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Excel in Health: Proposition

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Excel in Health: Proposition
Excel in Health: Proposition
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Excel in Health: Proposition

  1. 1. Excel in Health Proposition
  2. 2. Three day programme overview 1. Understanding the NHS 2. Relevant knowledge and skills for success 3. Applying your learning and pitching your innovation
  3. 3. By the end of our session today, you will be able to: ● Write a value proposition ● Understand the importance of real world validation ● Design a business case
  4. 4. Find someone you’ve never met: ● Spend TWO MINUTES (each) sharing: o What was the most valuable thing you learnt about NHS structures? o What was the most valuable thing you learnt about NHS procurement and commissioning? o What was the most valuable thing you learnt about NHS culture?
  5. 5. ● What specifically are you offering to whom? ● Show how your solution fits into the existing pathway ● Do you complement commonly used technologies, or do you displace them? ● Do you change the way certain business processes get executed, or how care is delivered?
  6. 6. Discuss the VALUE of your INNOVATION in context of what you now know about NHS structure, processes and culture. Respond to Reflection #1 in your workbook
  7. 7. Building your value proposition Laura Boland @innovationlaura
  8. 8. ● The principles of building an value proposition ● Understanding NHS need ● Evaluation your value ● Planning your value proposition ● What makes a good (and bad!) value proposition
  9. 9. ● Think back to reflection #1
  10. 10. A promise of value to be delivered and acknowledged and a belief from the customer that value will be delivered and experienced (Wikipedia) A statement that proves I know what they want and need, why they want and need it, and why they should believe I will provide it to them (Boland) The value proposition should be a credible and coherent set of claims that demonstrate the value of the product or service to health and care providers and patients The financial director and other decision makers of a Trust or a CCG will want to see a good value proposition before they commit to your innovation.
  11. 11. The NHS is a risk averse organisation – they need to feel it is riskier to maintain the status quo than to make a change Lead your Value Proposition with the Case for Change
  12. 12. Understand Evaluate Construct Test
  13. 13. Understand Evaluate Construct Test
  14. 14. NHS Needs Product benefits
  15. 15. 1. Is the problem Unworkable? 2. Is fixing the problem Unavoidable? 3. Is the problem Urgent? 4. Is the problem Undeserved? If you don’t fully understand what their problem is and how they’d manage it without you, you can’t isolate your UNIQUE VALUE.
  16. 16. The need behind the need ● Is the need in Primary, Secondary or Social Care? ● What is the burden of that disease or condition? ● Why isn’t current practice sufficient? ● Which professionals will prescribe, recommend or implement your product? ● Who is going to pay for it? ● What are the higher level strategic drivers as well as operational need? ● How does the problem impact the lives of the patients? ● What is the cost to the system of both the disease and the current standard of care?
  17. 17. 1. Take a few minutes to think through what you know about the problem you are trying to address. Can you answer your 4 U’s? 2. Work through the checklist to understand the need behind the need. Gaps = a good place to start your research.
  18. 18. “Our ultimate objective, as NHS England and central government, is the provision of better care and improved health outcomes” “Focusing on the monetary value of the challenge risks missing the real essence of the task facing the NHS, which is about getting better value from the NHS budget. This means maximising the outcomes produced by the activities the NHS carries out, while minimising their costs. Framing the debate in terms of efficiency and costs also risks losing the opportunity to engage clinical staff in the challenge of changing the way in which care is delivered.” (Kings Fund)
  19. 19. Understand Evaluate Construct Test
  20. 20. Find out if your breakthrough product or service is unique and compelling • Does your product offer transformative benefits over the status quo? • Is your product unique? • What measurable value does your product deliver? • Is it cost-effective compared to the alternatives? • What resources will the buyer need to implement your solution? • What are the risks?
  21. 21. Value = outcomes / cost Any cost-effectiveness analysis should relate back to your core value proposition: ● What is the need? ● Which outcomes can you deliver to address that need? ● How much will it cost?
  22. 22. 1. Use the EVALUATION CHECKLIST to identify gaps 2. Consider OUTCOMES and COSTS you could measure to demonstrate your product is a solution to identified unmet need Task
  23. 23. Supporting evidence VP Burden of Disease Data Evidence of Unmet Need Clinical Trials Cost-Models Economic Evaluations Case Studies
  24. 24. Gain / Pain ratio ● NHS is risk averse ● SMEs must offer a higher Gain / Pain ratio ● Non-disruptive innovation is easier to adopt
  25. 25. Attributes that aid innovation adoption Relative advantage * Low complexity Compatibility / Interoperability Observability Trialability Potential for customisation Ease of use
