Real World Talk

September 15, 2020

The Evolving Relationship Between Real World Data and Clinical Trials with Nancy Dreyer and C.K. Wang

In this episode of Real World Talk, host Zoe Li talks to Nancy Dreyer, Chief Scientific Officer of IQVIA, and COTA’s own Chief Medical Officer, Dr. C.K. Wang.

They discuss the interactions between real world data and clinical trials, and how the two approaches can complement each other. They also look at why the Lancet retracted a large study into the use of hydroxychloroquine to treat COVID-19 in June, after questions were raised about its curation and application of real world data. 

“Those standards that we apply to clinical trial data to see if it's a good clinical trial need to be in place for real world data as well,” Dr. Wang says. “Just because [COVID-19] is a novel situation, the way we think about what good research is and what good data is should not be thrown out the window.”

They consider the circumstances in which real world data can make a difference in furthering research, and its possible limitations. They talk about implications that go beyond clinical uses to directly improve patient care.


Episode Key Points

  • Real world data provides fast insights into rapidly developing situations. Whether that’s around COVID-19 or new cancer treatments, looking at real world data can help manufacturers and clinical scientists make decisions about which research to fund and where to focus future investigations.
  • More transparency and clarity is needed when it comes to the provenance of real world data. Clinicians are right to be skeptical of data that doesn’t have a clear provenance, and of authors who don’t explain their collection methods and analytical approaches. Knowing where data has come from to a very specific degree makes it more trustworthy and easier to share.
  • Manufacturers are most interested in attention-grabbing results. Real world evidence that shows dramatic statistical significance makes more of an impact on manufacturers and clinicians. This explains why real world data studies into chronic conditions tend to make less headway.

Episode Highlights

  • [00:29] Introductions — Zoe Li introduces Nancy Dreyer, Ph.D, Chief Scientific Officer of IQVIA, and COTA’s Chief Medical Officer Dr. CK Wang, and asks why the Lancet recently had to retract a study about the use of hydroxychloroquine in the treatment of COVID-19.
  • [02:03] Insufficient information — Nancy Dreyer explains that reviewers who are used to clinical trials struggle to assess the quality of real world data, and that the authors failed to provide enough information on the provenance of their data.
  • [7:20] Trials and errors — Clinicians tend to be skeptical of real world data, but errors like this — and even fraud — happen in clinical trial settings too.
  • [11:57] Clear information — Dr. Wang explains that more transparency around data would make it easier for different labs to work together. Nancy Dreyer says that clearly showing the provenance of data is key to proving that it’s high quality and trustworthy.
  • [15:38] COVID-19 situation — As our understanding of COVID-19 continues to evolve, it’s the perfect example of how real world data and clinical trials can be used in conjunction to achieve fast and targeted research.
  • [18:30] Cancer drugs — Dr. Wang says that combining real world data and clinical trials also makes sense in cancer treatment, as the FDA is rapidly approving new drugs.
  • [20:30] Teaser evidence — Real world data can give manufacturers a preview of areas of interest, and provide an economic incentive to fund further research.
  • [24:09] Context matters —- The impact of real world data depends on the context: the bigger the effect you can prove, the more likely it will lead to a trial or more funding.
  • [26:24] FDA guidelines — The FDA is working to draft guidelines for the use of real world evidence by the end of 2021, looking at factors including structure, provenance, curation and integration.
  • [27:53] Importance of curation — Nancy Dreyer works with big sports leagues to record injuries, and she’s found that curation is a key component to ensuring accurate, useful data.
  • [29:40] Patient welfare — As well as considering the clinical uses for real world data, Dr. Wang wants to use it to improve patient experiences.

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August 18, 2020

Challenges and Trends with Value-Based Care Models Featuring Lili Brillstein of BCollaborative

During this episode of Real World Talk, host Emily Di Capua has a discussion with Lili Brillstein, the Chief Executive Officer of BCollaborative (Brillstein Collaborative Consulting). Lili works with Payers, Providers, Pharma, Start-Ups and other stakeholders to progress the movement from fee-for-service to patient-focused, value-based care models. The conversation explores the complex world of healthcare payment models and highlights the industry’s challenges when transitioning to a more value-based care model.


