Playing in the Real World Evidence Sandbox: Sharing, Teamwork, and Transparency

SandboxIs just playing in the same sandbox together an example of Real World Evidence (RWE) collaboration? Not really. So how exactly do you play nicely in the RWE ‘sandbox’, but really collaborate and actually get a project off the ground, into the field, and into publication?

Nathan White has some secrets to success. Nathan is the Director for NucleusX Market Access, a global healthcare consulting firm specializing in market access. On December 11, 2014 Nathan will share some of his knowledge and experience at the RWE Virtual Summit hosted by HealthEconomics.Com (for more information or to register, click on the graphic below or visit this link:

http://www.healtheconomics.com/home/1st-ever-virtual-summit-real-world-evidence

Thanks for downloading your copy of the Final Findings from the Survey 2014 on Real World Evidence_image001

Nathan will discuss findings from research he’s conducted and pull back the covers on what Payer-Pharma nathan-white-quoteCollaboration really means.  What works? What doesn’t work?

He’ll lay out some ideas of what to discuss, once you get the stakeholders to the table.  And even when everyone thinks they have a deal, there’s the dreaded contract! How do you survive the contracting process, and what are your barriers to getting through it? What does it take besides money?

Lastly, transparency of data is an obviously important component for all parties involved in research. Nathan will address transparency head-on, and discuss the need for consistent data in outcomes research. He’ll also provide some case studies of RWE collaboration, and the reasons why identifying a good example is difficult.

You won’t want to miss Nathan White’s presentation on Payer-Pharma RWE Partnerships at 11:25am on December 11, so click here to register!


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Transparency – there’s more there than meets the eye!  And there’s more on this topic.  Adding to the discussion on payers and partnerships (and transparency!) is Allan Korn, Chief Medical Officer Emeritus for Blue Cross and Blue Shield Association (BCBSA). As Allan says, “Health care is dangerous. Transparency and an understanding of the impact of innovations and discoveries on real patients in their own “real worlds” will make it safer. Much safer.”

Allan will focus more on metrics (outcomes) beyond those of a clinical trial, and begin to hone in on aspects of the patient side of RWE. He’ll discuss the pace of scientific discovery and how it has potentially outstripped the ability of a randomized, controlled trial to meet the needs of patients. How, on the date of FDA or EMA approval, can you assume a product tested in only 200-300 ideal patients in a controlled setting is safe and effective for all patients in all circumstances? He’ll also discuss the symbiotic relationship between a Quality Adjusted Life Year and a Patient Adjusted Product Year. We asked Allan about his opinion on expectations that payers have for RWE. His response? “Question everything with respect to the clinical research enterprise.”

Hear Allan’s talk at 11:45am on December 11 at the first-ever Real World Evidence (RWE) Virtual Summit: Practical Strategies for Addressing Multiple Stakeholder Needs.

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So if you are able to get everybody into the same sandbox (to continue the metaphor) for collaboration, and you convince the parties involved to extend themselves beyond the confines of a clinical trial…what happens next? What does it mean? Can you influence policy with your results?

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Neumann_PeterPeter Neumann, Director of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center and Professor of Medicine at Tufts will discuss evidentiary standards for evidence. He’ll discuss what and how much evidence you need to be sufficient. He’ll talk about the way things are currently being done, and how they should be done in the future. The existing standards (Guidelines?) are vague, so there needs to be some clarity from the FDA, and some flexibility from a regulatory standpoint about the things pharmaceutical companies are allowed to say. Alas, no discussion would be complete without the mention of FDAMA Section 114, so he’ll be sure to incorporate that into the virtual summit as well.

You won’t want to miss this, so if you haven’t already, please register for the FREE, virtual (you don’t have to leave your home/office/sandbox) event now!

Real World Evidence (RWE) Virtual Summit: Practical Strategies for Addressing Multiple Stakeholder Needs.

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Our next few blog posts will highlight even more speakers from the RWE virtual Summit!  Stay tuned to learn about the stakeholders involved in RWE and incorporating RWE over the product life cycle!

What issues would you like for our speakers to address?  We’d like to hear from you!  (The cartoon is just for giggles…we REALLY do want to hear from you.) Contact us here or leave a comment on this blog.

