FOMAT Website

FOMAT Launches New Website

CALIFORNIA (June, 9th, 2021) — FOMAT Medical Research is inviting visitors to explore our new website. The newly designed site has been designed to offer our online visitors a user-friendly interface, featuring improved site navigation and functionality. Our goal is to emphasize the company’s versatile experience and capabilities by highlighting the diversity that characterizes us. Created with user experience in mind, the site includes several new features including:

 

“Solutions for Sponsors and Contract Research Organizations (CROS)”:

This newly revamped web page provides information regarding our wide range of research solutions, featuring our direct experience in key therapeutic areas as well as emphasizing our core capabilities:

 

 Some of Our Highlighted Capabilities
  • eClinical Trial Center of Excellence
  • COVID-19 Trial Solutions
  • Our NASH Capabilities
  • Our Vaccine Capabilities
 
“For Sites”: 

We truly believe in the importance of developing and administering clinical trials for underrepresented populations. FOMAT actively seeks, invites, and welcomes potential sites to partner with one of the largest and growing clinical research networks in the world.

 

“For Patients”: 

We are seriously committed to clinical trial education. FOMAT is proud to offer health management education programs and clinical trial FAQs aimed to reduce ambiguity, fear, and misconceptions of clinical trials.

The new website goes live today, June 9th, 2021, and is located at the same address: http://www.fomatmedical.com

 

CONTACT INFO:

For More Information about Clinical Trials
Call Us: (805)-483-1185

 

Follow Us: Facebook | Instagram | LinkedIn

Email Us: [email protected]

Ecuador Flag Ruffled Beautifully Waving Macro Close-Up Shot

Clinical Research in Ecuador – Diversity in Hispanic Community Involvement

Why is diversity important?

FDA Action Plan

In 2012 the Food and Drug Administration Safety and Innovation Act was published. Most of this FDA Action plan is based to encourage researchers to include safety and effectiveness data by demographic subgroups, including sex, age, race, and ethnicity.

Section 907 of the FDA Safety and Innovation Act of 2012 also includes recommendations for improving the completeness and quality of analyses of data on demographic subgroups.

In other words, most scientist, physicians and researchers are aware on how some treatments and medicines usually work differently on the demographic spectrum, some of them even harming a group while benefiting another. New research should include data from all the spectrum to ensure that particular medicine or treatment would work properly.

Number of clinical trials per country

According to the webpage clinicaltrials.gov in Latin America there are over 16 thousands studies in Latin America. Most of them conducted in Brazil, Mexico, Colombia and Argentina. Hence clinical research in Ecuador is far from being saturated.

Figure 1. Number of Clinical Studies per Country

Clinical Research in Ecuador
Latin America is one of the unexploited regions for Clinical Trials. The region only has about 6% of the total Active Studies in the world and about 11% of total studies. Clinical Research in Ecuador has less than 1% of total studies with over 88% of the times exceeding the enrollment goal

 

 Figure 2: Active Studies per Region

Clinical Research in Ecuador

 

Clinical Research in Ecuador offers Access to a diverse population

One of the FDA’s goals is to create consciousness and make professional researchers aware about certain populations which may be more at risk for certain diseases—such as diabetes and heart disease—than others. It is important for researchers to include patients who are more likely to be treated for a condition that is common in those populations and recruit them in a trial.

Besides, data gathered over the years have shown that there can be important differences in how people from diverse groups respond to different medical treatments. Researchers should test these products in all groups and ensure they are safe and effective in everyone who will use them.

Information on those differences can then be included in the product labeling to help doctors and patients make treatment decisions.

Meeting these standards could be difficult in most regions. Nevertheless, Latin America offers a vast diversity for a rapid recruitment. Most countries are multicultural and had become a great location to develop a broad-spectrum research.

Figure 6: Population Makeup in Key Latin American Countries (%)

Clinical Research in Ecuador

Source: Inter ethnic ad mixture and evolution of Latin America populations, 2014

In conclusion, these key countries in Latin America are highly diverse. For example, conducting clinical research in Ecuador will make it easier and faster to complete a recruitment process. This while your study  is collecting  more diverse data than any other region.

