• Trial Better: A Clinical Trials Podcast

  • By: ERT
  • Podcast

Trial Better: A Clinical Trials Podcast

By: ERT
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  • Summary

  • The Trial Better Podcast is ERT’s best practices series for clinical trial research. In this series, we discuss the factors that determine a successful clinical trial. Topics we cover are patient engagement, data architecture, FDA guidelines, wearable devices and much more. With our expert guests, we explore how to address the many unseen obstacles of clinical research.
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Economics Science
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Episodes
  • Why Global Real World Evidence Matters

    Why Global Real World Evidence Matters
    May 21 2021
    Tell the audience a little bit about yourself.I’m currently at TriNetX as the Senior Vice President of Clinical Science and Operations, but I’ve been in the clinical and life sciences industry for 22 years. Throughout my experience, I realized a big piece missing in using data to better clinical research was patient-level data. About five and a half years ago, TriNetX came to me and I realized this was a new company up to great things, including using data to advance clinical trial research and planning.For our audience members who aren’t familiar with TriNetX, can you share a little bit about the organization and what role it plays in the clinical research ecosystem?TriNetX was founded in 2013 and commercially launched in early 2016. We are a global health research network and SaaS, on-demand patient data platform that includes advanced analytics and downloadable data sets. We connect the life sciences industry to patient data around the world and provide rapid insight generation to clinical and medical publications to advance thought leadership. We like to tell our customers, “Welcome to the revolution” - our mission is to help conduct trials that are faster and more efficient, so we can bring drugs to market faster and treat patients more quickly than they would have been otherwise.Looking back three to five years ago, there was some criticism of the non-global nature of real world evidence. Has TriNetX responded to these concerns and, if so, can you tell us how?It’s amazing how far we’ve come. Five years ago, TriNetX only had US data, but we knew early on that this wasn’t going to be enough. So, we set our sights on expanding outside the US, first targeting the EU, then the Asia-Pacific region and Latin America. This expansion, with the goal of building a network of data that is truly global, is very important to TriNetX.I’m sure capturing this data at a global scale comes with complications. Have you faced any challenges throughout this expansion?It hasn’t been an easy task to expand. The biggest challenge is how to get global data quickly. Our strategy has included organic growth of our network of sites outside the US, followed by inorganic growth through acquisition of Custodix, the “TriNetX of Europe,” in 2018. Over time, we’ve continued to expand our global footprint in every way; not just through our network, but through our employees, too. We’ve found it’s important to have boots on the ground around the world.Have you seen sponsor motivation to use real world data change over the last few years in response to changes like capturing more global data?We’re getting more and more requests for data outside the US on a daily basis. It’s still hard to come by this data, but there’s a high demand for global data that allows sponsors to optimize trials for patients, sites and PIs, or generate real world evidence of how drugs are being used in different countries.How can real world data help the industry address ongoing issues with representation of diverse patient populations in clinical research?Over the last few months, TriNetX has put an exceptional focus on diversity and inclusion in data. We believe real world data can provide a better understanding of all patient populations across various stratifications including age distribution, race and ethnicity, comorbidity, geography, and more. Sponsors can use real world data to expand their trials and pick sites that have more diverse populations of interest that would still be eligible for the study. They can also explore populations that may not be studied in randomized clinical trials, and how they’re using drugs and reacting to treatments in the real world. Having all this data and a large number of patients in observational studies is helpful for both trial optimization and trial design.According to ERT research, as of last July, 82% of sponsors had adopted some type of virtual trial technologies into their studies. Does TriNetX have a role to play in helping sponsors run effective virtual or hybrid trials?Yes! We’re heavily engaged with many sponsors to address the expanded demand for virtual and decentralized trials. We can work with healthcare organizations to do virtual and hybrid trials, but also use our data to help clients with external control arms, retrospective and prospective observational studies, parallel arms, and dynamic cohort studies (examining the incidence of a condition within patient populations.) These efforts can happen alongside randomized clinical trials, but demonstrate other ways of conducting studies that don’t involve enrolling patients in the old-fashioned way.Do you have any final thoughts you’d like to share with our audience?I think we’re progressing well as an industry in terms of recognizing the power of real world data and what it can do. I encourage everybody listening to do what they can to unlock more real world data and make it usable for our industry. ...
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    17 mins
  • Progress in Alzheimer's Disease Research