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A little more about the speakers featured in this post:

Nathan White, CPC is the Director for Market Access at NucleusX.  Nathan has experience in the pharmaceutical and biotech arena, with a focus in managed markets, market access, HEOR, product commercialization, specialty pharmacy operations, account management, business development, patient program design, and consulting operations.  He also has global experience and a vast understanding of healthcare reform and HTA in the U.K., Australia, France, and Germany.
Allan Korn, MD, FACP,  is Chief Medical Officer Emeritus, Blue Cross and Blue Shield Association (BCBSA). He has extensive experience in patient care, managed care policy, procedure and program development and customer service as well as operational responsibility for the development and enhancement of programs supporting the many clinical and business requirements of a sophisticated health insurance enterprise. This includes technology assessment/management, claims data reporting, physician-hospital integration, and creation of policies to support claims adjudication quality improvement programs, and managed care initiatives. He has also worked extensively to improve relationships between physicians and payers.
Peter J. Neumann, Sc.D. is the Director of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, and Professor of Medicine at Tufts University School of Medicine, in Boston, Massachusetts. He has conducted numerous economic evaluations of medical technologies, the use of willingness to pay and quality-adjusted life years (QALYs) in valuing health benefits, and the FDA’s regulation of health economic information, and the role of clinical and economic information in healthcare decision making. He has served as President of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and as a trustee of the Society for Medical Decision Making. He has also held policy positions in Washington, including Special Assistant to the Administrator at the Health Care Financing Administration.

This blog posting was written by Meg Franklin, PharmD, PhD, Owner and President Franklin Pharmaceutical Consulting, LLC, on behalf of HealthEconomics.Com. Dr. Franklin may be reached at mfranklin.fpc@gmail.com or www.franklinpharmaceutical.com.

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Is Your RWE Study In the Weeds? Meet Some Experts Who Can Help.

This year, you can’t swing the proverbial “dead cat” without running into a meeting on Real World Evidence.  This flurry of activity portends good things in that decision-makers are placing greater importance on real world effectiveness data.  Most of us celebrate that this research field is rapidly developing and expanding.  The most creative of our researchers are borrowing methods, approaches, and techniques from other disciplines to improve the efficiency and utility of our RWE studies.  However, there is much ground left to cover.  What is the next vista in RWE?  How do you get your current study out of the weeds?

HealthEconomics.Com, the global digital portal for Health Economics and Outcomes Research  (HEOR) and Market Access, is taking a leadership role in the future of Real World Evidence development by looking beyond the “usual suspects” and expanding RWE concepts into new arenas:  digital health applications, untapped stakeholders like pharmacists, real (vs. pretend) patient engagement, and how the pharma organizational approach can facilitate RWE more successfully and  efficiently.  Interested to know more?

Then join us for the first-ever Real World Evidence (RWE) Virtual Summit: Practical Strategies for Addressing Multiple Stakeholder Needs on December 11, 2014.

Thanks for downloading your copy of the Final Findings from the Survey 2014 on Real World Evidence_image001

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This Summit is virtual, meaning you can join in from your own computer from anywhere in the world, with just an internet connect, and spend the entire day – for FREE – learning about what’s trending for Real World Evidence!  For more information on the summit or to register for this FREE meeting click on this the image below or visit this link: http://www.healtheconomics.com/home/1st-ever-virtual-summit-real-world-evidence/

In this tHEORetically Speaking blog over the course of the next several weeks, we will introduce you to the Speakers and Experts who will be presenting at the December 11 RWE Virtual Summit.  You will get a peek into their futuristic insights, get a teaser of their presentation, and hopefully, will sign up for this free, unparalleled day-long summit on where the RWE field is going…so when 2015 rolls around, you’ll be ready to lead your organization into the future.

Let’s start out by introducing you to our first 3 speakers:  David Haddad, Jeff Trotter, and Amy Smalarz!  But first, why don’t you take a moment to view the agenda and register for the virtual RWE Summit? Just click below.

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Digital Health.  Patient Engagement.  Data Visualization.  Do any of these phrases resonate with you? They do with David Haddad, Executive Director of Open mHealth, a non-david-quoteprofit company that brings a variety of professionals together with the expertise necessary to integrate digital data into the healthcare arena. David is the Keynote Speaker for the first-ever Real World Evidence (RWE) Virtual Summit: Practical Strategies for Addressing Multiple Stakeholder Needs, on December 11, 2014.

