What Is Real World Evidence In Healthcare?

What Is Real World Evidence In Healthcare
Definitions – Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.

What is an example of real world evidence?

Examples of RWD are electronic health records (EHRs); wearables; medical claims data; surveys; and product, patient, and disease registries. RWE is the clinical evidence obtained from RWD with regard to the use, potential benefits, and potential risks associated with a medical product.

What is the difference between real world evidence and clinical trials?

What Is Real-World Data (RWD)? – In order to understand real-world evidence and its role in healthcare, we must first define real-world data, or RWD. Real-world data is any data that is collected in the context of the routine delivery of care, as opposed to data collected within a clinical trial where study design controls variability in ways that are not representative of real-world care and outcomes.

Clinical data  from electronic health records (EHRs) and case report forms (eCRFs). This data provide patient demographics, family history, comorbidities, procedure and treatment history, and outcomes.
Patient-generated data  from  patient-reported outcome (PRO) surveys, These data provide insights directly from the patient, and they help researchers understand what happens outside of clinic visits, procedures, and hospital stays.
Cost and utilization data  from claims and public datasets. They provide information regarding healthcare services utilization, population coverage, and prescribing patterns.
Public health data  from various government data sources. These add critical information to enable stakeholders to best serve the needs of the populations they serve.

What Is Real World Evidence In Healthcare

How is real world evidence used in clinical trials?

Real-world evidence (RWE) is a method of gathering information from medical records and other sources about how a treatment works in practice. RWE can assist researchers in understanding practical outcomes that go beyond what they see in studies, allowing them to make more informed decisions about which treatments to make available.

What is real world evidence health economics?

RWE describes evidence relating to patient health or experience or care delivery collected in the ‘real world’, i.e. outside of controlled research studies. The quality of RWE varies widely and its use is not consistently accepted but it has the potential to reduce uncertainty and improve decision-making.

How do you explain real world example?

Other forms: real worlds The real world is reality, rather than an idea, fantasy, or dream. If your dad tells you, “You need to live in the real world !” he probably means that you should be more practical and face your responsibilities. People who “live in the real world ” generally have successful careers or serious plans for the future.

noun the practical world as opposed to the academic world “a good consultant must have a lot of experience in the real world ” synonyms: real life

DISCLAIMER: These example sentences appear in various news sources and books to reflect the usage of the word ‘real world’, Views expressed in the examples do not represent the opinion of Vocabulary.com or its editors. Send us feedback EDITOR’S CHOICE

What is the definition of a real world example?

If you talk about the real world, you are referring to the world and life in general, in contrast to a particular person’s own life, experience, and ideas, which may seem untypical and unrealistic.

Which clinical research phase is called real-world setting?

Real-world data trials – summary – Real-World Data (RWD) is collected during drug development and post-marketing approval (particularly safety analysis) to either prospectively indicate or retrospectively measure the potential impact that a therapy will have in a real-world setting, rather than the trial environment.

We used the definition offered by Rachel Sherman (FDA Principal Deputy Commissioner) and colleagues as: “information from multiple sources outside typical clinical research settings, including electronic health records (EHRs), claims and billing data, product and disease registries, and data gathered through personal devices and health applications.” So this can mean recruiting participants via registries, using registry data to create a “virtual” or “historical” control group, or using wearable devices to gather data.

In this study, we focused on Phase II and III trials. Regulators and reimbursement authorities are increasingly seeking evidence of real-world effectiveness to drive value based decisions. The evidence base from RWD can support market access by improving discussions with payers, so drugs not only get approved by regulatory bodies, but also make it to the marketplace and onto formularies.

What is observational and real-world evidence?

RWE is usually generated in the form of a study using RWD to develop insights and inform healthcare decision making. Observational studies are a type of RWE that analyze RWD that has already been generated (retrospective) or is collected for study in the future (prospective).

Why are real world studies important?

The importance of real-world studies 01.07.2022 Real-world studies reflect current practices with respect to how patients react to treatment in terms of tolerance and efficacy. Such observational studies enhance medical knowledge, as well as patient and doctor experiences by helping to develop better treatments that ultimately benefit patients.

