Real-world evidence (RWE) studies have become a cornerstone in evaluating product efficacy in non-pharmaceutical fields like skincare, supplements, and cosmetics. Unlike traditional clinical trials, RWE studies gather data from everyday product use, giving companies valuable insights into how products perform outside controlled settings. This approach is particularly useful for brands aiming to prove the efficacy of their products under typical, real-world conditions. In this post, we’ll explore the essentials of conducting a successful RWE study, from study design to data collection and analysis.
What Are Real-World Evidence Studies?
Real-world evidence studies are designed to assess a product's safety, efficacy, or impact in natural settings. Instead of relying solely on data from tightly controlled environments, RWE studies capture data from real-world usage, offering insights into how people actually use products in their daily lives. For brands in cosmetics, skincare, and supplements, these studies can validate claims about product effectiveness and help build consumer trust.
Why Conduct Real-World Evidence Studies?
Improved Credibility: RWE studies enhance credibility by providing insights from real-world data, which is often more relatable for consumers.
Better Understanding of Product Use: These studies show how customers interact with a product in their everyday routines, revealing factors that controlled trials may overlook.
Regulatory and Marketing Support: RWE studies offer data that can support marketing claims and help meet compliance standards, especially with increasing scrutiny on product efficacy claims.
Key Steps to Conduct Real-World Evidence Studies
1. Define Your Study Objectives
Start by identifying what you want to learn. Are you interested in proving the long-term benefits of a skincare serum? Or perhaps you want to understand if a supplement’s benefits hold up under varied usage patterns? Common objectives in RWE studies include:
Evaluating long-term benefits or adverse effects
Assessing product performance in different demographic groups
Observing adherence rates and product use patterns
Well-defined objectives will guide every step of the study, from selecting participants to analyzing results.
2. Choose the Right Study Design
There are several study designs commonly used in real-world evidence studies:
Observational Studies: These studies simply observe outcomes without influencing them, ideal for assessing real-life product use. They can be cross-sectional (one-time data collection) or longitudinal (data collected over time).
Cohort Studies: These follow a specific group over time to measure how product use correlates with specific outcomes. They are beneficial for tracking long-term benefits or adverse reactions.
Case-Control Studies: These compare outcomes between users and non-users of a product, useful for understanding comparative effects.
For many consumer goods brands, observational studies are a popular choice due to their relatively low complexity and natural approach to data collection.
3. Identify Your Data Sources
In RWE studies, data can come from a variety of sources, including:
Surveys and Questionnaires: Often the most direct way to gather data, surveys allow participants to report their experiences, usage patterns, and outcomes.
Wearable Devices and Apps: For products with measurable effects (e.g., fitness supplements), wearables can provide data on metrics like heart rate or sleep patterns.
Retail and Online Purchase Data: If available, this data can reveal insights into repurchase rates and customer demographics.
Social Media and Online Reviews: These sources can offer qualitative insights into customer experiences but require careful analysis to ensure data reliability.
4. Develop a Clear Data Collection Plan
A well-defined data collection plan is crucial for producing reliable, actionable insights. Your plan should specify:
Data Collection Method: Surveys, mobile apps, and in-person evaluations are all common methods for collecting RWE data.
Frequency of Data Collection: Will you gather data at one time point, or will you follow up periodically? Frequent data points can help capture more accurate insights but may also increase costs and participant burden.
Informed Consent and Privacy: Ensure that participants are aware of data collection procedures and agree to participate. This is essential for ethical standards and, in some cases, regulatory compliance.
5. Analyze the Data
The analysis phase is where RWE studies reveal their value. Here are some approaches to make sense of the data:
Descriptive Analysis: Summarize key findings, such as average improvement in skin hydration among users of a particular moisturizer.
Comparative Analysis: If possible, compare outcomes for different demographics or usage patterns (e.g., daily vs. occasional users).
Trend Analysis: Identify patterns or changes over time, especially useful for products with long-term benefits like hair growth supplements.
RWE studies often involve larger datasets than traditional trials, so statistical software or analytics tools can help streamline the process.
6. Report Findings Transparently
Transparency is crucial for RWE studies. Ensure your report includes:
Methodology: Describe your study design, data collection, and analysis methods.
Limitations: Acknowledge any biases or limitations, such as self-reported data or the absence of a control group.
Results: Present your findings clearly, with visuals if possible, to make the information accessible and compelling.
Transparent reporting builds trust and allows other researchers and consumers to evaluate your findings.
Best Practices for Conducting Real-World Evidence Studies
Ensure Representative Sampling: Make sure your sample reflects your target demographic, as this improves the generalizability of the results.
Use Multiple Data Sources: Combining surveys with other data sources, like wearable devices or social media insights, can lead to a richer dataset.
Focus on Practicality: Keep the study design simple enough to ensure participants can comply without extensive effort.
Communicate Regularly with Participants: Engage participants with reminders, updates, or incentives, especially in longitudinal studies, to maintain high retention rates.
Stay Ethical and Compliant: Maintain ethical standards in data privacy, informed consent, and participant safety.
Real-World Evidence Studies in Action
Brands across cosmetics, skincare, and supplements are increasingly relying on RWE studies to back up claims. For instance:
Skincare Brands: A skincare brand may conduct an RWE study to understand the long-term effects of a moisturizer on a wide variety of skin types and ages.
Supplement Brands: For a supplement aimed at energy enhancement, an RWE study could track usage patterns and measure user-reported energy levels over a month.
Cosmetics Brands: A cosmetics company might run an RWE study on a new mascara to see how it performs across different climates, capturing how long it stays intact in varying humidity levels.
Leveraging Real-World Evidence for Product Success
Real-world evidence studies offer an invaluable tool for brands aiming to understand how their products perform in the real world. By following best practices, including clear objectives, suitable data collection methods, and transparent reporting, brands can conduct RWE studies that are both credible and actionable. Whether you’re in cosmetics, skincare, or supplements, investing in RWE studies can set your product apart, helping you make credible claims that resonate with today’s savvy consumers.
With careful planning and execution, your brand can leverage real-world evidence studies to build trust, validate claims, and ultimately strengthen your market position. If you’re ready to explore the benefits of RWE studies, follow these guidelines to ensure reliable, actionable results.
Curious about utilizing RWE for your brand? Learn more about how Citruslabs can help by contacting us today!