Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
Saturday, December 5, 2020
UK, Baptist and Norton in clinical trial of coronavirus vaccine
Lisa Edwards, a clinical nurse researcher at the University of Kentucky, spoke with UK's Carl Nathe for "UK at the Half" Saturday about a clinical trial of an investigational coronavirus vaccine by UK's Center for Clinical and Translational Science, Baptist Health Lexington and Norton Healthcare. Adults 18 and older may be eligible to participate.
Wednesday, July 19, 2017
Owensboro Health is sixth hospital to join UK's Markey Cancer Center Research Network; will bring clinical trials to patients
Patients at Owensboro Health will have easier access to clinical research studies through the hospital's new partnership with the University of Kentucky Markey Cancer Center.
Markey Cancer Center is a National Cancer Institute-designated cancer center, which will open the hospital to up NCI-led trials in addition to other trials in Markey's research network. "Cancer care is constantly improving, due in part to the groundbreaking work being done in clinical research," Dr. Tim Mullett, medical director of the research network, said in a news release.
"Our state has some of the worst cancer incidence and survival rates in the entire country, and we at Markey have an obligation to address this devastating disease. By increasing access to many of our current clinical trials through the Markey Cancer Center Research Network, we have an opportunity to make real progress in improving cancer statistics in Kentucky."
Owensboro Health is now one of six research sites in the network, and the first in Western Kentucky. The hospital's Mitchell Memorial Cancer Center sees more than 1,000 cancer patients annually and serves nearly 400,000 people from 14 counties in Western Kentucky and Southern Indiana.
The research will include "epidemiology, prevention and early detection of cancer," and will target cancers with the highest incidence and mortality rates in Kentucky, including lung, colorectal and cervical cancers, the hospital said.
"Clinical trials represent the latest, best treatment options for most patients, and being able to participate in major national and regional clinical trials right here in Owensboro means that patients are able to stay closer to their own support systems at home and under the direct care of their doctors here," Dr. Mark Evers, director of the UK Markey Cancer Center, said in the release.
The network also includes Hardin Memorial Hospital, Elizabethtown; King's Daughters Medical Center, Ashland; St. Claire Regional Medical Center, Morehead; Tri-State Regional Cancer Center, Ashland; and St. Mary's Regional Cancer Center, Huntington, W.Va.
Markey Cancer Center is a National Cancer Institute-designated cancer center, which will open the hospital to up NCI-led trials in addition to other trials in Markey's research network. "Cancer care is constantly improving, due in part to the groundbreaking work being done in clinical research," Dr. Tim Mullett, medical director of the research network, said in a news release.
"Our state has some of the worst cancer incidence and survival rates in the entire country, and we at Markey have an obligation to address this devastating disease. By increasing access to many of our current clinical trials through the Markey Cancer Center Research Network, we have an opportunity to make real progress in improving cancer statistics in Kentucky."
The research will include "epidemiology, prevention and early detection of cancer," and will target cancers with the highest incidence and mortality rates in Kentucky, including lung, colorectal and cervical cancers, the hospital said.
"Clinical trials represent the latest, best treatment options for most patients, and being able to participate in major national and regional clinical trials right here in Owensboro means that patients are able to stay closer to their own support systems at home and under the direct care of their doctors here," Dr. Mark Evers, director of the UK Markey Cancer Center, said in the release.
The network also includes Hardin Memorial Hospital, Elizabethtown; King's Daughters Medical Center, Ashland; St. Claire Regional Medical Center, Morehead; Tri-State Regional Cancer Center, Ashland; and St. Mary's Regional Cancer Center, Huntington, W.Va.
Thursday, December 1, 2016
Republicans agree on bill to speed medical research and drug approval, increase funding; some Democrats want changes
Legislation to speed up the federal approval of new drugs and medical devices and to increase funding of medical research passed the U.S. House of Representatives 392-96 on Wednesday, Nov. 30 and is likely to get a Senate vote soon, though it faces opposition from some Democratic senators.
"This medical innovation bill is one that can have a
substantial impact for families across the country," said Senate Majority Leader Mitch McConnell, R-Ky., a strong supporter of the legislation. He has pushed for a provision in the bill to allow the U.S. Food and Drug Administration to accelerate approval of stem cell therapies, formally called "regenerative advanced therapies," Sheila Kaplan reports for Stat, the health-and-medicine supplement to The Boston Globe.
The provision "call(s) for devices used with a stem cell product to be considered moderate risk, unless the secretary of Health and Human Services determines that the device or use requires a higher risk classification," Kaplan reports.