Real-world data are collected from a variety of sources and relate to the lived reality of patients and doctors, drawing on information such as the delivery of health care, treatments, as well as the impact of the disease and its treatment on patients’ lives. In other words, these data reflect the real lives of people affected by the illness in question and complement those derived from traditional clinical trials.

Such additional robust analysis on the experience people have of living with diseases and medical treatment helps to expand therapeutic understanding.

What is a real world case study?

A case study, in a business context is a report of an organization’s implementation of something, such as a practice, a product, a system or a service. The case study can be thought of as a real-world test of how the implementation works, and how well it works.

What is an example of evidence based practice in clinical?

Examples of Evidence-Based Practice in Nursing – Through evidence-based practice, nurses have improved the care they deliver to patients. Key examples of evidence-based practice in nursing include:

Giving oxygen to patients with COPD : Drawing on evidence to understand how to properly give oxygen to patients with chronic obstructive pulmonary disease (COPD).
Measuring blood pressure noninvasively in children : Using the auscultatory method and then comparing the measurement against data obtained with the oscillometric method as suggested by evidence,
Using the correct intravenous catheter size : Recognizing the benefits of using smaller-gauge catheters to improve patient comfort.
Valuing the role of family members: Knowing that the recognition of family involvement may lead to more efficient and effective care, as family members may significantly influence how a patient presents symptoms to healthcare providers.
Improving infection control practices : Understanding that wearing personal protective clothing and practicing handwashing are key to infection control,
Recognizing alarm fatigue : By reflecting on current practices, nursing staff can create effective protocols ensuring that nurses who are desensitized to sound due to alarm fatigue are monitoring patients correctly.

When you apply scientific evidence to your nursing practice, it helps you deliver high-quality, safe care—and it improves outcomes for patients, your workplace, and your own career. If you are studying to become a nurse or a nurse practitioner, you can expect to learn how to evaluate research, make informed decisions, and deliver the best care you can.

At the University of St. Augustine for Health Sciences, coursework in both of our graduate nursing programs—the Master of Science in Nursing (MSN) and Doctor of Nursing Practice (DNP)—is dedicated to the evidence-based practice process. The University of St. Augustine for Health Sciences (USAHS) offers a Master of Science in Nursing (MSN) program, a Doctor of Nursing Practice (DNP) program, and Post-Graduate Nursing Certificates designed for working nurses.

Our degrees are offered online, with optional on-campus immersions* and an annual interprofessional trip abroad. Role specialties include Family Nurse Practitioner (FNP), Nurse Educator,** and Nurse Executive. The MSN has several options to accelerate your time to degree completion.

How big is the real world evidence market?

Global Real World Evidence (RWE) Solutions Market Report 2023: A $78.8 Billion Market by 2030 – Shift from Volume-to-Value Based Care & Favorable Government Regulations Bolstering Growth Dublin, March 13, 2023 (GLOBE NEWSWIRE) – The report has been added to ResearchAndMarkets.com’s offering.

The global real world evidence solutions market size is expected to reach USD 78.80 billion by 2030, growing at a CAGR of 8.2% from 2023 to 2030. The key factors driving the real-world evidence (RWE) solutions market include favorable government regulations and a shift from volume to value-based care.

Furthermore, the increasing prevalence of chronic disorders is anticipated to positively influence market growth. During the pandemic, companies in the RWE solutions market diverted their focus on providing solutions for curbing the spread of COVID-19.

For instance, IBM collaborated with Salesforce for building digital health passes, which incorporated data such as vaccine status, temperature checks, and COVID-19 test results for helping organizations to reopen safely. It also partnered with ServiceNow on Watson AIOps for supporting it to continue its leadership in transformative artificial intelligence by helping clients automate IT operations and reduce risks.According to PerkinElmer, real-world evidence solutions offer around USD 300 to 500 Billion in top-down opportunity for the U.S.

healthcare industry alone. In addition, many life science companies are witnessing ad hoc value from selected RWE case studies and demonstrating around USD 100 million of bottom-up impact. Therefore, if a company captures USD 1 billion in real-world evidence value, it ultimately creates more than USD tens of billions in terms of healthcare improvements.

This is anticipated to boost market growth.The adoption and usage of RWE solutions are higher in developed markets of North America and Europe owing to supportive initiatives by legal, government, and other regulatory bodies. For instance, in October 2021, FDA selected the Aetion Evidence Platform to use RWE to analyze COVID-19 interventions and further regulatory science and innovation.