Conclusions

  • The Hispanic community is one of the largest groups forgotten by the clinical researchers. For many different reasons including the inexperience from both sides; researchers and patients.
  • Efforts should be re-directed to encourage the inclusion of this community. This will provide better healthcare, medicine and treatments for them.
  • In the U.S. many institutes and colleges are aware of this situation and are already creating plans and educating patients and doctors to include minorities.
  • Since Ecuador is an unexplored region for most pharmaceutical companies, conducting Clinical Research in Ecuador provides diversity of data, shorter recruitment times and important savings in money if you know how to manage these studies around the region. It’s highly recommended to contact experienced partners to help you move through the region effectively.
  • It is important to keep in mind that pharmaceutical markets in the Latin American region and in countries like this one, are far from being saturated.

To summarize, Ecuador is an important region to develop clinical research. Ecuador provides opportunities to small, mid-size or even big pharmaceuticals and CROs to provide the world with new and better treatments.

About FOMAT Medical Research developing Clinical Research in Ecuador

FOMAT Medical Research is pioneering Clinical Research in Ecuador, Colombia, Peru and Latin America. We are directing the Clinical Research Departments for several of the largest hospitals throughout the Americas. In Ecuador, FOMAT is a Site Management Organization (SMO) with local Contract Research Organization (CRO) capabilities.

Diversifying Clinical Research is a top priority at FOMAT, which is why collecting data from Hispanic Sites is essential. Numerous clinical research sites in Ecuador are ready to gather diverse data for your study in record-time.

Related Articles:

https://fomatmedical.com/2017/05/6-reasons-diversify-clinical-trials/
https://fomatmedical.com/2014/03/reasons-run-clinical-trials-latin-america-region/
https://fomatmedical.com/download-free-white-paper/

Picture taken from: http://www.dddmag.com/news/2016/11/innovative-approaches-ocular-drug-delivery

Innovative Approaches in Ocular Drug Delivery

The estimated number of visually impaired people in the world is 285 million, with 39 million blind people. About 65 percent of visually impaired people and 82 percent of all blind people are 50 years or older. Four major blinding diseases are age-related macular degeneration, diabetic retinopathy, diabetic macular edema, and glaucoma, due to their whole or partial impact on the posterior segment of the eye.

Current therapeutic options for these diseases may at best manage the condition, slowing or halting further deterioration or disease progression. New breakthrough treatments would benefit from robust sustained delivery of the drug to the target tissues in the posterior segment and, importantly, enhance compliance of patients with long-term treatment regimens for these chronic diseases–for example, avoiding or reducing the need for frequent injections. These drug delivery challenges to the posterior segment of the eye, for both small and large molecules, provide a significant market opportunity for the development of new therapies based on enhanced drug delivery methods and technologies.

The technologies required to deliver agents specifically and effectively to the eye are rapidly evolving. These technologies will have the potential to radically alter the way many diseases are treated, especially retinal blinding diseases. The next decade promises great strides in therapy for many currently poorly treated or untreatable ocular diseases. The future for sustained-release ocular drug delivery lies in reducing the treatment burden by innovations in delivery technology, biologics delivery, targeting gene therapy to the appropriate cell types, and combining effective small-molecule therapeutics with the appropriate drug delivery system. Patient compliance and convenience will be key drivers for drug delivery success.

In order to address these topics, a special issue entitled “Ocular Drug Delivery” has just been published in Drug Delivery and Translational Research. It is co-edited by Dr. Ilva Rupenthal, Senior Lecturer and Director of the Buchanan Ocular Therapeutics Unit at the University of Auckland, New Zealand, and Michael O’Rourke, President of Scotia Vision Consultants, who has a track record of launching several products in the market. The special issue contains articles by recognized global experts and researchers in the field of ophthalmic drug delivery, covering a broad spectrum of drug delivery topics including current challenges faced with regard to the ocular barriers presented and establishment of suitable models to drive future technology success.

