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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 ...
 
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show series
 
International Clinical Trials Day, celebrated each year on May 20th, commemorates the day that James Lind began the first randomized clinical trial in 1747. It also provides an opportunity to recognize and thank everyone involved in clinical research. In this episode, Bruce Hellman, Co-founder and Chief Patient Officer at uMotif offers a practical …
 
Bob Harrington interviews fellow cardiologist Jacqueline Tamis-Holland, vice chair of the recent ACC/AHA revascularization guidelines, who takes us inside the process. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington 2021 ACC/AHA/SCAI Guideline for C…
 
The use of mobile devices, social media, wearables, and other biosensors continues to expand year on year. The curation and analyses of health-related data is accelerating, and these data provide the potential to answer questions previously thought infeasible. When a researcher is seeking answers to a health question, when is it appropriate to use …
 
The European Union (EU) has been on a path to harmonize the clinical trial process and requirements since 2004 starting with the Directive. The next step came 10 years later, in 2014, with the Clinical Trial Regulation (CTR). This year, as of January 31, the Clinical Trials Information System (CTIS) went live and supports the flow of information be…
 
Robert Harrington, MD, interviews Ziyad Al-Aly, MD, about his recent paper in Nature Medicine focused on the long-term cardiovascular effects of COVID-19. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington Robert A. Harrington, MD, Arthur L. Bloomfield…
 
There are more than seven thousand rare diseases in the world – 95% of which have no known treatment. The term rare diseases is a cruel misnomer – in fact they aren’t that rare, and importantly, the definition of what constitutes a rare disease differs by country. To raise awareness, Rare Disease Day is recognized on the last day of February annual…
 
A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research finances, it can end up costing you a lot of money in the long run. To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between…
 
Life sciences organizations face intense pressure to speed clinical trials while boosting operational efficiencies to battle the rising costs of drug development. So what does the future of clinical trials look like? In this episode, Dr. Avi Kulkarni, senior vice president of research and development at Cognizant, and Henry McNamara, senior vice pr…
 
Trials on lowering salt consumption and treating hypertension in the community impressed Drs Harrington and Gibson in this discussion of the best public health research of 2021. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit: https://www.medscape.com/author/bob-harrington CV Public Health Trial…
 
Drs Harrington and Gibson provide their annual roundup of what they consider the key cardiovascular trials of 2021. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit This podcast is intended for US healthcare professionals only. To read a full transcript of this episode or to comment please visit:…
 
When Nicole and James Angiolino’s son Joey was diagnosed with the rare disease Hurler’s Syndrome at seven months old, they did everything they could to save his life. They left their eldest son Nicholas, their family, friends, and teaching careers behind and headed to Duke University Hospital in North Carolina to get him the care he needed. James a…
 
As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for clinical research sites. It goes without saying you need a laptop and stable internet connection to do business in this day and age. But what else do you need to keep yourself organized as a clinical research sit…
 
Anxiety, stress, and exhaustion are on the rise and impacting many of us. With a lot happening in our world that we don’t have much control over, our routines have been disrupted and it’s affecting our overall health and mindset. Combine that with the stress holidays can bring, and you have a recipe for total burnout. In episode 22, we wanted to co…
 
Men across the globe are dying too young. In the US, three out of four suicides are men, and one in eight (around 10.8 million) will be diagnosed with prostate cancer and testicular cancer, the most common cancers in young men. Our fathers, partners, brothers, and friends are facing a health crisis that isn’t being talked about, and it’s time to sp…
 
Instead of trying therapies and hoping for the best, the RECOVERY trial investigators designed randomized trials to test which therapeutics were truly effective for COVID-19. Dr Harrington interviews lead investigator Martin Landray, MB ChB, PhD. To read a transcript or to comment: https://www.medscape.com/author/bob-harrington The Bob Harrington S…
 
There’s no question that clinical research is the backbone of healthcare invention, helping to improve the prevention, detection, diagnosis, and treatment of disease. But at the heart of it all you’ll find that patients are the true lifeblood of clinical research, keeping things moving and allowing researchers to save more lives every day. With pat…
 
Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB. Previously she served as senior vice president, research, at the Brigham and Women’s Hospital for 11 years, and was the institutional official for human and a…
 
Medical devices are an integral part to many procedures and treatments, and last month we started to investigate the vast and innovative world of these types of technologies in a two-part series on The Latest Dose. In part one, our esteemed guests, Dr. Khaudeja Bano, the executive medical director of combination product safety, global patient safet…
 