Initiatives by regulatory agencies are supporting the expansion of RWE from post-market safety monitoring to other applications, such as for clinical trial design and observational studies and to substantiate coverage decisions.Market players are investing in many strategic initiatives, such as acquisitions, mergers, partnerships, and product launches, to maintain a competitive edge in the market.

For instance, in August 2021, Syneos Health partnered with Action for offering RWE solutions for advanced drug development and commercialization.
This partnership brought together Syneos Health’s proprietary data collection research solutions and Aetion’s Evidence platform, AEP, for generating evidence through patient data curation and real world data.

What is the 21st century cures real world evidence?

On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top strategic priority for the FDA.” FDA opened a docket for public comments on the Framework through February 5, 2019.

The Framework focuses in particular on the use of RWE to support regulatory decisions about effectiveness. The agency outlines three considerations that will guide its overall RWE Program and inform the agency’s assessment of individual drug applications. The Framework also offers background on the agency’s previous use and current initiatives with respect to RWE and related topics, such as innovative clinical trial designs.

This blog post provides an overview of FDA’s proposal and highlights a few initial takeaways noted by Covington’s Digital Health team. The 21st Century Cures Act (“Cures Act”) required the agency to create a program for evaluating the use of real-world evidence (“RWE”) for two purposes: (1) to help support the approval of a new indication for an already-approved drug, and (2) to help support or satisfy postapproval study requirements.

The Cures Act also mandated that the agency publish a framework for implementing the RWE Program that describes the sources of RWE; the gaps in data collection activities; the standards and methodologies for collecting and analyzing RWE; and the priority areas, remaining challenges, and potential pilot opportunities that the RWE Program will address.

The new Framework covers drugs and biological products; FDA addressed the use of RWE in the context of medical devices separately in 2017. As a threshold matter, FDA underscores the distinction between real-world data and real-world evidence, The Cures Act defined “real world evidence” as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.” In contrast, but similar to FDA’s approach for medical devices, the Framework differentiates between RWE and RWD as follows: RWD is defined as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources”; RWE, on the other hand, is ” clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD” (emphasis in original).

Whether the RWD are “fit for use” in regulatory decision-making;
Whether the methodologies used to generate RWE can provide “adequate scientific evidence” to address the regulatory questions presented; and
Whether the approach used in a particular case meets FDA’s regulatory requirements, such as established standards for data collection and study monitoring.

Here are a few initial takeaways from the Framework:

Guidance on RWE is Coming. Within this Framework, FDA sets forth an overarching plan to develop guidance in a number of specific areas, including:
- the reliability and relevance of RWD from medical claims and electronic health records used to generate RWE regarding drug product effectiveness;
- potential gaps in sources of RWD and strategies for addressing them (one strategy identified in the Framework is exploring the use of mobile technologies, electronic patient reported outcome tools, wearables, and biosensors);
- considerations for designing clinical trials that include pragmatic design elements and generate evidence of effectiveness for regulatory decisions;
- observational study designs using RWD, including whether and how these studies might provide RWE to support product effectiveness in regulatory decision-making; and
- as discussed in greater detail below, whether additional guidance is needed to address regulatory considerations when utilizing electronic source data. Of note, the agency says that it will not address HIPAA in future guidance, but it leaves open the possibility that it might provide additional guidance on other aspects of data privacy and cybersecurity of electronic source data.

Effectiveness Data. The RWE Program will focus on the potential use of RWE to support changes to labeling about drug product effectiveness, including adding or modifying an indication, adding a new population, or adding comparative effectiveness or safety information. Although the Cures Act also calls for FDA to establish a program to evaluate the potential use of RWE for fulfillment of postapproval study requirements, the Framework contains little discussion of this potential use of RWE.

Concerns About Observational Studies and RWD. The Framework acknowledges “observational studies may provide credible evidence,” but finds a stronger scientific justification for using randomized controlled trials as evidence of drug effectiveness. Indeed, the Framework indicates FDA will “consider reporting requirements for used to support effectiveness determinations.” These statements in the Framework signal that FDA remains cautious about the potential uses of RWE for regulatory purposes; FDA appears focused on an incremental approach, such as RWE to support a supplemental indication of an approved oncology drug or RWE from a “hybrid” clinical trial with both traditional RCT and RWE elements used to generate data. Bottom line, the burden will be on relevant stakeholders to demonstrate to FDA the ways that RWD and RWE can and should be used to support regulatory decisions.