“The demand for new sustained release ocular drug delivery systems has never been greater. With the growing incidence and prevalence of the major eye diseases, patients and doctors are seeking new approaches to deliver therapeutics including both small and large molecules, balanced with the need to reduce the frequency burden of repeat intravitreal injections. New innovations will come from a greater understanding of the pharmacokinetics and technical demands of matching a drug with a sustained release delivery platform. This publication will address these needs and help push our understanding of ocular drug delivery to the next level,” said Michael J. Cooney, MD, MBA, a retinal physician practicing in New York, U.S.A.

The market for potential new technologies is significant; the global pharmaceutical market was estimated at $18.1 billion at year end 2013 and is estimated to grow to approximately $23 billion by year end 2018. Within this time period, retinal pharmaceuticals are demonstrating the greatest growth, from $6.9 billion to $9.9 billion, or 7.5 percent compounded annual growth (CAGR). Glaucoma is the second largest segment, with a projected $5 billion in 2018 (3.1 percent CAGR), followed by dry eye at $3.1 billion (4.3 percent CAGR).

Source: http://www.dddmag.com/news/2016/11/innovative-approaches-ocular-drug-delivery

Date: 11/10/2016

Close-up of a mosquito on human skin

Scientists Begin Testing Zika Vaccine in Humans

On Monday scientists began a Phase 1 human clinical trial to test safety and immunogenicity, or the ability to provoke an immune response, of the Zika purified inactivated virus (ZPIV) vaccine.

The study, supported by the National Institutes of Health’s National Institute of Allergy and Infectious Disease will vaccinate 75 healthy adults.

Zika is a flavivirus that is transmitted primarily by the Ades mosquitos and causes rashes and mild fevers in adults. It has also been linked to birth defects such as microcephaly.

Scientists from the Walter Reed Army Institute of Research will first vaccinate some volunteers against other similar flaviviruses, such as yellow fever, before administering the ZPIV vaccine.

Preclinical studies showed that ZPIV was successful in protecting rhesus monkeys against two strains of the Zika virus.

“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and built the case for subsequent efficacy trials,” Col. Nelson Michael, director of WRAIR’s Military HIV Research Program and Zika program co-lead said in a prepared statement. “All of this was done in 10 months.”

The new vaccine candidate was established at the beginning of 2016 using the same technology used to develop the Japanese encephalitis vaccine.

Sanofi Pasteur recently entered into a cooperative research and development agreement with the Army to obtain the ZPIV technology so that it can invest in larger scale manufacturing and to further develop the vaccine.

The Army is invested in this research not only because troops are deployed to areas where Zika virus is a cause for concern, but also because many members of the military are concentrated in U.S. southern states where Zika transmission is more common.

According to a news release, since the beginning of November there were 149 confirmed Zika virus cases in the military health system.

Principal investigator of the study, Maj. Leyi Lin said that Zika infections can lead to severe birth defects and neurological issues and that a proven Zika vaccine is a global public health priority.

In addition to the current study, three other Phase 1 trials will test ZPIV this year. Scientists from St. Louis University will investigate ideal dosing to be used in further studies, while researchers from Harvard Medical School and Beth Israel Deaconess Medical Center will examine the immune response and safety of a compressed vaccine schedule. There will also be a trial to test ZPIV’s immunogenicity and safety in patients who have already been infected with the Zika virus.

Source: http://www.biosciencetechnology.com/news/2016/11/scientists-begin-testing-zika-vaccine-humans

Date: 11/09/2016

http://www.dddmag.com/news/2016/11/nano-decoy-lures-human-influenza-virus-its-doom

Nano-Decoy Lures Human Influenza A Virus to Its Doom

To infect its victims, influenza A heads for the lungs, where it latches onto sialic acid on the surface of cells. So researchers created the perfect decoy: A carefully constructed spherical nanoparticle coated in sialic acid lures the influenza A virus to its doom. When misted into the lungs, the nanoparticle traps influenza A, holding it until the virus self-destructs.

In a study on immune-compromised mice, the treatment reduced influenza A mortality from 100 percent to 25 percent over 14 days. The novel approach, which is radically different from existing influenza A vaccines, and treatments based on neuraminidase inhibitors, could be extended to a host of viruses that use a similar approach to infecting humans, such as Zika, HIV, and malaria. Results were published today in the advanced online edition of the journal Nature Nanotechnology.

