Since the FDA introduced the 21st Century Cures Act in 2016, pharmaceutical companies have recognized that regulatory approval alone does not determine a drug’s efficacy or even commercial success, compelling them to evaluate every product from a value standpoint. Consequently, today’s pharmaceutical sector relies heavily on health economics and outcomes research (HEOR) and real-world evidence (RWE) to gain a clear understanding of how their drug is performing with the patient population on which they are focusing.
Challenges with Traditional Clinical Trials
Conducting a traditional clinical trial is not enough. In the traditional method, patients are typically homogeneous, exposed to a specialized clinical environment, and placed under strict observation. Whereas in the real world, patients are highly diverse and are not always put under strict observation by physicians – indicating that what happened in a clinical trial does not always reflect what happens after a drug enters the market. To counter such concerns, you need real-world clinical evidence to best understand the risks and benefits associated with your product throughout its product life cycle. HEOR facilitates the evaluation and selection of best treatment alternatives as it presents a “big picture” of the real world by generating RWE.
RWE is derived from the analysis of real-world data (RWD), which provides clinical evidence and associated risks concerning the product and supports the clinical trial framework and observational studies to develop innovative treatment solutions that meet patients’ expectations.
In a nutshell, HEOR and RWE provide insights into the prospective outcomes of the product by addressing the following issues from early-stage through launch and post-launch product planning:
- Product Safety and Risk Concerns: RWE offers a comprehensive insight into patient profiling and product exposure in the real world, including those products’ relative safety concerns, risks, efficacy, and more. These insights allow you to evaluate the standard of treatment, evaluate the product to what is already on the market, and update clinical recommendations as necessary. Additionally, it aids in obtaining regulatory permissions.
- Clinical Trial Design: Due to the frequent exclusion of certain demographics in traditional clinical trial designs, it can be quite challenging to assess a product’s effectiveness in a real-world situation. To address such issues, RWE can assist in gathering information about a broader demographic of society, which will be beneficial in developing protocol design and patient and site selection strategies, developing appropriate sample selection for clinical trials, and reducing trial failures.
- Healthcare Decision Making: The HEOR study provides the most recent research on patient traits and treatment patterns as well as pinpoints the subgroups that are appropriate for the drug. Such a study offers a more in-depth perspective on the product’s effectiveness, enabling you to make well-informed decisions. Also, it can facilitate patient-professional decision-making collaboration, which is essential in cases involving uncommon diseases.
- Cost Justification of Product: HEOR and RWE focus on bringing out the economic evidence in addition to providing real-time clinical evidence; these pieces of evidence empower you to better support and convey your product’s treatment protocols and effectiveness to your targeted stakeholders.
- Brand Adoption Strategies: To understand how your product is performing in the real world, HEOR advocates empirical studies on product adherence and adoption. It helps you map out the patient’s journey and quickly discover business possibilities and constraints. From there, you can fine-tune your brand adoption strategies by selecting the ideal target audiences and creating customized marketing campaigns.
Along with all these concerns, HEOR and RWE also support demonstrating value for optimal formulary positioning by establishing an effective communication chain to illustrate the benefits of your products and increase your negotiating leverage. Additionally, it can be used to expand an indication for a medicine that has already received regulatory approval for another use.
Bridging Knowledge Gap with HEOR and RWE
The real-time information provided by HEOR and RWE explains why a drug’s performance after approval might be similar to, superior to, or inferior to that of the clinical trial outcomes. With these analyses, you can close the knowledge gap and strive to make relevant changes to a drug’s usage to improve patient care.
By generating and utilizing RWE early in the product development process, drug companies are more likely to achieve regulatory and commercial success while providing better care for patients in need. KMK’s HEOR and RWE team dive deeper into Real World Data (RWD) using rigorous scientific techniques and cutting-edge big data processing tools.
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