Relation to Prescription Drug-Use-Related Software. FDA published the Framework shortly after issuing a proposal for regulating prescription drug-use-related software (see our earlier blog post here ). That said, these documents does not discuss whether and how they relate to each other, even though both implicate software disseminated by or on behalf of a drug sponsor.

Data Standards for Submissions. FDA recognizes the importance of developing data standards for submissions, to help ensure efficient review of RWD by the agency. FDA indicates it has “already been active in developing data standards for regulatory use and will continue to expand its work in this area.” This work will include identifying the relevant standards and methodologies to maximize the utility of RWD.

Use of Electronic Source Data for RWE. FDA touches on some of the regulatory considerations that arise from use of electronic source data, such as electronic health records and electronic data from clinical studies. The agency points out that it already has published some relevant information on these topics, including regulations that focus on the quality, authenticity, and reliability of electronic records (21 CFR Part 11) and a related guidance published in 2017. The agency highlights several key regulatory compliance issues, including informed consent, validation of electronic systems, audit trails for electronic records, and agency inspections. FDA is considering whether additional guidance on the use of electronic source data is needed.

FDA stresses the importance of continued engagement with all stakeholders in building out its framework. As FDA continues to develop policy in these areas, the agency will provide an opportunity for stakeholders to comment on specific regulatory issues and the agency’s proposed guidance documents.

What is real world evidence in pharmacovigilance?

Abstract – Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and mortality has resulted in mandatory phase IV clinical trials, black box warnings, and withdrawal of drugs from the market.

Real‐world data, data collected during routine clinical care, is being adopted by innovators, regulators, payors, and providers to inform decision making throughout the product life cycle. We outline several different approaches to modern pharmacovigilance, including spontaneous reporting databases, electronic health record monitoring and research frameworks, social media surveillance, and the use of digital devices.

Some of these platforms are well‐established while others are still emerging or experimental. We highlight both the potential opportunity, as well as the existing challenges within these pharmacovigilance systems that have already begun to impact the drug development process, as well as the landscape of postmarket drug safety monitoring.

Further research and investment into different and complementary pharmacovigilance systems is needed to ensure the continued safety of pharmacotherapy.
The safety of a drug continues to be monitored after approval and marketing in an ongoing process of pharmacovigilance.1 This postmarket drug safety monitoring is especially important with regard to adverse drug reactions (ADRs) that are rare, only occurring in certain subgroups, and/or only develop after long‐term drug exposure.

In some cases, serious ADRs are not recognized until long after a drug has been approved for market, as seen in the case of thalidomide where its use in pregnant women led to congenital malformations. Accordingly, the importance of postmarket monitoring is highlighted by the finding that one‐third of newly identified safety issues in the postmarketing period are added to the warnings and precautions section of the label, the second highest tier of severity, indicating the serious nature of newly identified ADRs.2 The passage of the 21st Century Cures Act has modernized clinical trials and requires the evaluation of the potential use of real‐world data (RWD), data collected during routine clinical care in the form of electronic health records (EHRs), medical billing, and other data generating activities in the regulatory decision making and approval process.

Real‐world evidence (RWE) is the evidence of the potential benefits of the medical product in a clinical setting derived from RWD. Results from various study designs and analyses, both prospective and retrospective, that use RWD are accepted as RWE. The US Food and Drug Administration (FDA) guidance on RWE describes several contexts in which it can be used during the product life cycle, such as proving an unmet medical need, substituting for a control group, as supporting evidence for a label expansion, and as a part of postmarketing studies.

The multiple emergency use authorizations granted to drugs during the coronavirus disease 2019 (COVID‐19) pandemic highlights a situation where postmarket pharmacovigilance becomes pivotal to maintaining long‐term patient safety. Collectively, the legislative acts and regulatory practices have led to an increased reliance on postmarket pharmacovigilance to inform drug safety.

What is a real world problem example?

