5 Ways Real-World Evidence is Transforming Healthcare

Key Takeaways:

1. Real-world evidence can be used to evaluate the history (as it is) of disease incidences, prevalence, current treatment plans, unmet medical needs, and standard of care.
2. Some data sources of real-world evidence in healthcare are claims, clinical settings, clinical studies, pharmacies, and patient-powered sources such as patient communities and social media.
3. The FDA created a framework for the RWE program to analyze the use of real-world evidence in regulatory decision-making.
4. The majority of the uses of real-world data in healthcare lie in pharmaceutical and medical device companies, healthcare providers, patients, regulators, and payers.

RWE or Real-World Evidence in healthcare bridges the gap between theory and practice. It harnesses data from everyday sources such as EHRs, wearables, registries, lab reports, etc., and analyzes it to check what works for patients and what doesn’t. Patients may share their experiences that may be used to improve the efficacy of clinical trials.

Now, as per the FDA (US Food and Drug Administration), real-world data (RWD) is the data related to patient health status or the delivery of healthcare that is periodically collected from varied sources. The RWE is the clinical evidence about the usage, benefits, and risks of medical products derived from the analysis of RWD.

Real-world evidence in healthcare isn’t just about data, it’s a thin line where reality meets theory. It can pave the way for personalized healthcare experiences and better care quality. This article is all about understanding the pros, usages, and sources of data generation for RWE. Knowing this will help pharmaceutical and medical device companies, along with providers and researchers to amplify healthcare delivery.

Pros of Real-World Evidence in Healthcare

Here’s a list of pros of using real-world evidence to its full potential:

1. So, RWE takes less resources, little time, and is cost-effective, compared to RCT (Randomized Clinical Trials).
2. Data is accessed quickly and it is retrieved conveniently.
3. Real-world evidence can be used to evaluate the history (as it is) of disease incidences, prevalence, current treatment plans, unmet medical needs, and standard of care.
4. RWE is a good option to understand current health care services.
5. It is a plausible choice for studying health economics and supporting patient outcomes.
6. Research that isn’t possible with randomized clinical trials can be well executed with RWE, for instance, studies on high-risk patients.
7. Side effects of medical products can be studied better with RWE.

What are the Data Sources of Real-World Evidence?

The generation of real-world evidence in healthcare largely depends on the collection of clinical data from diverse sources in real-life settings. eCRF software is widely used by researchers to collect data during clinical trials.

Here, are the prominent data sources of RWE:

1. Claims: These encompass medical claims, state Medicaid, prescription drug claims, and insurance companies.
2. Clinical Setting: This includes billing data, laboratory tests, and EHR from hospitals and clinicians.
3. Clinical Studies: This consists of disease registries, product registries, and clinical trial data.
4. Pharmacies: This includes prescription data and sales data.
5. Patient-Powered: This encompasses patient communities, patient advocacy groups, and social media.

Ways to Extract Real World Evidence

A variety of observational and experimental data can help to extract RWE from RWD. Data can be analyzed retrospectively or prospectively. Here’s how to go about it:

1. Cross-Sectional Studies: Cross-sectional studies aim to assess disease outcome and prevalence, with a single group of patients at a time.
2. Cohort Studies: Here, a group of individuals share the same diseases, environment, and characteristics. This type of study aims to assess the risk factors, disease prevalence, treatment outcomes, and disease prognosis.
3. Case-Control Studies: This is conducted retrospectively. The goal is to assess a single outcome, and also build for simultaneously assessing multiple variables.
4. Claims and EHR Database Studies: EHR database studies are observational analyses from medical charts that are aimed at studying outcomes and treatment. Also used to study hospital admission and discharge information, along with diagnosis.
5. Registry Analysis: This method is used to gain information about a particular patient population. For example, identifying the state with the highest prevalence of type 2 diabetes.

FDA Guidelines on Real-World Evidence in Healthcare

The goal of the FDA is to develop the best methods and guidelines for RWE and RWD in the fields of study design, data quality, and data analysis.

So, the 21st Century Cures Act added the section 505F to the FD&C Act (Federal Food, Drug, and Cosmetic Act). Per this section, the FDA created a framework for the RWE program to analyze the use of real-world evidence in regulatory decision-making. Here are recent guidelines for real-world evidence in healthcare, as published by the FDA:

1. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, which updates and clarifies how the FDA evaluates RWD to determine if it is sufficient to be used in regulatory decision-making for medical devices and provides expanded recommendations for sponsors collecting RWD.
2. Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products, which provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety.
3. Data Standards for Drug and Biological Product Submissions Containing Real-World Data, which addresses considerations for the use of data standards currently supported by the FDA in applicable drug submissions containing study data derived from RWD sources.