Opponents of the provision believe stem-cell therapies should be more closely regulated and subject to clinical trials.
Sen. Elizabeth Warren, D-Mass., in a Monday floor speech, said a big contributor to McConnell's campaign would benefit from this stem-cell therapy provision, Kaplan reports in a separate article. “This mega-donor has poured millions of dollars into Mitch McConnell’s personal campaign coffers and into his Republican super PAC, and now he wants his reward. So the Cures Act offers to sell government favors," she said.
The $6.3 billion legislation would give states $1 billion to fight the opioid crisis; provide $4.8 billion for continuing three "signature Obama administration research programs" over the next 10 years, including: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative; a $500 million increase to the FDA and a number of programs to improve mental health care, Kaplan reports.
A "major sticking point" for the bill, Kaplan reports, is that House Democrats required it to have funding for medical research, but Republicans on the Senate Health, Education, Labor and Pensions Committee would not approve funding without determining where the money would come from.
But now that the Patient Protection and Affordable Care Act is likely to be repealed, with the election of Donald Trump, Democrats have agreed "to underwrite the Cures Act with some money from the ACA, and some to be generated by sales of part of the Strategic Petroleum Reserve," Kaplan writes. NPR adds that it will also be paid for through reduced payments to Medicare and Medicaid.
"Leaders from both parties have called passage of the Cures bill the most important thing Congress could do this year," Kaplan writes.
Opposition to the bill
Warren said she also opposed the Cures Act because she said it had been "hijacked" by the pharmaceutical industry.
The bill has been debated at length over the past three years, Kaplan notes, with "a parade of celebrities" and more than 1,300 lobbyists representing pharmaceutical companies, medical device firms and patient advocacy groups pushing for its passage.
The Society for Public Health Education opposes the bill because it takes money away from the Public Health and Prevention Fund, which pays for programs that address obesity, diabetes, smoking cessation, cancer screenings, access to vaccinations and access to healthy foods, to pay for the Cures Act.
"Taking $100 million from the Prevention & Public Health Fund will have disastrous consequences for the future of public health," the group said.
Many consumer groups continue to oppose the bill, agreeing with Warren, who has said that many Democrats are agreeing to the bill in order to get the additional funds for medical research, which isn't guaranteed and will have to be approved in future legislation.
“While there are positive aspects of this legislation, many provisions would severely weaken the FDA’s drug and medical device approval standards and seriously harm rather than help patients,” Jack Mitchell, director of government relations for the National Center for Health Research, which advocates for patient safety, told Kaplan. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”
Kaplan also reports that many public health advocates have called the bill's provisions a "weaker alternative to the current gold standard of randomized clinical trials."
Sen. Chuck Grassley, R-Iowa, has voiced his opposition to the bill because it "exempts companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals or textbooks, " Ed Silverman writes for Stat. Consumer groups have also called for the removal of this provision.
 |
| Senate Majority Leader Mitch McConnell |
The provision "call(s) for devices used with a stem cell product to be considered moderate risk, unless the secretary of Health and Human Services determines that the device or use requires a higher risk classification," Kaplan reports.
Opponents of the provision believe stem-cell therapies should be more closely regulated and subject to clinical trials.
Sen. Elizabeth Warren, D-Mass., in a Monday floor speech, said a big contributor to McConnell's campaign would benefit from this stem-cell therapy provision, Kaplan reports in a separate article. “This mega-donor has poured millions of dollars into Mitch McConnell’s personal campaign coffers and into his Republican super PAC, and now he wants his reward. So the Cures Act offers to sell government favors," she said.
The $6.3 billion legislation would give states $1 billion to fight the opioid crisis; provide $4.8 billion for continuing three "signature Obama administration research programs" over the next 10 years, including: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative; a $500 million increase to the FDA and a number of programs to improve mental health care, Kaplan reports.
A "major sticking point" for the bill, Kaplan reports, is that House Democrats required it to have funding for medical research, but Republicans on the Senate Health, Education, Labor and Pensions Committee would not approve funding without determining where the money would come from.
But now that the Patient Protection and Affordable Care Act is likely to be repealed, with the election of Donald Trump, Democrats have agreed "to underwrite the Cures Act with some money from the ACA, and some to be generated by sales of part of the Strategic Petroleum Reserve," Kaplan writes. NPR adds that it will also be paid for through reduced payments to Medicare and Medicaid.
"Leaders from both parties have called passage of the Cures bill the most important thing Congress could do this year," Kaplan writes.