  26. 26. 3. Construct Understand Evaluate Construct Test
  27. 27. Constructing your value proposition Are not: • Visions or mission statements • A list of product features • Catchy slogans (although they can feature) • A data dump • A proposition statement They are: A statement that proves I know what they want and need, why they want and need it, and why they should believe I will provide it to them.
  28. 28. My experience – fatal flaws Talking about a benefit that isn’t of any benefit Taking the wrong message to the right people, or the right message to the wrong people So many messages…and so much data…and cost models…and some more evidence….and what were you saying again?!
  29. 29. The good • Estimates suggest that around 216,000 individuals are chronically infected with the hepatitis C virus (HCV) in the UK. Hospitalisations, inpatient days and mortality linked to HCV diagnoses are all increasing. • Management of HCV-related end stage liver disease (ESLD) and hepatocellular carcinoma (HCC) can be very expensive. Could the cost of managing patient illness be better invested in presenting disease progression? • Achieving Sustained Viral response (SVR) with medication improves clinical outcomes for people with HCV by reducing morbidity, mortality and liver transplants. • SVR rates for treatment naïve patients with Peginterferon alpha + Ribaviron (PR) are less than 50% and less than 22% in treatment-experienced patients • In treatment-naïve and treatment-experienced patients, an INCIVO-based regimen offers the potential for significantly higher SVR rates, even in patients with advanced fibrosis or cirrhosis.
  30. 30. Don’t be afraid to keep it simple
  31. 31. Value proposition structure 1. The Issue (why it’s risky not to change) 2. The Solution 3. The Gains (benefits over the product or service alternative) 4. The Value Make it specific: tailor the language and the need to your audience and the supporting cost-effectiveness data to the patient group / Trust / CCG / region.
  32. 32. 4. Test Understand Evaluate Construct Test
  33. 33. Fatal flaws Not identifying a real problem Not identifying a real patient or system benefit Right person, wrong message Lacking evidence Too much emphasis on minor details Getting too creative with the numbers Blinding them with science Being vague or too complex
  34. 34. Summary Understand Evaluate Construct Test • Articulate your VALUE clearly. • Always recognise the constraints of the system into which the innovation is to be introduced (the IMPLEMENTATION CHALLENGE)
  35. 35. Real world validations What exactly are they and how are they useful? Laura Boland and Dr Rafaela Neiva Ganga
  36. 36. Why evaluate • Evaluation is essential to prove your product works • Evaluation data can be evidence, experience and endorsement • Your value proposition must be backed up by robust evaluation • Why is evaluation of your innovation important to you?
  37. 37. Why real world validation? ● Real-World Evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. ● Real-World Data (RWD) is the data relating to patient health status and / or the delivery of health care routinely collected from a variety of sources, for example: Electronic Health Records (EHRs), Claims and billing activities, Product and disease registries, Patient-generated data including in-home settings, Data gathered from other sources, such as mobile devices.  RWD and RWE are playing an increasing role in health care decisions. This data holds the potential to allow us to better design and conduct studies in the health care setting.  Randomized Controlled Trials (RCT) are time and resource-intensive, lack of generalisability and typically restricted to evaluating specific interventions one at a time.
  38. 38. What is real world validation (RwV)? • Real world validation is a cost-effective mix-method user inclusive observational study to assess the impact and benefits to patients, staff and the health economy, in a non-controlled environment, of an innovation that has already undergone a pilot process.
  39. 39. Task: real world validation of your innovation Think about your perfect real world validation to demonstrate the value of your product: 1. In one sentence explain your innovation. 2. Explain how your innovation is different / better / a step forward from your competition. 3. Explain the patient or system benefit you may want to prove (health and economic outcomes). 4. Has your innovation undergone a pilot study or evaluation? 5. What data do you have that can be used to support the RwV (pre and post intervention, control group, etc.)? 6. In how many sites has your product been tested? Were the results replicated? 7. If your product hasn’t been piloted, where would your ideal test site be?
  40. 40. Task: real world validation of your innovation
  41. 41. Task: real world validation of your innovation Think about your perfect real world validation to demonstrate the value of your product: 1. In one sentence explain your innovation. 2. Explain how your innovation is different / better / a step forward from your competition. 3. Explain the patient or system benefit you may want to prove (health and economic outcomes). 4. Has your innovation undergone a pilot study or evaluation? 5. What data do you have that can be used to support the RwV (pre and post intervention, control group, etc.)? 6. In how many sites has your product been tested? Were the results replicated? 7. If your product hasn’t been piloted, where would your ideal test site be?
