June 18, 2019 | SCOPE, the Summit for Clinical Ops Executives, is heading to Barcelona again September 17 and 18 for a deep dive into the challenges and opportunities for clinical research in Europe and beyond.

Opening the event, a keynote session will explore new technologies, patient connections, and data ownership questions featuring presentations and a discussion with Bert Hartog (Janssen Pharmaceutica), Koen Kas (HealthStartup.eu), Sheli Gupta (Hu-manity.co), and Greg Hersch (Novartis). On the second day of the event, the plenary speakers will address issues of patient centricity and engagement. Tine Lewi (Janssen R&D/Clinical Innovation) will explore virtual trials and patient centricity. Greg Hersch (Novartis) will discuss digital recruitment and patient outreach. Raj Pallapothu (Bayer Pharmaceuticals) will look at how digital technology will help us achieve next-gen consumer health.

The European Innovation Awards will be back for its second year. This awards program recognizes outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations that manifestly improve the clinical trial process. All SCOPE Europe Exhibitors and Sponsors are encouraged to participate! The entry deadline is July 12.

And opportunities abound for networking and discussion. On both days of the event time is set aside for breakout discussions—expert-moderated conversations around eConsent, real world data, site selection, wearable devices, protocol design in Europe, blockchain, AI, final ICH GCP E6 Guidelines and R2 Addendum, and much more.

Beyond all of that, five conference tracks are full of new research and content on risk-based monitoring, budgeting and outsourcing, digitalization of trials, feasibility and study start-up, and patient-centric enrollment and engagement. Here are a few of the sessions we've marked in our agendas.—The Editors

Oriol Serra and Jonathan Crowther, both with the Study Optimization group at Pfizer, will present a paradigm shift in evidence-driven site profiles for clinical trial participation. Can we challenge the status quo to effectively develop predictive algorithms to build an ideal site profile based on key indicators on performance, start up, quality and competitive intelligence, they ask? In a co-presentation, Serra and Crowther will provide a real-world demonstration on how a new methodology can improve transparency and collaborative efforts to optimize study execution. Tuesday, September 17

Thorsten Ruppert, the Association of Research-Based Pharmaceutical Companies, will provide an overview of the EU Clinical Trials Directive (EU-CTR). The pilots in different European member states enable sponsors of clinical trials to test the status of their preparation for the new authorization system in Europe. Ruppert will show details from the experience of the pharmaceutical industry, share insight into the status of the pilot project in Germany, and address the status of industry preparation for the new European authorization system for clinical trials. Tuesday, September 17

Narinder Chopra, Biogen, tackles patient input. He will review opportunities to gain insights from patients (and their families/caregivers) and share how these have been built into clinical development plans or protocols. Tuesday, September 17

Céline Quix, Janssen R&D, will share how EHR/RWD platforms can lead to strategic data-driven partnerships between hospitals and sponsors. Secure, GDPR compliant and innovative EHR/RWD platforms, leveraging federated data management, enable the re-use of EHR data for clinical research—benefitting both the sponsor and the hospital partner. For example: for sponsor companies, these platforms can be complementary to traditional feasibility approaches. At the hospitals, clinicians can use RWD/EHR platforms to support research studies and re-use the care data for insights into treatments and outcomes for their patient populations. Wednesday, September 18

The increasing number and complexity of clinical trials has resulted in an increasing need for independent Data Monitoring Committees (DMC), says Ana Herradon of Bristol-Myers Squibb. But the number and availability of qualified candidates, coupled with a lack of cultivation of new generation DMC candidates, has resulted in few available DMC candidates. Herrandon will share the results of a TransCelerate initiative which collaborated with and built on existing CTTI DMC assets and expert network recommendations. She'll explain a concept for a DMC Registry as well as a proposed DMC apprenticeship model. Wednesday, September 18

Maya Zlatanova, Co-Founder, FindMeCure Foundation; Partner, International Alliance of Patients' Organizations & ACRES, tackles site selection across countries. How do you know if your clinical trial is attractive to patients in various countries? We often focus so much on identifying the best set of sites that have both historical data on performing clinical trials and access to patients, Zlatanova says, but this does not ensure patients are on board in time. Why? Because at the end of the day, it's the patient's decision to participate or not. How can we leverage data to understand what patients want and need, and improve our decision-making process on-the-go? Zlatanova will share tricks and hacks for predicting whether you may face difficulties with patient recruitment. Wednesday, September 18

Sophie Evett (Pfizer) and Gareth Powell (National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre) are taking patient centricity to the next level—moving past intention into action. Meaningful patient and public involvement and engagement in clinical research design and delivery has been taking place across England for the decade, but it has often been regional or localized to specific institutions or disease areas, they say. The UK is now realizing the ambition of implementing a national framework for patient involvement with a clear route for life science companies to engage with relevant patients who can help shape clinical trial design and delivery at the earliest possible opportunity. This requires meaningful involvement at the protocol design stage, not just at the patient information leaflet stage. Evett and Powell will describe a collaboration to design, develop and pilot a network approach to connecting companies and patients who are willing and able to contribute at the protocol design stage. Tuesday, September 17

A panel will discuss how to measure the effectiveness of risk-based monitoring. Marion Wolfs, Director, Risk Management-Central Monitoring, Janssen, will moderate the discussion. Panelists include Michael Walega (Bristol-Myers Squibb), Marcin Makowski (UCB) and Adam Baumgart (AstraZeneca). Effective RBM improves quality and creates efficiencies, the panel argues. They will discuss how to measure improvement of quality after implementing RBM (KRIs, QTLs, audit and inspection findings); how to measure efficiencies gained; and how to deal with noise in measurements, created by other process improvements/changes to processes. Wednesday, September 18

Innovative digital technologies are starting to disrupt the highly regulated and conservative biopharmaceutical industry. Munther Baara will share how Pfizer has created a single data collection hub to promote interoperability and seamless integration of direct-to-patient activity. The single data hub can harmonize recruitment, eConsent, patient outcomes and other relevant systems that must be simplified for direct-to-patient trials, and capitalize on opportunities to remotely administer wearables and other trial activity. Tuesday, September 17

Janet Munro at Novartis will work to dispel myths about sensors and digital endpoints. Digital technologies provide an opportunity to modernize the current site-centric clinical trial model by enriching the quality of data collected and enabling real-time decision making, thereby increasing probability of success, she says. Tuesday, September 17

The real-world data (RWD) hype caused high expectations, prompting speculation that randomized controlled trials might only play a minor role in future drug development. Dorothee Bartels, Boehringer Ingelheim, argues that RWD help to define target populations, and are key for drug utilization, safety and effectiveness studies, but cannot replace randomized controlled trials. The same is true for artificial intelligence: AI is a tool applicable in different stages of drug development, supporting randomized controlled trials as well as RWD studies to generate evidence. Wednesday, September 18

Matt Cooper, in the UK's National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre, will report on the UK's new unified approach to costing and contracts. The UK is tackling the global issue of costing and contracting head-on by introducing a new standardized national approach to costing and contracting for all NHS service provider sites in England conducting commercial clinical research. The next phase will allow life science companies to negotiate the resource allocation required to deliver the trial at any site with one single national coordinator. Once the resource allocation is agreed, all sites thereafter partaking in the trial would abide by that agreement and use the mandated costing tool to price the study. Wednesday, September 18