Understand how real world data is developing the pharmaceutical industry’s business model
Real World Data stands to allow payors to better understand the outcomes of various treatments and only pay for those which are most beneficial to society through conditional reimbursement. Although this may be risky, it will reward innovation, rather than interative developments. The report provides a comprehensive assessment of the key challenges, opportunities, and disruptive influences associated with real world data and how these are affecting your business model.
Some key findings discussed in the report include:
- What are the best sources of Real World Data and why
- Who could pharma look to partner with and what makes a productive partnership
- Examples of partnerships and discussion on how these are formed and the commercial take aways from them
- Understand the different types of trials which utilize real world data
- How conclusions drawn on turning quantitative data into qualitative data will help interpret epidemiology trends show true Outcomes and will be used to help calculate a measure of true health outcomes
- How to apply RWD and how this will help reduce costs associated with Random Clinical Trials (RCT).
- Case studies and insights into what companies are aspiring to do with RWD. Including a detailed study on GSKs Relovair (Salford study) with their lead medical director who designed the trial
- How to use RWD to satisfy payor needs – what does pharma need to do to achieve reimbursement for their new treatments
- Regulations which affect real world datas usage in major European economies and the US
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- Welcome 3
- Industry reviews 4
- About eyeforpharma 5
- Acknowledgments 6
- Index of figure and tables 8
- Executive summary 9
- Introduction 13
- Real World Data Defined 13
- Pros and Cons of RWD 13
- Using RWD in like-for-like trials 14
- How RWD use is changing in the healthcare industry 16
- Factors driving rise in use of RWD 16
- Gaps in knowledge of RWD 19
- Methodology 20
- 1. Sources of RWD 23
- 1.1. Databases 23
- 1.2. Observational data 25
- 1.3. Patient reported outcomes 25
- Case study: PatientsLikeMe 25
- 1.4. Registries 26
- 2. Partnerships-Competitive cooperativeness 28
- 3. Data regulations and quality control 33
- 3.1. Policies and regulations surrounding data ownership 33
- Case study: National Committee for Quality Assurance 34
- 3.2. Industries thoughts on how to ensure quality of data collection 36
- 4. How are RWD being used? 38
- 4.1. Using RWD to perform head-to-head trials to identify cost benefits 38
- Case study: Cost benefit of RWD 39
- 4.2. Using RWD to determine drug effectiveness and efficacy 39
- Case study: Using RWD to assess risk 40
- 4.3. Payors’ use of RWD studies 43
- 4.4. Methodologies behind RWD usage 43
- 5. Payors’ needs and their use of RWD 46
- 6. What the industry has to gain from increased use of RWD 48
- Industry learning 50
- Abbreviations 51
- References 52
- Appendix A 56
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The eyeforpharma Real World Data (RWD) Report, 2013 was based on 4 months research involving 34 in-depth interviews with decision makers based in Europe and North America, an exclusive survey on RWD and detailed secondary research on papers published within the past 2 years as well as those which were referred to by interviewees.
In order to get an accurate feel for RWD within the pharmaceutical industry we initially conducted 21 interviews with industry leaders. The interviews were used to understand current market trends and helped capture qualitative information by using open ended questions. Given how new this topic is to many people we focussed on the key challenges and needs going forward to understand what topics the report needed to focus on in order to add value.
Initial interviewees were selected based on their previous involvement with eyeforpharma - all interviewees were based in Europe and North America; 11 of them were from pharmaceutical companies, 3 consultants, 2 vendors, 1 payor, 3 academics and 1 healthcare professional.
Having established there was a need for business intelligence relating to RWD the various stakeholders were identified as holding valuable insights (figure 3):
- Consultants/solution providers
A survey was sent out to a targeted section our database (pharmacists, clinical trials managers, payors, marketing directors, R&D, and medical directors from across the globe) (figure 2); Of these there was a fairly even distribution of primary job functions, with the majority of those completing the survey coming from top level management (figure 3).
Figures 3&4 showing primary job function and their businesses primary function respectively
Surveys were distributed electronically in December 2012 and the questions asked were based on:
- The 21 preliminary interviews with pharmaceutical professionals regarding their challenges and needs surrounding RWD
- Published material on RWD
- Participant requests from eyeforpharma conferences
Having conducted the initial interviews, survey, a review of additional datasets, literature and conference proceedings pertaining to RWD usage a decision was made to conduct a further 13 interviews with key figures who have been involved in the development of RWD in the pharmaceutical industry (from the main stakeholders), most of whom are acknowledged in this report.
The additional interviews were very focussed and structured around the questions which had been identified as business critical in both the initial interviews and surveys. Interviewees were asked to openly share their thoughts, ideas and personal experiences surrounding the questions asked, and where possible were asked to provide case studies to help contextualise a particular subject.
Once the information had been collected it was were integrated to uncover the industry trends which are discussed and presented in this report. Key findings have been presented in the form of chapters and case studies and where relevant contributors are quoted with examples given into their particular case.
Finally the report was sent out to 5 peer reviewers who were independent of the project to hear their unbias opinion on what had been produced. The peer reviewers were selected based on their experience and insights into RWD, in this report the reviewers were Tehseen Salimi Sanofi, Sandy Kildegaard Nielsen Ferring Pharmaceuticals, Dr Richard Barker CASMI Oxford University, Sarah Garner NICE, Rob Thwaites UBC
Industry insights from 37 interviews with key opinion leaders with decision makers based in Europe and North America. Some key interviewees include:
- Novo Nordisk
- Janssen of Johnson & Johnson
- Agency for Healthcare Research and Policy (AHRQ)
- PKPD Strategies
- OptumInsight Life Science
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