Welcome to Clinical Leader Live – An interactive forum to discuss some of the most important technologies and trends impacting clinical trials.
Throughout the year, our Chief Editor, Ed Miseta, sits down with industry experts to discuss how sponsor companies can tackle some of today's biggest challenges they may face in managing a clinical trial. Even better, the audience gets to ask questions during the presentation. Each Clinical Leader Live session is archived and can be accessed at any time by registered site users.
WHAT RISKS DOES EU (536/2014) POSE TO YOUR TRIALS?
What Risks Does EU (536/2014) Pose To Your Trials?
In January 2022, major changes came to the way clinical trials are conducted in the European Union. EU (536/2014) came into effect and is a binding regulation across all members of the EU. The new regulation will streamline procedures and remove duplication single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirement.
IS JANSSEN'S PATHWAY APPROACH THE FUTURE OF DRUG DEVELOPMENT?
Is Janssen’s Pathway Approach The Future Of Drug Development?
Drug development continues to evolve. In the last 20 years, the industry has progressed from evidence-based drug development to more targeted precision medicines. But is the industry now ready to move into a new phase of drug development?
Our October Clinical Leader Live featured three executives from Janssen discussing their work in the immunology space and the company’s current approach to discovering new treatments.
HOW RWE IS TRANSFORMING CLINICAL TRIALS
How RWE Is Transforming Clinical Trials
According to the FDA, real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. Computers, wearables, mobile devices, and biosensors are all enabling researchers to gather and store large amounts of health-related data. For drug developers, RWD and RWE are being used to support clinical trial designs and observational studies to generate new treatment approaches. But how exactly is this information being used by regulators and sponsor companies? And what will it mean to the future of drug development?
PHARMA, SITES, AND CROS: 3 TAKES ON HOT-BUTTON ISSUES
Pharma, Sites, And CROs: 3 Takes On Hot-Button Issues
Sponsors, sites, and CROs are generally required to conduct a successful clinical trial. But those three entities do not always see eye-to-eye when issues arise. Whether it’s site payments, patient recruitment, or clinical technology adoption, disagreements can and do occur.
SOLVING THE TOP 5 CHALLENGES OF DECENTRALIZED TRIALS
Solving The Top 5 Challenges of Decentralized Trials
In February 2021, I had the opportunity to sit down with Tero Laulajainen, VP and head of global clinical science and operations for UCB, and Hassan Kadhim, global head of clinical trial business capabilities, clinical innovation, and industry collaborations at Bristol-Myers Squibb to discuss the challenges and what companies will need to do to overcome them.
CLINICAL TRIALS 2021 – WHAT CAN WE EXPECT
Clinical Trials 2021 – What Can We Expect
In December 2020, I had the opportunity to sit down with Craig Lipset of Clinical Innovation Partners, Debbie Profit of Otsuka, Michelle Longmire of Medable, and Jeff Kasher of Patients Can’t Wait to discuss the advances we have made in trials and what we can expect going forward.
SOLVING THE PATIENT DIVERSITY PROBLEM
Solving The Patient Diversity Problem
Patient diversity remains a hot topic in clinical trials. Regulators are focused on increasing diversity in patient populations while sponsor companies, CROs, and sites continue to struggle to find the right balance of gender and ethnic participation. What everyone would like to know is where we are now and where we go from here.
IS AI IMPROVING OUTCOMES IN CLINICAL TRIALS?
Is AI Improving Outcomes In Clinical Trials?
The complexity of initiating clinical studies continues to grow. The complexity is a confluence of complicated protocols, globalization, and regulatory changes, all at a time when there is intense pressure to restrain costs and shorten timelines. The key to reducing these complexities is the ability to use machine learning to gain critical operational insights, which will allow organizations to learn and adapt. The insights gained will allow organizations to transition from subjective decisions to data-driven decisions.
CRO SELECTION: INSIDER TIPS ON SELECTING THE BEST OUTSOURCING PARTNER
CRO Selection: Insider Tips On Selecting The Best Outsourcing Partner
Of all the tasks that are handled by executives in clinical operations, few bring as much anxiety and stress as the selection of a CRO partner. Make the right choice and your trial will be a breeze. Make the wrong choice and your trial can go off the rails and require the necessary but hated task of CRO replacement.
EDC TRANSFORMATION: MEET TODAY'S CLINICAL TRIAL NEEDS
EDC Transformation: Meet Today's Clinical Trial Needs
When EDC in clinical trials began almost 30 years ago, it was revolutionary to clinical research. Since then, advances in science and technology are forcing the industry to consider new methods for collecting and using clinical trial data. The initial electronic data capture systems were not designed to store and manage the influx of clinical data we are seeing today, and frankly will not be able to support trials in the future. Further, the current global environment is shining a spotlight on antiquated systems and processes and is compelling the industry to rapidly embrace new ways of approaching clinical development, and specifically data collection.