Crucial Uses of Real-World Evidence in Healthcare

What’s the use of all this data? Where to use it? And how to use it to yield the best possible results? This section will highlight all the essential uses of real-world evidence in healthcare.

1. In Pharmaceutical and Medical Device Companies

Pharmaceutical and medical device companies are major consumers of RWE. It helps researchers overcome the limitations of traditional clinical trials. A traditional setting has strict inclusion criteria, hence is challenging for researchers to precisely extrapolate the results of a trial to a larger population. In addition, a traditional trial is limited to only those whom the researchers can recruit, so varied demographics cannot participate. With the help of RWE, researchers can dive into a broader cross-section of the population.

Furthermore, real-world evidence in healthcare reveals market opportunities for medical device companies. For example, disrupting the usage of artificial intelligence and machine learning in medical devices. AI algorithms can analyze vast amounts of data and aid clinicians in making data-driven decisions.

Apart from this, pharma companies can use RWE throughout the product lifecycle to improve clinical guidelines, and trial designs, to ameliorate financial discussions, and disease understanding.

2. RWE for Healthcare Providers

Healthcare providers are a vital source for data gathering. For instance, EHR used by providers to enter clinical data such as lab tests, diagnosis, medications, treatment plans, etc., is used as real-world data, which is then used as a source for RWE.

Further, data submitted to claims is another source of RWD. Healthcare providers can make use of real-world evidence to understand the nature of a disease and make data-driven decisions about a health condition.

3. Use of RWE Among Regulators

The FDA has issued guidelines for using real-world evidence from registries, EHR, and administrative claims data to support regulatory decision-making. The data from these sources offers new insights into the performance, usage, and clinical outcomes of medical devices. It can be used by medical device manufacturers to display compliance with the devices.

Apart from this, real-world evidence plays a pivotal role in monitoring the post-market performance of medical devices. The aim behind utilizing RWE is to protect patients from medical devices and drugs that may trigger adverse events and failures.

4. Leveraging RWE for Payers and Health Plans

Payers also see the value of real-world evidence in healthcare. They may use it to monitor the safety of devices and drugs and cost analysis. Payers are leveraging claims data to augment the facets of healthcare affordability. In the USA, payers are implementing outcome-based contracts with healthcare providers and prescribers.

Payers increasingly rely on RWE to inform reimbursement decisions, formulary management, and coverage policies. By analyzing RWE, payers gain insights into treatment effectiveness, safety profiles, patient outcomes, and healthcare utilization patterns in diverse patient populations and care settings.

5. How Patients Can Use RWE?

In today’s time, patients are becoming more aware of their health and are regularly participating in fitness and health activities. They are turning to social medical platforms to gain others’ perspectives about varied health topics such as quality of lifestyle, treatment options, adverse events, etc. Since social media is quite accessible, patients tend to visit it to connect with patients, find information about their health conditions, find social support, and share experiences.

Another source of RWE is PPRNs (Patient-Powered Research Networks). They are an online platform that is managed by patients, patient-run organizations, support groups, and stakeholders such as clinicians, researchers, and caregivers.

PPRN gathers and organizes data focused on specific or multiple diseases and facilitates patient-centered outcomes. For example, PCORnet, set up by the PCORI in the USA has around 30 PPRN as it fosters data-sharing collaborations to medical data, so to improve services, products, and patient care.

Summing Up

The significance of real-world evidence in healthcare is becoming popular day by day. Pharmaceutical industries and medical device companies are harnessing the power of RWE to ameliorate patient access to safe medicines, that are also cost-effective. In addition, real-world evidence aids providers in clinical decision-making. Payers are making good use of RWE in gaining insights about the effectiveness of treatment. That’s not all, patients are turning to RWE sources such as social media and PPRN to augment their health conditions.

There is so much real-world evidence that can be offered to the healthcare sector. Incorporating RWE during pharmaceutical software development can aid researchers in testing the efficacy of drugs and medical devices. Arkenea, a healthcare software development company offers custom pharmaceutical software that will ameliorate clinical trials, and adhere to all regulatory norms. We deliver top-notch products that adhere to industry standards and meet client requirements. To know more hop on to a consultation call with us.