The Clinical Trials Processing Laboratory is certified to ship biological specimens both domestically and internationally using any courier. And it has the expertise to make sure those specimens are packaged properly!
Clinical Trials Processing Lab 'always looking for more people to help'
There's a gap that often confronts investigators whose clinical trials involve collecting blood or tissue samples that need to be sent out for testing. Investigators often lack the necessary laboratory equipment to properly prepare the samples for testing, or the regulatory expertise in how to properly package, ship and track them.
That's where the Clinical Trials Processing Laboratory comes in.
"We're a good source of help for clinicians or investigators who want to do a study either with a pharmaceutical company or other funding source, such as the NIH, but they don't necessarily have the lab space or know what do with all these samples once they collect them," says Director Carrie Dykes, an Assistant Professor in the Infectious Diseases Division.
And she's eager to get the word out. "We're always looking for more people to help. We have lots of capacity, and that's one of the reasons I want to let people know that we're here, because the more we do, it lowers fees even more," Dykes said.
The lab was created by the Infectious Diseases Division, which conducts a number of vaccine studies that require immunological assays to be performed on white blood cells (peripheral blood mononuclear cells -- PBMCs). That requires separating the PBMCs from whole blood -- a labor-intensive and lab-intensive procedure.
"PBMC processing is our specialty" -- on the order of 400 to 500 such procedures a year, says Dykes. But the lab also does blood spinning to collect serum and plasma, and fixing a variety of tissues for whatever a study requires.
Sample preparation is just the first step in the lab's chain of services. "We're very good at following all of the necessary government regulations for handling samples, for storing them, shipping them and tracking them so that they are compliant with all the government regulations that would pertain if an FDA audit was performed," Dykes noted. For example, all specimens follow a strict chain of custody, including electronic tracking that incorporates barcoding and laboratory data management software.
After 20 years of working with major pharmaceutical companies and commercial testing companies, "we know how they operate, and how they like things done," Dykes added.
To learn more about the lab, contact Carrie Dykes at 273-4104.
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UR researchers use 3-D printing to model aortic aneurysms
The advent of 3-D printing represents an entirely new way of modeling aneurysms, Ankur Chandra, Associate Professor of Surgery and Biomedical Engineering, explains in an article at QMed. "We start by creating a patient-specific 3-D model of an aneurysm," Chandra notes. "Next, we print it using a biologically accurate material that simulates the properties of the aortic wall, and then we mount it on a hemodynamic simulator, subjecting it to such tightly controlled hemodynamic parameters as intraluminal pressures, blood flows, and cardiac outputs." As different hemodynamic and material properties change and stable aneurysms begin to fail, the researchers can study aneurysm behavior.
"To investigate most disease processes, you need a good animal model and the ability to study it experimentally," Chandra explains. "But because animals rarely develop aneurysms, most such studies involve infusing the aorta with a toxic substance or other material to degrade or inflame the wall, causing it to weaken. While this approach may work in certain studies on biochemical pathways, it cannot help to explain how overall biomechanical forces influence the degeneration and rupture of an aneurysm."
By the same token, using human models to study aneurysms is ethically fraught. "The ultimate outcome of aneurysms that we want to avoid is rupture, Chandra notes. "Because the rupture event is often fatal, we have not been able to conduct ethical human trials to the point of rupture to try to get an idea of what factors can predict these events." By foregoing the use of both animal and human models, 3-D printing represents a genuine breakthrough in modeling aneurysm disease.
Click here to read the full story.
Consent quandaries: Is electronic consent the wave of the future?
(One in a series of postings examining ethical dilemmas in obtaining informed consent from human research subjects, explored at the recent 2014 CTSI symposium "Ethics in Research: Consent Quandaries.")
During a meeting to review a research study, Nicholas Steneck noticed that the consent form stated that participants would be part of the experiment's first "cohort." But it didn't explain what "cohort" meant in the context of the study.
Steneck, the Director of the Research Ethics and Integrity Program at the Michigan Institute for Clinical and Health Research, approached the principal investigator afterwards for clarification.
The investigator gladly sat down with Steneck and proceeded to explain, sketching on the back of a piece of paper as he elaborated on the key points.
