pharma
In today’s world, the pharmaceutical industry is striving for more efficient and innovative drug production, and evidence-based evidence (RWE) is becoming a key element in this endeavor. RWE is the accumulated data on the actual use of drugs in real-world settings, which is different from the data generated in controlled clinical trials (https://digitalho.com/blog/what-is-real-world-evidence-rwe-in-pharma/). In this article, we will look at how evidence generation influences the future availability and value of medicines, break down the benefits of RWE and the challenges to its successful implementation in practice.
What is real-world evidence?
Real-world evidence (RWE) is real-life data on the use of medicines and medical technologies. Unlike data from scientific studies, RWEs are based on information we learn from actual patient care. This data helps us understand how well and safely medicines work in different groups of people.
Sources of RWE include:
electronic medical records, which contains information about treatments and outcomes;
claims data from patients;
registries, which record treatment outcomes in real-life medical settings.
These sources provide valuable insights into how medicines interact with patients in real-life settings, which complements information obtained in controlled clinical trial settings.
The growing importance of real-world evidence
In recent years, real-world evidence (RWE) has become increasingly important in pharmaceutical research. Historically, clinical trials have been the primary source of data for drug development, but RWEs are introducing a new way of looking at this process. Rapid advances in technology and the availability of large amounts of patient health data, such as electronic health records, allow for more complete and accurate evaluation of drug efficacy and safety. This makes RWE increasingly influential in the development of new drugs, helping companies better understand the real benefits and risks of their products when used by a wide range of patients.
The use of real-world evidence (RWE) in pharmaceutical approvals, market access issues and post-marketing continues to evolve, particularly in light of the expanding role of real-world evidence for regulatory decision-making and product safety. This trend is enhanced by the active involvement of the US Food and Drug Administration (FDA) and other global regulatory agencies.
Real data on drug development
Pharmaceutical companies are now actively using real-world evidence (RWE) to improve the drug development process. They analyze data on the real-world use of drugs in real-world settings, allowing companies to gain a better understanding of the efficacy and safety of their products. RWE also helps optimize clinical trial design, refine drug indications, and predict potential side effects.
Thus, the use of RWEs facilitates more accurate and adaptive drug development, which helps improve the quality and efficacy of new medical products. RWEs are also used to support the approval of new drugs. An example is the drug Dulaglutide, marketed under the brand name Trulicity, which is a GLP-1 receptor agonist and is used to treat type 2 diabetes. In 2014, real-world data studies in MEDLINE, EMBASE, NHS Economic Evaluation Database and Health Technology Assessment databases were able to demonstrate its effectiveness in reducing blood sugar levels, controlling weight and reducing cardiovascular risk. These data helped support the FDA approval of Dulaglutide.
Improving access to and cost of medicines
Real-world evidence is bringing significant changes to the assessment of the cost-effectiveness and value of medicines. They enable more accurate assessment of the real benefits and costs of using medicines in real practice settings, which is changing the approach to assessing their value.
RWEs also play a key role in informing drug pricing and reimbursement decisions. Analyzing real-world use data helps determine the actual value of drugs to patients and health systems. This allows for more accurate pricing, taking into account actual clinical outcomes and societal needs. This approach can contribute to a more equitable and affordable drug delivery system.
Real evidence and patient-centered care
Real-world evidence (RWE) plays a key role in creating patient-centered healthcare:
Provides a more personalized approach to care. RWE can be used to collect data about specific patients and their response to treatment. This data can help physicians make more informed decisions about the treatment that is best for each patient.
Improves treatment quality and effectiveness. RWE can be used to monitor treatment outcomes and identify areas where quality and effectiveness can be improved. This data can help physicians improve their treatments and provide the best possible outcomes for patients.
Improves patient satisfaction. RWE can be used to collect data on how patients perceive their treatment. This data can help physicians understand what is important to patients and make changes to their treatments to improve their experience.
In other words, analyzing data on real-world experiences with medications and medical technologies can help individualize treatment approaches, taking into account the diversity of patient needs.
Challenges and limitations of real-world evidence
The use of real-world evidence has its own challenges. For example, data may not be completely accurate due to unrepresentative samples or incomplete information. There may also be errors due to inadequate standardization of data collection or exposure to factors that are not accounted for.
To address these problems, efforts are being made to improve data quality and standardization. The implementation of rigorous data collection protocols and the use of large amounts of data make samples more representative. Methods to assess and manage possible distortions and biases are also being actively developed, thus increasing the validity of results and the use of RWE in making more informed medical decisions.
The future of real-world evidence
RWE is expected to play an increasingly important role in the drug development process, helping companies better understand the efficacy and safety of their products in real-world use. With advances in technology and data analysis techniques, RWE is expected to be actively used to optimize therapeutic strategies and improve treatment outcomes. In the future, RWE can also play an essential role in shaping fairer and more affordable drug prices, given the real value of drugs to patients and society.
Thus, RWE is expected to play a key role in the evolution of the pharmaceutical industry by facilitating more efficient and patient-centered development practices and access to innovative medical products.
Conclusion
As we can see, real-world evidence is emerging as a powerful tool with a transformative impact on the pharmaceutical industry. The analysis of real-world evidence enables companies to better understand the efficacy and safety of drugs in real-world settings, paving the way for more precise and personalized medical product development. RWE’s role in shaping the future of drug access and value is particularly significant, empowering the pharmaceutical industry to create more adaptive and fair pricing strategies. In this way, RWE is not only reshaping the approach to drug development, but is also having a significant impact on shaping the future availability and value of medicines.
