Town hall meeting addresses clinical research challenges
Conducting clinical research in the current regulatory environment and what the NIH
Clinical Center is doing to address related challenges was the focus of an early June
Clinical Town Hall meeting in Lipsett Amphitheater.
Research enhancement efforts
highlighted at the Town Hall Meeting:
- Clinical Research Informatics System (CRIS)
- Picture Archiving and Communication System through the Web (PACSweb)
- Prototype: a web-based clinical protocol-writing application
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Clinical Center Director Dr. John
Gallin's opening remarks emphasized that in a time when everyone is being asked to do
"more with less" it is important to evaluate, assess, and design tools that will improve
the facilitation of clinical research and streamline the bureaucracy.
"This is something we have to do together. We're here today to share information with
you and get your feedback about the directions we're taking. Your input will enable us to
approach these directions in support of an efficient, forward thinking,
comprehensive clinical research vision," he said.
Three integral research enhancement efforts were highlighted at the Town Hall
meeting:
the Clinical Research Information System (CRIS); the Picture Archiving and Communication
System through the Web (PACSweb); and ProtoType: a web-based clinical protocol-writing
application. A construction progress update for the Mark O. Hatfield Clinical Research
Center was also provided.
Clinical Research Information System (CRIS)
Dr. Stephen Rosenfeld, chief, Division of Clinical Research, Research Informatics,
pointed out that when the Medical Information System (MIS) was installed a quarter
century ago, it did what it was supposed to do in streamlining patient care. Today
with MIS the Clinical Center has an information system that will support the Center
during the extensive transition to CRIS. MIS will remain "live" and serve as a fallback
system while CRIS is being implemented.
There are two main components to CRIS. One is the Clinical Data Repository,
which is
basically where all data (i.e., lab reports, etc.) are collected. This replaces the MIS
core piece on the patient care units. The other system component is the Clinical Data
Warehouse, the research arm that feeds the Institute research system. The new core piece,
the Clinical Data Repository, should be selected by September and is expected to be 'live'
ten months later, according to Dr. Rosenfeld.
"The Clinical Center comprises individuals with competing priorities and
very different
ways of using data. We're moving away from a culture of restraint to one where the
system will adapt to us, not us to the system," said Dr. Rosenfeld.
Picture Archival and Communication System through the Web (PACSweb)
"The PACSweb will replace images and reports in your hands with access to the same items
through any personal computer interface in the Clinical Center," said Dr. King Li, associate
director for Radiologic and Imaging Sciences.
He described three advantages to a digital approach: it allows images to be viewed in
many places at the same time; it produces a large volume of imaging data quickly
(as high as 1,000 images in two minutes); and it allows the use of features such as
color-coded maps, 3-D renderings and quantitative data.
With PACSweb, authorized users can easily access relevant exam reports and images.
The tool has features that allow for magnifying and moving images, saving them to a disk
or CD, utilizing different layout formats, printing films, and using any monitor size.
Other benefits of the PACSweb are that it uses JPEG images with compressed files that
are easily delivered over the web and that the FDA has certified use of these web-based
images for clinical review purposes. Physicians can use an online request form and all
patient information is encrypted and resides on a secure internal server. Email notices
are sent to the user when the request is received, filled and available. Both same-day
(up to 10 requests per user per day) and next-day (no limit) service is available.
"Our next plans are for the PACSweb Enhanced. This will provide better images but the
downloading time will be slower," said Dr. Li.
ProtoType: a web-based clinical protocol-writing application
"ProtoType will change the way we do our clinical research business," said Dr.
Robert Nussenblatt, Director, Office of Protocol Services. He noted that this application
is the first step in the protocol services migration toward better use of information
technology and paperless systems, standardization of systems with built-in flexibility
and enhanced patient care and safety.
ProtoType will simplify the protocol writing process by providing recommended language
cassettes for protocol and consent form use. The application will assure that regulatory
requirements are met by providing help on relevant parts of the protocol and linking to
NIH/Clinical Center policies. Ultimately, it will provide links to other clinical and
research databases.
Dr. Nussenblatt demonstrated that the application contains all the essential protocol
elements. Thus, an investigator can have multiple protocols under construction; view
pages that show the major subdivisions of a protocol; search on keywords that will be
linked to the clinicaltrials.gov website; buildout protocols in any order; make use of
updated standard language for consent forms; and quickly and electronically submit
information to agencies, institutional review boards and other relevant organizations.
Investigators are encouraged to test ProtoType at http://www2.cc.nih.gov/protocoltest.