  42. 42. E.g. RwV – Oxford Academic Health Science Centre Point of care flu testing in emergency departments • Using the test in the emergency department enabled quicker treatment decisions and faster patient turnaround, leading to better patient flow and management during a time of intense pressure • After evaluating a different test in each hospital over the winter of 2017/18, the preliminary health economics showed that average lengths of stay were halved, and there was a saving of roughly £200 per patient tested.
  43. 43. The evaluation pathway It can help to break evaluation down into an evaluation pathway. The pathway is made up of four evaluation stages: 1. Setting outcomes 2. Collecting evidence 3. Analysing & reporting 4. Acting on your learning
  44. 44. Logic models What is a logic model? A logic model presents a picture of how your intervention or initiative is supposed to work. It explains why your strategy is a good solution to the problem at hand.
  45. 45. Logic models Inputs Your time My time Venue & travel costs Activities Presentation Questions Worksheets Groupwork Outcomes Under- standing of real world validation First drafts of a logic model Ability to make a start on your real world validation Impacts The programme is a success. You can demonstrate the value of your product to the NHS
  46. 46. Logic models Logic models capture and summarise your validation project. There are different approaches, but all share core elements* Inputs Resources used Activities Things done (measured by outputs) Outcomes Effects of activities Impacts Broader societal ‘goods’ Typically broken down into initial / intermediate and final, or short- and medium- term * Terminology may vary, but the basic concepts remain constant
  47. 47. Logic models Why use a logic model approach? ● Visually engaging approach ● Brings together existing evidence (and identifies gaps) ● Logically links activities and effects: ● Identifying barriers ● Clarifying assumptions making success more likely ● Provoking thought and triggers questions ● Builds understanding and promotes consensus ● Provides a common language ● Provides common point of reference
  48. 48. Practical exercise • Have a go at a logic model. Think about the inputs, activities and outputs that would best validate your innovation.
  49. 49. Innovation Agency Online Course: Evaluating your innovation A six module course: 1. Introduction to Evaluation 2. Types of Evaluations 3. Economic Evaluation 4. Real World Validation vs Randomised Control Trials 5. Planning an Evaluation 6. Getting the best out of your findings Self-paced course, 1-3 hours per module. Intended to develop your understanding of the methodologies of evaluation and the ways you can use your findings to demonstrate the value of your innovation in a health and care setting.
  50. 50. Business case Lorna Green
  51. 51. A business case is used throughout the NHS to provide the basis for change and transformation. It could also be used for the basis of a funding or tendering application. The content of a business case can vary depending upon the specific purpose but generally all have key elements A business case is the bringing together of all these key elements in a coherent way.
  52. 52. Your Product / Service will not be adopted (or funded)! But if luckily adopted, a poor business case will… Limit opportunity for spread. Good Business Case will facilitate both spread and adoption.
  53. 53. NHS unmet clinical need Key Activities Value Propositions – the Benefits Patient Engagement Management Team Risks Evidence Base Commercialisation – route to market
  54. 54. What is the health or social care problem to be addressed? What is the impact on patients as well as health and social care services? How does your solution support the NHS Long Term Plan and other strategy policies? What is the market size? Which patient population is affected? What is the NHS cost burden?
  55. 55. Presenting your product that meets the System Needs. Concise summary of the products or services to be offered Priorities focus - Answer the Exam Question not your own Question! How is your solution different to existing practise? Any Intellectual Property?
  56. 56. What is your Value / Benefit that you are offering? Discussed in earlier session so take the learnings from that. Should consider: NHS Cost savings Patient Outcomes Operational Efficiencies
  57. 57. How have patients been included within your product / service development? What is the impact on patient experience? What feedback have you had from patients? Are there any barriers from utilisation by patients?
  58. 58. Channels to the NHS Commissioning intentions procurement routes Size of market Pricing structure Comparison with existing products? Requirements for, and barriers to, entry
  59. 59. The basis on which the efficacy of your product / service is supported? Ideally with a RwV – Real World Validation As a minimum, theoretical evidence or other research evidence that may exist Stronger the evidence base, the easier the adoption.
  60. 60. Clinical adoption Technology/functionality Competition Operational / financial risk Legislation/regulation Product liability
  61. 61. Who are the key members of the team – brief summaries of background & experience? How will the company be organised? Who will do what? How will they be monitored? Are there any gaps in the team currently – if so, how will they be filled?