Real world problems are issues and risks that are causing losses or are likely to cause losses in the near future. This term is commonly used in science, mathematics, engineering, design, coding and other fields whereby students may be asked to propose solutions to problems that are currently relevant to people and planet as opposed to theoretical, insignificant or personal problems. The following are illustrative examples of issues and risks that can be considered real world problems.

Ableism	Access to Education
Accessibility for People With Disabilities	Addiction
Ageism	Agricultural Runoff
Air Pollution	Animal Rights
Automobile / Bicycle / Pedestrian Accidents	Avalanches
Aviation Accidents	Building Safety
Bureaucratic Inefficiency	Child Mortality
Climate Change	Corporate Accountability
Corporate Influence over Governments	Corporate Oppression
Corporate Tax Avoidance	Corporate Transparency
Corruption	Cost of Healthcare
Cost of Living	Cost of Nutrition
Crime	Cronyism
Cybercrime	Decline of Coral Reefs
Deforestation	Desertification
Destruction of Ecosystems	Disasters
Discrimination	Disease
Droughts	Earthquakes / Tsunami
Elitism	Environmental Disasters
Environmental Justice	Existential Risk
Extinctions	Fires / Wildfires
Floods	Food Safety / Contamination
Food Security	Fraud
Government Oppression	Government Transparency
Habitat Destruction	Habitat Fragmentation
High Inflation / Stagflation / Hyperinflation	Homelessness
Housing Affordability	Indoor Air Quality
Infrastructure Failures	Lack of Economic Opportunity / Participation
Lack of Public Space / Green Space / Freedom of Movement	Land Degradation
Landslides	Marine Debris / Microplastics
Maritime Disasters	Misinformation / Disinformation
Monopolies	Nuclear Incidents
Obesity	Online Safety
Pandemics	Poverty
Privacy	Product Safety
Public Safety	Public Security
Quality of Education	Racism
Radioactive Waste	Recessions / Depressions
Red Tape	Regressive Taxation
Rent Seeking	Resource Depletion
Rights & Freedoms	Rights of the Child / Child Welfare
Sexism	Shortages
Social / Cultural Oppression	Social Isolation
Space Junk	Sports Injuries
Starvation / Hunger	Sustainable Energy
Tax Evasion	Technology Risks
Terrorism	Toxic Waste
Transportation Safety	Unemployment
Unhappiness	Unhealthy / Unsafe Products
Unhealthy Lifestyles (e.g. sedentary lifestyles)	War / Conflict
Waste Disposal (e.g. plastic that is burned and not recycled)	Water Pollution
Water Scarcity / Water Security	Workplace Accidents

Why are real world examples good?

Concepts on this page were derived from faculty discussions and presentations at multiple InTeGrate workshops, What Is Real World Evidence In Healthcare Tackling real world problems can make sustainability issues more tangible and meaningful to students. Real examples provide concrete applications to knowledge and skills learned in the classroom as they relate to students themselves and society. Real examples also encourage students to be aware of the choices they make and how they fit into a greater societal context.

Real world examples demonstrate the complexity and unpredictability of real issues, and as such, can stimulate critical thinking. They also highlight the need for an inter- and multi-disciplinary approach to problem solving. Further, using examples from the real world demonstrates that, oftentimes, there is no perfect solution to a given problem.

But, in doing so, gets students thinking about solutions, rather than just focusing on problems.

What is an example of a real world application?

In the real world application, such as signal processing for wireless communications and multimedia processing, the data are streamed into the circuit instead of the coming in blocks. From: DSP for Embedded and Real-Time Systems, 2012

What is the difference between real life and real world?

“In real life” vs. “in the real world” The phrases are grammatically correct (and roughly interchangeable) with the original placement of “the”, but are not correct (or at least not idiomatic) when you swap “the” as you suggest. This gets into the complex details of the rules for using articles in English.

There are numerous questions here that cover this topic.) “Real life”, when used in the above context, is an uncountable noun, and hence does not accept articles (“the” or “a”).
But note that someone might say “Get a real life!”, and in that context “real life” is countable.
It’s the opposite for “real world”, when functioning as a noun.

It’s countable (there is one and only one) and hence needs an article (and, specifically, “the”). (But, eg, in the expression “real world politics” “real world” is being used as an adjective, and the noun is “politics” – another uncountable noun. Thus, no article.) : “In real life” vs.

