An integrated evidence plan (IEP) is a single, cross-functional plan that sets out the evidence a medicine or device needs over its life, which questions that evidence must answer, who will generate it, and in what order. It brings the needs of clinical development, medical affairs, health economics and outcomes research, market access, regulatory, and commercial into one document, so the company runs one evidence program instead of several that overlap. Medical affairs usually leads it.
Quick answer: The Medical Affairs Professional Society (MAPS) publishes the reference guidance. It describes an IEP as a common approach across departments, led by medical affairs, that covers the whole product lifecycle. The plan lists evidence gaps, ranks them by need and impact, assigns each one a way to close it, such as a company-sponsored study, real-world evidence, or an investigator-initiated study, and is reviewed as new insights arrive.
What an integrated evidence plan contains
The core of the plan is a list of evidence gaps: questions that someone outside the company will ask and that current data cannot answer well. For each gap, the plan records who is asking, why it matters, how important it is, how the company intends to close it, and when the answer is needed.
MAPS frames those needs around three decisions the product has to pass. Approval needs evidence such as effectiveness across diverse patients beyond the randomized trial. Access needs evidence such as budget impact for formulary committees. Adoption needs evidence that supports updates to clinical guidelines. A plan built only for approval leaves the access and adoption questions without evidence behind them.
Beyond the gaps, a working plan usually holds:
- the evidence the company already has, so nobody funds a study that repeats a published result
- the planned studies and analyses, with owners, budgets, and dates
- the stakeholders each piece of evidence is for, from regulators to payers, guideline committees, clinicians, and patients
- the research the team has decided not to do, and why
- how progress and value will be measured
Why the plan is integrated
Without one plan, each function builds its own. Clinical development designs trials for the regulator. HEOR plans an economic analysis for payers. Medical affairs approves investigator-initiated studies one request at a time. Each piece can be sound on its own, while together they duplicate effort or leave the question a guideline committee will ask with no study behind it.
The MAPS 2025 guidance on strategic integrated evidence generation planning lists the benefits of a shared plan. It aligns stakeholders, avoids siloed work and missed gaps, focuses effort on the work with the greatest impact, and gives every function, market, and budget the same access to the evidence. One benefit is easy to overlook: the plan gives the team an agreed basis for saying no to research that does not fit.
Who owns it
MAPS places medical affairs at the center, because it sees the needs of clinicians, patients, payers, and the internal functions at once. In practice an evidence lead or a medical director owns the document and runs a cross-functional team. Field medical feeds it: questions MSLs hear from experts are often the first sign of a gap, which is one reason medical insights are reviewed against the plan.
How a plan is built and kept current
Planning starts years before approval and is part of launch excellence. The team gathers the existing evidence, maps the stakeholders and what each will need, lists the gaps, and ranks them. Each gap then gets a method. A randomized trial is one option. Real-world evidence, a registry, a non-interventional study, a literature review, or a research collaboration may answer the question faster or at lower cost.
Investigator-initiated studies sit inside the same plan. An external investigator proposes the study and the company decides whether to support it. The plan tells reviewers which proposals address a priority gap. How a single study is run from request to publication is covered in how medical affairs runs an investigator-initiated study.
The plan is never finished. MAPS recommends reviewing it regularly, because new competitors, new indications, payer reviews, and field insights change what evidence matters. It also says that success is measured by what the evidence achieves, such as a guideline update or a coverage decision, rather than by the number of studies delivered.
Where the studies are tracked
The plan says what evidence is needed. The studies that come out of it still need an owner, milestones, and a budget. TikaStudies keeps investigator-initiated studies, company-sponsored non-interventional and real-world evidence programs, and research collaborations in one medical affairs portfolio, each with its principal investigator, institution, milestones, documents, and spend.
Frequently asked questions
What is an integrated evidence plan?
An integrated evidence plan is a single cross-functional plan, usually led by medical affairs, that lists the evidence a product needs over its life, ranks the gaps, and assigns each one a method, an owner, and a date. It replaces separate evidence plans in each function.
Who owns the integrated evidence plan?
Medical affairs usually leads it, often through an evidence lead or medical director. Clinical development, HEOR, market access, regulatory, commercial, and patient engagement contribute their needs, and MAPS guidance places medical affairs at the center of that group.
What is the difference between an integrated evidence plan and a clinical development plan?
A clinical development plan is built mainly to support regulatory approval. An integrated evidence plan covers approval, access, and adoption across the whole lifecycle, and includes real-world evidence, HEOR work, and investigator-initiated studies alongside the trials.
How often should an integrated evidence plan be updated?
Regularly, and whenever something material changes, such as a new competitor, a new indication, a payer review, or a pattern in field insights. MAPS guidance describes the plan as adaptive rather than fixed at launch.
If your team tracks studies in several spreadsheets and wants to see the portfolio in one place, we can walk through it with studies from your own therapeutic area.
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Sources
- Medical Affairs Professional Society. Strategic Integrated Evidence Generation Planning: Company and Non-Company Sponsored Research. Guidance document, 2025.
- Medical Affairs Professional Society. Standards & Guidance: Integrated Evidence Plan.
Glossary
November 1, 2026