Episode Highlights

  • Lili opens the conversation by setting the stage for those who are unfamiliar with healthcare payment models. She discusses the dominant form of payments, which is a fee-for-service model. She then discusses the core components of the value-based care model.
  • Lili discusses how there are a lot of different models under an umbrella, which is value-based care. Terms often used include population health, bundled payments and episodes of care.
  • The goal of value-based care models is to really shift the focus from the care provided by one provider to all the care that’s rendered to one particular patient across the full continuum of care.
  • Lili talks about the model of value-based care that she’s most familiar with - the episodes of care model. This model really focuses on the specialists associated with a value based scenario and considers individuals who have some real clinical similarities.
  • There are three main components to value-based care models - improving outcomes, improving experiences and getting the most from limited resources.
  • Providers often don’t have a longitudinal view of a patient’s care because they’re just focused on what services they’ve delivered to the patient.
  • In many cases, you often associate episodes with orthopedic procedures such as hip replacements or knee replacements because these are scenarios that are easier to define. There’s a starting point and an end point.
  • Lili talks about how it’s important for providers and stakeholders to understand that payers are gigantic bureaucracies and are often sitting on systems that rely upon a fee for service model.
  • Lili talks about how her goal as a partner is too often “build something that is clinically meaningful and also administrable by the payer and not burdensome for the providers and the other partners.”
  • Lili’s best advice around providers looking to engage with payers on value-based care, is to engage with payers that have value based care activities already. One way to make this determination is by finding payers who have staff members with titles using words such as innovation, transformation, pophealth, etc.
  • Lili provides some background on specific examples of episode programs, most notably mentioning CMS’s OCM (oncology care management) model. 
  • When considering the trends of value-based care, Lili feels it’ll involve more tweaks and an overall evolution versus a jump. The level of risk will be shifted between payers, providers and patients.
  • Lilii breaks down the components of a specialty care medical home model built around oncology - which was essentially a more hybrid model between the primary care medical home model and a specialty care episode model.
  • Lili talks about a model created at Horizon which involved a maternity episode. The model first focused on moms with low risk pregnancies and then shifted to higher risk patients.
  • When evaluating episodes, it’s important to go beyond claims data, and focus on what success is for the patient as well as the provider and payer. In order to do this, you need clinical data, claims data, social data and the technology to analyze the data.

Episode Key Points

  • Lili draws a distinction between fee for service and value-based care models, “Fee for service is a payment model that reimburses providers of care on a per service basis. So every service is paid for separate and apart from any other service that may be rendered to an individual patient. And reimbursement for the care provider then is increased when they provide them more services. So it...is a quantity over quality incentive in the model.”
  • Lili talks about some of the major drawbacks of the fee for service model, “There is this sort of perverse incentive around quantity rather than quality, for patient outcomes, which often results in fragmented and or unnecessary care for individuals and results in really, less than optimal outcomes. As we've seen medicine continue to evolve and people are living longer and with more complex diagnoses and co-morbidities the fragmented fee for service model really does not work effectively to support these patients and individuals with these situations and certainly not to produce optimal outcomes or a thoughtful use of limited resources.”
  • Lili mentions “And so one of the things I always say to providers and startups and tech vendors who are going in to talk to payers is you need to be thoughtful about what they can actually do and not do. And to listen to what they're telling you because they may not be saying no because they don't like your idea. They may be saying no because administratively it's difficult.”
  • When discussing value-based care models and the pandemic, Lili states “We're really interdependent upon one another to keep each other safe and protect ourselves. And those are precisely the principles at work in value-based care. It's really about being respectful, and understanding that we all have a role to play in the care and the health care, of each of us.”

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August 11, 2020

An Exciting Time for Real World Data with Michelle Hoiseth of Parexel

During this episode of Real World Talk, host Zoe Li has a conversation with Michelle Hoiseth, the Chief Data Officer of Parexel. Michelle talks about this being an exciting time for real world data and the opportunity that exists for the life sciences industry. She highlights some of the challenges involved with further adoption of RWD in clinical development and regulated uses and discusses how the industry can work together for the benefit of patients.