What is the definition of a real world application?

Meanings of real-world and application happening in the world or in someone’s life rather than in a book, in the imagination, on the See more at real-world. application. noun.

What are the types of real world evidence studies?

Real-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety-both of which will impact the eventual reimbursement and utilization of new products-is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting.

The result is that real-world evidence is now included earlier in the research and development phase.
Real-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization.
The growing industry need for broader information on real-world effectiveness and safety-both of which will impact the eventual reimbursement and utilization of new products-is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting.

The result is that real-world evidence is now included earlier in the research and development phase. Today, a regulatory authority may require post-approval research or monitoring to determine real-world safety, due to concerns about a product’s safety when it becomes widely prescribed, while payers may require validation of a product’s real-world clinical value and cost-effectiveness to determine optimal formulary placement.

Data about real-world patient experience also has the potential to improve the quality and delivery of medical care, reduce overall costs and improve outcomes by accelerating the understanding of how best to incorporate new therapies and technologies into everyday clinical practice. Essentially, these data help fill the knowledge gap between clinical trials and actual clinical practice.

While clinical trials remain the gold standard for drug approval, more information is needed on how specific drugs perform within different age groups, such as the elderly, and different genders, races and ethnicities, as well as differences in disease severity and unstudied co-morbid conditions for use of products in the real world, as reflected in Figure 1.

Figure 1. Patients Exposed to Inadequately Assessed Health Care Technologies Source: HealthCore Biopharmaceutical sponsors, providers, payers and regulators are eager to investigate real-world data for insights that can increase quality, drive down costs and improve patient safety.
For example, several years ago, Anthem, Inc.

asked HealthCore, its outcomes research subsidiary, to conduct a study comparing the effectiveness of oral asthma controller medications to that of inhaled corticosteroids. HealthCore found that when members took their medication as directed, those taking inhaled corticosteroids had fewer inpatient and emergency room visits and lower total health care costs.

But among members who were not taking their medication properly, those taking oral asthma controllers were less likely to have inpatient and emergency room visits.
The insurer’s pharmacy and therapeutics committee used this real-world evidence, in addition to the overall evidence supporting these therapies, to keep the oral controller medication on a less-expensive, preferred tier and remove the prior authorization requirement for its use so its members could continue to use the product that worked best for them.

This research was conducted when the products were far along in their life cycles, raising the question about what a difference this information could have made on this product’s reimbursement if it had been conducted, shared and acted on earlier. HEOR in Today’s Environment Health economics and outcomes research (HEOR) generates evidence of the economic value of new and existing products and helps decision-makers and payers determine reimbursement policies and insurance coverage for new and existing therapies.

HEOR has become a more integral part of traditional R&D, impacting clinical trial design and the management of economic endpoints within these trials. With major global shifts in health care systems to control costs, a growing number of Phase III trials now include economic endpoints and analyses, alongside the clinical outcome measures, to demonstrate the cost-efficacy of new products.1 A meaningful real-world research study design for a new product begins with a deeper understanding of its real-world environment.

Access to robust real-world health data, including administrative claims data and other clinical data sources, together with the technology and analytics capability to effectively analyze that data is essential. Other prerequisites are scientific excellence, the scope and scale of operations to efficiently execute studies, expertise in clinical trial design and HEOR, and knowledge of related regulatory requirements.

Real-World Research Approaches Real-world research is an area of methodological innovation.
Compared to clinical trial data, RWE data more closely describes how the product will perform in a broader, more representative population over a longer timeframe, and provides information on comparators and outcomes that are not part of the clinical trial protocol.2 There is a wide range of study types and complexities for a typical RWE research program.

RWE can be divided into two types: primary data, collected specifically for research purposes; and secondary data, collected for other purposes. Primary data are generally obtained from study-specific case report forms, electronic medical and health records, and/or clinical outcomes assessments.

These data are collected in interventional Phase IV studies and in non-interventional prospective observational studies, patient registries and health surveys. Secondary data are often obtained from clinical chart reviews, registries and/or insurance claims databases, and are used in retrospective database studies or as an input to prospective study design or hybrid studies.3 Pragmatic and Explanatory Trials Trials of health care interventions often are described as either pragmatic or explanatory.

