Home

Improving Diversity in Our Clinical Trials for Long-term Health Equity

June 01, 2022
2:19 pm

Across the healthcare industry work is taking place to address health disparities. The Healthcare Leadership Council (HLC) has delved specifically into social determinants of health, broadband access, disparities in care delivery, vaccine acceptance, behavioral health, and workforce and clinical trial diversity. Amgen, an HLC member, is a leader in improving clinical trial diversity as a means to ensure better outcomes for those of diverse racial and ethnic backgrounds. This recent post below lays out the company’s comprehensive strategy, strengthened by collaboration, to address systemic issues which affect participation in research.

Improving Diversity in Our Clinical Trials for Long-term Health Equity

Darryl Sleep, Amgen’s senior vice president and Global Medical and Chief Medical Officer

Last April, Amgen stood with PhRMA as the first-ever industry-wide Principles on Clinical Trials Diversity officially took effect. The goals of these Principles are to expand participation among diverse patient populations by increasing understanding and awareness about clinical trials and improving access. Since then, we’ve already seen two very significant positive outcomes. First, improving diversity and representation in clinical trials has evolved from a niche issue into a core industry commitment. Second is the development of enthusiastic, industry-wide initiatives to improve how sponsors approach and improve diversity and representation in clinical trials. We are sharing best practices and de-identified aggregated clinical trial data to continue advancing this work via our cross-industry collaborations and partnerships. In this purpose, there is no holding back; we are all dedicated to making long-overdue changes that will result in diversity and representation in clinical trials becoming a reality and not just an ideal.

Clinical trials are a critical part of the long and careful process of developing new medicines. This research is complex and multidisciplinary and there isn’t a single accelerator that can be used to address the systemic issues that deter people from participating. Instead, we need a range of different levers to update decades-old processes and create new best practices.

I want to use the one-year anniversary of the PhRMA Principles to share some highlights about the data-driven efforts we’ve taken at Amgen to lead the way in breaking down barriers and help us find new medicines supported by clinical trials that are representative of all patients who suffer from serious illnesses.

We have a dedicated team
While the push for more diversity and inclusion in clinical trials is not new to Amgen, we accelerated our efforts in 2020 with the formation of RISE (Representation in ClInical ReSEarch), a team dedicated to addressing the systemic issues that deter people from participating in research, especially those who have been historically excluded due to race, ethnicity, sex, age, and other factors. We have significant momentum with our goals as programs and teams across Amgen, including RISE, Global Medical, Advocacy, Compliance, and Global Development, trial execution and data & analytics teams work together to create greater equity through diversity and proportional representation in clinical trials.

Ongoing learning to gain understanding and insights
Communication and information-sharing are fundamental to driving change. The output from our Health Equity Summit: Disrupting Health Disparities through Partnership and multiple Community Advisory Boards focused on direct insights from Black, Indigenous and People of Color (BIPOC) which provided information on barriers, strategies, and tactics that can apply across communities. We are using these insights to directly inform the design and implementation of a long-term, study-agnostic community engagement plan – a critical step in building sustainable, trusted relationships. Additionally, our patient-focused advisory councils with representation of racial and ethnic minorities will inform our clinical trial design and execution.

Building foundational capabilities
Logistical and financial barriers, gaps in awareness, and lack of trust all impact participation in clinical trials. We are partnering with organizations and diverse suppliers to thoughtfully build our enrollment support capabilities, including providing transportation, and other potential support capabilities, as well as finding optimal ways to support staff at clinical trial sites. Taking a holistic approach to tackling these industry-wide issues will help us move the needle.

New partnerships and collaborations
Collaborative partnerships play a significant role in advancing understanding of the science and our ability to positively engage patient communities in clinical trials. Toward that end, we are engaged in a number of efforts including:

  • A pilot program of the American Cancer Society Cancer Action Network to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials, including navigators to help patients address logistical and financial challenges to enrolling and completing those clinical trials.
  • The CEO Roundtable on Cancer’s Going for Gold initiative, in partnership with Historically Black Colleges and Universities (HBCUs) and Hispanic Serving Institutions (HSIs), that focuses on equitable cancer care.
  • A collaboration with The Digital Medicine Society (DiMe) to drive inclusion in digital clinical trials by providing the tools and framework necessary to successfully engage underrepresented populations during the planning process for clinical trials that include a technology device for participation.
  • Creation of the HBCU BioTech Fellowship program, a professional development program that will prepare and empower 50 students (and soon-to-be graduates) from Historically Black Colleges and Universities for careers at Amgen.

Measuring progress in our own trials
We have undertaken important steps including a baseline study that will help us measure progress for trials currently underway as well as for new trials on the horizon. Additionally, we have a number of tools in development to help us measure and evaluate best practices for improvement in enrollment of participants from diverse racial and ethnic backgrounds.

Recognizing differences in disease incidence, exposure and response to medicines
We have long been committed to unlocking the potential of biology for all patients suffering from serious illnesses using advanced human genetics to unravel the complexities of disease. Accordingly, we are using data on human diversity in our own labs and with research partners. Together, we will better understand incidence of obesity, cardiovascular disease from risk factors such as elevated Lp(a), inflammatory diseases such as atopic dermatitis and lupus, and multiple cancers in diverse populations.

