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Increasing diversity in clinical trials: What can doctors, regulators, and patients do?

Most clinical trials do not score highly on the diversity front. In this Special Feature, we explore who takes part in clinical trials, what barriers prevent others from doing so, and what patients, doctors, and those involved in drug approvals can do to improve on this.Many diseases lack effective treatments, and many researchers worldwide are…

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Most clinical trials do not score highly on the diversity front. In this Special Feature, we explore who takes part in clinical trials, what barriers prevent others from doing so, and what patients, doctors, and those involved in drug approvals can do to improve on this.Many diseases lack effective treatments, and many researchers worldwide are trying to address these unmet needs. Clinical trials form the cornerstone of new drug approvals, and without the volunteers who participate in clinical trials, this process would not be possible.Yet, clinical trials overwhelmingly fail to represent the demographic diversity of the populations that the drugs in development aim to serve. A 2019 article in JAMA Oncology highlights disparities in race reporting and diversity in clinical trials in the cancer field.Along with their colleagues, Dr. Jonathan Loree, a medical oncologist and assistant professor at the University of British Columbia in Vancouver in Canada and Dr. Kanwal Raghav, an associate professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston analyzed 230 oncology clinical trials. These trials took place between 2008–2018 and resulted in the Food and Drug Administration (FDA) approving cancer drugs. They found that only 145 (63%) of the 230 trials, included any information about the participant’s race. More specifically, only 18 trials (7.8%) gave a breakdown of the participants by the “four major races in the United States (white, Asian, Black, and Hispanic)” as the authors put it. On average, 76.3% of the participants were white, 18.3% Black, 3.1% Asian, and 6.1% Hispanic. In the period that the authors looked at, these percentages changed only marginally. From July 2013 onwards, the proportion of Hispanic trial participants increased slightly, while the proportion of Black participants fell slightly. “Black and Hispanic patients were consistently underrepresented compared with their expected proportion based on cancer incidence and mortality in the United States, whereas Asian patients appeared to be overrepresented, and white patients had enrollment that nearly matched their expected proportion,” the authors write. A 2018 Comment in Nature echoes these findings. Here, the authors collated data on trials that led to FDA approvals between 1994 and 2014. “The median percentage of African and African American participants per trial ranged from 1.8–3.5%. For Asian participants, the range was 0–7%, and for any group unspecified or not described as white, Black or Asian, it was 1.4–3.4%,” the authors write. Many factors can influence how an individual reacts to a drug. Along with age and sex, a person’s ethnic background can play a role. A 2014 study in Clinical Pharmacology & Therapeutics found variations in how people from different ethnic groups reacted to around 20% of new drugs approved between 2008 and 2013. “Lack of diversity in clinical trials is a moral, scientific, and medical issue. When trial participants are homogenous (e.g., primarily one gender, race/ethnicity, or age group), findings may be skewed and result in a body of clinical knowledge that is not generalizable. Cardiovascular health and outcomes vary among racial and ethnic groups,” the authors of a 2019 paper in Current Problems in Cardiology commented. Medical News Today asked Dr. Loree to weigh in on this. “This ensures that the results of the trial are valid in all groups once the drug becomes available and is also a marker of access and equity in the health care system and society,” he told us.We also spoke to Rear Admiral (RADM) Richardae Araojo, who is the FDA Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE). “It is important for clinical trial participants to reflect the diversity of the population that is going to use the product so that sub-population data can be appropriately analyzed, and more meaningful clinical data can be communicated to the public,” RADM Araojo explained. “There are many benefits to diverse participation for researchers that extend, in a larger sense, to society. Racial and ethnic minority participation helps researchers find better treatments and better ways to fight diseases like cancer, diabetes, and heart disease, among other conditions that disproportionately impact diverse communities,” she continued. “In addition, it uncovers differences by race and ethnicity that may be important for the safe and effective use of therapies.”While there may be a will on the part of researchers and those involved in approving new drugs to improve the diversity of future clinical trials, they will have to consider many important barriers. “There are many different reasons why minorities have been under-represented in clinical trials. One barrier to participation that we all know well is a lack of trust because of past historical abuses,” RADM Araojo told MNT. “Other barriers to participation may differ based on the population you are seeking to enroll and may include language and cultural differences, health literacy, religion, and a lack of awareness and knowledge about what a clinical trial is and what it means to participate.” “Some barriers may be due to aspects of the trial design such as inadequate recruitment and retention efforts, accessibility to the site location, frequency of study visits, transportation, participation may conflict with caregiver or family responsibilities, and may cause time away from jobs and other commitments. Often times, there may be a perception that minorities do not want to participate, and they simply aren’t asked.” – RADM Richardae AraojoFor Dr. Loree, health inequity is a major factor that prevents some people from participating in clinical trials. “The barriers to participation are multifactorial, however equity in access to health care is an important determinant,” he said. “Costs for participating in clinical trials include direct health care costs (i.e., imaging, supportive medications, etc.) which may or may not be covered by a person’s insurance plan and also indirect costs such as the ability of a person to travel or have a caregiver take time off from work.