FDA seeks comments on changes to Adverse Events reporting forms
The FDA is planning to make changes to the forms used by health professionals, drugmakers, and hospitals to report adverse events, and has put out a call for comments on these proposed revisions. The FDA would like feedback on whether the information is perceived as necessary, and ways to minimize the burden of the collection of information on respondents. (Regulatory Focus)
FDA issues warning letters to duodenoscope manufacturers for failure to conduct studies
All three manufacturers of duodenoscopes in the U.S. were recently issued warning letters for their failure to conduct postmarket surveillance studies as ordered by the FDA in 2015, following nationwide outbreaks of infections associated with bacteria transmitted to patients who underwent surgery with contaminated duodenoscopes. (Regulatory Focus)
Most new clinical trials are in oncology, Immune-oncology drugs predominate
According to Global Data, oncology is the top therapy area for clinical trials initiated in 2018; most industry sponsored trials are for solid tumors; and, among all clinical trials, immune oncology drugs are the most common. North America, Europe and Asia-Pacific account for more than 90% of all trial locations, with most of the North American trial sites based in the U.S. (CLINICAL LEADER)
“Vulnerable populations” interested in participating in clinical trials, but left out of the information chain
Vulnerable populations, including racial and ethnic minority groups and individuals with low socioeconomic status, are underrepresented in clinical trials and biobanking. Focus groups among vulnerable populations found they were interested in participating in clinical trials, but lacked information and faced other barriers precluding their participation. (cure)
Parkinson’s Institute partners to conduct trials of cannabis-based treatments for Parkinson’s symptoms
According to an article by CFN Media, India Globalization Capital (IGC), a U.S. cannabis pharmaceutical business, has partnered with the Parkinson’s Institute and Clinical Center (Sunnyvale, CA) to design clinical trials to determine if cannabis-based treatments can help ease Parkinson’s symptoms. Although medical cannabis is used by some Parkinson’s patients, physicians are reluctant to recommend it due to the lack of clinical data. (PARKINSON'S NEWS TODAY)
Literature review reveals scant evidence on the cost of randomized clinical trials
The “Making Randomized Trials Affordable” (MARTA) Group conducted a literature review of the evidence on resource use and costs for randomized clinical trials (RCTs), and found no articles providing data for all aspects of an entire RCT. We need more comprehensive and transparent cost and use data to support budget planning for RCTs. (Journal of Clinical Epidemiology)
Clinical trial professionals are quitting for career advancement opps
In a new survey of clinical trial professionals, over 40% were currently looking for a new job. Among these, a perceived lack of professional advancement and career development opportunities were cited as the two biggest factors driving them to seek employment elsewhere. (ACRP)
U.S. Rep. Louise Slaughter, historic figure in clinical trials, dies
Flags at the Capitol were lowered to half-staff last Friday in honor of U.S. Rep. Louise Slaughter, who died on March 16 at the age of 88. “Ms. Slaughter, a 16-term liberal Congresswoman who represented an upstate New York district in Congress for more than three decades, pushed to protect health privacy and abortion rights and played a key role in the passage of President Barack Obama’s health care overhaul. “ (New York Times) U.S. Sen. Kirsten Gillibrand said the congresswoman will be remembered “as one of the great, pioneering women in our country’s history.”
Slaughter had many legislative achievements, especially related to public health, but perhaps her role as a co-sponsor of the National Institutes of Health Revitalization Act of 1993 was most significant. Slaughter fought to ensure the legislation included language guaranteeing that women and minorities were included in all federal health clinical trials from that point forward. Previously, all NIH-funded research was done on white males, even in trials related to predominately female diseases such as breast cancer. Slaughter also fought to include language establishing an Office of Research on Women’s Health (ORWH) at the NIH in the legislation, and in 1993 secured the first $500 million earmarked by Congress for breast cancer research at the NIH.
In 2007, she first introduced the Preservation of Antibiotics for Medical Treatment Act (PAMTA), which would limit the use of antibiotics in livestock feed, to counter the threat of antibiotic resistant bacteria. Slaughter also strongly supported the Genetic Information Nondiscrimination Act of 2008, designed to prohibit discrimination by employers or health insurers based upon an individual’s genetic information. (Wikipedia)
A QUIZ FOR YOU!
About 31,500 people participated in clinical trials for 221 drugs approved by the FDA in 2016. Below we provide the demographics of the overall population at that time. Can you estimate the demographics of the study volunteers? (Assume that this is all U.S. data.) (St. Louis Post-Dispatch)
- Women were 51% of the population, and 48% of study volunteers.
- Those age 65+ were 15% of the population and ___% of study volunteers.
- "Whites" (incl Hispanic) were 77% of the population and ___% of study volunteers.
- African-Americans were 13% of the population and ___% of study volunteers.
- Asians were 6% of the population and ___% of study volunteers