In addition, we are seeking to understand and actively address the social determinants of health (SDOH) that contribute to wide health disparities and inequities that impact disease burden and access to healthcare.

Reaching the finish line will allow us to get new medicines faster to patients who need them. It will also help doctors assure their patients that the medication they’re being prescribed was studied in people like them, with results that indicate they are likely to benefit. We’re not there yet, but we’re taking informed steps with care, with the scientific expertise for which we are known, and with humility. Every day, we dedicate ourselves to serving patients by transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. As we work to fulfill our own values and PhRMA’s Principles, we’ll get closer to serving all patients, beginning with clinical trials that include people of all races and ethnicities who will benefit.

For more information, please visit Clinical Trial Diversity & Representation.

The Systemic Flaw that is Health Inequity

April 15, 2020
5:51 pm

During times of crisis, a point of structural weakness becomes glaringly visible and vulnerable.  The COVID-19 pandemic has placed a spotlight on the inequities that exist in this country when it comes to health and well-being.  The importance of the social determinants of health is more apparent than ever.

As concerns grew about the virus spreading, the predominant proportion of white collar workers could storm the grocery stores and then settle in for the long haul in front of their laptops.  Meanwhile, blue collar workers began losing jobs and health protection, or were forced to work in hazardous conditions, constantly at risk of exposure to the virus.  Available data is making clear the socioeconomic divide that COVID-19 has laid bare.  In New York City, the bottom income quadrant accounts for 36 percent of all coronavirus cases in the city while the top quadrant accounts for just 10 percent.

Those who have no choice but to risk exposure in order to receive a paycheck, or conduct daily life activities like visit a laundromat or make frequent trips to the grocery store because they don’t have the money to stock up the pantry, are the ones who have the least access to quality healthcare to protect their lives.  People in low-income jobs, or who have lost their job during the pandemic, face hospitalizations with high out-of-pocket costs if they become sick.  They also frequently don’t have the support systems to help them in the event of serious illness.

As this virus has a greater impact on those who are less able to achieve social distancing, it’s creating a greater awareness of the work that needs to be done on social determinants.  The World Health Organization has provided examples of the factors that, besides clinical care, play a role in population health.  Safe and affordable housing, access to education, public safety, availability of healthy foods, local health services, toxic-free environments – all have a tremendous effect on our health and longevity and too many Americans are lacking some or all of these determinants.

The good news is that the healthcare industry is devoting considerable resources and attention to addressing health disparities and the social determinants of health.  The Healthcare Leadership Council has held a national summit on the issue and issued a report with specific recommendations.  And, on the ground, we’re seeing multiple initiatives that are demonstrating how community health programs, telehealth services, and expanding the definition of health benefits to include commodities like housing and transportation are making a difference in the lives of vulnerable populations.

The COVID-19 crisis is making it clear that we need to accelerate these efforts.

National Obesity Care Week: Behind the Scenes of Obesity

September 19, 2019
4:19 pm

September 16-20 is National Obesity Care Week (NOCW).  NOCW is a source for science-based information on obesity.  More than 93 million Americans are affected by obesity, with an estimated cost of $480 billion to the healthcare system.  The Healthcare Leadership Council (HLC) has joined as a partner of NOCW, advancing our conviction that people who struggle with obesity deserve access to quality care and must be treated with dignity and respect.

Recently, HLC has been focused on how the healthcare system can utilize research on social determinants of health so that essential socioeconomic and environmental factors can be considered and addressed in addition to one’s clinical care.  At the beginning of this week, HLC hosted a Hill briefing that had an expert panel present on reducing disparities in health.  While this particular briefing looked at the whole patient from a pediatric and senior perspective rather than zeroing in on obesity, there is a strong relationship between obesity and low socioeconomic status that cannot be ignored.

Many HLC members have recognized the need to reach out and invest in the well-being of surrounding communities:

  • BlueCross BlueShield of Tennessee has taken many avenues to encourage healthy lifestyles of Tennesseans, such as revitalizing neighborhoods with parks, and repaving the roads with bike lanes.
  • The Bristol-Myers Squibb Foundation provided resources to establish one of New Jersey’s largest and most comprehensive children’s hospitals which includes a clinical center of excellence dedicated to the study and treat childhood obesity.
  • Fairview Health System launched a new 24-week Healthy Lifestyle Plan that combines evidence-based weight loss strategies with one-on-one lifestyle coaching.  This approach can address medical issues that make it hard for someone to lose weight on their own, such as hormone levels, the side effects of prescription drugs, or chronic conditions like sleep apnea.
  • Teladoc Health has invested in a personalized virtual care platform for physical and behavioral health, addressing the root of the problem for chronic disease with digital therapeutic interventions and sustainable behavioral change.