“These economic barriers have been shown to be major barriers to participation and impact minority groups disproportionately. There has been a move to improve the coverage of clinical trial costs among insurance plans in the United States, but economic barriers still exist for many, and those indirect costs I mentioned are not covered,” he continued. “I think one of the best things physicians can do to address [the] disparity in trial accrual is to get to know their patients’ perceptions and social determinants of health. We need to listen to our patients and understand how they feel about research and the barriers each patient faces,” Dr. Loree told MNT. But doctors are not the only ones who can strive for more diversity in clinical trials. “Another important aspect is including the patient voice during the planning of clinical trials. Research groups are increasingly incorporating patient advocates during all stages of research,” Dr. Loree pointed out. “Patients have a wealth of experience to contribute to making sure research is feasible for patients and also addresses questions that are important to them.”Dr. Raghav meanwhile suggests how patients themselves can influence the demographics of future trials. “Clinical trials form benchmarks for future standards of care. All patients with cancer should regularly inquire about their possibilities of participating in clinical trials from their oncologists through the course of their treatment,” he told us. “Hav[ing] this opportunity will benefit patients, progress in combating cancer, and allow for better representation.” RADM Araojo calls for a multi-disciplinary effort. This should ideally include involving patients in how researchers design and run trials, and in developing strategies to reach diverse patient populations. “There is not a one size fits all approach to overcoming all the barriers to recruiting diverse participants in clinical trials, and there may be specific considerations for various populations that you are intending to recruit,” she told MNT.She suggested that the location of a study site is important in more ways than just the logistics of access. “Site locations where there are more racial and ethnic minorities and diverse study team staff are also efforts that support recruiting minority populations,” she explained. “A plan to address inclusion should be developed early on, should not be an afterthought, and begins and ends with the patient in mind. Consistent and continued community engagement through working with cultural ambassadors, faith-based organizations, and with trusted leaders in the community are examples of efforts that have helped support diversity in clinical trials,” she continued. MNT asked RADM Araojo about what the FDA are doing to address the barriers that prevent diversity in clinical trials. “FDA is committed to encouraging diverse participation in research used to support marketing applications for regulated medical products. The Agency has continued its ongoing efforts to support diverse participation in clinical trials through hosting public meetings, developing tools, and issuing guidance documents,” she explained. “Over the past few decades, FDA policy initiatives have focused on promoting enrollment practices that lead to clinical trials better reflecting the population most likely to use the product if the product is approved.”We also asked her about the work that her office are doing. She told us this:“In addition, the FDA’s Office of Minority Health and Health Equity (OMHHE) continues to work to advance racial and ethnic minority participation in clinical trials through a variety of culturally and linguistically competent strategies and resources, including an ongoing campaign to raise awareness on the need for racial and ethnic minority groups to participate in clinical trials.” The OMHHE have a number of strategies, including educational material, public service announcements, and social media programs in English and Spanish. Also, there is outreach to diverse communities and healthcare professionals and collaborations across industry, academia, and the government with the aim to raise awareness about the need for more diversity in clinical trials. “Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be unnecessarily underrepresented in many clinical trials. The FDA continue to recommend and work with drug sponsors on approaches that will increase enrollment of underrepresented populations in their clinical trials,” RADM Araojo noted. “As clinical trials continue to modernize and evolve, it offers new opportunities to reach diverse populations that we may not have reached in the past. So, a multisector approach, partnerships, engaging patients and providers, and sharing of best practices are opportunities to continue to advance racial and ethnic minority inclusion in clinical trials.” – RADM Richardae Araojo
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Sabah election: Polls open in key test for Malaysia’s Muhyiddin