From bandaging a sprained ankle and diagnosing HIV/AIDS, to implanting an artificial hip and monitoring your heart, medical devices are an integral part to many medical procedures and treatments. There is a lot to unpack when it comes to medical devices, so we’ve invited industry leaders Dr. Khaudeja Bano, the executive medical director of combinat…
 
This podcast episode highlights the top reasons for patient recruitment failure in clinical trials from an investigator perspective. The podcast episode will help you understand how Sponsor and CRO personnel including software vendors can best support investigators meet or exceed their patient recruitment. The goal is to bring more awareness on how…
 
The clinical research ecosystem has undergone an evolution over the past 18 months, and many want it to continue. To help set the industry on a solid path forward, ICH has created guidelines that provide direction on behaviors and actions to take. Recently, a specific set of these guidelines, ICH E6 Revision 3 and E8 Revision 1, have been referred …
 
A genomics giant with a family history of heart disease and an Olympic athlete accused of cheating are just two of the medical mysteries unraveled by DNA analysis. Bob Harrington interviews Euan Ashley, author of The Genome Odyssey: Medical Mysteries and the Incredible Quest to Solve Them (https://us.macmillan.com/books/9781250234995), who was insp…
 
Clinical trials are conducted in compliance with regulations. Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. As a clinical researcher, there have been times I’ve felt lost because I did not understand the regulatory framework. To close this knowledge gap, I thought it woul…
 
The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we’re headed in the right direction. The change in turn has led to an increased focus on decentralized clinical trials (DCTs). But what exactly is a DCT? To learn more, I invited Derk Arts, Founder & CEO of Castor. Derk has ove…
 
Aboard the HMS Salisbury of Britain’s Royal Navy on May 20th, 1747, surgeon James Lind performed what is often considered to be the first randomized clinical trial. Now, every May 20th, International Clinical Trials Day gives us a well-deserved occasion to honor and thank both the professionals and patients who make clinical research possible. It a…
 
As a methodology that’s generally been underutilized in the past, the pandemic has brought telemedicine to the forefront as a way for doctors to care for their patients, without them having to come into an office or site. But how exactly is it being used in medicine and clinical research today, and will it still be widely used after the pandemic en…
 
Recently, Covance announced that they are transforming to a fully decentralized CRO – an exciting step in the life sciences industry. In this episode, Kathy speaks with Covance’s Director of Decentralized Trials, Jane Myles, and Vice President and Head of Decentralized Trials, Bola Oyegunwa, about how they’re driving the implementation of decentral…
 
What is the incidence of post-COVID myocarditis and when is it safe to return to play? Bob Harrington and Manesh Patel discuss our evolving understanding of how SARS-CoV-2 effects the hearts of athletes and weekend warriors. To read a transcript or to comment https://www.medscape.com/author/bob-harrington Early Studies Outcomes of Cardiovascular Ma…
 
My guest for this interview is Rebecca Matthews, Chief Clinical Operations Officer at Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation. In this interview, Rebecca shares with us what it takes to conduct clinical trials investigating the use of MDMA, a psychedelic drug, in conjunction with psychotherapy to trea…
 
Clinical Trial Transformation Initiative (CTTI) announced on January 25, 2021, a new vision for clinical trial ecosystem and beyond, called Transforming Trials 2030. The pandemic has changed the way we perform clinical research, and many constituents have implemented new and efficient solutions, systems, and processes to conduct trials. CTTI member…
 
The pandemic has created a lot of disruption in clinical trials, but not all of it has been negative. From accelerating the adoption of decentralized trials and speeding up the delivery of vaccines, to telemedicine and mHealth playing bigger roles in patients’ lives, opportunities have emerged to help us rediscover and recalibrate the way we perfor…
 
Do you want to enroll a diverse patient population in your clinical trial? Are you a sponsor looking to develop a solid clinical trial strategy? Are you looking to develop foundational skills as a clinical research scientist? If you answered “Yes” to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well. Jenn c…
 
One of the biggest challenges in clinical study start-up and conduct is “training.” A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more. With many clinical research and trial activities goi…
 
Research shows that animals can improve the mental, physical, and emotional wellbeing of their human companions. From this strong bond comes the concept of therapy animals, or in this case, therapy dogs. But what is a therapy dog, and how are they being used today? In this episode, Kathy speaks with Children's Hospital Los Angeles and the Alliance …
 
Many people tout about technical skills in clinical research. You need to know Microsoft Excel. You need to understand Good Clinical Practice. You need to memorize the FDA guidance documents. Have you ever heard someone talk about soft skills in clinical research? I realized the importance of soft skills after joining Abbott in 2007 as a Clinical P…
 
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