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All Pharma Wants to Be “Patient-Centric” – What Does That Really Mean?

September 22, 2016
[caption id="attachment_23249" align="alignleft" width="220"]Liz Lewis, Chief Counsel and Head of Patient Advocacy at Takeda Oncology Liz Lewis, Chief Counsel and Head of Patient Advocacy at Takeda Oncology[/caption]

The concept “patient-centricity” has become a pharmaceutical industry buzzword in recent years, making it difficult to see how this concept translates into meaningful practice. Most organizations work for the benefit of patients, but infusing the patient needs and opinions into the discovery, development and delivery of medicines requires a different level of commitment.

For Takeda Oncology, that commitment spans nearly two decades, beginning before the company even launched its first product in oncology. From the start, we made it a priority to foster long-term relationships with the multiple myeloma patient community and then quickly expanded our advocacy efforts to encompass a broad range of cancers, including lymphoma, amyloidosis and other hematological malignancies.

One area where patient input is critical, but has often been overlooked, is clinical trial design. Today, less than five percent of patients with cancer choose to enroll in studies, raising the question of whether others might volunteer if patient needs were more front-and-center. Takeda Oncology has been a pioneer in ensuring patients’ voices and experiences are part of the development of treatments – especially when it comes to investigating those treatments in trials.

The company’s “prognostic journey mapping” process, which begins before trial design, involves working directly with patients to understand how their diseases impact their lives. Then, armed with this knowledge, researchers can engage patients to provide input on clinical trial protocols, helping answer questions ranging from the appropriate inclusion criteria to the endpoints that matter most to patients. Shaping clinical studies around the patient – rather than force-fitting patients into a set design – helps to speed recruitment and, more importantly, minimizes logistical burdens and improves the experience of those participating in trials.

As an example, Takeda Oncology recently initiated a global non-interventional, observational study called INSIGHT–MM. The trial aims to track patterns and advance understanding of real-world experience with therapies and clinical outcomes in patients with newly diagnosed and relapsed/refractory multiple myeloma.

In addition to being the largest pharmaceutical company-sponsored study of its kind in multiple myeloma, INSIGHT-MM is unique in its focus on patient feedback. The study will collect data not only from routine office visits and medical records, but also from validated patient self-reported outcomes questionnaires, which invite participants to share their experiences of living with multiple myeloma and undergoing treatment.

The INSIGHT-MM study is being led by a steering committee of international myeloma experts, which includes a patient. This governance structure ensures that patients are part of the conversation as the steering committee makes decisions regarding the analysis and release of study data. Further, INSIGHT-MM will be open for the broader multiple myeloma community to propose analysis and request data that has been collected during the study.

Employees at Takeda Oncology are committed to a framework that infuses patient engagement in drug development in the hopes of advancing drugs that have a profile that truly addresses patient needs. Their struggles matter. Their opinions matter. Having a full understanding of the patient’s journey is what challenges Takeda Oncology to bring better medicines to market. We are committed to ensuring that patients get access to the right therapies as we continue to aspire to cure cancer.

This November, BIO will host the Patient and Health Advocacy Summit, an annual event that brings together stakeholders for timely policy discussions and best practice seminars. This is the first in a series of guest blogs highlighting efforts by BIO members to bring the patient voice into the discovery, development and delivery of life-saving medicines.