Study shows that people who walk and bike to main streets spend 40 percent more than people who drive
Doing street improvements for pedestrians and cyclists increases sales by 30 percent. So why aren't cities doing it?
Study shows that climate change is really bad for your health
Along with climate-killing CO2, there are a lot of people-killing pollutants. Perhaps we should change our message.
Study links uranium contamination of US groundwater to nitrate run-off from farming
Radioactive uranium occurs naturally in soils but farming techniques may be causing it to dissolve into groundwater
Study reveals the obvious: The rich are different from you and me, especially behind the wheel
It appears that drivers of fancy cars are more likely to go through pedestrian crosswalks
Study describes chicken nuggets as edible "super glue"
Doctors from the University of Mississippi dissected two nuggets and were shocked by what they found.
Study lights up anti-vaxxers' Twitter habits
Pinpointing the sources of myths that threaten the health of children could help get the truth out to where it is needed
Study finds that e-bike riders get as much exercise as riders of regular bikes
E-bikers use their bikes more, go longer distances, and often substitute it for driving or transit.
Study: Second hand toys pose risks to childrens' health
"Reuse" is usually a good motto; this study reminds parents to take care in the case of toys originally sold in yesteryears. We offer some tips for selecting safer used toys.
Study Shows That If You Shop Daily, You Live Longer
We have made the case that small fridges make good cities; now a new study indicates that small fridges make healthier people.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies
This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world.
Need More Self-Control? Try a Simple Ritual
Study finds an unusual technique for eating less
Study: Potato protein a winner for women
The recommended daily allowance of protein may be inadequate to support maintenance of muscle in young women and eating protein from the humble potato can help to maintain muscle, according to research from McMaster University funded by the Alliance for Potato Research & Education.
Study Sites: Show 'Em Your QC!
Sites frequently want to know how they can stand out to Sponsors and CROs to win more studies.
Our advice: Implement internal QC procedures.
Sponsors and CROs we work with consider a tight quality control program to be evidence that a site can be counted on to produce reliable data. It shows that managing quality at your site is a continual process, and doesn’t wait for monitors to arrive. In a risk-based monitoring environment, this is an increasingly compelling attribute.
It makes sense for you to focus your QC efforts on those areas where you’ve historically had the most problems. If the phrase “trend analysis” makes you want to jump through a window -- it's okay -- you can climb back inside. You don't have to do a trend analysis. We've identified 3 areas in which audit findings are common and how you can avoid them.
Adverse Events (AEs) and Concomitant Medications (ConMeds). Often two sides of the same coin, AE and ConMed documentation needs to tell a consistent story. If source documents indicate a study participant had a sinus infection, it must be documented on an AE page, and any associated medications documented on the ConMeds page. A medication noted on the AE page must have a corresponding notation on the ConMed page. And all start and end dates must match across the source, AE, and ConMeds pages.
Drug Accountability Records. Calculating compliance percentages and counting pills are positively uninteresting tasks, easy to mess up, and involve math (which for some people triggers terrifying flashbacks of word problems about trains leaving stations). Is it any wonder that drug accountability records are frequent sources of error? Do some spot-checking: verify that the number of returned tablets matches the tallies recorded for them and recheck compliance calculations.
Essential Documents. Maintaining a complete, organized, uniform set of essential documents is an important, yet decidedly unsexy task. That’s why it’s a good indicator of your commitment to quality; a site that is disciplined enough to keep tight control over its essential documents is likely to carry that control into all aspects of trial execution. Make sure to file all documents associated with protocol amendments, such as IRB approvals and revised informed consent forms -- our auditors find these are the items most frequently missing from the essential document set.
Write It All Down
Document your QC procedures in an SOP. It will serve as training material for site staff and a repository for worksheets and checklists.
There’s no magic organization for this QC SOP. A general set of instructions could outline how reviewers can verify that all documents follow ALCOA principles. For example, on (paper) source documents, are all pages and required signatures present? Are entries legible? Are corrections initialed, dated, and explained? Does the data make sense and lie within expected ranges? Have all data elements been populated? (Tip: turn the paper upside down to catch missing data.)
Checklists that are focused on particular types of documents should be as specific as possible. For example, QC reviews of source documents for screening visits would verify that the correct informed consent form was used, administration of consent was documented, medical release forms were sent if required, demographics were correct, all labs were received, reviewed and signed, all protocol assessments were completed, and all inclusion/exclusion criteria were met and documented.
A Virtuous Cycle
While designed to control quality, performing QC over time may actually improve quality. Results of QC reviews often suggest revisions you should make to your tools and operations to reduce error in the future.
Okay, you can climb back through the window again -- no one said CAPA. (But wouldn't that be impressive?)
