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Clinical Trial Patient Recruitment and Retention

Remarks as Delivered by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Washington, DC
Office of Women’s Health (OWH) and Society for Women’s Health Research (SWHR) Symposium
September 22, 2011

Thank you Marsha for that kind introduction and for all of your work on behalf of the FDA and women everywhere…and thanks to the Society for Women’s Health Research.  I am delighted that our two organizations have worked together in so many ways over the years, and this conference is another important product of that collaboration.

And so it’s a special pleasure for me to welcome all of you to this landmark conference—a conference whose goal is to focus in a positive, proactive way on the best practices and successful strategies in the recruitment and retention of women and minorities…and the analysis of data concerning these subpopulations.

Earlier this month, there was another landmark event in DC—the opening of the Martin Luther King Memorial on the national mall just a few blocks from here.  Dr. King once noted that he would not give up until—in his own words—“we live out the true meaning of our creed.”  That creed says we are all created equal–and so we are all owed an equal chance at good health and long life. 

Unfortunately, we know that for women and minority populations, disparities in health and health care continue to exist.

Dr. King once called inequality in health care the worst injustice.  As an Administration—and at the FDA—we’re constantly working to address health disparities, to protect the special interests of women and minority populations, and to promote their health.  Of course, we all know that we cannot fully achieve these goals without the inclusion of more woman and minorities in clinical trials to ensure safer, more effective treatment….treatments which take into account the needs of special populations…and treatments which ultimately promote better health outcomes for all.

Regrettably, as we all know, in the past, neither women nor minorities have always been adequately represented in clinical trials. Enhancing participation of under-represented and underserved populations in clinical trials research is an over-arching goal for this conference—and a goal we must all work on together.

In light of this, today I want to discuss with you three things. First, I want to talk about what the FDA has done—and is doing—to increase participation in clinical trials by women and minorities.  Second, I want to discuss why increasing participation is so important to the overall mission of the FDA—and to the overall wellbeing of the American people.  Third, I want to address what all of us must do to help recruit and retain women and minority subpopulations in clinical trials research.  

Almost twenty years ago, the FDA began working in earnest to increase the participation of women and minority groups in clinical trials.  In 1992, The General Accountability Office reported that women were not adequately represented in clinical trials submitted to the FDA for review. To help address such disparities, two years later Congress established the Office of Women’s Health (OWH) at the FDA.  Its mission is bold:  
 

  • To protect and advance the health of women through policy, science, and outreach;
  • And to advocate for inclusion of women in clinical trials and analysis of sex/gender effects.
     

Thanks to the efforts of the Office of Women’s Health—and so many of you here today—we’re seeing real glimmers of hope. Participation rates for women in clinical trials have definitely improved.

Women's participation went up from approximately 46% in 1992, to an average of 50% today, in late phase drug and biologic clinical trials—depending on therapeutic areas. Participation in early phase drug trials also increased from 22% to 31%. And analysis for sex differences in drug trials has increased from 47% to an impressive 76% over the past two decades.

While this is all good news, we know that there are still therapeutic areas where gaps exist, such as HIV, and where more attention on women is needed.  We know we can do much better.

The same could certainly be said about minority inclusion. We need greater emphasis on the conduct of not just gender based, but race and ethnicity, analysis for clinical trial outcomes.  That was one of the many reasons that FDA’s Office of Minority Health was established by the 2010 Patient Protection and Affordable Care Act.   Its charge is to advance FDA’s regulatory mission and advise on Agency actions that can help reduce racial and ethnic health disparities and achieve the highest standard of health for all.  

We’re building and growing this new Office.  And we’re also helping to implement the recently released “Health and Human Services Health Disparities Action Plan.”  The plan is focused on realizing a nation free of disparities in health and health care…a nation, in the spirit of Dr. King, where no American is left behind, left out, or left on the sidelines.

In other efforts to increase women and minority participation in clinical trials, in 2005 we created new policies and guidances to address participation and analysis of important subgroups. Investigational New Drug Applications (INDs) submissions…and New Drug Applications (NDAs) application clinical data must now be broken out by sex, race, and age.  

