Patient Centered Solutions

Patient perspectives can shape trial design.

Design your trials around patients as well as products. With tools to measure, analyze and improve patient experience in trials, support regulatory approval and differentiate your drug for payers.

A difference you can measure

The 2016 21st Century Cures Act in the United States reinforced the importance of patient centricity in healthcare research and mandated the FDA’s Patient Focused Drug Development program. Guidance documents subsequently issued by the FDA clarify the expectations of Sponsors to measure and report the patient perspective on the benefits and risks of new interventions.

Similarly, since about 2020 the European Medicines Agency has been encouraging Sponsors to engage in patient-focused medicines development, and to specifically collect patient experience data regarding aspects of disease management that are important for patients. They too have offered guidance on collecting and sharing data for benefit-risk decision-making.

IQVIA can help you meet the expectations of FDA and EMA and make the patient experience a meaningful measure of therapeutic value.

IQVIA’s Clinical Outcome Assessment (COA) Process

Our solutions are designed to dovetail with existing internal capabilities, so from strategy development to regulator and payer communications, you have what you need to amplify the patient perspective.

Scientifically rigorous, easily interpretable and actionable patient experience data (PED) can help researchers and clinicians make pivotal decisions during the development and commercialization of interventions
Matthew Reaney, Global Science & Analytics Lead, Patient Centered Solutions, IQVIA

Seamlessly integrate digital data

Widespread use of mobile devises is bringing patients closer to trials than ever before, from enabling remote recruitment to giving patients an "always on" way to report information about symptoms and quality of life.

IQVIA's e-Clinical Outcome Assessment (eCOA) seamlessly integrates self-reported data from patients into the overall endpoints reporting process. So internal and external stakeholders can seamlessly extract insights from traditional and digital data.

Start with experiences, not assumptions

Beyond meeting regulatory and payer asks, taking patient feedback into account can change the way your trials work, and the quality of your outcomes. Listening to patients can give you a different point of view on what constitutes better treatment. So you can design trials that respond to what patients value, and get to better treatments faster.

That in turn can support significant differentiation and attendant advantages, both in gaining market access, achieving regulatory acceptance and finding the highest and best applications for your therapy.

Patient experience data industry experts

As an increasingly important cornerstone in successful intervention development, patient experience data (PED) can help developers make decisions about which interventions will most likely meet unmet needs and live up to the promise of maximizing health and well-being.

Our team of experts are specialists in PED. Our recently published book – Using Patient Experience Data to Evaluate Medical Interventions – provides a robust overview of how PED can be generated during intervention development, and how it can be utilized to inform decision-making at the regulatory, payer, healthcare professional and patient levels. Contact us to learn how to apply these principles in your product development.

To learn more, download chapter 1, “Patient experience data (PED) in intervention development – what is it, why should you care, and how can this book help?”

IN-TRIAL INTERVIEWS
IQVIA’s Patient Centered Solutions team is a global leader in the design and delivery of in-trial interviews
Our experience includes conducting nearly 100 interview studies in clinical trials in over 50 indications, including with populations with psychiatric and neurological conditions, elderly and frail populations, adolescents and children, across Europe, the Americas, and Asia.
IQVIA COA Licensing & Usage
Learn more about all Clinical Outcome Assessments (COAs) available for licensing through IQVIA

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