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Joey Gaspero

Need for Diversity in Clinical Trials

By | Clinical Trials, Diversity & Inclusion, Drug Costs | No Comments

Clinical trials are essential to bringing new medicines to patients. An important aspect of clinical trials is to make sure that the drug is effective for a diverse group of people. Diversity in clinical trials has recently been a key issue. There is no comprehensive way of defining diversity, as it could include gender, race, ethnicity, sexual orientation, and more, depending on the dimension from which it is viewed. Unfortunately, many clinical trials lack diversity in representation.

A diverse nation like the United States has an assortment of populations, with White Americans forming the ethnic majority. Hispanic and Latino Americans amount to 16% of the population, making up the largest racial minority1. African Americans are the second largest racial minority, accounting for 12% of the population1. Adding to this is the international community which lands in the U.S in search of opportunities. Already diverse cities are becoming increasingly mixed with immigrants from Asia, Africa, and Latin America. The U.S. is a diverse country, so why do our clinical trials not reflect the same level of diversity?

Clinical trials are an essential part of drug development. These provide a base of evidence for evaluation of a drug. Each drug needs to be tested for its efficacy, ease of application, side effects, and many other factors before being launched into the market. The average drug developed by a major pharmaceutical company costs billions of dollars to develop. In general, the drugs are not specifically designed with every racial group in mind due to the cost of production. That is why clinical trials are an important tool to determine the drug’s effectiveness on the population as a whole. The trials are performed on a sample population and researchers try to prove its statistical significance on the entire population. Hence, it is very much essential for clinical trials to be diverse to represent the population. People from diverse cultures differ among factors such as their predisposition to diseases or the environment they are exposed to. To create awareness, the FDA announced 2016 as “The Year of Diversity in Clinical Trials.” Despite an increase in awareness, the current trend is unsatisfactory. According to the FDA, African Americans represent 12 % of the U.S. population, but only 7% of clinical trial participants. Additionally, Hispanics represent 16% of the U.S. population but only 1% percent of clinical trial participants2. In a country where minorities are estimated to outnumber white Americans by 2044, the inclusion of individuals of varied races, ethnicities, ages, gender, and sexual orientation in clinical trials can help to prevent disparities in the evaluation of potential new medicines2. Clinical trials ensure top quality drugs and diversity in clinical trials should be considered to provide better treatment.

The 7th Annual Diversity, Inclusion, and Life Sciences Symposium will discuss the trends, facts, insights, and best practices regarding diversity in clinical trials. Attendees will learn the newest insights and ideas, discuss practical solutions, and meet industry and marketplace colleagues. Please visit http://chisite.org/dilss/ for more info or to register.

 

  1. Source: Wikipedia
  2. Source: Center for Healthcare Innovation – DILSS 2016 Executive Summary

CHI Leads 3rd Annual Understanding Value in a Consumer-Oriented, Patient-Centric Era Roundtable

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The Center for Healthcare Innovation (CHI) is organizing our 3rd annual healthcare executive roundtable.  This year’s roundtable, entitled Understanding Value in a Consumer-Oriented, Patient-Centric Era, will take place on Thursday, October 15th, 2015 at 1:00PM EST in New York, NY, USA.

The healthcare executive roundtable an exclusive, intimate discussion that brings together the top thought-leaders, visionaries, and executives from the patient advocate, provider, payer, pharma, and pharmacy sectors to discuss and increase understanding of what patient-centric healthcare value means in the 21st century.  The healthcare landscape has rapidly shifted towards a consumer, patient-centric model of care delivery.  Today’s patients have become more empowered in their health and well-being, better informed, and more financially invested than ever before.  This paradigm shift has had dramatic implications not only for patients, but also for providers, pharma, and payers, as these latter groups attempt to define and deliver patient-centric healthcare value.  Furthermore, the roundtable explores the relationship between the definition of value and quality, access, and cost issues.  As healthcare costs continue to rise, capitation payment models become the new norm, and incentives shift as a result of moving to a value-based healthcare system, understanding and integrating patient-centricity into healthcare value will become more important than ever.  This consumer-focused discussion brings together the best and brightest healthcare leaders from around the globe to share their ideas and expertise on the intersection of healthcare value and patient-centricity.

Past years’ roundtables have featured executives from: Aetna, AstraZeneca, Bristol-Myers Squibb, Columbia University, GE Healthcare, Genzyme, Humana, inVentiv Health Clinical, Johnson & Johnson, Kaiser Permanente, Merck, Metropolitan Chicago Healthcare Council, Navigant Consulting, New York City Health & Hospitals Corporation, Novartis, NYU Medical Center, Otsuka, Owens & Minor, Pall Life Sciences, Pfizer, Princeton University, Quest Diagnostics, Stanford, TEDMED, Teva Pharmaceuticals, and the University of Pittsburgh Medical Center.

Please visit http://www.chisite.org/ for more information.