A defeat for Prime Minister Muhyiddin Yassin’s allies in Sabah state could increase pressure for snap national polls.Polls have opened in Malaysia’s eastern Sabah state in a vote seen as a referendum for embattled Prime Minister Muhyiddin Yassin’s seven-month-old unelected government. The outcome of Saturday’s state election will not directly alter the balance of power…

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A defeat for Prime Minister Muhyiddin Yassin’s allies in Sabah state could increase pressure for snap national polls.Polls have opened in Malaysia’s eastern Sabah state in a vote seen as a referendum for embattled Prime Minister Muhyiddin Yassin’s seven-month-old unelected government.
The outcome of Saturday’s state election will not directly alter the balance of power at a national level, where Muhyiddin’s coalition commands a razor-thin majority, but serves as a key test of the prime minister’s popularity.
A defeat for Muhyiddin’s allies could erode support among his coalition partners and increase pressure for snap national polls, according to Al Jazeera’s Florence Looi.
“There’s a lot at stake in these elections,” Looi said, reporting from Sabah.
“This is the first test for Prime Minister Muhyiddin Yassin since he took power in a political coup. There are calls even within his coalition for snap elections to secure a stronger mandate. Now, a general election is not due until 2023 but the results of this vote could have an impact on when the next parliamentary election will be called.”
Adding to the stakes, Looi noted, opposition leader Anwar Ibrahim declared on Wednesday that he has secured majority support in the national parliament to remove Muhyiddin and form a new government.
“Anwar’s challenge has underlined just how fragile the support for the prime minister is, even within his own coalition,” said Looi.

Malaysia has been gripped by turmoil since February, when a reformist government headed by Mahathir Mohamad, and including Anwar, collapsed amid bitter infighting.
Muhyiddin defected from the reformist government and seized power to form a new Malay-centric administration. His alliance has since taken control of many states with many legislators defecting to his camp.
The opposition now controls only Sabah and two of the country’s richest states, Selangor and Penang.
Saturday’s election in Sabah was called after a Muhyiddin ally launched a bid to take over the opposition-controlled local government. But rather than cede power, the chief minister dissolved the state assembly.
Loose coalitions are backing the government and the opposition, but analysts say the vote is too close to call.
Results are expected late on Saturday.
“A win will strengthen Muhyiddin’s position but a loss will embolden Anwar’s attempt to reclaim power,” Oh Ei Sun, a senior fellow at the Singapore Institute of International Affairs, told The Associated Press news agency.
Shafie Apdal (C), president of the Sabah Heritage Party, cast his ballot at a polling station in Semporna [AFP]Anwar, who claims to have won majority support, including from legislators in Muhyiddin’s camp, has not revealed details as he is waiting to meet Malaysia’s king, who is in hospital for treatment. The king has the power to appoint a new prime minister or dissolve parliament for early general elections.
Muhyiddin has said Anwar’s declaration is a mere allegation until he provides evidence.
The prime minister has campaigned heavily in Sabah, pledging development, and billboards of his smiling face, dubbed “Abah” or father, are prominent in many constituencies.
In contrast, former Sabah leader Shafie Apdal urged the state’s multiple Indigenous groups to reject Muhyiddin’s Muslim government and unite behind him.
Sabah and neighbouring Sarawak on Borneo island are seen as crucial for political leverage as they hold about a quarter of parliamentary seats. The two states are rich in oil and timber but among the poorest in Malaysia. They have a greater level of autonomy in administration, immigration and judiciary.
The Sabah election is heavily contested with 447 candidates vying for 73 state seats. More than a million voters, many in rural areas, are eligible to cast their ballots.
With coronavirus cases rising in the state in recent weeks, election officials have tightened rules with health screening and other strict precautions.

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‘Blatant disregard and disrespect of Black people’: Virginia district apologizes for segregated schools – 50 years later

CLOSE 50 years ago, US Supreme Court established the right to public education for all races. But in rural Virginia, black students were shut out of school for 6 more years because the county closed down the public school system. Duration: 02:51 Video pro Loudoun County Public Schools in Virginia issued a formal apology Friday for…

