Incorporating the Patient Voice into Scientific Research to Better Understand Their Needs

Our Patient-Centered Outcomes team captures the patient voice and engages with patients – whether that is part of the development of clinical outcomes assessments (COAs) such as patient-reported outcomes (PROs), through studies of patient preferences to understand the characteristics most important from a patient perspective, or to describe the patient’s journey through diagnosis and treatment to understand patients’ and caregivers’ unmet needs.

We have been at the forefront of the evolution of patient-centricity and have seen the positive impact of engaging patients throughout the product lifecycle. A patient-centric approach starts with patients participating in clinical trials and continues to patients becoming active bloggers to support marketed medicines as experts in their own condition.

Pre-clinical Development

The pre-clinical phase is the best time to strategize and define how patients will be engaged throughout the drug development process and to characterize burden of illness and unmet need.

Phase I/II – Clinical

In this phase, we optimize trial design to capture endpoints that matter to patients. We identify what measures exist to capture the patient experience and, if not fit for purpose, begin developing evidence.

Phase III - Clinical

With the correct measures in place, Phase III trials provide an opportunity to represent the patient voice to its fullest. In this phase there is a constant assessment of trial design and we determine how patients are comparatively assessing benefits and risks with respect to treatment selection.

Post-Approval

Once a drug is approved, there are a number of ways to take a patient-centric approach. Consider preference studies and partnerships with advocacy groups or qualitative assessments and social listening. Registry and survey studies are also an option to understand the real-world impact of interventions.

Partnering for Improved Outcomes

Strategy/Instrument Selection

PRO/COA Strategy and Instrument Selection
Patient-Focused Literature Reviews
Regulatory Support for PRO/COA Incorporation into Trials
PRO Dossiers

Qualitative

Development of Novel PRO/COA Instruments
Qualitative Interviews and Focus Groups
Patient Journey Studies
Within-Trial Exit Interviews

Psychometrics/PCO Analytics

Psychometric Validation of PRO/COA Instruments
PRO Data Analysis
Q-TWiST Analyses

Preference

Preference Elicitation
Utilities Elicitation

Primary Data Collection

Design and setup of registries collecting PROs
Quantitative surveys

Patient Engagement

Research partnerships with advocacy groups
Advisory boards and focus groups
Consulting on the patient engagement landscape
Patient emotional journey mapping
Research partnerships with advocacy groups
Patient writing
Market research
Behavior change
Digital development
User-certified design

Why Us?

Our scientific and patient engagement experts are actively involved in the patient-centered outcomes field. We have the experience needed to guide you to the right solutions and be a partner in patient-centered research.

Active Projects

FDA-Funded Grants for PCO Development

PCO Publications

Symposiums, Invited Presentations, and Workshops

Case Study

Multidimensional PCO Support within Rare Respiratory Conditions

OBJECTIVE
Analyze existing clinical trial PRO data, leveraging expertise to also help design future studies.

SOLUTION
Across 3 conditions, Pharmerit supported the analysis and interpretation of PROs

RESULTS
Given the multidisciplinary team within Pharmerit and OPEN Health, we were able to strategically support PRO initiatives for clients within and across product pipelines. We actively worked with members in other Centers of Excellence to provide seamless support for activities from trial design to support of product launch.

Resources

What You Should Know About Patient-Centered Outcomes Interviewing

View webinar playback

Emerging Approaches for Patient-Centered PRO Endpoints: Qualitative Methods to Capture the Patient Voice in the Interpretation of PRO Scores

Read Kelly McCarrier’s blog

Patient Journey Studies

View our recent work.

Meet Our Patient-Centered Outcomes Team

Katharina Verleger

MPH, MA

Berlin, Germany

Krystallia Pantiri

MSc

Rotterdam, The Netherlands

Marieke Heisen

PhD

Rotterdam, The Netherlands

Angela Stroupe

Boston, United States

Caitlyn Solem

PhD

Bethesda, United States

Caroline Seo

Bethesda, United States

Charlie Iaconangelo

PhD, MS

New York, United States

Daniel Serrano

PhD, MA

Bethesda, United States

Namita Joshi

PhD, MS (Pharmacy Administration), BPharmacy

Bethesda, United States

Xinyi Ng

MS, BS

Bethesda, United States

Barbara Potrata

PhD, MPhil, MA, BA

Rotterdam, The Netherlands

Rachel Shah

Bethesda, United States

Alyssa Uzumcu

Boston, United States

Kelly McCarrier

PhD, MPH

Bethesda, United States

Hrishikesh P. Kale

PhD

Bethesda, United States

Sophie Tsai

MD, MS

Bethesda, United States

Maya Gerstein

DrPH

Bethesda, United States

Nancy Touba

New York, United States

Sayeli Jayade

BS, MPH

New York, United States

Ella Engstrom

Bethesda, United States

Ana Pena-Molina

BS, MPH

Bethesda, United States

Alexis Cooke

MPH, PhD

Bethesda, United States

Patient-Centered Outcomes Publications

Date

Headline

Midwives’ Perspectives of Respectful Maternity Care During Childbirth: A Qualitative Study

Authors: M Moridi, F Pazandeh, S Haijan, B Potrata

The Development of the ICIQ-UAB: A Patient Reported Outcome Measure for Underactive Bladder

Authors: A. Uren, N. Cotterill, C. Harding, C. Hillary, C. Chapple, K. Lasch, A. Stroupe, C. Deshpande, L. Delbecque, G. Van Koeveringe, M. Oelke, M. Belal, R. Bosch, B. Blok, V. Nitti, M. Gotoh, M. Takei, B. Crawford, M. Klaver, D. Bongaerts, Z. Hakimi, T. Kos, P. Abrams

Symptoms of Major Depressive Disorder Scale: Performance of a Novel Patient-Reported Symptom Measure

Authors: DM Bushnell, KP McCarrier, EN Bush, L Abraham, C Jamieson, F McDougall, MH Trivedi, ME Thase, L Carpenter, SJ Coons, PRO Consortium's Depression Working Group

Patient-Reported Prevalence of Metamorphopsia and Predictors of Vision-Related Quality of Life in Vitreomacular Traction: A Prospective

Authors: PJ Patel, DH Steel, C Hirneis, J Brazier, A Aly, B Lescrauwaet, MeMo Study Group

Effects of Monthly Buprenorphine Extended-Release Injections on Patient-Centered Outcomes: A Long-Term Study

Authors: W Ling, VR Nadipelli, C Solem, NA Ronquest, YC Yeh, SM Learned, V Mehra, C Heidbreder

Please get in touch

To learn more about our Patient-Centered Outcomes research and discuss what we could do for you, please get in touch.

Caitlyn Solem

Patient-Centered Outcomes Lead

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