Episode Highlights

  • Michelle Hoiseth opens up the conversation by stating how she feels like, with real world data in clinical development, we're in an incredibly exciting time for change that we haven't really seen for 15 years.
  • Michelle mentions how real world data has the opportunity to play a critical role in the clinical development continuum.
  • According to Michelle, real world data is “showing up” in many places throughout the cycle, including up front in a clinical trial, during design, as a source of patient level data, during changes in the regulatory environment and in the prescribing environment.
  • Leveraging the experience of groups like epidemiology, and health economics - that have had more experience with data in the clinical development end of the spectrum - is key to gaining more traction with real world data.
  • Michelle covers some of the barriers to the adoption of RWD in clinical development and regulated uses. 
  • In the COVID environment, Michelle talks about how the industry has a lot of tolerance now to try new methods and it’s forcing the industry to figure things out - like plumbing, traceability matrices and data lineage.
  • Michelle talks about one of the positive results of organizing as a society around COVID includes changes on the healthcare provider side around data. 
  • Michelle mentions that for a long time, there was opacity in the data. This included a lot of variability and insufficient access to data. Technologies are now catching up and it’s really changing the industry.
  • Michelle mentions that protocol design is often the very first point of failure.
  • Michelle discusses the key steps, as a drug developer, that must take place in order to rethink the planning of protocol design.
  • Michelle discusses whether the current ecosystem is set up for using more real world data in clinical development.
  • For CROs, many are exposed to study execution across a broader number of studies in a certain therapy area...but are not always brought in during the design stage. This means that a CRO’s ability to spark discussion isn’t always soon enough.
  • Michelle talks about how, “we as patients and the loved ones of patients”, want the safest and most efficacious therapies available. And, this ultimately all comes down to trust.
  • So much of trust is about transparency and that’s why Michelle believes the life science industry must operate differently. Most of the time, there’s a lack of transparency because there’s a concern about intellectual property.
  • Michelle highlights that no single organization is going to pierce through all of these data challenges and that it’s important to come together as an industry.

Episode Key Points

  • According to Michelle, there are a number of barriers that have prevented the adoption of RWD, “There have been a number of barriers to the adoption of RWD in clinical development and regulated uses. And they have spanned from things like cost and budget to uncertainty about the reliability of the data to risk aversion coming from uncertainty of the regulatory acceptance of that as a data source. It has really spanned an array of issues.”
  • Michelle states that “Being data agnostic matters, being clear about how you're going to use the data matters.”
  • When asked whether the industry can collaborate better to bring in real world data, Michelle stated “It's a big heavy yes, because it's such a complex environment as we're, thinking about all the different players and in the way that we interact...the points of interaction today in our standard way of working. And it's complex in that we have a number of different industry initiatives going on around real world data that aren't necessarily coordinated or talking together. “
  • Michelle pointed out that, “...as we move into leveraging new sources of data, it's on us to be able to look any patient in the eye and say, ‘We've done the best job we can here. We stand behind this result and the analysis, and that's us all coming to the table together.’”

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August 4, 2020

The Origin of COTA and Using Real World Data During a Pandemic with Dr. Andrew Pecora

During this episode of Real World Talk, host Kevin Keogh talks with Dr. Andrew Pecora of OMI (Outcomes Matter Innovations). In 2011, Dr. Pecora founded COTA and has been an innovator in the oncology space for over 25 years. Dr. Pecora talks about the origin of COTA after discovering 1 out of every $3 is wasted in healthcare. During the discussion, he envisions a future where patients can access healthcare as seamlessly as they can access a car using Uber or Lyft. He also takes a deeper dive into the challenges COVID-19 has on cancer patients and what the future holds for real world data and its adoption within healthcare.


Episode Highlights

  • In the first part of the episode, Dr. Andrew Pecora discusses his background and what motivated him to start COTA.
  • Over the years, Dr. Pecora has been involved in the evolution of hematology oncology and stem cell biology and immunology - particularly their application in cancer.
  • Because of Dr. Pecora’s leadership in these fields, he was invited to participate in a group of people in the U.S. that analyzed the total cost of care issues the nation was facing.
  • Dr. Pecora discusses the challenges the pandemic creates with the documentation of a patient’s journey.
  • Sheltering in place has created unintended consequences for cancer patients who are sitting at home - many with active cancers growing in their body and unlikely to seek care or early diagnosis.
  • Since the colonoscopies have stopped during the pandemic, some professionals believe that there are already 150,000 undiagnosed cases of colon cancer in the U.S.
  • Dr. Pecora describes COTA’s collaboration with Hackensack Meridian Health and the use of their Epic system, which is an electronic medical record system, to extract large amounts of data for COVID-19 infected patients.
  • Dr. Pecora discusses the challenges COVID-19 poses for the field of oncology, which include interruption in business flow, maintaining employment of highly trained professionals and simply covering the costs associated with running a practice.
  • During the pandemic, those participating in the evidence accelerator (a collaboration between COTA, Hackensack Meridian Health and the Reagan-Udall Foundation), realized that each patient was a treasure trove of information and had the ability to extract massive quantities of data in a very short amount of time.
  • The evidence accelerator provided an ability to answer fundamental questions for the CDC and FDA well in advance of other peer reviewed publications.
  • Dr. Pecora builds a metaphor to discuss how COTA’s solutions equate to the services Uber provides.
  • COTA’s promise is around the ability to have an overarching view of real world data and even determine the “best value-based road” for patients.
  • Dr. Pecora discusses how organizations can prepare for a value-based care world.
  • Dr. Pecora discusses the challenges a rise in healthcare creates, most importantly taking resources away from other necessities such as military, roads, education and more.
  • At some point, there will be a tipping point with real world data and it’ll come as companies work with the FDA to embrace real world evidence more and more.
  • Dr. Pecora concludes the interview by discussing a point where CMS moves to utilizing real world data and evidence, “ultimately this will catch up to the point where CMS will be like, all right, well, you know, the country has moved, we're going to do it. And then, you know, when Godzilla says we're going, right, we're going right.”