Explanatory trials generally measure efficacy, the benefit a treatment produces under ideal conditions, often using carefully defined subjects in a research clinic. These specialized studies recruit as homogeneous a population as possible and aim primarily to further scientific knowledge.4 By contrast, pragmatic randomized clinical trials measure effectiveness, the benefit the treatment produces in routine clinical practice, and are carried out after product approval.

A pragmatic trial reflects variations between patients that occur in real clinical practice and aims to inform choices between treatments, as portrayed in Figure 2.
These trials should represent patients to whom the treatment will be applied, and test whether an intervention works in real-world circumstances.

Pragmatic trials offer a scientific method of research for policymakers and clinicians, and serve as real-world evidence sources for decisions, such as for funding, regulations, policy and organizational changes.5 Figure 2. Schematic of the relationship between explanatory and pragmatic trials.

The wide based of the pyramid depicts the relatively higher proportion of explanatory trials. Source: Reproduced from Dialogues in Clinical Neuroscience with the permission of the publisher (Les Laboratoires Servier, Suresnes, France). ©Les Laboratoires Servier.6 An example of a pragmatic RWE study is a new Sanofi Aventis trial to determine the efficacy and health outcomes of Toujeo, a long-acting basal insulin to improve glycemic control in adults with type 2 diabetes.

Currently recruiting patients, the objective of the study is to demonstrate the clinical benefit of the drug in achieving specific therapeutic targets in patients initiating basal insulin therapy in a real-world setting. The secondary objective is to compare the drug to commercially available basal insulins after initiating insulin therapy in a real world setting, in terms of patient persistence with the assigned therapy, differences in patient- and provider-reported outcomes, and health care resource utilization, including hospitalizations and emergency department or other provider visits, and health care costs.7 Cluster RCTs In a cluster randomized trial (CRT), groups of subjects, rather than individual subjects, are randomized to receive one of the interventions being studied.

Clusters may include provider practices, families, schools, clinics, health plans, towns and others. An example of the application of a CRT is in the assessment of health promotion programs, where it is problematic to design a study in which one member of a cluster (e.g., a town, a community or a patient in a group practice) can be exposed to the full impact of a program while another member would have no exposure.

A CRT can provide a way to better approximate the real-world setting for drug/program combinations. With the increased interest in pragmatic clinical trials, comparative effectiveness research and community health promotional activities, the use of CRTs has been growing.5 RWE Support Organizations Several organizations have been formed to help the life sciences industry supply practical information about its products.

The Patient-Centered Outcomes Research Institute (PCORI) was established to help patients and clinicians improve key health outcomes.
The group identifies critical research questions, funds patient-centered comparative clinical effectiveness research and disseminates evidence-based results.8 The Institute for Clinical and Economic Review (ICER) is an independent source for evaluating the value of new drugs and providing a transparent, objective basis for price negotiations and coverage decisions.

Over the next two years, ICER will produce 15-20 public reports on new high-impact drugs near the time of FDA approval, and calculate a benchmark price for each new drug anchored to the real benefits of the drug.9 Another organization, the American Society of Clinical Oncology (ASCO), is the world’s leading professional organization representing physicians who care for cancer patients.

Recently ASCO published a conceptual framework to assess the value of new cancer treatment options based on clinical benefit, side effects and costs.
The framework is intended as a user-friendly, standardized tool doctors can use to discuss with patients the relative value of new cancer therapies compared with established treatments.10 Advancing Capabilities for RWE Studies To meet the increasing demand for RWE studies, sponsors and clinical research organizations (CRO) are ramping up their capabilities in this growing area of interest.

Many are forming partnerships and building capabilities to leverage the opportunities offered by RWE. As an example, PPD and HealthCore recently established a collaboration to further expand their services to help biopharmaceutical clients demonstrate more quickly and cost-effectively how their products will perform and benefit patients in the real world.

Through this collaboration, PPD and HealthCore have all the capabilities needed to plan, execute and deliver all types of RWE studies, in particular, pragmatic Phase IV trials.
This alliance combines extensive experience and expertise in clinical trial design, HEOR, medical affairs research, epidemiology, access to large databases of integrated medical and pharmacy claims and lab results, innovative real-world research designs, analytics, and qualitative research.

