show episodes
 
Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doc ...
  continue reading
 
Loading …
show series
 
Medical practices are increasingly being acquired by private equity. Bob Harrington discusses why and what the ramifications are with the authors and editorialist of a research paper on the private equity landscape in cardiology vs other specialties. This podcast is intended for healthcare professionals only. To read a transcript or to comment, vis…
  continue reading
 
To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast. Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School…
  continue reading
 
In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more. Dan is a seasoned insurance professional with 10+ years of underwriting and broking experienc…
  continue reading
 
Bob Harrington and Mitch Elkind discuss "food is medicine" initiatives and the challenges associated with conducting clinical trials. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington Health Care by Food Initiative https://healthcarexfood.org/ 2021 Di…
  continue reading
 
Bob Harrington interviews fellow cardiologist Mike McConnell about his new book Fight Heart Disease Like Cancer and the need to model heart disease prevention and treatment after cancer. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington Fight Heart Di…
  continue reading
 
Cardiology researchers Bob Harrington and Bobby Yeh discuss how to do better observational research and the controversial notion of making causal inferences from such data. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington Academic Cardiology and Soci…
  continue reading
 
To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast. Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs) Prior to joining…
  continue reading
 
Bob Harrington, Erin Michos, and Brahmajee Nallamothu discuss how the publish or perish culture can lead to sloppy research and the need for alternative models to measure success in academic medicine. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington …
  continue reading
 
Bob Harrington and Mike Gibson discuss two of the hottest topics in cardiology and medicine for 2023: a proposed alternative to the maintenance of certification process, and artificial intelligence. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington Ca…
  continue reading
 
For this year's review, Bob Harrington and Mike Gibson revisit the major cardiology conferences -- from ACC in New Orleans to AHA in Philly. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit: https://www.medscape.com/author/bob-harrington ACC 2023 Top Trials - Bempedoic Acid Cuts CV Events in Stat…
  continue reading
 
Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike. To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison​ ​Bateman​-​House​, ​PhD​, ​MPH, MA​, ​an​ ​Assistant​ ​Professor​ ​in​ ​the​ ​Division​ ​of​ ​Medical Ethics​ ​at​ ​NYU​ ​Gross…
  continue reading
 
Bob Harrington and Manesh Patel discuss sudden cardiac death in athletes and the importance of the chain of survival. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington COVID and the Athlete's Heart https://www.medscape.com/viewarticle/945282 Outcomes …
  continue reading
 
Artificially intelligent tools are revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry. As the drug discovery and preclinical stages speed up and potentially produce more drugs to test in the clinical trial phase, how do clinical researchers prepare and …
  continue reading
 
Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either. To explore the topic of clinical research as a profession, I invited Erike Stevens on the pod…
  continue reading
 
To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast. SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their patients to clinical trials and…
  continue reading
 
Artificial intelligence (AI) is one of the most discussed technologies across all industries. Life science professionals working in the pharmaceutical industry strive to improve people’s lives tackling incredibly complex diseases. Drug development is often perceived as slow. As the pharma industry looks to improve the drug development process AI pr…
  continue reading
 
Bob Harrington interviews Jag Singh about the COVID journey that led to his book, Future Care: Sensors, Artificial Intelligence, and the Reinvention of Medicine. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit: https://www.medscape.com/author/bob-harrington Future Care: Sensors, Artificial Intel…
  continue reading
 
Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. President Biden has reignited the Cancer Moonshot initiative and set a new national goal: “if we work together, we can cut the death rate from cancer by at least 50% over the next 25 years and improve the experience of people and their families living wit…
  continue reading
 
The US cancer death rate has fallen by 33% since 1991 with an estimated 3.8 million deaths averted. This is attributed to “good progress” improvements in cancer treatment, decreases in smoking, and increases in early detection. A recent rise in advanced cancer cases reported is believed to be an outcome of the COVID-19 pandemic which delayed screen…
  continue reading
 
Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials. Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth. Mercy Research is one of the largest fully integrated, co…
  continue reading
 
The success or failure of clinical trials is dependent in large part on the engagement of the principal investigator (PI). PIs play an important role in trial selection, site activation, and study execution. This includes but is not limited to, the development and implementation of a strategy to maximize enrollment, optimize data quality, and ensur…
  continue reading
 
In this episode, we’re going to talk about Postmarket Surveillance Studies. In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies. The importance of such studies has grown in recent yea…
  continue reading
 
Robert Harrington, MD and Jenine John, a cardiologist and machine learning research fellow discuss what you need to know about AI and ML in healthcare and where to find some helpful resources. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit: https://www.medscape.com/author/bob-harrington 'One Br…
  continue reading
 
In this episode, we explore the role of design in clinical trials. Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials. One such technology product is electronic Patient Reported Outcomes or ePROs. eP…
  continue reading
 
Researchers use controls to help them understand what effect a new therapy or drug might have on a particular condition. Clinical research practice favors placebo controls over usual-care controls. Sometimes a person can have a response, positive or negative, to the placebo control. These responses are known as the "placebo effect and nocebo effect…
  continue reading
 
Clinical research professionals across all types of research organizations often struggled with implementing process improvements and the adoption of digital tools. When external factors (such as pandemic disruptions) force transformational process changes, the adoption of digital tools follows. At that point, the value of the new solutions suddenl…
  continue reading
 
Clinical research can make all the difference when it comes to saving people’s lives or improving their quality of life. In this episode, Mathias Eichler-Mertens, Managing Director of Accenture Life Sciences R&D Europe, and Henry McNamara SVP and GM of Oracle Health Sciences, will discuss what can be done to boost innovation and productivity in the…
  continue reading
 
There are advantages and disadvantages when it comes to being a standalone clinical trial site. Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial. This is where site networks come in. For example, a site can run more efficient marketing campa…
  continue reading
 
Bob Harrington talks to two former colleagues who made a mid- and senior-career switch to pharma and digital tech, respectively. How did they make this decision and what advice do they have for others? This podcast is intended for healthcare professionals only. To read a transcript or to comment https://www.medscape.com/author/bob-harrington Jeff B…
  continue reading
 
Loading …

Quick Reference Guide