It is promising that across the healthcare spectrum there have been a variety of solutions offered to address obesity, but much progress must still be achieved to make a lasting impact on the health of millions of Americans.  Many people do not know that obesity is a disease, and education is the just the first step to achieving NOCW’s goal of access to comprehensive obesity care.  More voices are needed to enact change.  Additional information about ways to take action is available on ObesityCareWeek.org/ACTION.

Action Needed for Market Stability, Access to Health Coverage

July 18, 2018
11:24 am

There is a consensus in this country that people who are struggling with illnesses and have a greater need for healthcare services should not be prevented from acquiring health insurance.  Recent actions at the federal level, though, need to be addressed in order for that ideal to be met.

Risk adjustment payments provide financial stability to insurance providers that provide coverage to relatively high numbers of sicker, higher-cost consumers.  Without those payments, premiums would become unaffordable for millions of Americans who buy their coverage through small businesses or on their own in the individual insurance market.

And that brings us to the current dilemma.

A federal district court judge ruled in February that the Department of Health and Human Service’s methodology for calculating risk adjustment payments was flawed and impermissible.  Subsequently, on July 7, the Centers for Medicare and Medicaid Services (CMS) announced that payments under the risk adjustment program, including amounts already owed for the 2017 benefit year, would be suspended.

This is an issue that carries extraordinary ramifications.  It will create more market instability – at a time in which we need just the opposite – and the potential for reduced coverage options for those who have the greatest need for healthcare access.  Further, it could result in increased costs to taxpayers if the federal government has to increase premium subsidies.

An analysis by Change Healthcare, a major technology and analytics firm, found that the individual health insurance market attracts an extremely wide range of enrollees in terms of healthcare utilization.  In fact, according to Change, the health plans attracting the sickest patients have health costs at least 450 percent higher than the plans with the healthiest clientele.  Thus, the need for risk adjustment payments.

CMS has asked the district court judge to reconsider his ruling.  We hope he will.  Americans with serious healthcare needs should have affordable coverage.

The Power in Planning Ahead

April 17, 2017
4:53 pm

Now that most of us have filed our taxes for 2016, this is an opportune time to review our health planning with the same level of attention.  There is a nationwide effort to make the day after Tax Day “National Healthcare Decisions Day” – a day in which we think about our long-term healthcare needs and make a plan for how we would like to be cared for in our final days.  At one point or another, all families face challenges with advanced illness and must make decisions about end-of-life care, but too few of us have given thought to issues like designating power of attorney or creating advance directives and living wills.  Advanced illnesses cause many challenges for families.  One of the most difficult is when family members become the primary caregiver for their loved ones and are placed in decision-making roles that they never expected.  Advanced care planning is a useful tool that can assist individuals in preparing for end-of-life care, and keeping family members and healthcare providers updated on their wishes.

For individuals faced with end-of-life care decisions, it is important to have conversations with their physicians about their treatment options and their wishes regarding advanced illness care.  Studies indicate that patients and their families are interested in discussing their end-of-life options with their physicians.  However, there is concern that physicians may lack the training or resources to engage in long-term conversations with their patients on end-of-life healthcare decisions.   For instance, a recent survey of 736 physicians, link above, found that less than one-third reported any formal training on discussing end-of-life care with their patients and their families.

The Coalition to Transform Advanced Care (CTAC), a non-partisan organization, is collaborating with the AHIP Foundation on “The Advanced Care Project,” which offers suggestions for how healthcare professionals can help patients make their decisions about their end-of-life care needs.  A combination of education and collaboration on advanced care allows for patients and family caregivers to develop their own care plan that is specifically designed to fit their needs.

Healthcare plans and providers are embarking on their own initiatives to assist and ensure that patients are able to make their own decisions about their healthcare.  For instance, Aetna offers support to its members through its Compassionate Care Programs, in which individuals experiencing end-of-life care are assisted by nurse care managers who are available to provide resources to patients and their family members, as well as assist physicians in managing the care of the patient.   The Franciscan Missionaries of Our Lady Health System in Louisiana is collaborating with the Louisiana Health Care Quality Forum in the Louisiana Physician Orders for Scope of Treatment (LaPOST) initiative on how a patient’s desires and goals into their treatment plan can be medically translated and applied to multiple healthcare settings.

SCAN Health Plan has constructed a new system to make it possible for patients and their families to understand the full array of care options available to them and to receive treatment that best fits their values, goals, and cultural preferences.  This system is called the Program for Advanced Illness (PAI). A palliative-trained nurse case manager serves as the member’s personal advocate.  The nurse will help members and their caregivers navigate care options that reflect patient’s goals and wishes, encouraging articulation and documentation of end-of-life requests while identifying healthcare proxies and making referrals to hospice.  Additionally, the nurse will communicate with all medical staff and other parties to ensure everyone understands the critical decisions being made as well as following up with the family to offer bereavement services.  More program details are available in the Viable Solutions compendium recently released by the Healthcare Leadership Council.

On National Healthcare Decisions Day, let us continue to have the conversation about how healthcare providers can best assist individuals in making their own decisions about their health care needs.  Create an advance directive and talk to your family and friends about the importance of care planning.  Visit www.nhdd.org for more information.