    Progress in Alzheimer's Disease Research
    Apr 16 2021
    Tell us about your experience.After I finished medical school/neurology training, I started on faculty at Indiana University, School of Medicine in the neurology department. I ran a few clinical trials during my time there and became increasingly interested in clinical trial design. Beginning in 1998, I went to work at Eli Lilly and Co. where I focused on late phase work and worked primarily on Alzheimer’s. I started this consulting business about three years ago, and Cogstate was one of the first companies I started consulting with.For our listeners who aren’t as familiar with Alzheimer’s disease, can you explain the specific diagnosis versus one of dementia or mild cognitive impairment?Alzheimer’s is the most common of what we call neurodegenerative diseases; in other words, diseases where brain cells are slowly dying. Alzheimer’s is the most common cause of dementia, but isn’t the only kind of dementia. Recently, the development of biomarkers has allowed clinicians to evaluate if people have the classic pathology to diagnose Alzheimer’s without an autopsy. It turns out, for Alzheimer’s and neurodegenerative diseases you have pathology for many years before you have symptoms. For Alzheimer’s in particular, one of the most important pieces of pathology are amyloid plaques. These plaques are present in the brain for 15-20 years before the onset of any symptoms. After developing these plaques, people develop what’s called mild cognitive impairment which means they experience changes in cognition, but do not meet the strict criteria for dementia. Eventually, people move into mild, moderate, and severe dementia.We know that 50 million people worldwide have dementia and as you state, Alzheimer’s contributes to about two-thirds of cases. Can you tell us a bit more about the current state of Alzheimer’s research?Alzheimer's disease research began with Dr. Alzheimer in 1906, but drug treatment got started in 1990. The first drug approval for Alzheimer’s was a drug called Tacrine in 1993, but this was taken off the market due to causing liver problems. The last new drug approval for Alzheimer’s came in 2003. These medicines are really used to treat the symptoms of the disease. They don’t get at the underlying pathology of the disease. For the last several years, researchers have been more focused on what are typically called disease modifying drugs, which get at the underlying pathology of Alzheimer’s. 99.6% of all Alzheimer's trials fail. Do you think the high failure rates of these trials scare sponsors and prevent them from wanting to invest?That’s been a bit of a rollercoaster. At times, I think that has been the case. There’s a huge unmet need for Alzheimer's research as it is the sixth leading cause of death in the United States. Since we are an aging population, the population growth we will experience will cause the cost of Medicare in the United States to be a trillion dollars a year. Pharmaceutical companies will step up to the plate to try and meet the needs of our population. But then, as you pointed out, when we went through this period when there were so many drugs that were well studied, it just turned out they didn’t work, so there was a time when pharmaceutical companies were skittish about getting into something so risky. What has allowed us to identify these new discoveries and potential advancements in Alzheimer’s disease research?There are a number of factors that come into play. A lot of it is hard work and a lot of it takes longer than one would like. Another aspect is: what do we know about the biology of Alzheimer’s disease and how are we refining the targets? The other advancement in the field is study design. People have learned from past experiences and learned the importance of demonstrating target engagement, meaning ensuring the drug gets into the brain and does what it is supposed to do.It sounds like we may be on the verge of the first disease modifier for Alzheimer’s disease. If it gets approved in the next few months, how will that affect the perspectives on Alzheimer's disease at large?My personal perspective is that it really doesn’t matter if certain drugs are approved or not. From a scientific standpoint, the field knows that the antibodies being researched are giving us a signal. Psychologically, I think it does make a difference for a lot of people, including some of the investors.Are there any final thoughts you would like to share with our audience about Alzheimer's disease research?Yeah, just to reiterate, I think it is a really exciting time for our field. I think we are really starting to get a foothold on treatment modalities, targets, and study designs that can start leading towards more rapid successes. The limiting step in Alzheimer's disease research is recruitment into clinical trials. The only thing I would mention is that if people are having symptoms or even just have a family history, there is a study going ...
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    21 mins
  • Public Trust in Clinical Research