FDA also now requires that NDAs should include summaries of effectiveness and safety data for these important demographic groups. A standardized approach for collecting and reporting race and ethnicity information in clinical trials has also been recommended.  

Additionally, new areas such as pharmacogenomics are now being incorporated into product development and regulatory review to further address subgroup population needs. New scientific tools also continue to be developed to overcome the challenges of the “one-size-fits all” model of patient treatment and to steer us into the 21st Century of personalized medicine for all—including those in underserved and underrepresented groups.  

These efforts recognize that increasing the participation of women and minority subgroups in clinical trials is central to the mission of the FDA and, ultimately, to the wellbeing of the American people.  That brings me to my second area of discussion.

As most of you are aware, The FDA was created when President Teddy Roosevelt signed the Pure Food and Drugs Act more than 100 years ago and vowed to promote and protect the health of the American people…and recognizing the urgent need to apply better science in the service of public health. We are, in other words, America’s public health agency.

The world has changed enormously since those early days, but the importance of quality science—and its application—has only become more profound. The FDA is committed to using the best available science as we strive to fulfill our overall mission of ensuring the safety, efficacy, and security of drugs, medical devices, vaccines and biological products…as well as the safety of our nation’s food supply, cosmetics, dietary supplements, animal drugs and feed, certain products that emit radiation, and, most recently, tobacco products.  These are products that make up somewhere between 20 to 25 cents of every dollar consumers spend on products in the United States.  They’re also products, with the notable exception of tobacco, that the American people care about and rely on in fundamental, sometimes lifesaving, ways.

As part of our mission, we must promote the science and innovation it takes to produce tomorrow’s breakthrough products…and to ensure that our nation is equipped to address the public health challenges of the 21st Century.   As part of our mission we must ensure that new ideas and new science are translated into the products and opportunities that people need and count on.  And as part of our mission, we must engender real innovation.  We must ensure that outdated, outmoded, or insufficient systems, patterns, and ways of doing things are replaced with new, better, and more effective ones that truly promote safety and help bring effective products to market in a timely way.
    
That’s why we must change those past ways of doing things that did not ensure adequate participation of women and minorities in clinical trials.  The mission of the FDA requires it—but so does the overall wellbeing of the American people.  After all, no society can be truly healthy if it suffers from disparities in health care and health outcomes.  And by recruiting and retaining underserved and underrepresented populations, we will help close the gaps.

Ensuring greater participation of women and minorities in FDA clinical trials is our task.  It is our challenge.  It is our goal.  But it is a challenge we know that we cannot meet alone—and that brings me to my third and final point.  

Recruiting and retaining subgroup populations in clinical research rests on all our shoulders.  This symposium provides a wonderful opportunity to strengthen ongoing collaborations and to form new partnerships, and I am so grateful to see all of you here today.  I want to thank, again, the Society for Women’s Health Research, and its President and CEO, Phyllis Greenberger, and the FDA Office of Women’s Health, for their leadership in bringing together academia, industry, health care providers, patients and advocacy groups on this important issue.

Surely today’s conference is a great step, but it is a step to build on.  We must continue to work together.  We must find new ways to cooperate—and succeed—together.  We must always search for common ground in our common cause.  And, working together, we must continue to build momentum in utilizing the best available science and to develop new approaches to recruit, retain, analyze and treat not only a population—but an individual.

Working together as partners, I know that we can overcome the disparities in recruitment and retention for clinical trials…as well as broaden our approaches to clinical trial design to advance the public health.  The FDA is eager to help lead the way—but, as I noted, we can’t do it alone.  We need each of you.  We need your ideas and input.  And we need your commitment.  

Dr. King once noted that “I can walk to freedom, but only if I have a healthy body.”
Working together to help recruit and retain women and minority populations for clinical trials will help ensure health and hope for every American.  It will help ensure a nation free of disparities in health and health care. And it will help ensure a nation of which Martin Luther King would be indeed proud.

Thank you.