Hinweis der Redaktion

  • 5 minutes

    Brief overview of course
    Introduce guiding document
  • 10 minutes
  • 15 minutes

    Two or three rounds, depending on time
  • 10 mins to discuss at table

    10 mins to write out their own in their workbook
  • A value proposition tells the NHS why they should do business with you rather than your competitors, and makes the benefits of your products or services to them and their patients crystal clear from the outset.
  • NHS is about as risk averse and organisation as you can imagine. They are the epitome of loss aversion (care more about loosing something e.g patient health, money than about gaining something of equal value). They will usually choose stable, certain rewards over risky ones, even if the average payoff from both options is the same. 
    You must create a case for change that leads them to believe it is riskier to maintain the status quo than to make a change.
  • 4 step process – helps to break the task of creating your VP into a logical process and prevent you going astray before you waste lots of time and energy finding out that you are focusing on the wrong features of your innovation
  • The bigger picture
    Before approaching anyone in the NHS, or even starting to develop a solution, SMEs and entrepreneurs need to be aware of the current situation in health and social care.
    Research the overall market and understand how it all works.  Consider the growing population and associated costs, declining budgets, and limitation of resources; remember that although the NHS has a huge budget which provides great opportunities, it is a highly challenging market with expenditure and requests for time and resource challenged at every step.  This is why it is important to make sure claims about improving care and cost savings can be evidenced.

  • As this simple Venn diagram shows, your VP should focus on where the NHS need matches your products benefits.
    A good VP is 50% understanding the NHS need and 50% mapping that to your story
  • Don’t make the mistake of diving headlong into the solution before really understanding the problem you’re looking to solve.
    Start by asking yourself these questions ( the 4 U’s):
    Is the problem Unworkable?
    Does your solution address deficiencies in and/or fix a broken healthcare delivery process where there are real, measureable consequences to inaction? Are patient outcomes and experience currently being compromised due to the lack of a solution?
    Is fixing the problem Unavoidable?
    Is solving the problem driven by a mandate with implications driven by fundamental requirements associated with regulatory body requirements (CQC/NICE/MHRA) or is it driven by a fundamental requirement for better resource efficiency?
    Is the problem Urgent?
    Is it one of the top few priorities for the NHS? In selling to the NHS, you’ll find it hard to command the attention and resources to get a buying decision if you fall below this line.
    Is the problem Underserved?
    Is there a conspicuous absence of valid solutions to the problem/unmet need you’re looking to address?  Focus on the whitespace in a market or segment. If the answer is yes – then you know the market is primed for the solution

    You have to be in position to articulate the problem to your customer to get their attention. If you don’t fully understand what their problem is and how they would solve it without your product, you can’t find your value to them.
  • Don’t make the mistake of diving headlong into the solution before really understanding the problem you’re looking to solve.
    Start by asking yourself these questions ( the 4 U’s):
    Is the problem Unworkable?
    Does your solution address deficiencies in and/or fix a broken healthcare delivery process where there are real, measureable consequences to inaction? Are patient outcomes and experience currently being compromised due to the lack of a solution?
    Is fixing the problem Unavoidable?
    Is solving the problem driven by a mandate with implications driven by fundamental requirements associated with regulatory body requirements (CQC/NICE/MHRA) or is it driven by a fundamental requirement for better resource efficiency?
    Is the problem Urgent?
    Is it one of the top few priorities for the NHS? In selling to the NHS, you’ll find it hard to command the attention and resources to get a buying decision if you fall below this line.
    Is the problem Underserved?
    Is there a conspicuous absence of valid solutions to the problem/unmet need you’re looking to address?  Focus on the whitespace in a market or segment. If the answer is yes – then you know the market is primed for the solution