Mark O. Hatfield Clinical Research Center (CRC)
"Construction has progressed well since we first began in January 1999," said CRC
Project Director Yong-Duk Chyun. "The entire concrete structure is in place, and I am
very pleased with how things are moving along," he said.
Chyun highlighted several unique features of the structure including: use of the
NIH Clinical Research Model providing a bridge from basic research to inpatient and
outpatient care; flexibility and adaptability, including modular planning, allowing
patient care units and the research labs to interchange if necessary, and interstitial
(between floors) space to accommodate a changing utility infrastructure; and indoor
air quality, assuring a clean air supply and thermal comfort levels.
"I am confident we will be ready for the target readiness timeframe of March 2004,"
said Chyun.
Bringing the Town Hall meeting to a close Dr. Gallin said, "These four individuals have
presented what will be an exciting transition for clinical research at NIH. I view the
CRC as a new laboratory as we move forward in this century."
—by Dianne Needham
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Team NIH races for a cure
Team NIH members, 400 strong, braved the heat and humidity on June 1 to run and walk
3.1 miles in the National Race for the Cure in Washington, D.C. A crowd of 70,000 race
participants took to the streets in support of research for breast cancer and related women's
health initiatives.
Several hundred teams took part this year. The Clinical Center spearheaded organization
of Team NIH. Family members, patients and friends joined with employees to represent NIH.
For many the reason to participate was personal—a wife, a mother, a sister, a brother,
had experienced breast cancer. For others the reason was simple—expressing the importance
of breast cancer research and breast health.
The National Race for the Cure is the largest 5K event in the world. It has grown steadily
from 7,000 runners and walkers in 1990 to 26,000 in 1995, to more than 70,000 in the past
several years. The race is part of a series of 5K runs and fitness walks in support of breast
cancer research and breast health initiatives, with more 1 million participants in at least
100 American cities and three foreign countries.
Onsite Clinical Center registration, publicity and word-of-mouth communication throughout
NIH helped to get people involved. Many NIH volunteers assisted in making the first Team
NIH a success. Pat Piringer, Special Assistant, Office of the Director; Georgie Cusack,
Clinical Nurse Specialist, Nursing Department; and Dianne Needham, Deputy Chief, Office
of Communications served as Team NIH co-captains.
There will be a Team NIH in 2003. Preparation and planning will begin in the Fall.
Anyone interested in volunteering should contact one of the 2002 co-captains.
And don't forget to keep using those running or walking shoes-to be ready for
the next National Race for the Cure!
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PACSweb now available across NIH
Web access to the Picture Archiving and Communication System (PACS), which stores and
displays new and prior digital radiology images is available on workstations and desktop
computers across NIH.
Developed as part of the new CRIS system, PACSweb is a collaboration by the Diagnostic
Radiology Department, Department of Clinical Research Informatics and Department of
Networks and Applications. The application makes images and reports available to
authorized users (currently physicians, physician assistants, nurse practitioners
and anesthesiology nurses) on their desktops on the day the study is performed.
"This significantly increases efficiency of patient care," said Dr. King Li, associate
director for Radiologic and Imaging Sciences. "For many studies, physicians no longer
need to send for films or run to the film library to see their patients' images. They
can access them from their office computers within minutes of test completion."
Authorized users can search for images by patient name or medical record number. On
the day a patient exam is scheduled, users can view the four most recent prior studies
taken in the scheduled modality (MRI, CT or X-ray) of the requested body region
(head and neck, torso, or extremities), as well as the two oldest prior studies
in the system.
Imaging modalities stored and available on the system include all MRI and CT scans
taken since1995, and X-rays taken in the past two years. The images displayed can be
enlarged, magnified, panned, displayed as a series, and displayed in different orientations.
For a tutorial and further information on the PACSweb system,
go to http://www.nihtraining.com/pacsinfo.html.
—by Colleen Henrichsen
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New FDA guidelines increase need for Blood Bank donations
The Clinical Center's Blood Bank is calling for increased blood donations to compensate
for deferments caused by new Food and Drug Administration guidelines that took effect June 1.
Previously, those who spent six months in the U.K. from 1980 to 1996 were deferred from
donating blood or blood products for patient care. Now, new guidelines reduce the acceptable
travel period from six to three months. In addition there are new travel restrictions on
those who have been in Europe for a total of five years since 1980, as well as a requirement
to defer those who lived on a military base for six months or more in certain European
countries.