IS PHARMA READY TO EMBRACE VIRTUAL TRIALS?
Is Pharma Ready To Embrace Virtual Trials?
For years, technology vendors have pitched the benefits of virtual (decentralized) trials. Virtual trials are patient-centric and site-centric and can produce cost and efficiency benefits for sponsor companies. While adoption has been slow, the COVID-19 pandemic suddenly has companies scrambling for solutions that will protect patients and relieve the burden on sites. But are sponsors ready to embrace virtual trials?
COMMUNICATION BREAKDOWN – CROS, SITES & IMPROVING TRIAL QUALITY
Clinical Leader Live: Communication Breakdown – CROs, Sites & Improving Trial Quality
Poor communication between sponsors, sites, and CROs can doom a clinical trial. Fear, clinical systems, and hierarchies can create issues that keep individuals from developing a clean and clear line of communication. When communication fails, the result is protocol deviations, trial errors, and quality issues which, in turn, will lead to time delays and higher trial costs.
WHAT IS WORKING, WHAT MORE NEEDS TO BE DONE?
What Is Working, What More Needs To Be Done?
In February 2020 Clinical Leader Live presented a virtual conference on the topic of patient centricity. The goal of the third session was to hear the insights of patient groups, consultants, and sites on what is working, what isn’t, and what more needs to be done. Panelists included Jeannie Regnante, Founder and CEO of Patient3i, Jeff Kasher, President of Patients Can’t Wait, Leslie Hanrahan, SVP at Lupus Foundation of America, and Jennifer Mcnary, consultant and patient advocate.
THE PATIENT PERSPECTIVE ON CLINICAL TRIALS
The Patient Perspective On Clinical Trials
No one is in a better position to discuss what is and isn't working for patients than those who have experienced clinical trials first-hand. In February 2020, Clinical Leader Live presented an interactive virtual conference examining what sponsor companies are doing to make trials more patient-centric, and what more still needs to be done. This video clip is from the second session titled "The Patient Perspective on Clinical Trials." The goal of this session was to explore how clinical trials have impacted the lives of these patients and their families, what pharma can do to (1) increase patient recruitment and retention and (2) better meet the needs of patients and caregivers in trials.
INCORPORATING THE PATIENT VOICE INTO CLINICAL TRIALS
Incorporating The Patient Voice Into Clinical Trials
Every company wants to design trials that are more patient-centric and incorporate the patient voice into their trials. But how many are actually making progress? And are sponsor companies meeting the needs of their trial participants? In February 2020, Clinical Leader Live presented an interactive virtual conference examining what sponsor companies are doing to make trials more patient-centric, and what more still needs to be done. The video clip is from the first session titled "Incorporating The Patient Voice Into Clinical Trials." The goal of the first session was to discover what pharma companies were doing to hear the voice of patients.
CLINICAL TECHNOLOGY IMPLEMENTATION
Overcome The Challenges Of A Clinical Technology Implementation
New technologies can offer many benefits to a clinical operations department. Those benefits can include faster, more efficient, and less costly trials. Still, the risk averse nature of many pharma companies can make them reluctant to adopt new technologies. In November 2019, Lawrence Florin, president of LBF Biopharma Consulting, provided actionable information on how to overcome the hurdles of acquiring a new technology.
CRO BENCHMARK PRICING MODELS
Clinical Leader Live: How Do You Implement A Benchmark Pricing Model?
In August 2019 Clinical Leader Live was proud to feature Bari Kowal, Jonathan Cohen, and Reb Tayyabkhan of Regeneron Pharmaceuticals to discuss Developing a Benchmark Pricing Model for CROs. During the presentation, the team covered several topics, including implementing the model, the effects of company size, why the sudden interest in these models, and the feedback from CROs. In this video, the three executives discuss how you go about implementing a benchmark pricing model.
WHEN TO OUTSOURCE CLINICAL TRIALS
Clinical Leader Live: In-House Vs. Outsource - Considerations For Biotechs
Every small to mid-sized pharma and biotech company has to make tough decisions about how to staff and which aspects of development they should build vs. buy.
RISK BASED MONITORING
Clinical Leader Live: RBM: Challenges And Opportunities
If you’re like most clinical operations professionals from a small- to mid-sized pharma and biopharm, what you have heard about RBM has left you with more questions than answers. Jennifer Newman is the Global Project Leader for Regulatory Affairs and Clinical Operations at Celldex Therapeutics. Jennifer's experience with RBM stems from having been part of the first team to implement RBM in a large-scale study.