LAST YEAR’S DCT IS TODAY’S CLINICAL TRIAL

• Last Year’s DCT Is Today’s Clinical Trial

  Experts explore the clinical trial landscape, including the positive impact of DCTs and their transition from innovation to indispensable practice in the era of evidence generation and modern trials.

• Much More Than Siteless Trials
• DCT: A Revolution And An Evolution
• What Makes Up A DCT At Sanofi?
• How Bayer Is Still Learning About DCT Trials
• Some Common DCT Concerns Addressed
• Seeking Clarity With DCT Guidance

REAL APPLICATIONS FOR AI IN CLINICAL TRIALS

• Real Applications For AI In Clinical Trials

  You’re fooling yourself if you think AI isn’t going to impact the clinical trial space. It already is, and our guests on this Clinical Leader Live talk about their firsthand experiences — and possible future applications — with AI in everything from protocol design to numerous clinops activities. 

• Can AI Help With Documenting A Clinical Trial’s TMF?
• How AI Can Be Used In Alzheimer's Clinical Research
• There’s A Giant Gap Between Understanding AI And Real-World Applications
• Is AI Biased Toward “Exceptional Responders?”

WHY ISN'T MORE TECH BEING USED IN CLINICAL TRIALS?

• Why Isn’t More Tech Being Used In Clinical Trials?

  Check out this discussion from Clinical Leader Live on why many sites are still relying on paper-based systems and what "e" technologies are helping and increasing in adoption.

• When Considering eConsent, First Assess Your Staffing Levels
• Biggest Challenges: No Interoperability And Fear Of The Unknown
• The Potential Of Clinical Trial Tech
• Why Aren’t More Sites Moving To eSource?

DCTS: OPINIONS, EXPERIENCES, AND REGULATIONS

• DCTs: Opinions, Experiences, And Regulations

  We are three years away from when the hype machine surrounding decentralized trials (DCTs) first got revved up, but is interest really slowing? Sure the pros and cons have been debated ad infinitum, but like any polarizing topic, the real result or ultimate change probably lies somewhere in-between traditional site-only trials and “site-less” trials where patients wear and interact with every type of newfangled gadget that tracks and reports back all the data in a perfect little package. Regulatory bodies have weighed in, which means change of some sort is inevitable, and likely, irreversible.

• Sometimes, More Technology Means More Problems For A Clinical Trial
• Big Changes Ahead For IRBs Regarding DCTs
• DCTs Can Work, But Expect More Time & Costs
• Site Perceptions Strongly Influence DCT Acceptance
• Unexpectedly Adopting Mobile Clinical Services At The Start of COVID
• How DCT Adoption Is Like A New Relationship

TRIAL PROTOCOL DESIGN DO’S AND DON’TS

• Trial Protocol Design Do’s And Don’ts

  Designing a clinical trial protocol that exhibits the value of a new drug is central to bringing innovative treatments to market. Listen in as experts share tips for ensuring no missteps go unnoticed.

• Phase 2 Clinical Trials: What to Include (And What To Leave Out)
• The Model-Informed Drug Discovery and Development Program
• Biomarkers in Trial Protocol
• FDA & ex-U.S. Product Approval
• Engaging Patients & Investigators To Improve Trial Performance
• Trial Control Arms - Best Practices

CVS AND WALGREENS SURVEY THE PATIENT RECRUITMENT LANDSCAPE

• CVS And Walgreens Survey The Patient Recruitment Landscape

  Patient recruitment has always been one of the most difficult aspects of clinical trials. Drug developers must recruit the required number of patients to get the study off the ground, retain those patients to keep the trial on track, and must now place a greater focus on patient diversity as well. Have the challenges of patient recruitment changed since the pandemic, and what trends will impact it in the future?

  Tony Clapsis, Senior Vice President of Clinical Trial Services for CVS Health, and John Campbell, Head of Decentralized Clinical Trials for Walgreens Boots Alliance, joined Clinical Leader Live to discuss advancements in clinical trial recruitment. Available for on-demand viewing.