"It was great," Steneck said. "It was something a research participant could easily understand."
This wasn't something that could be conveyed on a standard consent form, but it could easily be videotaped and presented online.
Which is one reason why Steneck believes that "going to electronic consent really offers a host of ways of improving the informed consent process."
He acknowledges there are several aspects of this that need to be carefully addressed: verifying that signatures are valid; privacy and security issues; cost; acceptance by regulators, and developing a standardized language and terminology for the consent process.
The advantages? Steneck lists several:
1. Enhanced understanding on the part of research subjects whose attention is more likely to be engaged with an online presentation than with a standard consent form.
2. Opportunities to include quizzes at different points in the process to help validate comprehension.
3. Greater flexibility to present supplemental material specific to the study at hand, such as a videotape of the investigator explaining a cohort.
4. Better documentation of consent with videotaping.
5. More efficient entry into tracking systems.
6. A full electronic record.
"I think it's the wave of the future -- much in the way electronic health records are now becoming the norm," Steneck said.
(Next: Challenges of obtaining consent from the deaf.)
Optics student embarks on novel undertaking
Daniel Savage is about to undertake something that's never been done at the University of Rochester -- earn a dual Ph.D. at The Institute of Optics and M.D. from the School of Medicine (MD-PhD Program). "It's an incredible privilege and honor to be studying here at Rochester," Savage said. "You have The Institute of Optics, which is one of the top, premier schools for optics. You have the Center for Visual Science -- what a hotbed that is for visual science. And you have the Flaum Eye Institute. You couldn't ask for a better place. I could not do what I want to do anyplace else." Savage hopes to improve vision at two levels: as a research scientist who can contribute new knowledge -- and perhaps new technologies -- that benefit mankind as a whole, and as a physician who can treat the specific, individual needs of patients. Click here to read more.
Worth pondering . . .
James C.M. Li, the Albert Arendt Hopeman Professor of Mechanical Engineering and Professor of Materials Science, once observed:
"Waiting to read the literature sometimes may be too late. That is why you should go to conferences to listen firsthand [to] the findings of others. The best is to interact with fellow workers in your own institution. This is not as easy as you think. Some people are reluctant to talk to you. So you must be generous to give ideas to others. If you give 10 and get 5 in return, you should be satisfied. Otherwise you must work alone and you would not get even the 5. So do not be afraid of giving away ideas. . . . Some people may be as generous as you and you can publish jointly. Others may acknowledge your help or discussion. But some may just take you ideas and consider [them] as [their] own. Do not worry about it. If you do not interact, you would never discover what kind of person he or she is."
Click here to read more about the career of Prof. Li, who plans to retire after this semester.
Mark your calendar
April 7-8: Grant Winners Workshop, sponsored by AS&E Dean's office, featuring Robert Porter, national leader in research development. Four sessions: Writing successful grants, writing the NSF career proposal, grants in the humanities and social sciences, and strategies for success in sponsored research. Click here to learn more.
April 8: "Mobile phone-based asthma self-management aid for adolescents," featuring James Allen, Professor of Computer Science, and Hyekrun Rhee, Associate Professor in the School of Nursing. CTSI Crossing Elmwood seminar series. 12:15 to 1:15 p.m., Helen Wood Hall Auditorium (1w 304).
April 10: 14th Annual Technology Showcase, sponsored by the Center for Emerging and Innovative Sciences, 1 to 5:30 p.m., Eastman Business Park's Theater on the Ridge. An opportunity for University researchers to present their work to industry, other researchers and organizations.
April 15: Deadline for pre-proposal applications for next round of awards from the Technology Development Fund. For more information contact the TDF Fund Manager, Omar Bakht, call direct at (585) 276-6610 or visit the website.
April 25: International experts in infectious diseases and vaccine development gather to honor their colleague and collaborator, Caroline Breese Hall. Join the Department of Pediatrics for a Festschrift involving a full day of scientific talks and discussions. See Schedule of Events.
May 1: Deadlline to apply to the Institute for Innovative Education for grants of up to $5,000 each to support interprofessional research projects that examine how electronic health records can be used to improve access to information and foster and improve humanistic patient interactions. Click here for complete details.
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