An evidence generation strategy is an advanced plan for generating evidence necessary for all the steps of the product life cycle. Traditionally, research follows consecutive steps which is more of a reactive process. Using an evidence generation strategy allows for proactive planning and execution of a holistic strategy.

What is evidence generation and what is it used for?

Evidence generation is multifaceted and includes various study designs and data sources. Typically, each department involved in the process (e.g., clinical development, medical affairs, and health economics and outcomes research (HEOR)) works in a siloed structure and independent from one another to come up with evidence to support their specific research topics.

Integrated evidence-generation plan (IEP) is a strategy used where the upfront research plan is developed specifically to find evidence to address the concerns of each stakeholder group (payers, clinicians, patients). Beyond simply proving if a therapy is effective and safe, pharmaceutical companies need to prove that the new treatment is addressing market gaps that the current products do not meet.

Each of these stakeholders have different needs and questions regarding new treatments. Payers, those who pay for the development of the treatment, want to ensure the final product has a value to the healthcare system and will prove to be profitable when launched. Clinicians look for evidence-based research to show how the new treatment is different from existing options. Patients need to know how the new treatment will meet their needs and solve their problems.

An IEP will pinpoint these motivations from each group and strategically set up testing to address each one. Considered in the planning are all functions, geographies, and the entirety of the life cycle to meet the needs of the various stakeholders. Demonstrating the economic, clinical and patient burden of a disease is a key need early in the development process and sets the stage to inform stakeholders regarding the potential value of a product.

Why it is important to have a plan early?

Early evidence-generation planning is key to allowing time to connect all the dots between functions and requirements. It is of vital importance when demonstrating value for the new treatment and it must be demonstrated throughout the lifecycle of the product (early development, clinical research, launch, and post approval) to understand the implications of how the product will address needs at each step along the way.

Impactful data points for each function team (medical, clinical, commercial) can be identified and a roadmap created to ensure the evidence-generation plan includes steps to achieve these data results which will add to the products overall value proposition. A cross-functional and early approach ensures the funding and required expertise is available at all stages.

What are the main steps where you could need evidence?

The ultimate goal of the treatment is to hit the market and provide a solution for the patient, add value to the healthcare community in the form of a differentiated treatment, while being profitable for the developer. Therefore, during the development of the product, it is beneficial to incorporate these factors into each stage of the product lifecycle.

In the early stages of development, there is a need to understand the current state of care for the target patient population. This includes conducting market research, literature reviews and developing a Health Economics and Outcomes Research (HEOR) strategy, identifying possible clinical trial designs, among other tasks that could benefit from evidence-generation. At this point in the product life cycle, the payer stakeholder is interested in the economic burden of disease in order to justify resources required to develop and adopt a new treatment.

During the clinical research and development stage is when patient trials and market access strategies start to be executed. Evidence generation collected from Randomized Clinical Trials (RCT) and patient reported outcomes (PRO) can be paired with Real World Evidence for proof of treatment effectiveness and differentiation of current on-the-market products. Clinicians will be most interested in the data that comes from this stage.

To launch a new product, a medical affairs team may use the evidence to inform their market access strategy and develop communications that target patient needs identified early on in the IEP. The launch stage is where the end prescriber and patient will be convinced of the value of the new treatment based on evidence leveraged through the marketing campaign.

The integrated evidence-generation plan utilizes the research results of all functions: market research, health economics and outcomes research, clinical trials, market access, patient-reported outcomes, literature reviews, etc, and combines them with the strategic objectives and ultimate value proposition. Be proactive with your go-to-market strategy, and plan in advance to address the needs of each stakeholder group. Along with a software suite for clinical trials, EvidentIQ offers the ability to run prospective and direct-to-patient studies with patient-reported outcomes through its Carenity Patient Platform. Carenity part of the EvidentIQ Group is a key partner to consider to support your data generation plan.

Take a look at our RWE offer.