There is a severe underrepresentation of African Americans, Hispanics, and Asians in clinical trials, the processes pharmaceutical companies undertake to test and hone treatments for illnesses. Due to genetic differences between ethnic groups, diverse representation in clinical trials is vital to tailoring healthcare treatments for various demographics.
Yesterday, the Pharmaceutical Research and Manufacturers of America (PhRMA), in conjunction with the National Minority Quality Forum, announced the launch of its “I’m In” campaign and website, a patient-centered, community-focused initiative designed to educate the public about the importance of clinical trials and raise awareness about clinical trial opportunities. During a press conference, doctors, experts, and a former clinical trial patient and breast cancer survivor joined PhRMA President and CEO John Castellani to express the needs and goals of the initiative.
“PhRMA and our member companies are committed to raising awareness and increasing participation in clinical trials, particularly among historically underrepresented populations,” said Castellani in a statement. “Through this collaboration of health care leaders, we are taking a major step forward to help reduce health disparities through greater inclusiveness in clinical research.”
The Need for Diversity
Speakers at the press conference provided alarming statistics on the dearth of diversity in clinical trials, but expressed hope that, thanks to broadband, mhealth, and the overall increased connectivity in today’s digital world, the lack of minority representation in clinical trials could be remedied through the I’m In initiative.
Castellani stated that minorities are “dramatically underrepresented” in clinical trials, noting that although African Americans make up 12 percent of the nation’s population, they make up only five percent of patients in clinical trials. Hispanics make up 16 percent of the population, but just one percent of patients in clinical trials.
Dr. Carlos Cardenas, Chairman of Doctors Hospital at Renaissance, stressed the importance of increasing diversity. “It’s not possible to roll out medications without knowing who you’re going to treat,” he said. “Different populations deal with medicine and respond to it in different ways. Hispanic and pediatric populations respond differently to leukemia medication. Some minorities respond differently to high blood pressure medication. Hispanics make up 40 percent of diabetes cases, but only represented four percent of clinical trials patients from 1993 to 2001.” Cardenas noted that each of these populations are lacking in clinical research studies. “We should not leave their responses to medications to chance,” he warned.
Dr. Ho Tran, President and CEO of the National Council of Pacific Islander Physicians, discussed some of the reasons minorities are so underrepresented. According to statistics, she said, medical providers have the greatest impact and responsibility in educating the public about clinical trials. But while two-thirds of Americans in a survey responded that they would participate in a clinical trial if their doctor recommended it, only 32 percent of Americans have had such a conversation with their physicians.
“As physicians, we want patients to view us as a trustworthy source,” Dr. Tran said. “In return, we must ensure we are a source of comprehensive, reliable information and present them with every option available. Findings demonstrate that if we don’t talk to them about medical research, few others will. Who will be the other ones?”
Castellani stressed the importance of collaboration and participation, adding, “Individuals are encouraged to serve as I’m In champions to help spread the word. It’s going to take all of us together to make a difference.”
Institutional, Ideological, and Technological Barriers to Diversity
When asked why there haven’t been efforts to diversify clinical trials before, Castellani stated, “I think part of it is institutional inertia. We’re just doing things how we’ve always done it. Science has evolved as we’ve taken advantage of decoding the human genome. There are lots of explanations, not the least of which is that it was more complicated because we were a lot fickler than we thought we were. But this is where the science is.”
Dr. Gary Puckrein, President and CEO of the National Minority Quality Forum, believes such an effort hasn’t been made before simply because the technology was not there. “The world today is different than the year 2000,” he said. “Minority serving institutions were not digitized. New information systems are now making possible what we couldn’t do 10 years ago. This is the new frontier because what we’re doing today will be so antiquated 10 years from now. As soon as we connect – what I like to call ‘creating the center of gravity’ – around research and minority health, it will be combustible. What we can deal with now is the connectivity.”
Thanks to technology, PhRMA and its partners can reach out to previously underrepresented communities, promoting education and engagement. Salvatore Alesci, PhRMA’s Vice President of Scientific and Regulatory Affairs, chimed in on the importance of connectivity. “Thanks to connectivity, there are pockets in this country where we can get stories of success. We cannot be successful if we don’t connect patients, physicians, and investigators at the same time. We’re creating a new infrastructure, partnering with [organizations] that already have the links to the community,” he said. “We need to bring the clinical trials to the community and not vice versa,” he added.
Dr. Puckrein also cautioned against the apathy created by the mentality that “putting minorities in clinical trials has nothing to do with me.” Instead, he said, “It has everything to do with you. Forty percent of the U.S. population will be minorities by 2020. Increasing diversity in clinical trials is an essential component of 21st century medicine. According to the FDA [Food and Drug Administration], increased diversity in clinical trials could help researchers find better ways to fight diseases that disproportionately impact certain populations and may be important for the safe and effective use of new therapies.”
Dr. Cardenas expressed hope that due to the interconnectivity brought by 21st century technology, more communities can be reached, informed, and engaged. “Connectivity and the Digital Age make it possible to do things we couldn’t do before and think differently and bring medications to different populations because we do it one person at a time,” he said. “We need to remove any and all stigma associated with clinical trials – through positive outreach and thorough ongoing education.”
A Survivor’s Story
Joining the experts at the press conference was Averi Anderson, a five-year breast cancer survivor who says she owes her life to clinical trials.
“I didn’t just have any breast cancer. I had Stage 3 triple negative breast cancer, a very aggressive form of breast cancer in African-American women,” said Anderson. “There are many different cancers and genetics, and clinical trials are tailored to specific groups. That’s why it’s crucial that people of color and minorities take part in clinical trials, whether as a healthy person or as a patient. We need to do that for our communities. Thanks to the clinical trial I was in, I’m able to see my grandkids graduate from high school.”
Anderson also offered reasons why African Americans are hesitant to participate in clinical trials. “I understand the misconceptions, and also the Tuskegee experiment where people have a lot of mistrust of medical research. Even in my family, I heard my grandparents talk about those incidents. But I feel if it were not for other 55-year-old African-American women who participated in a clinical trial, I might not be standing here talking to you today.’’
Advocacy, Education, and Technology to Bring People In
The I’m In campaign will increase clinical trial participation among traditionally underrepresented populations through advocacy, education, and technology. An important piece of that technology is the Clinical Trial Engagement Network, which provides a secure, Internet-based environment connecting patients, clinical trial sponsors, clinical investigators, health care professionals, their institutions, and advocacy organizations across the nation. Through the network, authorized clinical trial sponsors can easily identify potential clinical trial participants who meet specific study requirements.
The I’m In website also provides several toolkits in English, Spanish, Korean, and Vietnamese for advocacy groups, healthcare providers, and the media to engage their communities and spread the word.
At the conclusion of the press conference, Anderson expressed her gratitude for clinical trials and their volunteers. “I thank God that today’s cures were yesterday’s clinical trials and today’s clinical studies are tomorrow’s cures,’’ she said. “When it comes to lifesaving research, I’m in. Are you in?”
Marcella Gadson is the Editor-in-Chief of the Broadband and Social Justice Web Magazine and Director of Communications at the Minority Media and Telecommunications Council (MMTC).