Opposition to the bill
Warren said she also opposed the Cures Act because she said it had been "hijacked" by the pharmaceutical industry.
The bill has been debated at length over the past three years, Kaplan notes, with "a parade of celebrities" and more than 1,300 lobbyists representing pharmaceutical companies, medical device firms and patient advocacy groups pushing for its passage.
The Society for Public Health Education opposes the bill because it takes money away from the Public Health and Prevention Fund, which pays for programs that address obesity, diabetes, smoking cessation, cancer screenings, access to vaccinations and access to healthy foods, to pay for the Cures Act.
"Taking $100 million from the Prevention & Public Health Fund will have disastrous consequences for the future of public health," the group said.
Many consumer groups continue to oppose the bill, agreeing with Warren, who has said that many Democrats are agreeing to the bill in order to get the additional funds for medical research, which isn't guaranteed and will have to be approved in future legislation.
“While there are positive aspects of this legislation, many provisions would severely weaken the FDA’s drug and medical device approval standards and seriously harm rather than help patients,” Jack Mitchell, director of government relations for the National Center for Health Research, which advocates for patient safety, told Kaplan. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”
Kaplan also reports that many public health advocates have called the bill's provisions a "weaker alternative to the current gold standard of randomized clinical trials."
Sen. Chuck Grassley, R-Iowa, has voiced his opposition to the bill because it "exempts companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals or textbooks, " Ed Silverman writes for Stat. Consumer groups have also called for the removal of this provision.
Saturday, December 12, 2015
Baptist Health joins national network that combines data to help patients get the best cancer care
With the addition of four new healthcare systems, including Baptist Health, GRN will now encompass 76 hospitals in nine states. By 2020, it expects to include one million patients with full clinical, imaging, laboratory and significant molecular profiles.
“Baptist Health is excited about the opportunity to be a member of the Guardian Research Network," Timothy Jahn, chief clinical officer of Baptist Health, said in the release. "Participation in GRN offers Baptist cancer patients a personalized approach to the care and treatment of their disease in their own communities,”
Following strict HIPAA privacy regulations, GRN uses this data to identify patients who are eligible for clinical trials.
"This rapid patient-to-trial identification process will significantly reduce the time it takes to enroll a patient in the most advanced clinical trials available," says the release.
Saturday, May 31, 2014
UK researchers work to improve identification of lung cancer patients eligible for participation in clinical trials for new treatments
At the University of Kentucky, researchers are developing better strategies to identify lung cancer patients who could participate in clinical trials for new treatments. Lung cancer causes more deaths than any other kind of cancer worldwide, and Kentucky's rates of lung cancer and mortality are the highest in the nation.
Unfortunately, fewer than 1 percent of lung cancer patients participate in clinical trials in part because identifying and recruiting eligible participants is difficult and time-consuming, Mallory Powell writes for UK. The disease is often diagnosed so late that there is little time for clinical trials.
"The combination of the burden of lung cancer in Kentucky and the urgency of identifying patients who are eligible for clinical trials motivated Dr. Eric Durben and his team to devise a more efficient method for screening patient eligibility," Powell writes. Durben is director of the Cancer Research Informatics Shared Resource Facility at UK's Markey Cancer Center and an assistant professor in the division of biomedical informatics in the College of Public Health.
Durbin and his team are using unique electronic data sources managed by UK's Center for Clinical and Translational Science, the Institute for Pharmaceutical Outcomes and Policy, the Markey Cancer Center and the Kentucky Cancer Registry to create system system to identify patients who for clinical trials. The two-year project is in its seventh month.
"Clinical trial recruitment is critically important to the Markey Cancer Center if we're going to get lifesaving therapeutics to our patients," said Dr. Susanne Arnold, associate professor in medical oncology and radiation medicine at Markey. "It's also how we make progress in cancer treatment."
While the project is geared toward lung cancer, its results could address other cancers. "What's really exciting about Dr. Durbin's study is that it has the potential to greatly improve clinical research not only in the lung cancer but in other cancers and disease conditions as well," said Dr. Nathan Vanderford, assistant director for research at Markey. (Read more)
Unfortunately, fewer than 1 percent of lung cancer patients participate in clinical trials in part because identifying and recruiting eligible participants is difficult and time-consuming, Mallory Powell writes for UK. The disease is often diagnosed so late that there is little time for clinical trials.
"The combination of the burden of lung cancer in Kentucky and the urgency of identifying patients who are eligible for clinical trials motivated Dr. Eric Durben and his team to devise a more efficient method for screening patient eligibility," Powell writes. Durben is director of the Cancer Research Informatics Shared Resource Facility at UK's Markey Cancer Center and an assistant professor in the division of biomedical informatics in the College of Public Health.
