Learn how to best address the change being driven by the FDA PFDD Initiative
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The recent draft guidance issued by FDA (Oct 2019) “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients” (PFDD) encourages industry to conduct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. 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
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Audience
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
Presenters
Benoit Arnould
Benoit has over 25 years experience in the clinical research industry, and has been conducting studies to develop and validate patient reported outcomes (PROs) and other clinical outcomes assessment (COA) instruments for two decades, measuring a large variety of concepts including health-related quality of life, functions symptoms, satisfaction and adherence. In recent years, Benoit has increasingly assisted clients in their endpoint strategy definition. His current primary interest is mixed methods research in clinical trials.
Alexia Marrel
Alexia has over 15 years of experience, with significant expertise in the management of international projects in the field of patient centered outcomes. At ICON she is responsible for the direction of PRO projects and proposals, with specialized interest in qualitative research, specifically in patient interviews within clinical trials, also known as mixed methods research. 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 covers a wide range of disease areas, including several rare diseases.
Olga Moshkovich
Olga 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 Olga has overseen an embedded interview program spanning several clinical trial protocols, with over 500 interviews conducted to date.
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