Video Recap of Diversity Symposium now Available

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The video recap of CHI’s 5th annual Diversity, Inclusion, & Life Sciences Symposium is now available at https://www.youtube.com/watch?v=6JgrJmOOSjA

The symposium is the world’s leading forum focused specifically on diversity, inclusion, healthcare, and the life sciences. It is an interactive and collaborative discussion for life science and healthcare executives, professionals, patient advocates, entrepreneurs, policymakers, researchers, scientists, technologists, and academics to discuss best practices, challenges, and opportunities of topics such as: Understanding Obstacles to Clinical Trials & Healthcare for Underrepresented Populations, Leveraging Employee Resource Groups (ERGs) for Success, and How to Recruit & Develop a Diverse, Talented Workforce. Attendees will gain valuable knowledge, information, and insights, as well as meet new colleagues and connections.

Just some of the organizations represented included: AbbVie, American Diabetes Association, American Medical Association, Astellas, Baxter, BlackDoctor.org, Dell, DePaul University, GE Healthcare, Genentech, Genzyme, GSK, Hospira, inVentiv Health Clinical, Lundbeck, Lurie Cancer Center, MCHC, Northwestern University, Novartis, Pfizer, Quest Diagnostics, Sanofi, Takeda, and the University of Chicago Medical Center.  The symposium was sponsored by Sanofi, Takeda, the Lurie Cancer Center of Northwestern University, and the Clinical Research Exchange. The symposium is hosted by the Chicago offices of Seyfarth Shaw.

Next year’s symposium will be Wednesday, June 8th, 2016.  For more information, please visit lifesciencesdiversity.org.

Unintended Consequences of Healthcare & Life Sciences Legislation

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Unintended consequences are the unanticipated and unforeseen outcomes from government action that are not the outcomes intended by the executive and legislative branches. There are three basic categories: (i) a positive, unexpected benefit, (ii) a negative, unexpected detriment, and (iii) a perverse effect substantially contrary to the original purpose of the law or regulation. Examples in healthcare and life sciences include the Orphan Drug Act of 1983 and the emergence of mini-med healthcare plans (total coverage capped at very low amounts). There are likely to be a wide array of unintended consequences resulting from the Affordable Care Act and other legislation in the U.S. and around the world.

In addition to any positive or negative unintended consequences of current or future legislation, the U.S. healthcare system will be faced with a series of dramatic changes unlike anything we’ve seen before.  Patients are more informed, engaged, and financially invested in their healthcare than ever before.  And as a result, provider and biopharma organizations are following patients’ lead and recalibrating themselves as patient-centric, consumer driven organizations.  Moreover, healthcare costs are rising at unsustainable rates.  As these major trends drive healthcare change, there will be a new emphasis on maximizing healthcare value, with a particular emphasis on improving quality, increasing access, and reducing costs.

CHI recently published an executive summary and research report on the Center for Healthcare Innovation’s 2nd annual Unintended Consequences of Healthcare & Life Sciences Legislation Symposium, which took place in Washington, DC on October 15, 2014.  This non-partisan symposium featured some of the world’s leading healthcare, life science, and government experts coming together in a collaborative setting to discuss the most pressing legislation   issues facing the healthcare and life sciences industries in the 21st century.  The executive summary can be found at http://chisite.org/research/2014unintendedConsequencesSymposiumExecutiveSummary

This executive summary captures and examines some of the insights, ideas, best practices, and new perspectives from the Symposium and the broader healthcare legislation discussion. It is meant to serve as a summary and a resource of the innovative ideas and insights regarding legislation for healthcare and the life sciences. We hope that you find it to be both thought-provoking and useful, and we welcome your feedback. We thank you for your interest, and hope this can be an asset for you and your organization.

The Value of Sovaldi: Societal Cost Issues of New Interventions on Hepatitis C

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In December 2013, the FDA approved a new drug, sofosbuvir, for the treatment of Chronic Hepatitis C. The drug, commonly known as Sovaldi, was developed by Gilead Sciences, a U.S. biotechnology company. The initial price tag of a 12-week treatment of Sovaldi was reported as approximately $84,000, or nearly $1,000 per pill. This resulted in considerable media attention and an ensuing pricing controversy. Editorials and op-eds sprung up around the country debating Sovaldi’s price tag and the broader debate over fair drug pricing. Some politicians expressed outrage over the cost of new drugs, while others argued for free market pricing and rewards for the considerable R&D costs that biopharmaceutical companies incur when bringing a new drug to market. The often niche drug pricing debate had officially spilled over into the mainstream conversation. Payers, policymakers, pharma, patients, and providers all voiced strong— and sometimes contrasting— opinions.

