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Getting the numbers right
October 2013
by Jeffrey Bouley  |  Email the author
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WASHINGTON, D.C.—The reality is that many diseases affect people of different races, ages and genders differently; sadly, the reality also is that clinical trials often don't have proportional—or sometimes any—representation by minority populations. One effort to help correct this is found in the news recently that the Pharmaceutical Research and Manufacturers of America (PhRMA) is partnering with the National Minority Quality Forum (NMQF) and Microsoft Corp. to help increase diversity in clinical trials.  
 
As noted by Dr. Salvatore Alesci, vice president of scientific affairs at PhRMA, "Promoting awareness and creating connectivity that can translate into enhanced participation in clinical trials by a diverse patient population is a priority for PhRMA and our member companies. This collaboration brings clinical research and healthcare closer to each other to prevent disparities in the evaluation and access to innovative medicines."  
 
The collaboration in part involves joint outreach efforts but perhaps most important for the long-term effort is mutual support for the creation of the National Clinical Trial Network (NCTN), an interactive portal linking communities of patients, practicing physicians and researchers to increase participation and diversity in clinical trials. About a year-and-a-half ago, Alesci recalls, PhRMA was approached by a number of its members who wanted to know how the organization was addressing the problem of clinical trial diversity.
 
"We brought these people together, along with others, to brainstorm the issue," Alesci tells DDNews. "Although it wasn't a problem that could simply be solved with that brainstorming because of the complexity of the issue, we did come up with three major areas in which PhRMA could add to the efforts already underway by member companies. Those were creating better awareness of clinical trials, such as what they are and what participation in them means; training and education for physicians and potential physician investigators in trials; and connectivity to link together patient communities and other communities that can bring diversity into trials."  
 
PhRMA began to talk to the NMQF about ways in which they might be able to work together in such efforts and, over the course of these discussions, PhRMA learned that the NMQF had just begun a cooperative effort with Microsoft to create the NCTN.
 
"We felt that joining that effort directly would bring a lot of value to NMQF and Microsoft, as well as help us achieve our own goals of encouraging more connectivity. Clinical trial structures as they mostly exist today are very silo-like and fragmented, and what networks exist are often for specific trials. We thought it would be good to bring together the outreach power of the NMQF with our own outreach and educational abilities—along with Microsoft's ability to build the infrastructure—and build a network to connect patients, investigators, healthcare professionals, clinical trial networks and companies and organizations."  
 
The NCTN will provide a permanent IT infrastructure enabling research investigators to quickly identify minority populations who share a medical need and, when appropriate, facilitate their recruitment into clinical trials in a timely and cost- efficient manner, Alesci says. NCTN will maintain a data warehouse of patient and investigator registries as well as community-level health statistics that are expected to integrate isolated data repositories into a searchable national archive.  
 
"The collaboration with PhRMA and Microsoft, innovators in medicine and technology, sets us on a course to solve one of the longstanding challenges in public health, the need for increased heterogeneity in clinical trials," said Gary Puckrein, president of the NMQF, in an official statement. "Infrastructure and broader public-private partnerships will be needed to complete the journey, but the path forward is now clear. This joint effort helps lay the foundation for that future."
 
"This collaboration is truly a 21st-century healthcare venture, combining the best of big data, software and communication tools to link researchers with practicing physicians whose diversity of patients may be candidates for clinical trials," added Michael Robinson, vice president of U.S. health and life sciences at Microsoft. "With PhRMA joining our collaboration, we expect to measurably increase minority participation in clinical research, enabling a data warehouse approach that can identify representative samples of risk populations who might benefit from potential therapies."
 
Shortly before the PhRMA announcement, Sanofi noted on its "Speaking of Sanofi" blog how it has two new partners in raising awareness about the benefits of clinical trials and hopefully increasing diversity in them: PatientsLikeMe and the Center for Information and Study on Clinical Research Participation.  
 
In that blog post, Melva Covington, Sanofi director of global evidence and value development, pointed to currently disheartening figures that Alesci also mentioned to DDNews: While African Americans, for example, represent about 12 percent of the U.S. population, they account for only 5 percent of clinical trial participants. Worse yet, Hispanic Americans, who make up 16 percent of the American population, only represent 1 percent of clinical trial participants.  
 
"To further put these numbers in perspective," Covington wrote, "we know that some medical conditions affect certain groups more than others. Take diabetes, for example. Compared to Caucasians, African Americans are on average twice as likely and Hispanic Americans are 1.7 times more likely to develop type II diabetes. Yet, they are often underrepresented in studies of promising new treatments. Research has also demonstrated race and ethnicity can affect the efficacy of certain drugs on clinical outcomes, such as beta blockers in the treatment of hypertension in African Americans."  
 
Also around the same time as the PhRMA announcement, Eli Lilly & Co. was able to tout that one of its employees, Dr. Coleman Obasaju, had just won the National Medical Association's top honor, the Scroll of Merit Award, primarily for his work to remove barriers for minorities enrolling in clinical trials.  
 
The methods Obasaju has identified largely mirror what Alesci pointed out to DDNews, including on-site visits to trial sites to identify and address existing barriers, translating patient materials into various languages, creating culturally appropriate patient tools, actively recruiting investigators who have diverse patient populations and employing professionals who can help guide trial participants through the treatment process.
 
Code: E101305

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