Together, their RWE capabilities include: observational research, post-approval safety studies, pragmatic Phase IV trials, patient, product, and disease registries, patient-reported outcomes, and economic evaluation. Looking Forward: Outlook for RWE Studies RWE studies serve many purposes and are creating new opportunities for evidence generation in drug development.

The EMA guidance 11 requires the collection of risk-benefit data in post-authorization safety studies. Pharmaceutical companies now must take a more granular approach, examining different subpopulations to determine their respective risk-benefit balance. There is also an increasing demand from payers to conduct observational studies on a new product’s effectiveness, and payers and clinicians are eager for more detailed health outcomes data to inform prescribing and reimbursement decisions.12 The outlook for RWE generation-stand-alone or in conjunction with clinical trials-is promising, with the potential to improve health outcomes and cost-effectiveness of new health technologies.

The demand for RWE is growing and is unlikely to subside as health care decision-makers become increasingly aware of what it offers. Biopharmaceutical companies and CROs need to stay at the forefront of developments in RWE, data sources, analytic techniques and study methodologies to ensure they are able to optimize patient access and formulary placement of new products.

Mark Cziraky is Vice President of Research at HealthCore; and Michael Pollock is Vice President, Real World Outcomes for PPD. References 1. Brooks K. CRO Outlook & Market Trends. Contract Pharma, June 5, 2013. Accessed at: http://www.contractpharma.com/issues/2013-06/view_features/cro-outlook-market-trends,2.

Fiminska Z. Real World Evidence: Maximize Benefits to Healthcare. Eye for Pharma, Feb.26, 2015. Accessed at: http://social.eyeforpharma.com/market-access/real-world-evidence-maximize-benefits-healthcare,3. Mack C and Lang K. Using Real-World Data for Outcomes Research and Comparative Effectiveness Studies.

Drug Discovery & Development, Nov.4, 2014. Accessed at: http://www.dddmag.com/articles/2014/11/using-real-world-data-outcomes-research-and-comparative-effectiveness-studies,4. Maclure M. Explaining pragmatic trials to pragmatic policy-makers. CMAJ, May 12, 2009;180(10): 1001-10003.5. Kowalski CJ and Mrdjenovich AJ.

Studying group behaviour: cluster randomized clinical trials. American Journal of Clinical and Experimental Medicine, Vol.1(1), 2013: 5-15. Accessed at: http://article.sciencepublishinggroup.com/pdf/10.11648.j.ajcem.20130101.12.pdf,6. Patsopoulos NA. A Pragmatic View of Pragmatic Trials.

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A “Real World” Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM). Sanofi.
Accessed at: https://clinicaltrials.gov/ct2/results?term=Toujeo+Real+World+Trial&Search=Search.8.
Why PCORI Was Created.
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Emerging Therapy Assessment and Pricing. Institute for Clinical and Economic Review. Accessed at: http://www.icer-review.org/etap,10. ASCO Publishes Conceptual Framework to Assess the Value of New Cancer Treatment Options. American Society of Clinical Oncology.

June 22, 2015.
Accessed at: http://www.asco.org/press-center/asco-publishes-conceptual-framework-assess-value-new-cancer-treatment-options,11.
Post-authorisation safety studies (PASS).
European Medicines Agency.
Accessed at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000377.jsp&mid=WC0b01ac058066e979,12.

Christel M. “Evidence” Trail Elusive. Applied Clinical Trials, June 30, 2014. Accessed at: http://www.appliedclinicaltrialsonline.com/evidence-trail-elusive-0,

What is real world evidence for decision?

Real-World Evidence – Real-world evidence (RWE) is evidence about the use, safety, and effectiveness of a drug, medical product, or technology based on data from a real-world health care setting. It is playing an increasingly important role in health care policy and practice decision-making. To learn more about RWE, read CADTH’s Real-World Evidence Primer.

Report Attribute	Details
No. of Pages	150
Forecast Period	2023 – 2030
Estimated Market Value (USD) in 2023	$45.37 Billion
Forecasted Market Value (USD) by 2030	$78.8 Billion
Compound Annual Growth Rate	8.2%
Regions Covered	Global

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