Provider and Patient Preference Studies: Demonstrating Product Demand for Drugs and Devices

Pharmaceutical manufacturers, medical device companies and advanced diagnostic companies are increasingly acknowledging the value of incorporating patients’ and providers’ perspectives and preferences into the clinical development process to deliver products with high levels of acceptability and utility.

On August 24, 2016, the U.S. Food and Drug Administration (FDA) specifically published a guidance document for medical device approvals stating that patient input in the form of preference studies is important to consider during the FDA’s decision making for these products. Companies that develop products that address patient and provider perspectives in the product development stage are more likely to deliver products that satisfy important unmet needs in the complex and dynamic healthcare market, which increases the odds of product success. Thus, insights from these studies are often part of the FDA premarket approval submissions as evidence of product demand and clinical utility.

Well-designed healthcare preference studies can answer a number of questions for innovators planning to launch successful products such as:

• Which attributes are most important for patients and physicians and by how much? What is the degree of alignment between these stakeholders regarding attribute importance?
• What are the minimum thresholds of product characteristics for viability?
• What is the maximum acceptable risk on select product attributes?
• What is the impact of the advanced diagnostic test on physician decision-making?

Register for this webinar to hear experts from BHA provide an overview of relevant approaches and methodologies considered optimal for preference studies, discuss their applications throughout the product development and patient management pathway and highlight how they serve as powerful evidence-generation tools for healthcare manufacturers.

Speaker

Dr. Manasi Datar, Director, Boston Healthcare Associates

Manasi Datar has 7 years of experience in healthcare research including Health Economics and Outcomes Research, Product Market Access and Commercialization, Payer and Provider Research, and Patient Preference and Satisfaction. She has experience leading retrospective observational studies, prospective studies, qualitative and quantitative research and systematic literature reviews involving biopharmaceutical products, medical devices and diagnostics.

She has coauthored over 30 peer-reviewed publications including abstracts, posters and manuscripts. Prior to joining Boston Healthcare Associates, Dr. Datar worked at research subdivisions of major health insurance providers (Humana, Inc. and Aetna, Inc.) and IQVIA (formerly known as IMS Health) leading and managing healthcare research for pharmaceutical, biopharmaceutical, medical device and diagnostics clients. Dr. Datar received her PhD in Pharmaceutical Sciences from the University of Mississippi in 2014.

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