At CHI, we aim to help these stakeholders increase their knowledge and understanding of healthcare value, which we view as a function of quality, access, and cost. Thus, we decided to further explore the value of Sovaldi and how the costs and benefits of the drug relate to the broader discussion of the treatment of Hepatitis C. Our goal is to offer a more informed and analytical approach to the discussion of the value of Sovaldi. One question that immediately arose was “How does the price of Sovaldi compare to the long term costs of the treatment of Chronic Hepatitis C?” Our goal was to analyze the complex interrelationships and broader macroeconomic principles relating to the costs and benefits of a drug, as well as the long term costs of treating Chronic Hepatitis C.  The White Paper, The Value of Sovaldi: Societal Cost Issues of New Interventions on Hepatitis C, can be found here

By analyzing the societal cost implications of Chronic Hepatitis C, we aim to help patients, providers, pharma, pharmacy, payers, and policymakers increase their knowledge and understanding of the value of this treatment—as well as the complex relationships between drug costs and the longer term costs of a disease. We hope that you find this white paper to be both thought-provoking and useful, and we welcome your feedback. We thank you for your interest, and we hope you enjoy our comprehensive analysis.

Preventive Medicine: Controlling the Nation’s Healthcare Cost Epidemic

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As defined by the American College of Preventive Medicine, preventive medicine focuses on the health of individuals, communities, and defined populations. The overarching goal of preventive medicine is to protect, promote, and maintain our health and well-being and to prevent disease, disability, and death. It is important to take these measures to ensure our nation is utilizing all available resources to promote preventive medicine because healthcare costs are continuing to rise to unsustainable numbers, and future projections are only getting worse.

As U.S. citizens, we may believe the value of the U.S. healthcare infrastructure is second to none. However, Larry Merlo, President and CEO of CVS Health, believes otherwise. In a recent article, Merlo states that the U.S. is still in the infant stages of implementing the necessary healthcare changes and innovations that will significantly reduce these seemingly endless healthcare costs (Winston-Salem Journal, February 2015). Although the healthcare industry has been moving in the right direction and has some great achievements in healthcare over the last few years, consumers and employers alike continue to find themselves tangled in a “cost-quality-access conundrum”.

So, what is it that makes up this seemingly never-ending conundrum? Merlo says that over $300 billion dollars are spent on avoidable and unnecessary health-care expenses every year (Winston-Salem Journal, February 2015). In addition to the recent cessation of cigarette sales at CVS stores, Merlo believes that in order to start reducing these unsustainably high costs, health organizations must implement “whole-body” evaluations. These are an effort to reduce people’s time in their doctor’s office, as well as their money spent.

Although there will always be analysts reporting the exact dollar amount of money saved (or lost) in regards to the healthcare and preventive medicine, one thing is for certain, when consumers commit to taking control and responsibility of their healthcare, the U.S. can make significant strides towards improvements in healthcare innovations. Not only will they save themselves time and money, they will be keep themselves as healthy as possible.

Additionally, preventive medicine has implications for not-only patients, but also the other healthcare stakeholders – including payers, pharma, and policymakers. And other trends such as capitation payment models, informed and empowered patients, the proliferation of ACOs, and consumer driven healthcare all have dramatic implications and are driving the shift from a fee-for-service to a value-based healthcare model. This paradigm shift will fundamentally change the way we view healthcare value, including quality, access, and costs. Please check back for more blog posts, as CHI will be exploring healthcare value in more depth in the coming months.

5th Annual Diversity, Inclusion, & Life Sciences Symposium on 6/10/15

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The Center for Healthcare Innovation is organizing our 5th Diversity, Inclusion, & Life Sciences Symposium on Wednesday, June 10th in Chicago, IL. The symposium is the world’s leading forum focused specifically on diversity, inclusion, healthcare, and the life sciences. It is an interactive and collaborative discussion for life science and healthcare executives, professionals, patient advocates, entrepreneurs, policymakers, researchers, scientists, technologists, and academics to discuss best practices, challenges, and opportunities of topics such as: Understanding Obstacles to Clinical Trials & Healthcare for Underrepresented Populations, Leveraging Employee Resource Groups (ERGs) for Success, and How to Recruit & Develop a Diverse, Talented Workforce. Attendees will gain valuable knowledge, information, and insights, as well as meet new colleagues and connections.

Just some of the organizations currently represented include: AbbVie, American Diabetes Association, American Medical Association, Astellas, Baxter, BlackDoctor.org, Dell, DePaul University, GE Healthcare, Genentech, Genzyme, GSK, Hospira, inVentiv Health Clinical, Lundbeck, Lurie Cancer Center, MCHC, Northwestern University, Novartis, Pfizer, Quest Diagnostics, Sanofi, Takeda, and the University of Chicago Medical Center.

The symposium is sponsored by Sanofi, Takeda, the Lurie Cancer Center of Northwestern University, and the Clinical Research Exchange. The symposium is hosted by the Chicago offices of Seyfarth Shaw.

Please visit lifesciencesdiversity.org for more information.

About CHI
The Center for Healthcare Innovation is an independent, 501(c)(3) research and educational institute that helps patients and providers increase their knowledge and understanding of the opportunities and challenges of maximizing healthcare value to improve health and quality of life. We aim to make the world a healthier place. CHI encourages and enables meaningful and executable innovation that aims to address existing and ensuing healthcare dynamics through communication, education, training, symposia, reports, and research. By bringing the best and brightest healthcare leaders from all over the world together to share their ideas and expertise, CHI creates a unique opportunity to address and improve healthcare value, which we view as a function of quality, access, and cost.