    Public Trust in Clinical Research
    Mar 16 2021
    To start off, why don’t you tell us about your experience in the clinical research field and a little bit about yourself.I have had 30 years of experience as an observer of the clinical research enterprise. First, my involvement in management consulting; then I started a publishing company called Center Watch which captured a lot of data and observations about the research enterprise and published that information. After I sold Center Watch, I moved into academia and the nonprofit world and I have been there for about 20 years. Ken, I know you are quite the advocate for building clinical research awareness, and you have certainly been a reliable source of data and insightful metrics on the clinical research industry. Why do you think the general has such a distrust in the pharmaceutical industry and in pharmaceutical development in general?This is such a critical issue and is a perennial problem in the industry. This industry has had questionable practices in R&D as well as the commercial side. There are also some unethical practices that have gotten some visibility, particularly among minority community involvement in government-funded and industry-funded research. As an industry, we have not done a good job of educating patients and the public. As a result, we saw a lack of response and misalignment of messages that come from industry and the clinical research enterprise in general. If you look at the way clinical research is depicted in mass media, a lot of clinical research is depicted as studies that have gone horribly wrong with some dark or unethical practice, and that is often the kind of lesson the public gets when they learn about clinical research.Throughout the pandemic, from February to July 2020, the percentage of the US population who gave the pharmaceutical research industry positive ratings increased by 22%. Some even referred to the industry as “cool”, which is welcome but surprising to hear. Why are we seeing such an uptick on confidence now?This is a very exciting phenomenon, but we have to watch it carefully. To your point, there have been a number of global public opinion polls that have looked at a variety of sectors throughout our economy. The pharmaceutical industry being one of them, and it has enjoyed a bump in positive ratings. It is one of the only sectors where public opinion has maintained this positive bump throughout the pandemic. We think a lot of it has to do with the drug development enterprise being at center stage with a tremendous amount of public visibility. It hasn’t necessarily influenced public trust because awareness around activity rarely translates into behavior.This confidence in clinical research might be rising, but we know the industry still needs to put in the work to repair and rebuild its relationship with the minority population.I think it is widely known now that COVID-19 incidents and severity is much higher in minority communities. This is all part of broader awareness for the critical need of diversity and awareness in clinical research. If you look at a minority or a Caucasian community what you see are very high levels of awareness of clinical research. They will self report that they know what clinical research is, however, there is a significant disconnect between awareness about research and personal involvement in clinical research. Some of it has to do with distrust in clinical research and the drug development process.Really good points, and I can share some of my personal interactions in my circles. Even in the minority population there is a difference of opinion in terms of if they should take the vaccine or not. If you look at healthcare workers in the minority population they feel as though they need to take the vaccine for their own safety, but for those not in the healthcare settings they will say things such as, “I am skeptical”, or “I don’t see the need to take it because of this distrust.” So yes, there is even a difference of opinion in the minority population about how safe these vaccines are.That is such a great point! There is kind of an insular community when you’re in the healthcare environment. We forget as clinical research professionals the vast majority of the public has no real exposure to healthcare unless they’re facing the burden of disease. There are obviously a lot of complexities that come into play. I don’t want to ignore the positives we have seen because despite all that, we were able to develop multiple vaccines much quicker than anyone anticipated. How did the industry work together to make that happen?There is just so much that has happened. Clinical research is heavily regimented and methodical activity. Historically, we not only deviate from it, but we treat the way we operate in a very rigid way. The pandemic forced everyone to become much more accommodating and flexible. There was a recognition that we all need to step in together to protect patient safety. We need to conduct ...
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    20 mins

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