This year marks Cambridge Healthtech’s fourth annual Summit for Clinical Operations Executives (SCOPE Europe), scheduled for April 20 and 21, 2022 in Barcelona, Spain. SCOPE Europe is presented in a hybrid format, allowing both in-person and virtual attendees to participate, share and learn.
As in past years, SCOPE Europe seeks to connect, educate and inform professionals responsible for planning and managing clinical trials, both in Europe and elsewhere. Participants come from a wide range of pharma, biotech, academic and commercial backgrounds.
This year’s SCOPE event focuses on the decentralization and digitalization of clinical trials. Over the two-day event, participants can explore four conference tracks, two plenary keynotes, interactive small discussion groups, panels and networking opportunities.
Some of the topics to be explored during SCOPE Europe 2022 include:
- Digitalization and decentralization of clinical trials.
- Adapting clinical trials to the realities of COVID-19.
- Choosing global clinical trial sites.
- Finding new ways to recruit, enroll, engage and retain patients.
- Improving site-study activation and performance.
- Complying with new regulations and guidelines.
- Incorporating big data, analytics, real-world data, artificial intelligence and other digital tools into the clinical trial process.
Here are six can’t-miss events we’re looking forward to at SCOPE Europe 2022.
Incorporating Site and Patient Input Into Clinical Development Planning
This session at 9 a.m. on Wednesday, April 20, 2022, kicks off the SCOPE Europe 2022 conference track on feasibility, site selection and study activation. It’s being presented by Barbara Valastro, Ph.D., senior director of patient insights and solutions at AstraZeneca.
Valastro explores AstraZeneca’s patient-centric approach to clinical development planning. By prioritizing the patient experience, AstraZeneca has found new ways to involve patient input and feedback in the clinical development planning process. During this presentation, Valastro will share the details of this process, including how to engage with stakeholders at early stages and how to turn their insights into actionable steps as a clinical trial comes together.
Accounting for the Patient Experience in Decentralized Trials
The second of four presentation tracks at SCOPE Europe 2022 focuses on enrollment planning, participant engagement and recruitment. Here, a significant issue is how to develop and maintain a patient-centric culture and systems in a world where hybrid, decentralized and remote trials are increasingly important tools in the execution of clinical trials. How can researchers stay connected to their patients when the two may be separated by thousands of miles?
On Wednesday, April 20, 2022 at 9 a.m., Sebastian Stratmann discusses how to account for the patient experience in a decentralized clinical trial setting. Stratmann, clinical trial recruitment and retention lead, R&D at Merck KGaA, explores how the short-term growing pains of switching to decentralized trials are now giving rise to new opportunities for additional operational flexibility. Using Merck’s TransCelerate initiative as an example, Stratmann discusses how new tools can help professionals spot potential challenges in virtual interactions and address them to improve the decentralized trial experience for both patients and caregivers.
What Can Clinical Innovation Teams Learn From Digital Health Startups?
Digital health startups seem at first glance to be competitors with established clinical innovation teams. On closer inspection, both parties learn that there is much to be gained from entering into dialogue with one another.
This keynote panel discussion starts at 12:40 p.m. on Wednesday, April 20, 2022. It’s being moderated by Francesca Wuttke, Ph.D., former chief digital officer at Almirall SA, and advisory board member at HealthXL. Participating panelists include HumanFirst CEO and cofounder Andrea Coravos, Janssen Pharmaceutica senior director of clinical innovation Bert Hartog, Ph.D., and Ampersand Health CEO and cofounder Nader Alaghband.
Digital health startups offer a number of important cultural elements that can help clinical innovation teams think creatively and reach their goals. For example, a startup can inject new capabilities for innovation. Startup teams can also promote an environment in which it’s safe to make suggestions, plan and carry out experiments, and embrace risk while also balancing it against the need for safety and stability. The combination can become a powerful driver for growth, and this panel explores how that growth occurs.
Evolution of Clinical Investigator Site Audits as a Result of the Pandemic
SCOPE Europe’s third presentation track focuses on risk-based quality management and monitoring (RBQM). The COVID-19 pandemic accelerated RBQM adoption, upending a pre-pandemic approach to the subject and placing additional pressure on clinical trial teams to address risk management and quality issues.
On April 21, 2022 at 2:30 p.m., Nuria Gomez Mas, GCP Auditor, EMEA at Janssen, explores how clinical investigator site audits have transformed as a result of the COVID-19 pandemic. The pandemic forced clinical investigators to innovate quickly — an initially uncomfortable situation that has blossomed into new ways to adapt and evolve methodologies in an era of decentralized clinical trials. Audience members will learn how hybrid audit approaches enable teams to better understand what’s going on during a clinical trial while keeping the audit process itself sustainable.
Novel Data Streams — The Next Challenge in Digital Health?
The fourth presentation track at SCOPE Europe 2022 focuses on clinical data strategy, digital endpoints and RWD. Here, presenters and participants take a deep dive into the ways in which digital technologies are transforming clinical development. Through the application of digital tools, researchers can improve the effectiveness of their work in developing new therapies. They can also enhance the patient-centric nature of clinical trials. Yet these tools can be harder to implement than it appears at first glance.
At 10:30 a.m. on April 20, 2022, you can join Janssen R&D data processing solutions lead Giacomo Ricca for a presentation on novel data streams. Ricca discusses how the use of biosensors is increasingly common in clinical trials. These sensors offer an opportunity for continuous data collection, allowing for a more comprehensive view of patients’ well-being during a clinical trial. This type of data collection also creates challenges. Once it’s available, teams must be able to store, summarize, analyze and report on that data for useful knowledge to be gleaned. Ricca explores the ways that clinical trials can make continuous data more useful.
Harnessing the Power of Real-World Data for Clinical Research: European Initiatives
In his keynote presentation at 11:55 a.m. on Thursday, April 21, 2022, keynote speaker Dipak Kalra explores the use of real-world data in clinical research by looking at how attempts to do so are being carried out in a European context. As president of the European Institute for Health Records and the European Institute for Innovation Through Health Data, Kalra examines how real world data has historically faced two barriers: being siloed within healthcare organizations and restricted through various laws and regulations, such as the GDPR in Europe. As European clinical trial actors take steps to overcome those barriers, they open up exciting opportunities for using real-world data to better understand and support clinical research. Kalra explores these opportunities and the challenges that arise alongside them, offering insight into how many of these challenges may be addressed.
Clinical trials are evolving rapidly as new digital technologies are applied to address existing issues and emerging challenges. SCOPE Europe 2022 offers professionals in this space the chance to learn more and share ideas, whether they visit Barcelona in person or attend virtually from the comfort of their own workspace.
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