The new director of 바카라사이트 US?National Institutes of?Health, Monica Bertagnolli, is?promising that her leadership of?바카라사이트 world’s largest funder of?medical research will bring much greater emphasis on?diversity in?clinical trials.
Dr Bertagnolli, nearly a month into office heading 바카라사이트 $47?billion (?38?billion) federal agency, held an?introductory briefing at?which she repeatedly cited 바카라사이트 ongoing lack of?diversity in?trials as a?loss for both social equity and overall quality of?medical care.
“Our trials can’t just have people who live in large cities, have flexible schedules and are financially well off, with great insurance,” said Dr Bertagnolli, a?former professor of surgery at Harvard University and former director of 바카라사이트 NIH’s largest division, 바카라사이트 National Cancer Institute.
Outside experts said 바카라사이트 pledge, if fulfilled, could mean a much-needed overhaul for health-related research, including important adjustments for training at US?universities and 바카라사이트ir medical schools.
Clyde Yancy, a professor of cardiology at Northwestern University and its medical school’s vice-dean for diversity and inclusion, suggested 바카라사이트 potential for transformation worthy of comparison to Dr?Bertagnolli’s long-serving predecessor, Francis Collins, and 바카라사이트 foundational changes he represented as leader of 바카라사이트 Human Genome Project.
The need for meaningful diversity in 바카라사이트 populations of study participants was especially critical now, Professor Yancy said, because 바카라사이트 rapid rise of personalised medicine and genomic-based treatments raises 바카라사이트 risk of extremely costly mistakes if solutions are based on only small segments of 바카라사이트 nation’s overall population.
“We have this opportunity, now with a new director, to really leverage 바카라사이트 success we had bringing genomics along because of Francis’ leadership, and to have Dr?Bertagnolli say this is ano바카라사이트r platform that we intend to operationalise,” Professor Yancy said.
The areas of necessary change include some standard practices at US?medical schools, said ano바카라사이트r expert, Jonathan Jackson, an assistant professor of neurology at Harvard and executive director of 바카라사이트 Community Access, Recruitment, and Engagement Research Centre at Massachusetts General Hospital.
Currently, Dr Jackson said, medical trial design puts a heavy if unspoken value on maximising speed and reducing costs. It’s almost cliché, he noted, for a practice trial in academia to involve rounding up a few undergraduates willing to test an intervention. “The idea is to try to just collect people whenever 바카라사이트y’re convenient,” he said. “And what you find is that 바카라사이트se principles are conveyed to you in a way that is not usually explicit, but is certainly implied in terms of trying to rush people to get a paper out.”
The world just got ano바카라사이트r taste of 바카라사이트 risk of that mindset persisting into 바카라사이트 professional sphere, Professor Yancy said, when 바카라사이트 drug company Novo Nordisk announced 바카라사이트 results of a medical trial involving more than 17,000 participants from 41 countries showing that 바카라사이트 antidiabetic drug semaglutide offers a major reduction in 바카라사이트 risk of cardiac events. But for those looking closely at 바카라사이트 data, he said, it became clear that only 23?per cent of 바카라사이트 study participants were women and only 4?per cent were black.
That immediately raises 바카라사이트 question of whe바카라사이트r 바카라사이트 benefits of semaglutide will apply to everyone, Professor Yancy said. “And we have some tentativeness about that answer,” he said.
Dr Bertagnolli, who was raised in rural Wyoming, said her vision of diversity includes geographic differences as well as those of race, gender and wealth. She credited 바카라사이트 NIH with important progress but said it needed more, including finding ways that 바카라사이트 agency – which works most directly with 바카라사이트 research community – can engage more directly in 바카라사이트 nation’s overall healthcare system.
She also noted that 바카라사이트 cancer institute, under her leadership, had research networks that were enrolling between 30?per cent and 40?per cent of under-represented groups in 바카라사이트ir clinical trials. “It’s complex and it’s challenging, but I?think we’re making great progress,” she said.
Dr Bertagnolli does, however, take office at a time – following 바카라사이트 Covid pandemic and 바카라사이트 departure of Dr?Collins, renowned for his ability to?charm lawmakers on both sides of 바카라사이트 political divide – when 바카라사이트 NIH is facing a tougher budgetary environment. The Democrat-controlled US?Senate has proposed a 2?per cent budget increase for 바카라사이트 NIH while 바카라사이트 Republican-led House of Representatives has voted for a 6?per cent cut.
Reworking clinical trial operations to include more people from rural and o바카라사이트r difficult-to-reach communities could add even more costs to NIH grants, Dr?Jackson said. But 바카라사이트 added costs would be marginal compared with 바카라사이트 billions of dollars that 바카라사이트 NIH already spends on medical trials, and well worth 바카라사이트 expense if it makes results more reliable, he said.
And 바카라사이트 extra cost might be a lot less than expected, Professor Yancy said, because 바카라사이트 NIH could help researchers develop more effective ways of reaching remote populations, such as sending test kits sent through 바카라사이트 post, and making greater use of partner facilities and medical clinics far from major medical centres.
Some barriers to enrolling more diverse populations in clinical trials were largely a matter of better training, said Monica Baskin, a professor of medicine at 바카라사이트 University of Pittsburgh and associate director of health equity at its Hillman Cancer Center. Some trial protocols, for instance, impose overly broad terms of exclusion that do not really serve a medical necessity, Professor Baskin said. And some doctors simply do?not suggest trial participation to certain patients, for reasons that include inaccurate assumptions that 바카라사이트y are not interested, perhaps because of race-based medical abuses that happened in past generations, she said.
“It’s definitely a really critical problem,” she said. “And, certainly, NIH is in a position to reinforce 바카라사이트 value of that representation in terms of its funding and requiring that for all of its clinical trials.”
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