“Instead of blocking the virus, we mimicked its target – it’s a completely novel approach,” said Robert Linhardt, a glycoprotein expert and Rensselaer Polytechnic Institute professor who led the research. “It is effective with influenza and we have reason to believe it will function with many other viruses. This could be a therapeutic in cases where vaccine is not an option, such as exposure to an unanticipated strain, or with immune-compromised patients.”

The project is a collaboration between researchers within the Center for Biotechnology and Interdisciplinary Studies (CBIS) at Rensselaer and several institutions in South Korea including Kyungpook National University. Lead author Seok-Joon Kwon, a CBIS research scientist, coordinated the project across borders, enabling the South Korean institutions to test a drug designed and characterized at Rensselaer. Authors included Kwon, Linhardt, Ravi S. Kane, Jonathan S. Dordick, Marc Douaisi, and Fuming Zhang at Rensselaer; and Korean researchers Kyung Bok Lee, Dong Hee Na, Jong Hwan Kwak, Eun Ji Park, Jong-Hwan Park, Hana Youn, and Chang-Seon Song.

To access the interior of a cell and replicate itself, influenza A must first bind to the cell surface, and then cut itself free. It binds with the protein hemagglutinin, and severs that tie with the enzyme neuraminidase. Influenza A produces numerous variations each of hemagglutinin and neuraminidase, all of which are antigens within the pathogen that provoke an immune system response. Strains of influenza A are characterized according to the variation of hemagglutinin and neuraminidase they carry, thus the origin of the familiar H1N1 or H3N2 designations.

Medications to counter the virus do exist, but all are vulnerable to the continual antigenic evolution of the virus. A yearly vaccine is effective only if it matches the strain of virus that infects the body. And the virus has shown an ability to develop resistance to a class of therapeutics based on neuraminidase inhibitors, which bind to and block neuraminidase.

The new solution targets an aspect of infection that does not change: all hemagglutinin varieties of influenza A must bind to human sialic acid. To trap the virus, the team designed a dendrimer, a spherical nanoparticle with treelike branches emanating from its core. On the outermost branches, they attached molecules, or “ligands,” of sialic acid.

The research found that the size of the dendrimer and the spacing between the ligands is integral to the function of the nanoparticle. Hemagglutinin occurs in clusters of three, or “trimers,” on the surface of the virus, and researchers found that a spacing of 3 nanometers between ligands resulted in the strongest binding to the trimers. Once bound to the densely packed dendrimer, viral neuraminidase is unable to sever the link. The coat of the virus contains millions of trimers, but the research revealed that only a few links provokes the virus to discharge its genetic cargo and ultimately self-destruct.

A different approach, using a less structured nanoparticle, had been previously tested in unrelated research, but the nanoparticle selected proved both toxic, and could be inactivated by neuraminidase. The new approach is far more promising.

“The major accomplishment was in designing an architecture that is optimized to bind so tightly to the hemagglutinin, the neuraminidase can’t squeeze in and free the virus,” said Linhardt. “It’s trapped.”

“Nanostructured glycan architecture is important in the inhibition of influenza A virus infection” appears in the Advance Online Publication (AOP) published today on Nature Nanotechnology’s website. The Digital Object Identifer for this paper is 10.1038/nnano.2016.181.

At Rensselaer, this research fulfills the vision of The New Polytechnic, an emerging paradigm for higher education, which recognizes that global challenges and opportunities are so complex, they cannot be addressed by even the most talented person working alone. Rensselaer serves as a crossroads for collaboration — working with partners across disciplines, sectors, and geographic regions, to address global challenges — and addresses some of the world’s most pressing technological challenges, from energy security and sustainable development to biotechnology and human health. The New Polytechnic is transformative in the global impact of research, in its innovative pedagogy, and in the lives of students at Rensselaer.

Source: http://www.dddmag.com/news/2016/11/nano-decoy-lures-human-influenza-virus-its-doom

Date: 11/02/2016

World cancer day (February 4). colorful awareness ribbons; blue, red, green, black, grey, white, pink and yellow color for supporting people living and illness. Healthcare and medical concept

Can We Put a Price on Healthcare Innovation in Cancer?