The measure is aimed specifically at reducing the risk of Bovine Spongiform Encephalopathy
(BSE, or "Mad Cow Disease") entering the U.S. blood supply. It was spurred by recent
research showing that a new human neurologic disease, vCJD, is caused by the same
infectious agent (prion) that causes BSE. Although there is no evidence that prion
infection is transmissible from person to person via transfusion, the FDA is taking
every precaution.
"The word 'guidance' gives the impression that compliance is voluntary, but this is
not actually the case," said Janet Browning, chief nurse of Blood Services in the
Department of Transfusion Medicine. "As usual, some experts are in total agreement
with the deferral criteria while others believe there is insufficient scientific
evidence that vCJD is transmitted through blood."
The impact of the new regulation is being monitored by Jaime Oblitas, managing director
of the NIH Plateletpheresis Center. The NIH Marrow Donor Program is concerned that the
deferral rate at NIH could well exceed the estimated national donor deferral rate of
six to eight percent, based on the fact that about 70 percent of donors are NIH
employees and many have lived abroad or traveled extensively. Blood products given
by deferred donors can be used for research but the FDA requires special labeling
that will inform investigators that the product was obtained from a donor with a vCJD risk.
Oblitas and Browning urge those who can give blood to do so to help make up the shortfall.
Questions about the eligibility to donate should be directed to the Blood Bank at (301) 496-1048.
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Kina Smith, a pre-intramural research training awardee working in the
immuno-genetics section of the Department of Transfusion Medicine, is the recent recipient
of a Minority Training Research Forum (MTRF) travel award.
Smith, who won the award for a scientific abstract on melanoma research, was one of 12
recipients from her educational level nationwide. The travel fellowship consisted of airfare,
hotel accommodations, and daily admission to a trainee breakfast, luncheon, and awards
dinner in San Diego this spring. There, she conversed with peers and met with representatives
from academia, the pharmaceutical industry, and other areas of NIH.
As a winner, Smith was required to give a 15-minute oral presentation with slides and a
one-hour poster session on her paper.
"I was very happy," Smith said. "It was a great honor to present the research I've been
working on."
Smith has a B.S. in biology from Syracuse University, Syracuse, N.Y., and will remain with
the Clinical Center until July. She then plans to complete a year of research at NIH or at a
local company, and go on to complete her post-graduate work.
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Intern awarded Goldwater Scholarship
Victoria Rose Sharon, who worked as a summer intern in the Department of
Transfusion Medicine last year, is the recipient of the 2002 Barry M. Goldwater Scholarship.
The scholarship is awarded to 300 undergraduate students in the United States and
Puerto Rico who have outstanding potential and intend to pursue a career in mathematics,
the natural sciences, or engineering.
Sharon is a junior at Columbia University in New York, majoring in biology and neuroscience
and behavior. She will receive a $7,500 award to cover tuition, fees, books, and room and
board for one year.
"She is an outstanding student and has done an outstanding job," said Dr. David Stroncek.
"That's why we are here-to bring students into the lab and teach them. We want them to have
a good experience and hope it will lead to a career in the clinical sciences."
Sharon worked with Dr. Stoncek for two months last summer. She researched the filterability
of red blood cells from people who carry the sickle cell anemia trait.
"I think my experience at NIH is what helped me to get the award," said Sharon. "It was just
a wonderful experience and it will definitely help me in the future."
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Not your typical rabbi
Teacher of Orthodox and "Polydox" brings new evening quorum outreach program
It's been said that Rabbi Reeve Brenner, of the Clinical Center's Department
of Spiritual Ministry, isn't your typical rabbi. And it's true. In his off time he raises
endangered turtles and releases them back into their natural habitats, and invents
competitive sports. But his work on the NIH campus is far more demanding, even hectic.
"I stay very busy," he laughs. "A chaplain at NIH has to be prepared to be supportive
of the needs of the entire diversity of the Jewish community," he explains. "That means
everything from an orthodox minyan, which is a quorum of men who pray during the week and
conducts a service, to Reform, conservative or secular members of the community and their
religious and service needs."
Because of this diversity, Brenner says, he serves as a rabbi of not only the orthodox
community, but of what he calls the "polydox" community. "That's everyone who isn't
orthodox," he tacks on. "When we have a service for the High Holy Days, it's much more
of a progressive, liberal service because we know the orthodox community has its own
service."
As part of its continuing outreach to the orthodox Jewish community, the Department of
Spiritual Ministries recently announced a completely new program of Monday and Wednesday
worship quorums on the 14th floor of Building 10.
When patients check in to the Clinical Center and indicate that they're Jewish, the
rabbi soon comes calling, combining genuine concern with well-honed humor. "Hello, I'm
Rabbi Brenner," he says, greeting both patients and family members. "How can I waste your
time this morning?"
