While healthcare aims to increase patient outcomes, Pharma is looking forward to means beyond randomized clinical trials (RCTs) to assess and promote the value they produce.
Pharma real-world evidence (RWE) has been in practice for decades; nevertheless, advances in digital technologies and analytics offer a new way to apply it. It gives us insight into how patient characteristics and behavior affect outcomes. Thereby, it helps to predict the course progress of the disease, a patient’s response to therapies, or the risk of adverse events. Also, it makes R&D (Research and Development) investments more efficient and accelerates time-to-market.
If any company deploys advanced pharma RWE analytics, success will rely on the proper framework and capabilities chosen. So, further below, we will disclose more info on the nature of real-world evidence in the pharmaceutical landscape.
What Is Real-World Evidence in Pharma?
To understand medical RWE (real-world evidence) and its role in healthcare, we should first understand RWD (real-world data).
Pharma real-world data is any data gathered in routine care delivery taking its place contrary to the data collected from traditional clinical trials where the system controls variability; therefore, it does not represent real-world care and outcomes. There are many different types and real-world data sources, such as
- clinical data from electronic health records (EHRs) and case report forms (eCRFs);
- patient-generated data from the patient-reported outcome (PRO) surveys;
- cost and utilization data from claims and public datasets provide information regarding healthcare services utilization, population coverage, and prescribing patterns;
- public health data from various government data sources.
The U.S. Food and Drug Administration (FDA) characterizes RWE as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from real-world data analysis.”
What Is the Difference Between Real-World Data and Real-World Evidence?
Real-world data presents value only when it’s converted into other formats. RWD is raw data that demonstrates the individuals’ experiences and characteristics, while real-world evidence can already be used for decision-making and other processes since it comes directly from RWD analysis. In essence, real-world evidence is created based on real-world data, which is why both often come together, instead of each being used separately.
Why Do We Need RWE in Pharma?
There’s a gap between research (what we learn) and everyday clinical practice (what we do) in healthcare, and it creates dissimilarity between what is anticipated to come and what we really get.
What happens is worth our concern. What has happened before, during, and after clinical treatments, interventions, and HCP live visits is the reality we stay in to drive measurable enhancements in healthcare.
RWE is meant to eliminate those gaps and keep us from going astray. It shows actual data on what happens when physicians treat several patients that do not appear in the homogeneous patient groups in traditional clinical trials. RWE in healthcare provides information on how therapies and treatments will fare in real-life settings, enabling doctors to anticipate the outcomes of new medications and various approaches. In contrast to clinical trials, which are frequently confined to specific criteria, real-world evidence encompasses aspects that might have gone unnoticed or been discovered too late.
That is why RWE has many uses and advantages across healthcare ecosystems.
Why Is Real-World Evidence Important?
It helps to comprehend how a new treatment innovation will behave in the real world rather than within classic randomized trials alone. While RCTs remain the general rule in approving new medical therapies, they often do not show the full picture. Standard RCTs cover a small segment of patients and test treatments in a controlled environment. Moreover, they are costly and time-consuming.
Using real-world evidence, we can improve our understanding of what works for different types of patients in a broader context. It allows researchers to study the safety and effectiveness of drug treatments and other interventions and consider other factors and variables. In addition, RWE generation is more cost-effective and can be more intelligent than standard randomized clinical trials.
Healthcare RWE can provide insight into how treatments work in specific patient subsets that may not have been encountered in RCTs. For instance, with RWE, researchers can study how therapy innovations work for patients with comorbidities, certain age groups, or certain socio-demographic groups. Real-world evidence can also provide what happens to the patient throughout life when isolated data from the randomized clinical trial period cannot be found.
Use of Real-World Evidence in Pharmaceutical Companies
Pharmaceutical companies have been using real data for decades to make informed decisions, respond to external stakeholders’ requests, and improve their drugs’ market position. Recently, growing acceptance from regulators, demand from payers and physicians, and greater familiarity with digital and analytics have enabled some companies to reap much broader benefits from real-world evidence.
Big Pharma Has Already Benefited From It
Examples include Pfizer’s use of electronic medical record (EMR) data to obtain approval to treat male breast cancer and AstraZeneca’s use of real-world data to demonstrate the effectiveness of its diabetes treatment against competitors.
Is Real-World Evidence a Growing Challenge for Pharma?
No matter how obvious it may sound, RWE is used across the entire healthcare system. From the physician’s office that logs the data to the register, life science researchers who operate with it throughout their studies to health plans, regulators, payers, and policy creators. So, it has a vast impact on the whole spectrum.
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Life Science Research
As traditional randomized clinical trials give out isolated data that does not deal with real-world life, science specialists and biopharmaceutical companies are significant stakeholders of RWE. It complements RCTs by providing additional insights into daily medication use in clinical care, considering the safety and efficacy of innovative therapies.
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Policy Makers and Regulators
The subject allows for monitoring aftermath safety and adverse events; therefore, it provides support regulatory decision-making. Operating with real-world evidence essentially affects the base for medication approvals and drug development acceleration.
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Health Plans and Payers
Safety monitoring, utilization management, and cost/value analysis are elements that health plans and payers derive from RWE affecting studies that inform pharmacy and therapeutic (P&T) committee decisions. Anyway, RCTs will stay necessary for payer decision-making; nevertheless, they begin to often appeal to RWE for better validation because they need to comprehend how the use of medicines impacts value-based care outcomes.
Additionally, they use RWE to assess pharmaceuticals and other therapies’ cost-effectiveness.
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Physicians and Healthcare Providers
Applying RWE to clinicians is more indirect than for other healthcare stakeholders. First, healthcare providers can use the clinical guidelines developed by RWE. Insights from real-world evidence can help care teams understand the disease and help inform treatment decisions. So they enable physicians to create more targeted and appropriate treatment plans for their patients.
RWE is only as good as the RWD used to create it. Physicians and other healthcare providers are vital to the data collection process. During an appointment with a patient, physicians typically use electronic health record (EHR) systems to enter structured clinical data such as diagnoses, scheduled laboratory tests with results, and prescribed medications. In addition, providers submit applications to payers who offer another source of RWD. This data can then be de-identified and used to obtain RWE.
Life Sciences Real-World Evidence and Viseven
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