    You have to be in position to articulate the problem to your customer to get their attention. If you don’t fully understand what their problem is and how they would solve it without your product, you can’t find your value to them.
  • Don’t make the mistake of diving headlong into the solution before really understanding the problem you’re looking to solve.
    Start by asking yourself these questions ( the 4 U’s):
    Is the problem Unworkable?
    Does your solution address deficiencies in and/or fix a broken healthcare delivery process where there are real, measureable consequences to inaction? Are patient outcomes and experience currently being compromised due to the lack of a solution?
    Is fixing the problem Unavoidable?
    Is solving the problem driven by a mandate with implications driven by fundamental requirements associated with regulatory body requirements (CQC/NICE/MHRA) or is it driven by a fundamental requirement for better resource efficiency?
    Is the problem Urgent?
    Is it one of the top few priorities for the NHS? In selling to the NHS, you’ll find it hard to command the attention and resources to get a buying decision if you fall below this line.
    Is the problem Underserved?
    Is there a conspicuous absence of valid solutions to the problem/unmet need you’re looking to address?  Focus on the whitespace in a market or segment. If the answer is yes – then you know the market is primed for the solution

    You have to be in position to articulate the problem to your customer to get their attention. If you don’t fully understand what their problem is and how they would solve it without your product, you can’t find your value to them.
  • Sketchnote by Karla. Even with this massive simplification, the NHS is a minefield. It might be called a ‘National’ Health service but its actually 10000 separate organisations. Who you are talking to dictates the How.
    You must know your audience and what motivates them before you begin.
    Research the overall market and understand how it all works. The customer or end user value proposition can sometimes get ignored in these conversations, and yet are key to the successful transformation of our healthcare system.

  • Example of infographic from Leeds Strategic Plan : making life simple for you to understand priorities and indicators.
    May also have a ‘plan on a page’
  • Remember you are giving them something to vote FOR and not just against. So cost is important but it’s the patient or staff benefit that will compel them to drive change.
    Demonstrate how and where the product will add value to people and the health and care system.
  • After you have determined the problem you’re solving and validated its criticality, ask yourself: What is unique and compelling about your breakthrough?
    Consider which evaluation methods you can use to determine whether each product is unique and compelling and how to measure potential adoption
    Consider, based on your identified need and market analysis, whether you need to evaluate CLINICAL OUTCOMES, SAFETY, EXPERIENCE, EFFICIENCY
  • Assigning a value to health outcomes = difficult
    It is important to make sure claims about improving care and cost savings can be evidenced.
    Be pragmatic
  • Convert your identified needs/ pains/ gains into measurable value. Stating facts like ‘improves patient experience’ is meaningless unless its evidenced and quantified e.g patient reported outcomes measure scales.
    If you can satisfy the top part of the value equation, the challenge now is the resources required and specifically the revenue cost of picking one intervetion over another.
    The intelligence regarding cost pressures or indeed savings opportunities is key in your value proposition. Savings may occur not only as reduced cost, but also as reduced length of stay, reduced time in theatre or a move of treatment from inpatient to outpatient.
  • Don’t make the mistake (a very common one) of thinking as all of your value ‘dossier’ or evidence portfolio as your value proposition.
    Your evidence are your ‘Core Pillars’ that support your VP. People often use value proposition and value story interchangeably . It helps if you think of you VP sitting above everything else and that it is your guiding proposition and core message to your audience. Everything else is better thought of as ‘supporting evidence’ to help you retain clarity about your VP and your goal. Don’t hand someone a 5000 word VP and expect them to tease out the bits important to them. It just wont happen. VP’s are fed by health economics and cost models and feed into business cases but are different things. The data informs the VP which in turn informs further evidence generation.
  • You might need to evidence more gains’ for the system to secure adoption as an SME. You can measuring potential customer adoption using the gain/pain Ratio
    Too many SMEs are so focused on the features they deliver that they sometimes fail to examine how hard it will be for customers to adopt their product and/or service − the gain/pain ratio involves measuring the gain you deliver the customer vs. the pain and cost for the customer to adopt it.
    Many healthcare decision-makers are looking for non-disruptive disruptions: technologies, products and/or services that offer game-changing benefits with minimal modifications to existing processes or clinical environments.
    Non-disruptive is critical to SMEs bringing innovative products or services to the healthcare market since the gain delivered will also be discounted by the risk associated with buying from a young company. Remember the NHS is risk averse and you need to make them believe it is more risky to do nothing than to take up your innovation. Loss aversion theory – people don’t like losing things so create the ‘case for change’ by building a sense of loss if they don’t take action. ‘This it what you or your patients will loose out on without our product’
    A successful SME will, therefore, need to deliver an order of magnitude improvement over the status quo. If a proposition can’t deliver a 10x gain/pain promise, healthcare decision-makers will typically default to “stick” rather than bear the risk of a procurement decision. 
  • Framework that can help when considering pain/ gain ratios and chance of your product getting adopted. Sometimes brilliant innovations fail to get any traction in a real healthcare setting. Why? The innovator hasn’t fully understood the impact of the innovation in a real setting, and spread and adoption is too challenging in reality.
    In a complex environment like the NHS it can help to have some of these attributes Taken from Trisha Greenhalgh’s book; How to Implement Evidence Based HealthCare. Great read if you want to get under the skin of some of the challenges faced by NHS decision makers when implementing innovation today. But originally taken from Everett Rogers’ ‘Diffusion of Innovation Theory’. The single most important one is relative advantage. If the clinician or buyer does not believe your product is ‘better’ ie. Faster, cheaper, safer, better outcomes then forget it.
    . It’s worth considering evaluating these attributes and then highlighting the powerful ones in your VP if they are validated as real pain points in the system.
  • Without explicitly saying so, Uber expertly highlights everything that sucks about taking a traditional taxi and points out how its service is superior. The simple (yet highly effective) copy above, taken from the Uber homepage, excellently conveys the simplicity and ease that lies at the heart of what makes it such a tempting service:

    The smartest = You’re clever!!
    One Tap = it’s simple!!
    Comes straight to you = you don’t have to even move a muscle!!
    Cashless = you don’t even need money!!

    Not convinced? More reasons to ride…

  • Clinical audience, traditional layout and not overly designed (although there was supporting marketing materials). Assumes some knowledge that SVR is a good outcome measure and that PR is current NICE recommended, gold standard treatment. Otherwise, its very clear what the product is for and the benefit it can deliver. Question half way through confirms the need is a true need in the mind of the reader.
  • If you can’t explain it simply, you don’t really know what you are trying to say
    It should be CLEAR, COMPELLING, AND DIFFERENTIATING. As short, sharp and tailored as you can manage.
  • Remember that the value proposition will change depending on who it is presented to….outcomes first or cost-effectiveness first? Core message could be different. If you can quote costs and cost-effectiveness per patient or trust specific value this is even better. It might be worth market research into what each group already knows and believes , what their values and priorities are.
    Keep it simple: Better, faster, cheaper, safer
    Have a go!
    Does it look different than your first attempt?

  • Test your value proposition until you get it right! Validation is essential. You can pre-empt some of the challenges by assessing barriers to entry, readiness for adoption, market potential/market opportunity etc…but you never fully know how it will land until to test it out.
    Ask the decision maker (clinician, manager, policy maker, finance director) : Are they persuaded by your Value Proposition and the supporting evidence AND do they believe that change is possible.

  • Is it clear why value proposition is so important? Your whole business strategy depends on it and it will guide your content in business plans/ evaluations and cost models. You need it for everything you sell. It will change with time and as your markets, needs and expectations evolve.
    Always think and reflect on the two key questions: What promise of value are you offering? Do your customers recognise and believe in that value?   These are not easy questions. If you have done your research and you are not sure of the answers, get out and talk to people. Best talk to some customers and potential customers. Otherwise talk to advisors, mentors, non-execs or anyone who will listen. There is no more important question on which to seek advice. By all means avoid the business jargon of the words value proposition. But keep the concept at the heart of your strategy.

  • Real-World Data (RWD) and Real-World Evidence (RWE) are playing an increasing role in health care decisions.
    Real-World Evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.
    Real-World Data (RWD) is the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, for example: Electronic health records (EHRs), Claims and billing activities, Product and disease registries, Patient-generated data including in home-use settings, Data gathered from other sources, such as mobile devices
    RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).
    Why now? The use of computers, mobile devices, wearables and other biosensors to gather and store huge amounts of health-related data has been rapidly accelerating. This data holds potential to allow us to better design and conduct studies in the health care setting

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