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
 
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
 
In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices. Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync …
  continue reading
 
Trials on heart failure, hypertension and lipid-lowering drugs, and the evolution of antithrombin and antiplatelet therapy are discussed in part 2 of cardiologists Bob Harrington and Mike Gibson's annual review. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-…
  continue reading
 
In part 1 of their annual review, cardiologists Bob Harrington and Mike Gibson discuss in-person meetings, wearables and AI, COVID lessons for medical research, and the growth of RCTs from China. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington COVID…
  continue reading
 
To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical. Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passiona…
  continue reading
 
The digital health ecosystem has helped create an infrastructure that supports the transformation of the organization-centered care model into a patient-centered care model. Various reports highlight the staggering investments and the market growth in digital health technologies supporting this change. In this episode of the Latest Dose, Naomi Frie…
  continue reading
 
This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose. You’ll be introduced to ISO 14971 Application of risk management to medical devices and le…
  continue reading
 
Monitoring safety of biological products, drugs, and devices in healthcare is a priority for inventors, prescribers, regulatory authorities and of course patients. Safety data are collected and analyzed throughout product development and assessed prior to approval for commercial use. In this episode, Dr. Joseph (Joe) Tonning medical and pharmaceuti…
  continue reading
 
In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings. Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs). These meetings are exceptionally critical to the success of any …
  continue reading
 
Drs Bob Harrington and Betty Raman discuss the cardiovascular impact and long-term sequelae of COVID-19, the potential biology behind multisystem effects, and ongoing research. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington Medium-term Effects of S…
  continue reading
 
"First, do no harm" is a popular saying amongst those involved in the healthcare, medicine, or bioethics field, and is a basic principle taught in health-related courses. To faithfully follow this principle, a health professional should help their patients by recommending tests or treatments for which the potential benefits outweigh the risks of ha…
  continue reading
 
On receiving news of a health concern there is an immediate thirst for knowledge to understand the condition, the care, and treatment options available. As a healthcare professional assesses the health status of a person, it may be decided that prescribing a therapeutic drug is the best course of action. These treatments are assigned systematically…
  continue reading
 
Do cardiologists from the AFFIRM generation treat AF less aggressively than the EAST-AFNET generation? Bob Harrington and Jonathan Piccini discuss this and upcoming trials on atrial fibrillation. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit: https://www.medscape.com/author/bob-harrington A Co…
  continue reading
 
When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe? To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early…
  continue reading
 
Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients. Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges. To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at Nucleus Network. Dr. Wood i…
  continue reading
 
Patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines. Participation in clinical research requires informed consent. The importance of informed consent cannot be overstated – participants must completely understand all that is involved in a clinic…
  continue reading
 
Medical Imaging in Clinical Trials with Elizabeth Dalton In this episode, I’m excited to talk about medical imaging in clinical trials. We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process,…
  continue reading
 
Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? Should a Sponsor get access to patient data collected outside a clinical trial setting? To answer these questions and more, …
  continue reading
 
Access to relevant and trustworthy data to make accurate and timely healthcare decisions is critical. Cohesive industry collaboration is key to removing barriers to data access and increasing adoption of sensors in health science. In this episode, Jennifer Goldsack, Chief Executive Officer of non-profit Digital Medicine Society (DiMe) discusses a m…
  continue reading
 
In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants. In other words, the success rate was 21%. And the total funding amount was $8,827,444,624. The question I had was, “What does it take to get grant approval and launch an NIH funded research project?” To answer this question, I i…
  continue reading
 
Clinical research is the study of health and illness in people. It’s about putting people – the participants and volunteers – at the center of finding out if a new treatment is safe and effective. What clinical research and clinical research participation means is often discussed and frequently shared. In this episode, Ken Getz, Executive Director …
  continue reading
 
Dr Bob Harrington talks with Drs Michelle Albert and Eldrin Lewis about the Association of Black Cardiologists' diversity scorecard for cardiovascular training programs. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit: https://www.medscape.com/author/bob-harrington The ABC Updates its CV DIBS Ra…
  continue reading
 
Loading …

Quick Reference Guide