• How CVS Health Intends To Overcome Patient Enrollment And Retention Hurdles
• Walgreens Sees “Optionality,” Or Flexible Participation, As The Way Forward With Hybrid Trials
• Improving Accessibility To Increase Patient Participation With CVS Health
• CVS Health, Walgreens Leverage Multi-Channel Outreach To Raise Recruitment
• How Do Most Patients Learn About Clinical Trials? Not Their PCP
• Are We Doing Enough To Reduce Participant Burden In Clinical Trials?
• Why Post-Study Patient Engagement Is Crucial To Patient Experience And Future Trial Success
• What Therapeutic Areas Have Walgreens And CVS Health Already Begun To Serve?
• What’s The Role of RWD In Walgreens And CVS Clinical Trials?

HARD-EARNED LESSONS FROM CLINICAL TRIAL IMPLEMENTATIONS

• Hard-Earned Lessons From Clinical Trial Implementations

  Clinical trials continue to become more dependent on new technology solutions. AI, machine learning, decentralized trials, remote monitoring, eTechnologies, and other new solutions are changing the face of clinical trials and having a profound impact on how studies are conducted and how companies are generating regulatory proof data.

  But how can companies implement new clinical software and technologies more effectively? And how can they avoid the common pitfalls that plague many others?

  Check out this webinar from Clinical Leader Live featuring experts sharing their insights, best practices, and real-world examples of what has and hasn’t worked for them.

• Embracing Change Management To Integrate New Technologies
• Are Clinical Trial Technologies, By Way of DCTs, Actually Making Trials Faster?

SANOFI RESHAPES PATIENT EXPERIENCE WITH DIGITAL TECHNOLOGIES

• Sanofi Reshapes Patient Experience With Digital Technologies

  Sanofi has adopted a Patient Informed Research And Development model within the organization. The goal of the model is to work with patients, patient groups, and patient communities to understand the concerns of patients and ensure those voices are heard throughout the company. The company defines this approach as engaging with patients and caregivers, hearing their concerns, and translating those insights into actions that will help develop meaningful healthcare solutions. Today, Sanofi’s development programs are 100% informed by individuals from the patient communities and 100% of Phase 2 and Phase 3 trials have a remote capability built into them. 

  In this Clinical Leader Live, two clinical executives from Sanofi join Chief Editor, Ed Miseta, to discuss the new R&D model, the company’s attempts to make its trials more patient-centric, and how digital technologies and devices are helping to create a better trial experience for patients.

• Why Sanofi Became A Patient-Centered R&D Organization
• Sanofi’s Plan: 100% Patient-Informed Development Programs
• How Sanofi Is Incorporating Hybrid Approaches Into Trials
• Sanofi And Digital Devices: Improving The Patient Experience
• How Digital Devices Enable Safety Monitoring At Home
• Sanofi Builds Single Patient Data Interface

DCTS AND SITES: WHAT SPONSORS NEED TO KNOW

• DCTs And Sites: What Sponsors Need To Know

  When the COVID-19 pandemic hit the U.S. in March 2020, many drug developers were caught by surprise. With clinics overwhelmed by COVID patients and the reluctance of some patients to venture out to those clinics, many trials faced the prospect of being delayed or cancelled. Decentralized clinical trials (DCTs) and hybrid trials, which can take studies from the clinics and to the patients, seemed to be the solution to keep things on track.

• How Did The Pandemic Impact Clinical Trial Sites?
• How Is The Expense Of DCTs Impacting Clinical Trial Sites?
• Are Clinical Sites Seeing Cost Reductions As A Result Of DCTs?
• How Can You Help Sites Manage Training And Education On DCT Technologies?
• Is The Stress Level At Clinical Sites Going Thru The Roof?