Episode Key Points

  • According to Dr. Pecora, “...as more and more therapies come to market and people are living longer and aging, that total cost of care burden as a percentage of the total economy was becoming disproportionate.”
  • Dr. Pecora discussed the origination of COTA, “we've in fact...may have been wasting one out of $3, in the application of healthcare. And so I started to think about the problem and realized that unlike the biology problems that I deal with...this was not a biology problem. This was an information technology problem.”
  • When discussing the impact of COVID-19, Dr. Pecora stated “I have seen several examples of people presenting with way more advanced cancer than they otherwise would have presented with...had this COVID-19 problem not existed. You see most cancers double every 30 days. So two or three months is material in the amount of cancer in your body and how far it can spread.”

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July 28, 2020

How Real World Data Can Make a Difference in Healthcare with Jess Federer of Boston Millennia Partners

During this episode of Real World Talk, host Emily Di Capua leads a discussion with Jess Federer, a COTA confidant, advisor and board member for several healthcare and technology companies. Jess talks about some of her past experiences, including a role as the first ever Chief Digital Officer at Bayer. Jess covers topics around the innovation of “older” companies like Bayer, the impact real world data has on healthcare and the changes we’re seeing with healthcare data as a result of the pandemic.

  • Jess Federer starts off the podcast with an introduction to her background and provides context on how she became a sought after corporate board member and advisor.
  • Jess mentions how the primary way she made it to the board was through data and a relentless commitment to public health.
  • She highlights how she convinced her undergraduate university to create a program for Public Health and subsequently became the first graduate at George Washington University with a Bachelor’s of Science in Public Health.
  • After periods of time with HHS and AHRQ, Jess went and obtained her Master’s in Public Health at Yale.
  • Jess moved to Germany and was part of the first team to roll out market access globally in her company.
  • After spending some time in communications and policy, Jess ultimately made her way to become the first ever Chief Digital Officer at Bayer.
  • When asked about Bayer’s innovation, Jess discusses how larger, older businesses do not get enough credit for their innovation.
  • According to Jess, the CDO is responsible for two primary things: 1) Cleanup of heterogeneous data and 2) Innovation.
  • Emily asks Jess about the most exciting areas of development within the health tech sector today and Jess mentions how interoperability is one of the biggest areas of innovation.
  • Jess talks about the rollout of EHRs did not lead to the expected innovation in the industry and now, with the current administration, there are efforts in place to unlock the data again.
  • Jess is most excited about data coming together where it can be connected across healthcare systems (across prescribers, prescription data, wearables and more).
  • Jess talks about the challenges of working with real world data and where advanced analytics are really the key to understanding unstructured data. The ability to use natural language processing to understand what’s in the information.
  • Emily poses a question to Jess about how the U.S. compares to other countries when it comes to fragmented healthcare data. Jess talks about how countries such as Germany or areas of Korea that have rebuilt their healthcare systems after wars and have more integration.
  • Jess talks about how COVID has shifted the risk paradigm for healthcare companies. Traditionally, big pharma companies were very risk averse, but now everyone in the industry has to move much faster and innovate more quickly.
  • As startups get to move quicker in this climate, the big challenge will be delivering on those promises in the marketplace.
  • Jess mentions how she’s never seen regulators move this fast and wonders if this speed is the “new normal”.
  • Jess breaks down the process she used to become the first CDO at Bayer and standout among 120,000 global employees.
  • Jess offers a few key pieces of advice for those building their careers. 1) Pick your boss, not the job. 2) Map up and build a roadmap for your career. 3) Hold the door open for others.
  • Jess recommends listening to the Epidemic podcast led by Dr. Celine Gounder.