Durbin and his team are using unique electronic data sources managed by UK's Center for Clinical and Translational Science, the Institute for Pharmaceutical Outcomes and Policy, the Markey Cancer Center and the Kentucky Cancer Registry to create system system to identify patients who for clinical trials. The two-year project is in its seventh month.
"Clinical trial recruitment is critically important to the Markey Cancer Center if we're going to get lifesaving therapeutics to our patients," said Dr. Susanne Arnold, associate professor in medical oncology and radiation medicine at Markey. "It's also how we make progress in cancer treatment."
While the project is geared toward lung cancer, its results could address other cancers. "What's really exciting about Dr. Durbin's study is that it has the potential to greatly improve clinical research not only in the lung cancer but in other cancers and disease conditions as well," said Dr. Nathan Vanderford, assistant director for research at Markey. (Read more)
Monday, November 18, 2013
UK is first in U.S. to conduct clinical trial for new Parkinson's treatment that shows improvement in all five patients so far
A new treatment strategy for Parkinson's disease at the University of Kentucky could change the way the ailment is treated, manage symptoms better and halt or reverse the progressive degeneration of the brain that comes with the disease, the university announced Monday.
UK is the first U.S. university to conduct a clinical trial of the strategy, led by principal investigator Dr. Craig van Horne, associate professor of neurosurgery in the College of Medicine, according to a news release from the university.
Parkinson's, a progressive and degenerative disease, affects around 1 million Americans and 10 million people worldwide, according to the release. Symptoms include both motor and non-motor symptoms including tremor, rigidity, slow movement and unstable posture. No cure exists.
The first course of treatment is medication, but any medication loses its effectiveness over time.The second line of treatment is deep brain stimulation, a surgical procedure that works like a "brain pacemaker." Electrodes are surgically implanted into the malfunctioning part of the brain where cells have died to emit electrical impulses to regulate the brain's abnormal impulses, according to the release.
Deep brain stimulation has improved the quality of life for many people with Parkinson's, but while it manages symptoms, it does not change the course or outcome of the disease, according to the release. UK's clinical trial explores an additional treatment option, and possibly a way to alter the course of the disease.
"They are conducting an innovative clinical trial that builds upon the established deep brain stimulation procedure by supplementing it with a nerve graft of patients’ own peripheral nerves," the release says. "The nerves in the brain do not regenerate when they are damaged, but peripheral nerves—nerves outside of the brain and spinal cord—can regenerate." The trial will "aim to use the regenerative capacity of peripheral nerves to allow the brain to heal itself."
The procedure will implant a small piece of a patient's peripheral nerve from just above an ankle. This can be done at the same time as deep brain stimulation, so the patient will get the benefit from both procedures, the release says. The effect of the implant will be tested by simply turning off the deep brain stimulator. The hope is that the peripheral nerve will "stimulate regeneration in the parts of the brain that have been damaged by Parkinson's disease."
So far, five Parkinson’s patients have undergone the combined procedure. The trial calls for six. All five have shown consistent improvement in symptoms and "were able to entirely go off the medication one month later, relying on the deep brain stimulation device to manage their symptoms," the release says. Normally, deep-brain stimulation patients are able to reduce their medication but not eliminate it.
"The patients can have more consistent 'on' times—fewer ups and downs with their symptoms," Van Horne said. "They’re not fluctuating due to meds if they’re just using the stimulation."
The trial has progressed quickly because it uses the patient's own tissue, with no risk of rejection or need for immuno-suppressant drugs, and takes only 30 minutes longer than standard deep brain stimulation. If successful, this procedure could significantly change the treatment of Parkinson’s disease, the release says, and could have an impact on other neuro-degenerative disorders. To learn more click here.
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| Dr. Craig van Horne demonstrated a deep-brain stimulation remote control unit on Parkinson's patient Rodney Parsons. (Lexington Herald-Leader photo by Charles Bertram) |
Parkinson's, a progressive and degenerative disease, affects around 1 million Americans and 10 million people worldwide, according to the release. Symptoms include both motor and non-motor symptoms including tremor, rigidity, slow movement and unstable posture. No cure exists.
The first course of treatment is medication, but any medication loses its effectiveness over time.The second line of treatment is deep brain stimulation, a surgical procedure that works like a "brain pacemaker." Electrodes are surgically implanted into the malfunctioning part of the brain where cells have died to emit electrical impulses to regulate the brain's abnormal impulses, according to the release.
