of evidence methods, team engagement, change-management skills and efficient project management.
As expert scientific facilitators, we have many years of experience connecting global cross-functional teams with key affiliates and external experts to work together to determine the future direction of medicines.
Our approach to evidence planning, shown below, can be adapted to match your in-house processes and systems.
First and foremost, planning should focus on understanding what evidence is desired by the key external stakeholders - regulators, HTA agencies, payors, guideline groups, healthcare providers and patients – in the context of the evolving competitive landscape.
A transparent, honest and thorough exercise - evidence-based, not opinion-based - to determine the data gaps between the present state of the evidence base and the desired state to achieve strategic goals.
Here, we bring together an understanding of the data gaps and priorities, vis-à-vis external stakeholder needs, to help our clients articulate their evidence-generation goals. In some cases, we advise formulating different sets of Evidence Objectives that reflect different potential competitive scenarios.
In this phase, we brainstorm a wide range of evidence-generation options that might address the Evidence Objectives (ranging from clinical trials to real-world approaches, as well as non-study methods such as SLRs, modeling and expert consensus statements). Working with internal and external stakeholders, we examine the pros and cons of all options to determine which should be taken forward to the detailed study-design stage.
Finally, we bring all the thinking together in a detailed tactical plan. The evidence generation concepts that have been agreed on are pulled together in a single visual, which will also highlight key work that needs to be done to enable a final go/no-go decision, as well as gating decisions and external milestones.
Integrating activities in this way helps ensure there is alignment and clarity across the global team and key affiliates. The roadmap can also be a powerful communication tool for senior management and external experts.