Most media attention is awarded to cancer’s success stories – new treatment breakthroughs are celebrated as researchers (and journalists) search for an exciting new “cure” for cancer. But what happens after these innovations hit the news? And who is going to buy them?

The newest drugs are frequently the most costly, and healthcare systems are already struggling. Where is the money going? And is there evidence that the money spent on innovation actually benefits cancer patients?

That’s why the latest Special Issue from ecancermedicalscience tackles the overlooked topic of health economics in cancer care. We’ve collected five new papers ranging from the policy level to the personal.

The papers have been curated by expert Guest Editor Prof Wim van Harten of the Netherlands Cancer Institute, Amsterdam, the Netherlands.

“The pipeline of new drugs is impressive, and health systems are already struggling with the fast-growing list of extremely high-priced treatments on the market,” says Prof Harten.

“This will inevitably put further strain on healthcare budgets – some politicians state that they are already nearing the maximum that Western countries can bear.”

The papers address the questions raised above, and offer solutions – including some methods to assess the “value” of healthcare innovation, allowing policymakers to make informed decisions about where funds should be spent.

But it’s not just policy that needs to change – these papers address the cost of healthcare at the patient interface as well.

“When physicians prescribe cancer treatment, we should consider if we would make the same decision if we were paying for the treatment ourselves,” says contributing author Dr Guy Storme of the Universitair Ziekenhuis Brussel, Brussels, Belgium. “I think this would lead to a positive change in mentality – one of my colleagues has already changed his clinical practice in this way.”

Dr Storme adds, “I would like the public to understand the real benefit and cost of each treatment, because most never see the cost breakdowns – and the added value of the individual treatment!”

For those who haven’t previously considered the costs of cancer care, the Special Issue will provide a thorough review of the subject.

Source: http://www.dddmag.com/news/2016/11/can-we-put-price-healthcare-innovation-cancer

Date: 11/1/2016

man hand holding gun on grey background

Researchers Develop Tool that May Help Predict Who Will Survive Gunshot Wounds

In 2014, there were 33,736 firearm deaths in the U.S., according to the Centers of Disease Control and Prevention. Knowing a person’s chance of survival following a gunshot wound in the head could help doctors make critical choices about treatment.

Now a new, first-of-its-kind tool, developed by researchers at the University of Massachusetts, can help determine a person’s survival chance with 96 percent accuracy.

The tool is a score, known as SPIN-Score, which is primarily determined by two factors: the person’s ability to react to stimuli, such as moving away from pain or performing commands, and how well their pupils respond to light.

To determine these factors researchers examined data going back 10 years from 413 people who suffered penetrating injury to the brain, usually from gunshots, to see what factors were linked to survival during their time in the hospital and also six months later.

The team also found other factors that contributed a person’s chance of living, but the first two predictors were so strong that other circumstances only changed the accuracy slightly.

The majority of the patients, 87 percent, were men, and slightly more than half were black.  The average age of patients was 33.  The researchers found that women had a significantly higher chance of survival, 76 percent, but it was unclear why.

The overall survival rate was about 42 percent.

The higher a person’s SPIN-Score was, the greater their chance of survival.  According to the study, published Oct. 26 in Neurology, almost all (98 percent) of people with a score of 35 and above lived.  Compared to only a 3 percent survival rate in those with a score of 20 or below.  No one with a score 16 or less lived through their injury.

“More research is needed to validate the SPIN-Score, so for now, it remains a preliminary prediction tool,” study author Susanne Muehlschlegel, M.D., of the University of Massachusetts Medical School said in a statement. “Still developing this tool is an important step toward improving overall outcomes.”

Source: http://www.biosciencetechnology.com/news/2016/10/researchers-develop-tool-may-help-predict-who-will-survive-gunshot-wounds

Date: 10/28/2016

Creative background, virus molecule close-up in the body, purple background. Concept biology, experiments, laboratory, experiments, quantum world. 3D illustration, 3D render.

Genetic Analysis Debunks Purported Origin of 1980’s AIDS Epidemic

A new study exonerates Gaetan Dugas, a French-Canadian flight attendant long considered to be “Patient Zero” in the 1980’s AIDS epidemic in the U.S.