Showcasing Site QC Processes
Does implementing a QC program require resources and time? Yes, and that’s the point. It’s evidence to Sponsors and CROs of your commitment to running a quality study. Not only that, but it demonstrates a proper respect for your study participants by ensuring their data can be used.
Oh, and make sure you highlight your QC program on feasibility questionnaires. It’s something to brag about.
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A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites
Study Sites: Too Many Vendors, Too Little Time
By Laurie Meehan
“I can’t get the IWRS to assign a kit number.”
“My ECG reports take forever to come back from the Core Lab.”
“The eCRF won’t let me create a new subject.”
“This stupid machine is blinking an error code again.”
Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.
And how are problems like these typically resolved? Someone at the study site works his/her way through a list of maybe 20 or more vendor contact numbers, places a call, navigates a series of menu options, and hopefully gets directed to someone who can help. And that assumes the site calls the right company; with tightly integrated systems, it’s not always obvious in which vendor’s system the problem lies. This is frustrating for sites. It takes time. It costs money (since “vendor wrangling” is seldom sufficiently covered in the budget). And it keeps study staff from doing what study staff does best – run the study, work with the study volunteers, and keep them safe.
So what’s the solution?
Hint: It’s Not Training
Calm down. Of course, adequate training on equipment and systems is important. But training doesn’t solve every problem. Training doesn’t keep equipment from malfunctioning. Training doesn’t ensure vendors deliver what and when they’ve promised. Training can’t anticipate every situation nor address an unusual site circumstance. And training doesn’t turn people into infallible little machines; we make mistakes. And so, in all these cases, we’re back to site personnel interacting with perhaps scores of vendors, by phone or email, all over the world.
The Solution: a Single Point of Contact
Q: How do you help sites interact with dozens of vendors?
A: You don’t. You do it for them. Establish a single point of contact within the Sponsor* organization for a site to call when vendor issues arise.
Why is this a good idea when the expertise to resolve the issue lies with the vendor? Why is this a good idea when the introduction of a middleman may result in some inefficiencies?
Excellent questions. Here are our responses.
- Better Vendor Oversight. When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track vendor performance. Are there vendors that provide low-quality solutions, are repeatedly late, or difficult to deal with? At best, these vendors are wasting time and money, and aren’t good for business (let alone site relations). At worst, these vendors are jeopardizing subject safety or study data integrity, and require immediate Sponsor intervention.
- Better Site Oversight. When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track site performance. Are there sites that routinely use equipment and computer systems incorrectly? (Yes, now’s the time for that training.) Are there high-performing sites that are able to work independently? This information has always been important, but in an RBM paradigm, it’s essential. Adaptive monitoring plans rely on on-going site performance measurements so Sponsors can adjust resources accordingly. A reduction in monitoring visits means less opportunity to assess a site’s comfort level with study technology. The corollary of “if it ain’t broke, don’t fix it” is “if you don’t know it’s broke, you can’t fix it.”
- Ability to Identify Pervasive Problems. After the third or fourth site reports the same problem, it’s clear that this is not an isolated occurrence. Knowing that, the Sponsor can work with the vendor to resolve the problem before other sites experience the same troubles.
- Better Functioning Sites. We have a saying: “The Site Comes First."™ In our experience, all things being equal, Sponsors that put their sites first -- make things as easy as possible for the study coordinators -- get the best results. They also build the good relationships that keep the best sites coming back to work on future studies.
- Better Functioning Vendors. The efficiencies for the vendor here are clear. Who wouldn’t rather interact with a single point of contact than field individual calls from multiple study sites? Plus, with far fewer players, miscommunicating both problem descriptions and problem solutions is less likely to occur. The Sponsor contact and the vendor contacts will eventually settle into common terminology and build a history regarding past issues and resolutions.
What Do You Think?
We know that not everyone espouses this idea, and we recognize there are probably other effective processes out there. Sponsors, how do you help your sites deal with multiple vendors? Sites, do you have experiences and/or suggestions you can share? (Be kind, anonymize!) Leave a comment here, visit our website, or send us an email.
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*When we use the term “Sponsors” in this post, we’re including CROs that take on Vendor Management responsibilities on behalf of Sponsors.
Study: Eating almonds may help lower CVD risk factors and associated healthcare costs
A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.
Study reveals most critically ill patients with COVID-19 survive with standard treatment
Study Backs Cytokine Targeting for COVID-19 Tx
(MedPage Today) -- Survival rates were significantly higher, though mechanical ventilation-free survival did not differ between hospitalized COVID-19 patients treated with high-dose anakinra (Kineret), an interleukin-1 receptor antagonist, and...
Study finds 160 ways to protect the Great Barrier Reef
From cloud brightening to heat-tolerant corals, a study has identified 160 possible interventions that could help protect the Great Barrier Reef.
