The following is an advertorial from Pfizer, INC.

You’ve just traveled to an unfamiliar destination. You researched it using guidebooks and know what to see and where to go – but you’re far from feeling like a local. 

Then, an experienced traveler puts a hand on your shoulder. They’ve spent time here and learned the culture – they will provide information to help you make decisions to navigate your stay.   

When venturing into the unknown, most people take comfort in the insights of those who have already had feet on the ground. For instance, an experienced traveler will take you to a favorite restaurant based on their own experiences and your preferences, not just the expert ratings. The information from guidebooks combined with the lived experiences of others are both helpful to prepare you to make wise decisions as you explore this new destination. 

Trusted sources of information are vital to helping people through new situations. This is true when it comes to travel, everyday life, and health. In metastatic breast cancer, understanding all the information available is especially important as each patient’s treatment journey comes with its own questions and personal circumstances. 

Considering the available information

The FDA evaluates prescription medicines before they can be sold in the US. The agency gathers information about how the medicine behaves in the human body. Randomized clinical trials are the gold standard for gathering data in a controlled setting. They can help answer the question: “Is the drug safe and effective for use in treating a particular type of patient with a specific condition?”

But learning about a medication does not end there. 

Rather, it’s just the start of an ongoing process. Once the FDA approves a medicine, its use in actual medical practice can be studied. Researchers gather data from the experiences of patients treated in an everyday care setting. The evidence that is produced after analyzing this data is known as real-world evidence. Complementing clinical trials, real-world studies can help answer the question: “How is the drug used in everyday medical care?”

Real-world evidence may be considered by the healthcare community as part of treatment decision-making. Recognizing that real-world studies may include patients or populations who would not have been included in clinical trials due to their study designs, this could provide clinicians with information that they otherwise may not have available.

Of course, real-world data have limitations. Without the same degree of structure and study design differences as in randomized clinical trials, it’s important to consider real-world data’s completeness and the potential for bias. Regulatory agencies are starting to establish guidance around use of real-world evidence in their decision-making, recognizing these limitations.

Just like other travelers’ experiences offer valuable insights in the travel analogy, insights from reliable real-world evidence can help build on clinical trial data to inform healthcare decisions.

Benefits for today and a foundation for future opportunities 

Real-world studies may access information from electronic health records and claims databases, which capture data from multiple sources and can reflect diverse and large patient populations. The reliability of real-world evidence is dependent on several factors, including the rigor of study designs, use of higher quality datasets, and following established methods to collect and analyze data.

Real-world evidence that has been rigorously analyzed also has the potential to give patients and providers additional helpful insights into treatment effectiveness based on information gathered from patients in a real-world setting. 

By building on the information gathered during clinical trials, real-world evidence can help to provide a variety of insights and information, depending on how the study is designed. Findings may include: 

• Information representative of a broader group of patients who are all taking a given treatment. Pfizer is among the many organizations that have been striving to broaden representation of diverse patient populations in clinical trials in recent years, but because clinical trials are designed to include strict controls, they don’t always represent the diverse backgrounds of all patients or everyday clinical practice. Real-world evidence may help provide additional insights into the use of a particular drug among groups that have been historically underrepresented in clinical trials – especially racial and ethnic minorities and older patients. Keep in mind, in real-world studies, randomization and blinding of the data are not possible, so there are chances for data bias and additional issues. 

• Knowledge of real-world clinical outcomes with a treatment. Clinical trials help determine whether a treatment is safe and effective to be used by people. After FDA approval, real-world evidence can capture how patients are using a given treatment while continuing to go about their daily lives outside of the setting of a clinical trial. This can provide additional information on medication use, including dosing instructions and adherence in everyday care settings over longer periods of time. All of this data can then be examined to help identify patterns and gaps in care and inform personalized treatment plans to achieve the best possible outcomes. However, it is worth noting that  bias and other external factors can limit conclusions drawn from real-world evidence. 

• Insights to help shape treatment decisions, taking into account circumstances such as other medical conditions. For example, patients may be living with multiple medical conditions and may be on many medications, which may not allow them to be in a clinical trial. Real-world evidence can provide insights into how a treatment is used in a more inclusive patient population, provided efforts are made to address factors like other medical conditions upfront when analyzing and interpreting real-world data.  

• Opportunities for future innovation to reflect the everyday experiences of patients in scientific innovation. Real-world evidence can build upon the findings from clinical trials and provide insights that may inform future research.

Making the most out of the information available 

When a healthcare provider is discussing potential treatment options with a metastatic breast cancer patient, it can be helpful to talk about patient experience in both clinical trials and everyday practice. As a complement to clinical trial results, findings from real-world studies, like treatment effectiveness, may help determine the right treatment plan for the right patient at the right time.

For many patients, newly diagnosed and living with metastatic breast cancer, treatment conversations with a healthcare provider can feel like entering uncharted territory. This is normal. But when arriving at new destinations, it’s important to ask questions that will ultimately lead to more informed decisions. 

If you have been diagnosed with metastatic breast cancer and are evaluating treatment options, consider having a conversation with your doctor about how potential treatments have been studied. It’s important to understand that randomized clinical trials are the gold standard for providing information used to evaluate the safety and efficacy of medications. You can also consider the real-world evidence that has been generated by rigorously analyzing others’ documented experiences. Real-world evidence is complementary to the findings from clinical trials, so considering both may help you feel more informed about your treatment choices. 

Pfizer sponsored the above paid advertisement.