An international team of researchers hailing from the University of Arizona and University of Cambridge used genetic sequencing to determine when and where the virus took hold in North America, according to NPR.

The scientists were able to sequence a complete HIV virus genome taken from Dugas and compared it with another genome that was sequenced from eight samples of men infected with HIV during the 1970’s.

Information provided by these genetic codes indicated the pathogen came to the U.S. from Haiti in either 1970 or 1971, noted NPR, which was almost a full decade before AIDs was officially recognized as a disease. New York served as a focal point for transmission with infections doubling each year before one person took the virus across the country to San Francisco in 1976.

“Our analysis shows that the outbreaks in California that first caused people to ring the alarm bells and led to the discovery of AIDS were really just offshoots of the earlier outbreak in New York City,” explained lead study author and University of Arizona evolutionary biologist Michael Worobey to Reuters.

Dugas passed away in 1984, but came to national prominence through newspaper reports and Randy Shilt’s 1987 bestseller And the Band Played On.

Dugas participated in a study being held by the Centers for Disease Control and Prevention where he was labeled as Patient O since he came from outside California. The letter “O” was later mistaken for zero labeling Dugas as the cause of the disease.

Essentially, these findings provide no biological evidence suggesting Dugas was the primary cause of this outbreak, according to Reuters.

“This individual was simply one of thousands infected before HIV was recognized,” study co-author and medical historian Richard McKay told reporters in a press briefing.

Source: http://www.dddmag.com/article/2016/10/genetic-analysis-debunks-purported-origin-1980s-aids-epidemic

Date: 27/10/2016

3D render of blood cells on abstract background

Study Determines Efficacy of 2 Drugs to Treat a Form of Leukemia

Researchers have determined that two Phase 1 drugs (CX-4945 and JQ1) can work together to efficiently kill T-cell acute lymphoblastic leukemia cells while having minimal impact on normal blood cells.

Although both drugs were previously tested as single agents in clinical trials to treat cancers, the success of the combined actions on cancer cells was previously unknown until now. The findings appear in the journal Haematologica.

Acute lymphoblastic leukemia, also known as acute lymphocytic leukemia or acute lymphoid leukemia, is a form of cancer of the white blood cells, characterized by the overproduction and accumulation of cancerous, immature white blood cells, known as lymphoblasts. Despite treatment improvement, T-cell leukemia remains fatal in 20 percent of pediatric and 50 percent of adult patients. Both CX-4945 and JQ1 are in clinical trials now as single agents to treat solid and hematological cancers.

“Previous studies provided us a rationale to test the combination of CX-4945 and JQ1 on refractory/relapsed T-cell leukemia,” said corresponding author Hui Feng, MD, PhD, assistant professor of pharmacology & experimental therapeutics at Boston University School of Medicine (BUSM). “Our findings suggest that the combination treatment of CX-4945 and JQ1 could be an effective strategy to target refractory/relapsed T-cell leukemia,” she added.

According to the researchers the efficacy of using a combination of JQ1 and CX-4945 in treating other cancers should also be investigated.

Source: http://www.dddmag.com/news/2016/10/study-determines-efficacy-2-drugs-treat-form-leukemia

Date: 10/26/2016

Allison Kalloo, MPH, is a patient recruitment consultant specializing in the dynamic intersection of marketing communications and underrepresented populations. She is the founder and CEO of Clinical Ambassador. She is a graduate of The Madeira School, North Carolina Central University, and Yale School of Public Health.

Minority Inclusion in Clinical Trials: When Diversity Priorities Show

Beyond the critical need for securing more study volunteers across the board in clinical trials, a popular concern in all areas of clinical research is achieving diversity in those trials.

Whether in medical journals, popular press, social media, or at professional conferences, both public and private sectors describe a deeper commitment to diversifying their pool of participants, acknowledging its role in research data integrity and the relevance of it reflecting today’s diverse society.

Many now know that while more than one third of the U.S. population is made up of minorities, only 16.7 percent of participants in any industry-funded trials are minorities, which underscores the high stakes and an urgent need for industry to set higher standards for inclusion.