ASIA PACIFIC: THE GROWING CLINICAL TRIAL HOT SPOT

• Asia Pacific: The Growing Clinical Trial Hot Spot

  The Asian-Pacific (APAC) region is one of the fastest growing areas for clinical trials. There are many benefits to conducting trials in the region, including low cost, ease of regulatory compliance, a growing patient population, and the presence of top clinical institutions. The APAC CRO market was valued at $7.6 billion in 2021 and is forecasted to reach $12 billion by 2025. 

  Still, there are challenges that drug developers must be aware of if planning to conduct studies in the APAC region. Those challenges include the lingering impact of COVID, geopolitics, and regulatory idiosyncrasies. Check out this On-Demand webinar from Clinical Leader Live featuring experts covering all aspects of trial conduct in this growing clinical hot spot. 

• Cost Savings Of Conducting Clinical Trials In The APAC Region
• What Are The Timelines To Start A Clinical Trial In China?
• What Factors Are Driving The Growth of Clinical Trials In the APAC Region?
• Is CRO Expertise A Factor For Companies Conducting Trials in APAC?
• Is Data Quality A Concern When Conducting Trials In APAC?

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.

• What Do You Need To know About EU (536/2014)?
• The EU (536/2014) CTIS Database Has Been Approved – What Happens Now?
• When Will Full Adherence To EU (536/2014) Be Required?
• The Harmonization Of Trial Documentation Under EU (536/2014)?
• EU (536/2014): What Should You Know About Country Activation Cycle Times?

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 Has Drug Development Evolved In The Last 20 Years?
• The Challenges Janssen Faced In Implementing A Pathway Approach
• Is Immunology Matching The Progress Made In Oncology?
• Partnerships Help Drive Janssen’s Pathway Approach
• Will The Pathway Approach Create More Efficient Clinical Trials?

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?

• How Do You Define RWE?
• How Can You Ensure RWE & RWD Is Clean And High Quality?
• What New Digital Devices Will Create RWE?
• How Do We Deal With Privacy Concerns Around RWD?
• Will RWE and RWD Lead To Greater Use Of Synthetic Control Arms?

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.

• Will New Clinical Technologies Create More Or Less Work For You?
• Will Decentralized Trials Create Less Work For Everyone?
• Will Clinical Trials Continue To Be Conducted At Hospitals And Sites?
• Will We Ever Solve The Site Payment Problem?
• How Can We Reduce The Workload And Turnover In The CRA Position?

SOLVING THE TOP 5 CHALLENGES OF DECENTRALIZED TRIALS

• Solving The Top 5 Challenges of Decentralized Trials

  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.

• How Reliable Is The Data From Decentralized Clinical Trials?
• How Are Sponsor And Site Employees Dealing With The Technology Tsunami?
• How Will Technology Adoption Change How Trials Are Conducted In The Future?
• Will Telemedicine Be An Integral Part Of Clinical Trials In The Future?
• Can Decentralized Trials Solve The Patient Diversity Problem?
• What Game-Changing Trial Advancements Were Made In 2020?

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.

• Patient Diversity And FDA’s Office Of Minority Health And Health Equity
• Why Is Community Engagement Key To Increasing Patient Diversity?
• Overcome Trust Issues To Solve The Patient Diversity Problem
• Help Minority Patients Overcome The Barriers To Trial Enrollment
• To Increase Patient Diversity In Trials, Lead With Humility And Empathy
• What Is Janssen Doing To Increase Patient Diversity In Trials?

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.

• How Will AI Impact My Clinical Trials?
• AI Implementation: A Human Problem, Not A Technology Problem
• How Do We Educate Employees To Understand The Benefits Of Machine Learning?
• Do Sponsors Have The Data Required For A Successful AI Implementation?
• What Needs To Change Before Sponsors Can Successfully Implement AI Solutions?

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.