As the Keynote Speaker, David will kick-off the meeting from a patient/provider level and address how to tell better patient stories with data.  Imagine a situation in which a patient collects their own data from wearable sensors and mobile health applications. Now imagine a way to connect the data from the patient to the clinician taking care of the patient. Suddenly the data aren’t siloed, and can now be used to understand patterns of health behavior.

David will discuss the progress his company has made with patients being able to tell their stories through such devices.   David will also discuss how to navigate through and make sense of the myriad of other apps and devices available on the market today.

Developing RWE in a rapidly evolving environment is challenging, so how do you generate RWE that matters and makes a difference?  If you’re a clinician, researcher, health administrator, provider, payer, or otherwise involved in healthcare, you won’t want to miss David’s Keynote address.


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Following David’s keynote address, Jeff Trotter and Amy Smalarz will expand from the patient and provider level and discuss specific strategies for pharmaceutical/ device companies who are striving to develop actionable RWE, both organizationally and operationally.

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 Jeff Trotter, MBA
President, Continuum Clinical
 Amy Smalarz, PhD
CEO, Strategic Market Insight

For an industry comfortable with the structure of randomized controlled clinical trials, studies to develop RWE can present a variety of challenges. How do you establish and manage appropriate expectations from stakeholders given the challenges and limitations of RWE? Jeff will provide an overview of strategic and operational considerations in planning for RWE so that it resonates and fulfills its greatest potential with key stakeholders.

To further facilitate the ability to produce actionable RWE, checklist-imageAmy will discuss a RWE Checklist for Success. One goal of the meeting is to customize a RWE checklist to ensure its usefulness for various participants in the healthcare arena involved with the generation and dissemination of RWE. Meeting participants will be given the opportunity to have input on the checklist, and encouraged to provide feedback on strategies that have worked (or haven’t worked!) based upon their own experience.

The remainder of the dynamic day-long virtual RWE meeting (register here!) will cover RWE needs and expectations, various stakeholders that should be involved with RWE (including stakeholders such as patients, pharmacists, and policy makers), and the lifecycle management of RWE.

Over the next few weeks we’ll post more information on our speakers and their topics, so stay tuned!  In the meantime, if you haven’t done so already, please register for this FREE meeting!  Additional information and how to register is only a click away….

Thanks for downloading your copy of the Final Findings from the Survey 2014 on Real World Evidence_image001

What issues would you like for our speakers to address at our December 11 Real World Evidence: Practical Strategies for Stakeholder Engagement virtual meeting?  We’d like to hear from you!  (The cartoon is just for giggles…we REALLY do want to hear from you.)

Dilbert Cartoon

http://www.healtheconomics.com/home/1st-ever-virtual-summit-real-world-evidence/


A little more about the speakers featured in this post:

David Haddad David Haddad is the Executive Director of Open mHealth. His experience includes both domestic and global health, where he’s worked for organizations such as the World Bank and UN Foundation. He has a master’s degree in health economics and policy form the London School Of Economics, and a bachelor’s degree in chemistry and public health from UC Berkeley.
amy-smalarz Amy Smalarz is the founder and CEO of Strategic Market Insight, a consulting company with clients in outcomes research, US payer assessment and positioning, clinical outcomes assessment, patient and clinician decision making, instrument and measurement development, and pay-for-performance metrics. She has a PhD in social policy and health services research from Brandeis University, a masters in health care administration from Simmons College, and a bachelor’s degree in biology and sociology from Brandeis University.
Jeff-Trotter Jeff Trotter is the President of Continuum Clinical, a company that brings together both clinical and commercial development in the areas of patient recruitment, Late-Stage research, health economics, and medical communications. He has been in the healthcare industry for over 30 years as an entrepreneur, researcher, consultant, and innovator. Jeff is an industry leader in the design and implementation of research studies generating “real world” evidence.  He holds an MBA from Northwestern University and a bachelor’s degree in accounting from the University of Illinois.

This blog posting was written by Meg Franklin, PharmD, PhD, Owner and President Franklin Pharmaceutical Consulting, LLC, on behalf of HealthEconomics.Com. Dr. Franklin may be reached at mfranklin.fpc@gmail.com or www.franklinpharmaceutical.com.

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