Addressing Patient Representation in R&D

Maintaining a robust pipeline of innovative, evidence-based device therapies that effectively address heart failure is more important than ever. The disease affects more than 6.2 million Americans,¹ with diagnoses projected to double by 2030.² Addressing the growing heart failure epidemic—and other chronic diseases—begins at the earliest stages of the medical device R&D process. That includes an urgent need to improve patient representation in clinical trials. 
 
Conducting clinical trials in populations with the highest disease burden is important for understanding the impact and outcome different therapies have on patients. Better representation is not only good clinical science—it’s now mandated by recent federal legislation.³ Device manufacturers are working to develop diversity plans and design standard operating procedures that ensure their clinical trials follow FDA guidance.⁴
 
The Heart Failure Collaboratory (HFC), a consortium of clinical investigators, clinicians, patients, government representatives, payers and industry collaborators (including Abbott), is conducting research that can help inform manufacturers’ efforts. HFC’s recent demographic study, Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations,⁵ reveals a correlation between clinical trial representation and adoption of newly approved devices. The study’s findings identify where the disparities in representation lie for one heart failure device, in particular—demonstrating how similar studies can inform diversity plans for any device or disease state.

Investigating the Correlation Between Clinical Trial Representation and Early Adopters

Published in JACC: Heart Failure, HFC’s demographic study sought to determine if characteristics of heart failure patients enrolled in a pivotal trial are associated with who receives an intervention after FDA approval. 
 
The study focused on Abbott’s CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial. The CardioMEMS HF System detects pulmonary artery pressure changes that can indicate worsening heart failure even before the patient starts to physically feel symptoms. As a remote monitoring platform, this technology can help serve patients who experience barriers to care. 
 
We first compared the demographics from 2,017,107 Medicare patients hospitalized for heart failure with those of the first 10,631 Medicare beneficiaries who received implantable pulmonary artery pressure sensors. We then compared the characteristics of the population studied in the CHAMPION trial with both groups of Medicare patients. 
 
The results showed that patients who were initially implanted with Abbott’s CardioMEMS mirrored the demographics of the CHAMPION trial’s participants. That’s not a coincidence—it’s a pattern indicating that there’s a stark correlation between clinical trial enrollment and the “first wave” of patients who receive newly approved innovations. 

Considering Race and Ethnicity, Gender and Regionality as Factors in Clinical Trials

Our study revealed that early adoption of CardioMEMS was disproportionate to the overall population of patients with heart failure, including disparities by race and ethnicity, gender and region. In the U.S., younger patients (<65 years) receiving the device were mostly White (64%) and male (59%), with African Americans comprising 29% of those initially receiving CardioMEMS. However, younger heart failure patients are more likely (33%) to be African American. 
 
Additionally, women were underrepresented in the total population of patients who received the device, even though they comprise more than half (51.5%) of patients hospitalized with heart failure. Furthermore, at the regional level, only 13.5% of older African Americans in the South received the device, despite the fact that the highest proportion of heart failure hospitalizations occur in the South (41%) and African Americans are more likely to be hospitalized in the South (42%). 
 
While different disease states see demographic variations, the broad implications from our heart failure study are clear and urgent. Race and ethnicity, gender and regionality are important factors that must be considered in all device manufacturing R&D, beginning at the earliest stages of clinical trials. Conducting a similar demographic study is a strategic way for manufacturers to develop a better understanding of these factors and help shape more effective diversity plans.
 
Closing gaps in representation and gathering more expansive, accurate patient insights align with Abbott’s patient-centric approach to every aspect of our business, including R&D. It’s true across disease states: patients are often the ones most invested in their disease and improving their condition. However, patients won’t seek access to care or medical therapies if these options feel out of reach or not made for them. Empowering and collaborating with patients more effectively at every stage of their healthcare will help improve outcomes.

Improving the Medical Device Development Ecosystem 

Clinical trials have a vital role to play in improving patient representation across the device development ecosystem. And, supporting better representation in clinical trials for medical devices means building up other aspects of our clinical research infrastructure. That includes—but isn’t limited to—developing new clinical research models, diversifying our pool of clinical research coordinators and establishing new research centers in underrepresented communities. 
 
However, while our industry has much work to do, it is encouraging to see the progress made so far and the ongoing, collaborative problem-solving. Together, we can advocate for better clinical science—and a landscape of clinical research that is as diverse as the people we aim to serve.

References

¹ Heart Failure | cdc.gov
² Circ Heart Fail. 2015;8:880-886. DOI: 10.1161/CIRCHEARTFAILURE.114.001778.
³ https://www.congress.gov/bill/117th-congress/house-bill/7667/text#toc-HAFE43CDC848D403E8BC2F0149CA806CD
⁴ Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability | FDA
⁵ Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations | JACC: Heart Failure

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Kartik Sundareswaran, Ph.D. is the divisional vice president of global clinical and regulatory affairs for Abbott’s heart failure division. In this role, he has oversight of clinical evidence generation, clinical trial design and execution, dissemination of clinical trial results and regulatory strategy for the business. He joined Abbott (formerly St. Jude Medical and Thoratec) in 2009.