A guide to delivering the right evidence, to the right stakeholders, at the right time.
Building an Integrated Evidence Plan
A Guide to Delivering the Right Evidence, to the Right Stakeholders, at the Right Time
An integrated evidence plan is one cross-functional plan for all the evidence a product needs across its lifecycle.
It sets out which evidence each stakeholder needs, why, and by when. It brings clinical development, medical affairs, HEOR, market access, and commercial teams together around one set of priorities. Generating evidence is slow and expensive, so the plan matters as much as the studies in it.
Start planning about three years before the evidence is needed.
For every evidence need, ask four questions: who, why, when, and what if.
Prioritize gaps by their impact on decisions and patient outcomes, not by completeness of knowledge.
Measure success by the change the evidence creates, not just by whether the study was completed.
Every stakeholder needs different evidence to make its decisions.
A plan built by one function tends to miss what the others need.
Evidence beyond the pivotal trial, especially for expedited approvals
Evidence that meets varying regional and local requirements for access
Evidence to choose among a growing number of treatment options
Evidence on quality of life to support shared decisions
A clearer picture of unmet patient need
Evidence for a differentiated value proposition across the lifecycle
Alignment across functions and stakeholders
Fewer gaps missed through siloed thinking
Less duplication, and one study meeting several needs
A shared basis for deciding which research to decline
The evidence plan should be part of the medical, access, and commercial plans, not a separate workstream.
Most evidence needs are predictable. They cluster around three milestones.
For example, effectiveness across diverse patient populations beyond the trial
For example, budget impact for formulary committees
For example, data ready for scheduled clinical guideline updates
Unmet need, disease burden, standard of care, trial design, target populations, PROs
Budget impact, post-marketing commitments, early utilization
Real-world effectiveness, adherence, comparative effectiveness, subpopulations
New formulations and indications, effects of switching, response to new competition
Evidence planning is cross-functional by design. It can be led by Medical Affairs, HEOR, or a dedicated evidence function. Clinical development, regulatory, market access, commercial, and patient engagement all contribute.
Evidence of real value starts with asking the right questions.
Who is the primary audience, and who else will value the information? What do they believe and know today, and which sources do they trust?
Why will this evidence matter to them, and how will it change their decisions or practice? Could one study meet several needs?
Exactly what is needed, and by when? What change are you trying to create, and in what sequence should the evidence arrive?
What happens if the evidence is late or doesn't answer the question? Is there a faster alternative, and is your company the right group to generate it?
Start with the end in mind. Evidence only delivers its value if it is available when the decision is made.
Not every gap is worth filling. The test is whether closing it changes strategy, practice, or patient care.
Analyzing outcomes by mutation to see how it affects disease course and treatment response
Profiling mutations already shown not to affect outcomes
Surveying members of a patient organization about their experience of care
Asking clinicians what they think patients experience
Map the path from first symptoms to long-term care, with patient input. Then ask where new evidence would most improve:
Awareness and diagnosis
Initial treatment choice
Access to treatment
Patient experience and outcomes
Weigh strategic value for the company alongside short- and long-term benefit for patients. Some needs can be met quickly even if their
impact is smaller.
A gap doesn't automatically call for a new company-sponsored trial. Depending on the question and timing, existing data or a more pragmatic approach may work better. Check what your stakeholders actually find compelling before choosing.
The company defines and manages everything. Full strategic alignment, highest investment.
Company and partner contribute roughly equally, drawing on each other's strengths.
The investigator proposes and runs the study. The company provides agreed support.
Low confidence in a therapy isn't always caused by missing data. Sometimes the data exists but hasn't reached the audience: publications only in English, messages aimed only at congress audiences. Presenting existing evidence locally, in plain language and in the channels clinicians already use, can close the gap faster.
A plan is not fixed. Its success lies in the outcomes it achieves, not in delivering it as written.
Review the plan regularly and whenever the environment changes.
Four kinds of change most often call for an update.
A new mechanism of action, a safety event in a similar product, a product withdrawal
Planned guideline updates, HTA assessments, new screening or coding
New federal policies, pricing evidence standards, or gatekeeping
External data that fills a gap or challenges established thinking
Agree the strategy and critical success factors, and track progress against them.
Plan scenarios for delays, and be ready to change course if a project isn't delivering.
Debrief after each project and communicate plan changes promptly.
Delivering evidence on time is essential, but it is only the first measure of success. The value grows as you move along the results chain.
For example, the study was completed.
For example, clinician education was updated to include it.
For example, better treatment sequencing improved outcomes.
What do stakeholders know, believe, and do today?
Set it with cross-functional input, and check it is realistic given external factors.
Use ongoing insights and markers such as guideline or formulary changes.
The evidence strategy defines what proof the product needs and why. The integrated evidence plan turns that into specific activities, owners, timelines, and budgets across functions. You need the strategy first. The plan makes it happen.
Strategy decides what to prove. The plan decides how and when.
A good rule of thumb is to start about three years before the evidence is expected to be needed. Many needs around approval, access, and adoption can be anticipated from experience. Longer studies, registries, and partnerships need the most lead time.
If a decision is three years away, the planning is already due.
The plan is cross-functional, and it can be led by Medical Affairs, HEOR, or a dedicated evidence function. What matters most is that one lead is accountable, every relevant function contributes, and senior leadership visibly supports cross-functional collaboration.
One accountable lead, many contributors.
When it addresses a priority gap with genuine scientific merit, especially questions from everyday clinical practice or populations trials don't cover. The investigator is responsible for design and conduct. Agree roles, safety reporting, compliance, and data ownership before the study starts.
Investigator-initiated studies work best when they fit the plan's priorities.
At Alkemi, we help biotechnology and pharmaceutical companies build integrated evidence plans that connect clinical, medical, HEOR, access, and commercial needs. We identify and prioritize evidence gaps, map them to the decisions they must inform, and help teams keep the plan current as the landscape changes.
If your functions are each building their own evidence plans, or you're not sure what evidence you'll need three years from now, let's talk.