Study shows 'climate-change fingerprint' in Australian bushfires
A study suggests Australian bushfires were 30 per cent more likely as a result of climate change but there was no clear climate-change driver for local drought.
Study begins into how coronavirus spreads and why some people are more affected than others
As part of the study, samples of blood, saliva and nasal swabs from healthcare workers in a bid to answer key questions about the virus.
Study finds breathing and talking contribute to COVID-19 spread
Current knowledge about the role of aerosols in the transmission of SARS-CoV-2 warrants urgent attention. Current guidance and public health information has slowly shifted focus towards aerosols as a transmission pathway - predominantly associated with breathing and talking by asymptomatic individuals.
STUDY: US death toll halved had it acted 4 days sooner...
Pence press secretary tests positive...
White House shaken...
President flouts virus protocols...
Secret Service has 11 current cases, as concerns about staff grow...
Nine disasters we still aren't ready for...
Why farmers dump food and crops while grocery stores run dry and Americans struggle...
Study spotlights the Allen Institute’s latest 3-D reference atlas of the mouse brain
The third time's the charm for the Allen Institute for Brain Science's 3-D atlas of the mouse brain. Version 3 of the atlas, known as the Allen Mouse Brain Common Coordinate Framework or CCFv3, is the subject of a research paper published today in the journal Cell. It builds on a partial brain map that focused on the mouse cortex and was released in 2016. Previous versions of the atlas were rendered with lower-resolution 3-D maps. The latest high-resolution maps are fine enough to pinpoint the locations of individual brain cells — which is crucial for interpreting datasets that contain thousands… Read More
Study reveals possible blueprint for UK's path out of coronavirus lockdown
The UK could start easing its lockdown by relaxing stay-at-home orders and allowing some types of non-essential businesses to reopen, according to a new study.
Studying Pterosaur fossils 'could help engineers design more efficient drones'
Learning more about flying reptiles that lived more than 200 million years ago could help more efficient drones be developed, scientists have said.
When Illness Strikes, Vampire Bat Moms Will Still Socialize With Their Kids
Studying how bats behave when they’re feeling ill could help researchers better understand how pathogens move through close-knit populations
Study reveals foodborne illness burden in Taiwan
One in six Taiwanese people suffered from foodborne illness annually during a four year period studied by researchers. From 2012 to 2015, almost 3.9 million foodborne illnesses and 50 deaths occurred annually in the country. Scientists said the study, published in the Journal of the Formosan Medical Association, provided the first national estimates on the... Continue Reading
Study: Single Gene Causes ‘Virgin Births’ in Cape Honeybees
A protein-coding gene called GB45239 is responsible for thelytokous parthenogenesis — the ability to produce daughters asexually — in the Cape honeybee (Apis mellifera capensis), a subspecies of honeybee found in the two southern provinces of South Africa, according to a new paper published in the journal Current Biology. The female worker caste of the [...]
Study Finds Underreporting of Clinical Data [News in Brief]
Since 2018, the FDA has required that U.S. clinical trial results be reported to clinicaltrials.gov within a year of trial completion, but this mandate is often ignored. A recent study found that less than half of U.S. trials submitted results to the site by the deadline. Industry-led trials were the most likely to be reported on time.
Study: Drivers who drink but arent legally impaired cause thousands of deaths
Drivers with blood-alcohol levels below legal limits cause 15% of all crash deaths that involve alcohol, a study in the March issue of the American Journal of Preventive Medicine finds.
Study Links Menopausal Night Sweats to Impaired Thinking
Title: Study Links Menopausal Night Sweats to Impaired Thinking
Category: Health News
Created: 9/25/2019 12:00:00 AM
Last Editorial Review: 9/25/2019 12:00:00 AM
Study Ties Brain Inflammation to Several Types of Dementia
Title: Study Ties Brain Inflammation to Several Types of Dementia
Category: Health News
Created: 3/18/2020 12:00:00 AM
Last Editorial Review: 3/18/2020 12:00:00 AM
Study Confirms Safety, Effectiveness of Children's Vaccines
Title: Study Confirms Safety, Effectiveness of Children's Vaccines
Category: Health News
Created: 4/23/2020 12:00:00 AM
Last Editorial Review: 4/24/2020 12:00:00 AM
Study Supports Radiation for Early, Hormone-Driven Breast Cancer
Title: Study Supports Radiation for Early, Hormone-Driven Breast Cancer
Category: Health News
Created: 4/26/2019 12:00:00 AM
Last Editorial Review: 4/29/2019 12:00:00 AM
Study Debunks Idea That Epilepsy Can Hamper Fertility
Title: Study Debunks Idea That Epilepsy Can Hamper Fertility
Category: Health News
Created: 4/30/2018 12:00:00 AM
Last Editorial Review: 5/1/2018 12:00:00 AM