Category Archives: Clinical research

Mar 4 2014
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NewPublicHealth Q&A: Clifford A. Hudis, MD, American Society of Clinical Oncology

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Several leading cancer organizations recently formed a think tank to address health disparities in cancer research with the goal of improving treatment access and outcomes for underserved populations. “Closing the inequality gap will not happen easily, and won’t get done if any of us goes it alone," said Otis W. Brawley, MD, chief medical officer of the American Cancer Society (ACS), one of four groups involved, in addition to the American Association for Cancer Research (AACR); the American Society of Clinical Oncology (ASCO); and the National Cancer Institute (NCI), a branch of the National Institutes of Health (NIH).

“Cancer mortality rates are decreasing for most minorities, but absolute death rates continue to be higher," said NCI Deputy Director Doug Lowy, MD. Lowy adds that it’s  important to understand the sources of the disparities in order to reduce them.

The goal of the collaboration is to address the fact that that some racial and ethnic minorities in the United States are more likely to develop cancer, less likely to access high-quality cancer care and more likely to die from cancer when compared to others and to whites. For example, the death rate for cancer among African-American males is 33 percent higher than among white males, and the rate for African-American females is 16 percent higher than it is for white females.

“We must move from describing the problems to more quickly identifying and implementing solutions to address the racial and economic-based disparities that continue to affect many cancer patients and families in the United States,” said ASCO president Clifford A. Hudis, MD.

NewPublicHealth recently spoke with Hudis about the new collaboration.

NewPublicHealth: What key issues help explain—and then overcome—differences in cancer incidence and severity among different populations?

Clifford A. Hudis: We can’t completely disentangle environmental factors, which include nutrition, access to care, general health behaviors, exercise and education, which relates to behaviors such as tobacco use. And of course underlying that is the socioeconomic status. But there also is a burgeoning understanding of the role of genetic variations that may be clustered in various populations and may influence things such as drug metabolism and diseases.

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Feb 6 2014
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How Do We Help People Who Drop Out of Obesity Clinical Trials?

A surprising piece of information at this week’s AcademyHealth National Health Policy Conference came during a session on what additional evidence is needed to move forward in the prevention and treatment of obesity. Linda Billheimer, PhD, deputy director of the health, retirement and long term analysis office at the Congressional Budget Office, said that one weakness of some obesity clinical trials is that they may not reflect the number of people who drop out during the trial. For example, while a study may show the success rate for 400 participants, it may not account for the number of people who left the trial and have not lost weight—or even gained weight—since their trial participation.

Billheimer noted that retaining patients can be difficult because people who plateau are often frustrated, which can combine with other reasons to lead them to leave.

Attempting to keep participants in the trial can be critical because the modality offered may be a strong opportunity for the participants to lose weight, since the trials often have novel approaches. There is also the support from the clinical trials team. Researchers at the session noted that trial funders might add criteria to the trial on follow up for participants who withdraw to possibly increase participation time among a larger group of patients.

Recent novel obesity trials listed by the U.S. National Institutes of Health on ClinicalTrials.gov include

  • A trial comparing low and high financial incentives for weight loss
  • Using virtual reality to help trial participants work on weight loss
  • Community based obesity prevention among black women
Jun 4 2013
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NIH-Funded Research to Explore Intractable Public Health Concerns

New funding by the National Institutes of Health (NIH) is aimed at improving treatment for bacterial infections, treating alcohol dependence and determining effective drugs for long-term diabetes treatment.

  • Antibiotic Resistance: Duke University has been awarded $2 million by the NIH for a clinical research network focused on antibacterial resistance. Funding could rise to close to $70 million by 2019. According to the NIH, bacterial infections resistant to antibiotic drugs were first reported more than 60 years ago and since then have become more common in both health care and community settings. In some cases, no effective antibiotics exist. The funding will be used to conduct clinical trials on new drugs, optimizing use of existing ones; testing diagnostics and conducting research on best practices for infection control.
  • Alcohol Dependence: A new study funded by the NIH and published in the Journal of Addiction Medicine finds that the smoking-cessation drug varenicline (brand name Chantix), significantly reduced alcohol consumption and craving among people who are alcohol-dependent. “Current medications for alcohol dependence are effective for some, but not all, patients. New medications are needed to provide effective therapy to a broader spectrum of alcohol dependent individuals,” said says Kenneth R. Warren, PhD, acting director of the National Institute on Alcohol Abuse and Alcoholism, part of NIH. Participants who took varenicline, compared with those taking a placebo, decreased their heavy drinking days per week by nearly 22 percent.  
  • Diabetes: The NIH is currently recruiting volunteers for a study to compare the long-term benefits and risks of four widely used diabetes drugs in combination with metformin, the most common first-line medication for treating type 2 diabetes. The study is important because if doctors find that metformin is not effective enough to help manage type 2 diabetes, they often add another drug to lower blood glucose levels. However, there have been no long-term studies on which of the add-on drugs are most effective and have fewest side effects. The study will compare drug effects on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years and will enroll about 5,000 patients at 37 study sites.