• Should The Size And Name Recognition Of A CRO Matter In The Selection Process?
• How To Select A CRO With The Right Culture
• Are Large CROs Properly Catering To Small Biotech Companies?
• Should You Trust Your Instincts When Working With CROs?
• What Was Your Most Difficult Challenge When Working With A CRO?

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.

• Has The Evolution Of EDC Kept Up With The Changes In Clinical Trials?
• What Are The Challenges Posed By Current EDC Systems?
• What Benefits Will Pharma See From Evolving EDC Systems?
• Will COVID-19 Technology Implementations Become Permanent?
• How To Be Patient And Site Centric When Implementing Technologies
• Are More Pharma Companies Capturing Data From mHealth Devices?

IS PHARMA READY TO EMBRACE VIRTUAL TRIALS?

• How Is COVID-19 Impacting The Adoption of Virtual Trials?

  In May 2020 Clinical Leader Live was proud to feature Brian Johnson, Director of Applied Innovation at Otsuka, and Katherine Vandebelt, Global Head of Clinical Innovation for Oracle to discuss whether pharma companies were ready to embrace virtual trials. During the presentation, Johnson and Vandebelt covered several topics, including how COVID-19 has changed the view of virtual trials, whether they will become a future best practice, how Otsuka opted to be a leader in the adoption of virtual technologies, the challenges and benefits of implementing virtual trials, incorporating virtual components into trial protocols, the impact these technologies can have on recruitment and retention, and therapeutic areas where virtual trials might have the biggest impact.

  In this video, Vandebelt discusses the impact of COVID-19 on the adoption of virtual trials.

  Click here to see the complete interview.

• Why Did Otsuka Become A Leader In Virtual Trial Adoption?
• When Should You Incorporate Virtual Components Into Your Trial Protocols?
• How Otsuka Is Incorporating Patient-Facing Technologies Into Protocols
• What Are The Benefits of Virtual Clinical Trials?
• What Therapeutic Areas Are The Best Fit For 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.

• How To Be A Good Communicator But Not A Micromanager
• Communicating As A Team Member And Not A Boss
• How Communication Skills Build Better Leaders
• Why Communication Builds Cohesive Global Teams
• What It Takes To Be A Good Communicator

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.

• Should We Stop Trying To Make ClinicalTrials.Gov Into Something It’s Not?
• Patient Centricity: What Is Working, What More Needs To Be Done
• Use Virtual Trials To Ease The Burden On Patients

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.

• How Can Disease Specialists Be Better Educated On Clinical Trials?
• What Can Pharma Do To Enhance Recruitment And Retention?
• When Recruiting For A Trial, Look For Patients Where They Are

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.

• Hosting Patient Engagement Networks To Hear The Patient Voice
• Making Trials More Patient Centric With Machine Learning And Virtual Trials
• How Janssen Uses Patient Advisory Boards To Hear Trial Concerns

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.

• How To Be A Champion For Your New Clinical Technology
• How To Determine Your Clinical Technology Selection Team
• Prepare A To Do List For Your Clinical Technology Implementation
• How To Manage Enthusiasm For Your New Clinical Technology
• How To Find And Vet The Right Clinical Technology Vendor

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.

• How Are Companies Trying To Manage Clinical Costs?
• How Do CROs Feel About Benchmark Pricing Models?
• Should The Size Of Your Company Impact Your Pricing Model?
• Why Are Benchmark Pricing Models Gaining In Popularity?

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.

• How To Balance Growth With Your Outsourcing Needs
• How Mature Are You? The Organization Maturity Model
• Transformation of the Clinical Operating Model
• What Are The Current Trends In CRO Outsourcing?
• What Is The Best Outsourcing Model For You?
• What Issues Should Be Part Of Your Outsourcing Decision?
• Your Outsourcing Decision Relies On Accurate Self-Reflection

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.

• Balance Capital And Labor For Successful RBM Implementation
• The Biggest Lesson Learned From Implementing RBM
• When Selling RBM Internally, Quality Matters
• How Should You Implement RBM?
• Is RBM Right For You?