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50 years ago, US Supreme Court established the right to public education for all races. But in rural Virginia, black students were shut out of school for 6 more years because the county closed down the public school system. Duration: 02:51
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Loudoun County Public Schools in Virginia issued a formal apology Friday for being one of the last school systems in the nation to desegregate its schools, following a year of controversy and a probe by the state’s attorney general into allegations of racism.In a letter addressed to the Black community of Loudoun County, officials said they were sorry for their segregated schools which lasted until 1967. That’s nearly 13 years after the nation’s highest court ruled on public school segregation.The U.S. Supreme Court ruled in the 1954 decision Brown v. Board of Education that public school segregation was unconstitutional, and that public schools should integrate “with all deliberate speed.” A federal court order in 1967 required the Loudoun County Public Schools to fully integrate, closing the loopholes that it had previously been using for over a dozen years.The apology is one step of the district’s 16-step action framework to address systemic racism, which the district released this summer after steeps of controversy surrounding allegedly racist policies.In a report released June 2019 by the Equity Collaborative, a consulting firm hired by superintendent Eric Williams, students shared anecdotes of their peers use of racial slurs, unfair disciplinary policies and academic expectations.”The N-word gets used ALL the time here,” said one student, who was anonymous.”When a kid who is misbehaving and is Black — why do you hear “that kid’s going to end up in jail someday” — but you don’t hear that about the White kids who mess up,” another student said.Later in 2019, the Virginia Office of the Attorney General sent a letter to the district announcing it was opening an investigation into the allegations outlined in the report, and accusations that the district barred Black students from equal access to advanced programs.The state’s attorney general said that the district must make available all requested records and certain personnel for interviews, according to the letter, which was attached in the superintendent’s response to the request.Virginia schoolapologizes for ‘insensitive’ Underground Railroad activityFriday’s letter further apologized for “negative impact, damage and disadvantages to Black students and families that were caused by decisions made” by the district, including unequal school plans and pay, as well as segregated buildings and transportation.The school board also wrote that it “must continually assess the status of racial equity in the school system and correct its past transgressions as it pertains to race. Although we recognize that we have yet to fully correct or eradicate matters of racial inequality, we hope that issuing this apology with genuine remorse is a valuable step.”Indeed, the letter comes as the school district reports racist incidents in its virtual classrooms on the first week of school.During the week of Sept. 8, several students used racist slurs during class and showed sexual or racist images on screens during online classes, Williams told families in an email, reported local college radio WAMU 88.5.But this incident is far from the only racist incident in the district in recent years.In Feb. 2019, the district’s Madison’s Trust Elementary School issued an apology for holding a physical education class where students in third, fourth and fifth grades pretended to be slaves while participating in an obstacle course representing the Underground Railroad.The lesson was meant to be a cooperative exercise where students worked together to move through six stations representing parts of the Underground Railroad.Contributing: Brett Molina, USA TODAYAutoplayShow ThumbnailsShow CaptionsLast SlideNext SlideRead or Share this story: https://www.usatoday.com/story/news/education/2020/09/25/virginia-school-district-apologize-school-segregation-racism/5645803002/Find New & Used CarsNew CarsUsed CarsofPowered by Cars.com
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Ant Anstead Posts ‘Old Skool’ Pic Wearing Wedding Ring After Christina Anstead Split

Kicking it old school. Ant Anstead interrupted his post-breakup social media hiatus to share a throwback pic. The Wheeler Dealers host, 41, uploaded a photo of himself to Instagram on Thursday, September 24, where he was pictured sticking his head out of a car window. “British cars, American TV, On set (old skool),” he captioned…

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Kicking it old school. Ant Anstead interrupted his post-breakup social media hiatus to share a throwback pic.

The Wheeler Dealers host, 41, uploaded a photo of himself to Instagram on Thursday, September 24, where he was pictured sticking his head out of a car window. “British cars, American TV, On set (old skool),” he captioned the black-and-white shot, in which a glimpse at his wedding band was shown.
The “old skool” portion of his caption seemingly implied that the snap was taken some time before the split.
Ant Anstead and Christina Anstead Shutterstock (2)Ant and Christina Anstead tied the knot in December 2018 after her divorce from Tarek El Moussa was finalized that January. The now-estranged pair welcomed their son Hudson, 12 months, in September 2019.

On September 18, the 37-year-old Christina on the Coast star announced their breakup via Instagram. “Ant and I have made the difficult decision to separate,” she wrote at the time. “We are grateful for each other and as always, our children will remain our priority. We appreciate your support and ask for privacy for us and our family as we navigate the future.”
Ant has not publicly addressed the separation. The U.K. native did, however, celebrate his stepdaughter Taylor’s 10th birthday, posting to his Instagram Story on Tuesday, September 22.
“TEN! And has perfected the perfect pinkie!” he wrote. “Stay just as cool, funny and sassy! Happy birthday TayTay! Love you!!”

Ant has two children from a previous relationship. However, the British TV presenter helped to raise Christina’s daughter alongside her biological father, El Moussa. The exes’ also share 5-year-old son, Brayden.
Christina has maintained a strong coparenting and working relationship with El Moussa, who is engaged to Selling Sunset’s Heather Rae Young. The Flipping 101 star, 39, recently spoke to Us Weekly about how they’ve gotten to a good place post-split.
“We’re cordial and we filmed together,” he said on September 14. “We’re not hanging out on Sundays having barbecues, but you know, it’s all good. Life goes on and we’re good. We’re doing great filming together. The kids are great. And life is good.”
Listen to Us Weekly’s Hot Hollywood as each week the editors of Us break down the hottest entertainment news stories!

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