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OCT Europe 2022: A Preview

Outsourcing in Clinical Trials Europe 2022 (OCT Europe) takes place May 4 and 5 at the Hyatt Regency Barcelona Tower. This year’s OCT Europe, the 12th annual event, offers in-person and streaming events across both days. The goal is to provide practical advice and ideas for attendees, allowing them to improve their own clinical trials.

Each day of OCT Europe offers two topic tracks for attendees. Learn more about outsourcing and clinical operations, or focus on clinical trial technology and innovation. Attendees can also move back and forth between these tracks, attending the talks and sessions that matter most to the work they’re doing right now.

Here are a few can’t-miss events coming up at OCT Europe in May 2022.

Opening Keynote: Decentralized/Hybrid Trials in the U.S. and Europe

OCT Europe 2022 opens bright and early May 4, with an 8:30 a.m. keynote by John Zibert, general manager at Future-Brain Aps and former CMO at LEO Innovation Lab. The keynote, titled “Decentralized/Hybrid Trials: Exploring the framework of the regulatory landscape and how to implement those trials in Europe,” looks at how decentralized and hybrid trials are being handled in the United States and how similar approaches might be implemented in Europe.

Among the topics covered in the keynote are identifying the top challenges to taking a U.S.-like approach to decentralized clinical trials in Europe and how to manage budgets for such trials. Patient education and generating buy-in from sponsors and healthcare professionals are also on the table, as well as ethics committee concerns. Zibert uses a case study to illustrate essential points and show how the American approach to decentralization might translate effectively to a European clinical trial context.

A Site Engagement Strategy for 2022 and Beyond

At 9:30 a.m. on May 4, 2022, join Karl-Ludwig Radek, EMEA Strategic Account Lead Global Clinical Operations, Janssen, for an inside look at Janssen’s strategic site engagement approach.

In this session, Radek will discuss how Janssen seeks to guide and deepen its relationships with clinical trial sites. Radek will examine the need for self-reflection during this process: What works in engaging a clinical trial site and building relationships, and what might need to change? How do clinical trial sites benefit from this type of relationship-building? How can Janssen use its approach to relationship cultivation to benefit overall trial performance? Where does the relationship-building process fit with decentralized trials and other innovations?

By digging into these questions, Radek will lead audiences to a deeper understanding and appreciation of the need to build strong relationships throughout the clinical trial process.

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Delving Into an Initiative To Reduce Bureaucracy in Clinical Trials

Can clinical trials be run in a way that reduces bureaucracy while also improving patient safety and trial efficiency?

At 5:15 p.m. on May 4, 2022, join Natacha Bolaños of the European Affairs Committee EUPATI & Lymphoma Coalition to explore ways to reduce bureaucracy in clinical trials without reducing patient safety or trial efficacy.

Topics in this session include the need to streamline paperwork and red tape in order to make clinical trials more patient-centric and efficient, as well as less costly to run. The discussion includes exploration of ways to work with various stakeholders, including regulators, policymakers, sponsors, and ethics and oversight committees to meet this goal.

At times it may be necessary, for instance, to reconsider whether regulatory requirements, safety reporting and informed consent requirements actually meet their goal of improving clinical trial quality and protecting patients, or whether a new approach is needed to meet these essentials in a way that also allows patients to participate more effectively in the clinical trial process.

By harmonizing requirements across the European Union, it may be easier to streamline reporting, consent and regulatory compliance. This session looks at ways to make that harmonization a reality.

Tech Keynote: Big Data, AI/ML and Our COVID-19 Strategy

The COVID-19 pandemic placed enormous pressure on technology to meet new and unprecedented needs imposed by the demand for social distancing and other pandemic control measures. It also accelerated technological research into tools for analyzing viruses and providing healthcare.

At 8:50 a.m. on May 5, 2022, join biotx.ai’s Chief Scientific Officer Marco Schmidt as he kicks off the morning with a tech keynote on biotx.ai’s approach to COVID-19 research.

The organization’s clinical trial testing process focuses on using artificial intelligence and machine learning to spot patterns in patients’ genomes and in COVID-19’s DNA. These patterns, in turn, may lead to insights about how the virus functions, how it produces symptoms, and how the damage it causes might be thwarted.

Schmidt explores issues like the best practices for finding and testing target candidates, using UK Biobank data to match COVID-19 patients with healthy control patients, and applying data to find the most promising drugs for use in the battle against COVID-19.

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Diversity and Inclusion in Clinical Trials: The Big Pharma Standpoint

Diversity and inclusion aren’t merely nice to have in clinical trials. They can have a profound impact on the quality of clinical trial data in many instances. When studies include patients from a variety of backgrounds, they also provide greater insight on the benefits and risks of a medication or treatment for humanity as a whole.

Currently, many journals have guidelines that require comment on a clinical trial’s approach to diversity and inclusion. Yet the pharmaceutical industry still struggles with diversity and inclusion in clinical trials and in meaningful reporting on D&I concerns. Many populations remain underrepresented in clinical trials, and various scientific organizations and government agencies are attempting to address the problem — yet not in any single cohesive manner.

At 11:30 a.m. on May 5, 2022, join Jose Manuel Ordoñez, Spain-CCO therapeutic area leader in oncology/hematology at Roche, to explore the biggest diversity and inclusion challenges facing pharma today and how clinical trial teams can remain sensitive to these questions as they develop trials and prepare findings for publication.

Nestle Case Study: Outsourcing Services Required for Food/Nutritional Clinical Trials

Nutritional clinical trials can pose unique challenges that don’t arise in pharmaceutical trials. At 12:30 p.m. on May 5, join Elvira Suniega-Tolentino, clinical project manager team lead and outsourcing manager at Nestle Research, to explore the particular challenges posed by nutritional and food clinical trials.

In this session, Suniega-Tolentino discusses the key differences between nutritional trials and pharmaceutical trials, how to outsource in ways that address the unique needs of nutritional trials, and where new opportunities are arising within the nutritional clinical trial research space. A case study from Nestle Research provides the foundation for discussion in this session, allowing participants to apply concepts to a real-world example.

Tech Spotlight: Streamlining Clinically Relevant Data Mining for Optimal Clinical Trial Planning and Investigator Identification

At 12:15 p.m. on May 4, join our own Anju Software Executive Vice President of Operations Mike Keens to learn about some tech-driven methods for site selection and trial design.

Keens will start by talking about the impact COVID-19 had on clinical trials from March 2020 up through the present day. This is something we’ve written about here, including what long-term impacts COVID-19 will have on clinical trials and how the pandemic underscored the need for communication and trust-building in clinical research.

From there, Keens will explore how census data can be used in both site selection and ensuring that a trial’s participants are truly representative of local patient populations. Finally, he will discuss ways researchers can optimize trial designs using dynamic simulation tools.

OCT Europe offers a wealth of opportunities for clinical trial managers and other professionals to explore pressing issues in the clinical trial space, from how to address regulatory needs to how to outsource key parts of a clinical trial while still generating the high-quality data needed for better insights and understanding.

Whether you attend in person or remotely, don’t miss these experts and topics at OCT Europe this May 4 and 5, 2022.

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