Parexel, Signify join forces to boost trial inclusivity

Parexel and Signify Health have announced a strategic collaboration designed to provide clinical research customers with solutions that contribute to increased diversity and inclusivity in their studies. The partnership reportedly will improve patient to access to trials, and facilitate better connections patients, local resources and caregivers.

Outsourcing-Pharma (OSP) spoke with Peyton Howell (PH), executive vice president and chief commercial strategy officer with Parexel; and Marc Rothman (MC), Signify Health’s chief medical officer, about the partnership and the importance of increasing inclusivity in clinical research.

OSP: Why is increasing trial diversity and inclusivity crucial?​

PH: Continuing to increase clinical trial access and inclusion will ensure medicines and vaccines have been tested across all populations and can effectively treat a disease or condition. This year in particular, the pandemic has revealed the close connection between racial disparities and health outcomes; our industry recognized this issue, as well as how trial populations with a lack of diversity weaken the ability to fully understand the safety, effectiveness and value of a medical discovery. In response we are actively working to create partnerships and offer resources to combat this issue.

As defined by the World Health Organization (WHO), social determinants of health (SDoH) are the conditions in which people are born, grow, work, live and age, and the wider set of forces and systems shaping the conditions of daily life. Issues stemming from SDoH that impact trial participation include limited availability for assessment tests, limited mobility and lack of reliable dependent care.

Through our partnership with Signify Health, Parexel is seeking to identify the factors affecting SDoH and facilitate connections among local resources, patients and caregivers to ultimately correct the disparities in healthcare and drive inclusion.

OSP: Similarly, what are some of the risks in failing to attract a sufficiently inclusive patient population?​

PH: Failing to attract an inclusive patient population can result in potentially under-researched products entering the market, ultimately leading to a potential lack of confidence in the scientific community or the medication being restricted to a subset of the population.

For example, the US Food and Drug Administration’s (FDA) 2019 drug trials snapshots summary report shows that more than 46,000 patients participated in trials of novel drugs. Of that population, 72% were white in comparison to minority populations, demonstrating a disparity that must be addressed.

In partnership with Signify Health, we are actively working toward equalizing these participant pools to be more encompassing and to address other critical factors such as age and socioeconomic status.

OSP: In the announcement, you say, “Simply saying clinical trial diversity is ‘important’ is not enough.” Could you share some of the ways (besides maybe stopping at lip service) that site and sponsor efforts to increase diversity can fall short and/or miss the mark?​

PH: Site and sponsor efforts can fall short due to issues integrating health and social care to treat the patient. Social conditions — especially those that contribute to financial burdens — are often not easily identified and go unaddressed. These gaps, while hard to identify, can result in a patient’s decision to not start a therapy, stop therapy or deter them from joining a clinical trial.

To improve diversity and inclusivity, we must consider all relevant SDoH that motivate or prevent people from participating. Specifically, Signify Health’s analytics and technology platform will enable us to use these social insights to further understand the factors that could impact inclusion.

Additionally, we will create new solutions to eliminate SDoH barriers and provide access to more diverse and traditionally underrepresented populations from the comfort of their home or within their community.

OSP: Can you share what your short- and long-term goals are for the collaboration?​

PH: Our goal is to keep the patient at the forefront of our work as we further lead in the implementation of decentralized clinical trials. This includes reducing and removing patient barriers to clinical trials and providing support that enables patients to initiate therapy sooner, maintain consistent use of their therapy for longer and have a more positive, overall experience. We look forward to partnering with Signify Health in 2021 and to initiating our pilot program addressing SDoH issues.

MR: In the immediate term, Signify Health is collaborating with Parexel to support the industry’s shift to decentralized trials by designing programs that will bring clinical studies to patients in their location of choice. We will leverage our mobile network of credentialed providers who can assist patients in the patient’s home. They are powered by our technology platform that helps ensure efficiency, clinical consistency, and accuracy of data capture.

We also intend to pilot programs that support recruitment and retention of diverse and underrepresented patient populations in clinical trials by identifying and addressing common social determinants of health, such as access to transportation and food insecurity, for both patients and their caregivers. 

Longer term, we hope our work together will remove barriers to clinical trial participation, thereby increasing clinical trial inclusion and diversity in diseases that typically have more complex treatment requirements, such as oncology and autoimmune diseases. 

In working across the pharmaceutical industry, Signify Health aims to bring coordinated, community-based clinical services and support to the patient, in their homes, so that they can initiate therapy sooner, thrive on therapy longer, and be more satisfied throughout their journey.