Deep brain stimulation has improved the quality of life for many people with Parkinson's, but while it manages symptoms, it does not change the course or outcome of the disease, according to the release. UK's clinical trial explores an additional treatment option, and possibly a way to alter the course of the disease.
"They are conducting an innovative clinical trial that builds upon the established deep brain stimulation procedure by supplementing it with a nerve graft of patients’ own peripheral nerves," the release says. "The nerves in the brain do not regenerate when they are damaged, but peripheral nerves—nerves outside of the brain and spinal cord—can regenerate." The trial will "aim to use the regenerative capacity of peripheral nerves to allow the brain to heal itself."
The procedure will implant a small piece of a patient's peripheral nerve from just above an ankle. This can be done at the same time as deep brain stimulation, so the patient will get the benefit from both procedures, the release says. The effect of the implant will be tested by simply turning off the deep brain stimulator. The hope is that the peripheral nerve will "stimulate regeneration in the parts of the brain that have been damaged by Parkinson's disease."
So far, five Parkinson’s patients have undergone the combined procedure. The trial calls for six. All five have shown consistent improvement in symptoms and "were able to entirely go off the medication one month later, relying on the deep brain stimulation device to manage their symptoms," the release says. Normally, deep-brain stimulation patients are able to reduce their medication but not eliminate it.
"The patients can have more consistent 'on' times—fewer ups and downs with their symptoms," Van Horne said. "They’re not fluctuating due to meds if they’re just using the stimulation."
The trial has progressed quickly because it uses the patient's own tissue, with no risk of rejection or need for immuno-suppressant drugs, and takes only 30 minutes longer than standard deep brain stimulation. If successful, this procedure could significantly change the treatment of Parkinson’s disease, the release says, and could have an impact on other neuro-degenerative disorders. To learn more click here.
Wednesday, January 16, 2013
Participating in a clinical trial can give patients access to advanced health care
Access to advanced care does not require big bucks or Cadillac insurance; it is offered on a limited basis through trials of new medical procedures at the University of Kentucky. People in the university's health-service region can access cutting-edge health care through participation in clinical trials, according to a UK press release. The University of Louisville also does clinical trials.
Clinical trials are necessary to evaluate a drug, device or mode of therapy for a disease. UK investigators recruit individuals willing to contribute to science to participate in various types of trials; some may require participants with specific conditions, while others require healthy participants. These participants are able to reap the benefits of advanced medical treatment while gaining access to top clinicians and the latest medical information.
"I would tell anyone who has a condition and is thinking about becoming part of a clinical trial that it is one of the most empowering things that people can do," said Dr. Leslie Crofford, chief of the UK Division of Rheumatology and director of Center for the Advancement of Women's Health. "It allows you to learn about a condition that may afflict you or a family member. It allows access and contact with investigators that are very knowledgeable about the condition. It allows a sense that you are doing something active to help not only yourself, but other people with the condition."
As a research insititution, UK is careful about the safety, privacy and oversight of clinical trials and it's important that participants understand the trial methodology, purpose and procedures. The UK Center for Clinical and Translational Science has compiled a helpful list of questions for clinical-trial participants. There are several ways to connect with clinical-trial opportunties and anyone can view currently available clinical trials at the university. Participants may also connect with clinical trials through their physician, or through national listings. (Read more)
Clinical trials are necessary to evaluate a drug, device or mode of therapy for a disease. UK investigators recruit individuals willing to contribute to science to participate in various types of trials; some may require participants with specific conditions, while others require healthy participants. These participants are able to reap the benefits of advanced medical treatment while gaining access to top clinicians and the latest medical information.
"I would tell anyone who has a condition and is thinking about becoming part of a clinical trial that it is one of the most empowering things that people can do," said Dr. Leslie Crofford, chief of the UK Division of Rheumatology and director of Center for the Advancement of Women's Health. "It allows you to learn about a condition that may afflict you or a family member. It allows access and contact with investigators that are very knowledgeable about the condition. It allows a sense that you are doing something active to help not only yourself, but other people with the condition."
As a research insititution, UK is careful about the safety, privacy and oversight of clinical trials and it's important that participants understand the trial methodology, purpose and procedures. The UK Center for Clinical and Translational Science has compiled a helpful list of questions for clinical-trial participants. There are several ways to connect with clinical-trial opportunties and anyone can view currently available clinical trials at the university. Participants may also connect with clinical trials through their physician, or through national listings. (Read more)
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