It makes no sense to develop new treatments for populations of patients who may be fundamentally different from those who will be using them. Simple enough, but making good on diversity has proven more complicated. We have known for decades that disease burden disproportionately affects minorities groups, but more recently, researchers also acknowledge that beyond social determinants of disease, minority underrepresentation in clinical trials also contribute significantly to health disparities.

Population shifts will make minorities the majority by 2050 (now described as “the Browning of America”) and create an urgency to achieve greater diversity among trial participants to ultimately better meet therapeutic needs. Further, President Obama’s Precision Medicine Initiative focuses more attention on cutting-edge research to understand the variability in genes, environment, and lifestyle in an effort toward optimizing individualized treatments. But this initiative depends on successfully building a participant cohort that realistically reflects the diversity of the U.S. population and can offer researchers a greater breadth of understanding on a variety of health questions about both prevalent and rare diseases, many of which disproportionately affect minorities.

Access to this genomic data from a diverse cohort will allow investigation into preventing disease and improving quality of life for more people. Currently, few U.S. biomedical studies sufficiently focus on recruitment efforts that stand a viable chance of achieving real diversity—that which reflects disease prevalence—sabotaging our capacity to answer critical questions about minority health, according to the Institute of Medicine.

The pressures mounting on industry to produce more targeted therapies based on better understanding the pharmacodynamics of all patient subgroups are coming from all sides: policymakers, payers, regulators, providers and patients alike. For the FDA, more attention to bridging gaps in study representation is shifting into higher gear, partially in response to the Security and Innovation Act of 2012 (FDASIA section 907).

Since then, the FDA has required industry to start counting, to effectively collect and report data quantifying their product’s safety and effectiveness by age, gender and race on all new drug applications they submit. Evidence of the ramping up of stricter federal policy also comes from the growing number of cases in which the FDA has sent drug makers’ new drug applications back, requiring minority cohort data that was previously lacking. As oversight intensifies, results are also being reported in the FDA’s Drug Trials Snapshots and reviewed in public meetings.

As pressures mount to diversify clinical trials, recent research by Brown and Moyer in Ethnic Health substantiate a willingness on the part of minorities to participate, despite popular rumors to the contrary. The authors reviewed the decision-making processes of 70,000 research volunteers and established that minorities are just as likely as the majority population to participate in clinical trials when approached about participating.

Despite being three times more likely to subscribe to conspiracy theories about genocide, blacks are more willing to participate in HIV-related studies than whites, effectively debunking prevailing notions about distrust being the primary obstacle to minority participation. In reality, the limiting factor to diversity in clinical trials has proven to be more “whether and how” people of color are invited to participate in the first place.

Being deliberate about study diversity means tackling both overt and subtle issues head-on. Factors within the study’s control are still taken for granted. Too often:

• Basic access—to referral sources and to clinical sites—is inadequate;

• Explanations about patients’ rights that can quell fears go poorly communicated;

• Logistical complications and demands on participants’ time are not sufficiently minimized;

• Patient education that connects the dots to clinical research is rarely provided; and,

• Nuanced cultural and linguistic barriers are not given enough time and attention.

Deliberate resources focused on these details hold the promise of eliminating many of the prevailing roadblocks. Despite dramatic shifts in our culture and the potential of precision medicine on our horizon, the pivot toward enhanced engagement setting the stage for real diversity has yet to take place. Committing to a broader mix of patient stakeholders is the first step to achieving durable inclusion, and it can affect outcomes in both broad strokes and with study specificity. The true value of clinical trial recruitment efforts will ultimately be measured not by the higher numbers of participants enrolled, but by the quality of efforts to make studies inclusive. Metrics meant to tell how well recruitment methods have worked must be replaced by metrics focusing more on tracking deliberate delivery of clarity, transparency and relevance, not just “regardless” of study indication, culture mix, and location, but because of those factors. Efforts will be obvious. Establishing sustainable partnerships with diverse participants is absolutely feasible as well, and will enhance the experience for all stakeholders in clinical trials.

Source: https://www.biospace.com/News/minority-inclusion-in-clinical-trials-when/433730

Date: 10/24/2016