Episode Key Points

  • After graduating with a Master’s from Yale, Jess joined industry. She mentions “I started in industry and regulatory affairs, which I can't recommend enough for anyone interested in drug development. Regulatory affairs gives you an incredible overview of the entire life cycle of both innovation and of the product. From when you're doing the research and working with regulators on the study design all the way through to when you have to stop making a product or maybe just continue making a product because it helps an underserved area in one country.“
  • As the first Chief Digital Officer at Bayer, Jess felt it was “really about using digital enablers to change a company, transform a company and not only improve the existing business models, but also create new ones.”
  • According to Jess, “we now have the technology capabilities to analyze all of that [healthcare] data and make sense of it. Because of course you got to find the signal through the noise because nobody has time to go through all that information.”
  • When talking about real world data, Jess highlights “This is a pretty fundamental evolution. This progression has been in the works for decades. This is a very meaningful, a very sustainable development with the right safeguards and the right management. This is going to be transformative, both for research and for care.”
  • According to Jess, “I think we're starting to see some changes in how we view healthcare data in the U.S. that's going to bring us closer to the way healthcare data is seen and viewed, and actually secured and protected as well.”
  • Jess mentions how startups are making fast moves in light of the pandemic, “And so we're seeing companies that used to have to knock on doors for 18 months, get deals done in seven days. And so the speed with which the technology is being adopted and integrated and put into strategic plans and put into operational studies is remarkable. I've never seen it moved this fast.”

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July 21, 2020

Dr. C.K. Wang and Dr. Ming He Discuss COVID-19's Impact on Cancer Research

In this episode of Real World Talk, host Kevin Keogh speaks with Dr. CK Wang, COTA’s Chief Medical Officer, and Dr. Ming He, our Senior Medical Director — the “internal and external medical voices of the company.” 

They discuss how COVID-19 has affected cancer research and treatment, including difficulties executing clinical trials and complications communicating with patients. They also look at the impact of real-world data (RWD) — especially in efforts to understand COVID-19. Federal agencies including CDC and FDA are increasingly turning to real-world data to better fight the disease. Looking forward, they suspect COVID-19 will increase the need for more standard telemedicine practices. They also discuss the changing oncology landscape, the increase of specialized practices and how using real-world data could shape the future of oncology.

Highlights

  • Kevin Keogh introduces Dr. CK Wang, COTA’s Chief Medical Officer, and Dr. Ming He, the Senior Medical Director. Dr. Wang and Dr. He discuss their backgrounds in science and medicine and their roles at COTA.
  • During COVID-19, clinical trials have been difficult, if not impossible, to execute, and Dr. Wang explains how using real-world data can help.
  • The doctors talk about how COVID-19 has made it difficult for medical providers to effectively communicate with patients and provide the best care.
  • Dr. Wang outlines the potential long-term effects of COVID-19 on patient care, including delays in cancer screenings and treatments.
  • Doctors traditionally take a hands-on approach with patients, but Dr. He talks about how they’ve had to adapt since COVID-19, and she hopes it’ll lead to more universal telemedicine standards.
  • Dr. Wang explains why he decided to transition from a general oncologist to a specialized practice.
  • Dr. He agrees specialized oncology has become more common and explains how the evolution of cancer care has shaped this trend.
  • As more and more targeted therapies emerge, Dr. He emphasizes the importance of using data, especially in smaller communities.
  • Dr. Wang explains COTA’s disease-specific data dictionary and how it’ll continue to evolve with cancer research.
  • Looking forward, Dr. Wang addresses some potential challenges to curating data, including the nonstandard format doctors use to document patient information.
  • Dr. He emphasizes the need for a standard electronic medical record (EMR) that includes clinical results documentation.

Key Points

  • COVID-19 has affected clinical trials and cancer treatments. Due to social distancing, clinical trials have been delayed, and cancer screenings and treatments have been put on hold. If more doctors could tap into real-world data, it could be leveraged to help find solutions for patients during this time.
  • Oncology has become more specialized over the past decade, which means more practitioners would benefit from a centralized database. This is due, in part, to an increase in targeted drug therapies. As more and more of these therapies are developed, doctors will have more and more options. Having access to a national database of patient information can help them seek the best treatments.
  • Challenges involved with collecting medical data persist. For example, many doctors have their own shorthand. Plus, EMRs don’t require doctors to report clinical results. However, this could be a simple fix and something doctors would quickly get used to.

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