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.

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.

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.

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.

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.

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.

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. 

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.

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.

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?

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.

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.

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.

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.

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.

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.

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.

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?

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.

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.

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.

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.

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.

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.

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.

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.