In the era of patient-centred research and healthcare, clinical researchers are being asked to think beyond hypothesis testing, and to engage in sometimes-difficult discussions about the meaningfulness of their trial results. Regulators, payers, clinicians and patient advocacy groups all want to understand how innovative products and treatments can change the course of disease, and how patients will experience and value these changes.

The recent draft guidance issued by FDA (Oct 2019) “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients” encourages industry to conduct qualitative research. While most stakeholders recognise the unique value of qualitative research, and researchers have strong qualitative methods to capture and report subjective experience communicated with natural language, adapting and integrating this into sophisticated clinical trials is not always straightforward.

Join us for insights on how to include qualitative research into your trials more effectively. Our experts will share knowledge from over five years of successfully designing and conducting entry and exit interviews in clinical trials. We will also discuss the solid and emerging set of scientific publications available to support this approach.

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Speakers

Benoit Arnould, Divisional Principal, Patient Centred Outcomes, ICON plc

Benoit has over 25 years’ experience in the clinical research industry, and has been conducting studies to develop and validate Patient-Reported Outcomes and other Clinical Outcomes Assessment instruments for two decades, measuring a large variety of concepts including Health-Related Quality of Life, Function, Symptoms, Satisfaction and Adherence. In recent years, Benoit has increasingly been asked by Industry clients to assist in their endpoint strategy definition. His current primary interest is Mixed Methods Research in clinical trials.

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Alexia Marrel, Lead Outcomes Researcher, Patient Centred Outcomes, ICON plc

Alexia is responsible for the direction of Patient-Reported Outcomes projects and proposals. With more than 15 years of experience, Alexia has significant expertise in the management of international projects in the Patient-Centered Outcomes field. She has specialized interest in qualitative research, specifically in patient interviews within clinical trials (also known as mixed methods). She has participated in the development and validation of a number of PRO measures and in the design and implementation of various PRO endpoint strategies for drug clinical development programs. This work has been performed in a wide variety of disease areas, including several rare diseases. Alexia has also co-authored a number of manuscripts published in peer-reviewed journals, as well as delivered presentations at international scientific conferences.

Alexia’s educational background is in English and Spanish translation, British and American Literature, Epidemiology, and Statistics applied to Medicine.

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Olga Moshkovich, Lead Outcomes Researcher, Patient Centred Outcomes, ICON plc

Olga Moshkovich directs patient-centric research projects with qualitative methodology. Her research experience spans many therapeutic areas including oncology and rare diseases. In addition to specializing in COA development and validation, for the past several years Moshkovich has overseen an embedded interview program spanning several clinical trial protocols, with over 500 interviews conducted to date.

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Who Should Attend?

This webinar will be particularly useful for cross functional teams involved in clinical research, including executives, directors, and project leaders from pharma and biotech involved in clinical research protocols development and clinical research conduct. Specific roles include:

Research and development
Clinical operations
Clinical science
Outcomes Researchers
Regulatory
Pharmacovigilance
Medical affairs
Clinical trial planning and optimization
Outsourcing and procurement

What You Will Learn

Attendees will learn:

Different types of entry, exit and other interviews conducted during a trial
The various types of questions that qualitative research embedded in clinical can answer
The do’s and don’ts of mixed-methods research
The times and situations when qualitative research can be most useful and critical for successful drug development

Xtalks Partner

ICON plc

ICON plc is a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organisations. The company specializes in the strategic development, management and analysis of programs that support clinical development. With headquarters in Dublin, Ireland, ICON currently operates from 97 locations in 38 countries and has approximately 13,380 employees. Further information is available at ICONplc.com.