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    Expert's Opinion

    How to Design Trials to be More Patient-Centered

    Three lessons learned and how pharma can use validated measures and strategies to engage patients at every stage in the drug development lifecycle.

    How to Design Trials to be More Patient-Centered
    Jean Paty, Vice President, Patient Centered Sciences, IQVIA, Matthew Reaney, Senior Principal, Patient Centered Sciences, IQVIA04.16.20

    Biopharma companies have come to recognize that patients, once considered only participants in drug and medical device development, can play a pivotal role by providing feedback at key points throughout the development lifecycle. In fact, patient-centered research allows pharma to capture meaningful data that enables them to maximize investments and deliver better treatments to market.

    Lesson 1: Speaking to patients and caregivers is the best way to generate disease insights

    Clinical trial sponsors need to understand how patients live with a disease before designing and implementing trials. Patients can most reliably and comprehensively explain their disease symptoms and the impact the illness has on their daily lives. Caregivers (spouses, dependents) and those who treat the disease (healthcare professionals) can also provide valuable insights.

    Patients’ perspectives can also reveal the burdens and other physical and emotional land mines trial participation poses. While this co-design approach will not eliminate all barriers, sponsors can use patients’ feedback to reduce unnecessary burdens, lessen patients’ fears and make them feel valued as partners in the trial process.

    Recommendation: Engage patients in qualitative research

    •          Start with patient advocates. Patient advocacy groups can communicate your interest in patients’ perspectives to people in their networks. These patients will bring an informed perspective and help you build grassroots support for your research.

    •          Talk to research-naïve patients. To ensure you have access to a broad understanding of patients’ relationships with the disease, talk to people who have never considered trial participation or are less informed about their condition or treatment options.

    •          Listen. The patient is the expert in conversations about life with the disease. Let them communicate their needs and use their feedback to shape the trial to be more patient-friendly.

    Lesson 2: Clinical outcome assessments bring structure to measurement of patient insights

    Qualitative insights bring value to a program but need a scalable strategy to measure what matters in a robust, reliable, valid, structured and systematic way.

    Clinical outcome assessments, including PRO, ClinRo, ObsRo and PerfO1, are scientifically rigorous instruments to capture unfiltered data directly from the patient in a clinical study in a consistent, integrated format. Recent electronic modes of collecting COA data have increased the reliability and validity of these assessments and ensure relevance and precision.


    With the science of COA development and use well-established, COA data is expected to be presented as part of regulatory reviews and, increasingly, payers are seeking COAs when deciding what treatments and price points to support.

    Recommendations: Build and select COAs that deliver relevant data

    •    Build a conceptual model to summarize the patient experience and the relationships between disease etiology, symptoms and the immediate impact of symptoms.
    •    Choose and/or build a COA from the conceptual model to guide the selection process and help sponsors determine whether an existing instrument should be modified or a new COA should be developed.
    •    Show that COAs work by examining for reliability and validity of measurement and research to understand what change is meaningful to patients.

    Lesson 3: COA data should be used beyond drug and medical device development

    Using COAs to collect data about the real-world treatment experience helps pharma craft more targeted information about treatment benefits and create support programs that help resolve patients’ issues.

    This is valuable for treatments that require a post-authorization commitment or use a novel mode of administration. For example, a client that spent millions developing a patient reminder app to increase adherence. However, in later COAs, the problem found was patients’ discomfort with a new injection mechanism. Had the company gathered patient insights through COAs at the outset, they would have had the data to make a more patient-centric plan. When pharma demonstrates a commitment to capturing this perspective, it can be a true differentiator.

    Recommendation: Generate data in clinical practice
    •    Capture patient feedback as an ongoing activity. Introducing COA measures to clinical research can create an ongoing dialog between patients, physicians and other stakeholders. These real-time insights can be used to adapt current engagement efforts, improve communication and inform future trial designs.
    •    Act now. Too often, pharma turns to patients for feedback after a problem occurs, adding time and cost to drug development and leaving patients frustrated. Instead, ask patients what they need or what obstacles they face when using your treatment, then build solutions around their input. This human-centered approach ensures your decisions serve patients’ best interests.

    The right way to collect patient data

    There are many ways to capture the patient perspective in clinical research. Sponsors who leverage validated tools to capture patient insights at every stage of drug development and embrace their findings will be better positioned to maximize their investments and deliver value-driven treatments to market.

    By adhering to these principles, COA data — collected in a patient-friendly way — can provide valuable insight and outcome information, which can shape review and approval, prescribing habits and, ultimately, patient health and well-being.

    1. https://www.fda.gov/drugs/drug-development-tool-qualification-programs/ddt-glossary


    Jean Paty
    As vice president and head of the Patient Centered Sciences team at IQVIA, Jean Paty is a leader in effective strategies and practices of capturing patient experience data for use in clinical development and commercial success of new and existing medical products.
     
    Matthew Reaney
    As senior principal and head of Scientific and Analytic Research for the Patient Centered Sciences team at IQVIA, Matt provides scientific oversight and support to PCE consulting projects, and other PCE services that require scientific participation, with a focus on patient insight generation and COA.

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