Most are very receptive.
"You see, a rabbi is a teacher. Nothing is off-limits because every Jew looks upon a
rabbi as his or her rabbi, regardless of where they come from. It's almost like the
extension of a family—an interchangeable uncle you can turn to in confidence."
Often, Brenner's duties are routine, obtaining candles or Torah texts for ceremonies,
or arranging for the dietary requirements of patients. But there are also the spiritual
needs that he meets for both Jewish and non-Jewish patients.
"Sometimes I'll call on a patient and end up talking to other patients and visitors who
drop by, and we have discussions," he says. The topics range from mundane to the philosophic.
One of the philosophical views Brenner expresses concerns atheism.
"It's difficult to be a Jewish atheist," he proclaims, "because you have to ask what idea
of God you have problems with and why. It's a philosophic position and it's more complex
than merely saying God is some consciousness in the sky, a super being-that's a very
narrow understanding of God. You have to earn being an atheist; you have to explain
what problems you have with Borowitz's conception or Kaplan's conception and all the
disciplines that deal with it. You have to define the God you deny, and for that you
need a good education."
Patients who are very sick and near death many times inquire of the rabbi about what
lies beyond this life. "They're concerned," Brenner says, "not only that there is a God,
but if there's anything waiting for them. The answer, of course, is that we don't know.
I say it's a 'country of no report.'"
In such circumstances, Brenner gives what he calls the "dragonfly analogy."
When dragonfly larvae are deposited on the bottom of a fresh water body, they exist in
a community, he explains. When the time comes, they "pop up" and ascend to the surface.
There, they find a reed or blade of grass and climb it, finally breaking free of a
protective shell and emerging as a dragonfly.
"Each one of the larvae community may think, when another pops up, that it dies," he says.
"One of the others may say to it, 'When you pop up, please communicate with us and
let us know what it's like.' But after its metamorphosis, the dragonfly can only
hover near the surface of the water. It can't convey that there's a different world,
a different consciousness. It's in a land of no report."
Brenner has been with the Clinical Center for three years and loves his work. About
half his time, he says, is spent at NIH. The rest of the time he spends writing books
and enjoying his grandchildren. His books include The Faith and Doubt of Holocaust
Survivors and Yiddle's Riddles. He is currently completing Jewish, Christian, Chewish,
and Eschewish: Interfaith Pathways for the 21st Century. His books have won the National
Jewish Book Award and the Yivo Prize.
An avid basketball player and fan, Brenner is enthusiastic about the sports he invents.
"There are plenty of running-, jumping-, speed-, stamina-, strength-oriented sports,"
he says. "I love''em all. Baseball, football, soccer, rugby, basketball—I've played 'em
all. But how many non-aggressive ball-playing sports can you name? How many games do you
know where you're not playing against someone, you're playing with or alongside someone?"
Brenner, in fact, is the president of The Bankshot Organization and has dedicated an entire
website to such sports (http://www.bankshot.com/).
Rabbi Brenner is one of the Clinical Center's staff of five chaplains. For further
information on the Monday and Wednesday quorums, or to contact him, call (301) 496-3407.
—by John Iler
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NIH'ers rally to beat the beltway blues
The Beat the Beltway Blues commuter bus route from Annapolis to downtown Bethesda
via Glenarden and Silver Spring is back in action with the help of nearly 100 NIH employees.
The route, which was slated to end April 30 due to low ridership, received overwhelming
support when 70 NIH employees met with Senator Ulysses Curry (District 25, Prince George's
County), at the Maryland Senate Office Building in May to request continuance of the bus
service.
"We made a big difference," said Betty Wise, Clinical Imaging Processing Service,
Diagnostic Radiology Department. "If we had not gone to the Senate Building with the
large number of people that we had, we would not have been taken seriously."
Wise took on the role of coordinator along with several other NIH employees; the group
got 300 riders to sign petitions for the bus route to continue and sent letters to Senator
Curry who granted them a meeting sponsored by the Maryland Transportation Authority.
The group presented a slide presentation about the benefits of commuting and offered to accept
an increase in fare in order for the bus route to continue.
"This is a great benefit for NIH commuters," said Wise. "It's an easier way to get to work,
and a stress reliever. You can relax in a comfortable coach bus, read, and not have to worry
about the traffic. It makes for a more productive day."
Tom Haden agrees. "Using mass transit or other forms of public transportation benefits the
employee," said Haden, a traffic management specialist with the Office of Facilities
Planning, Office of Research Services. "It saves employees money in gas and auto insurance
and also decreases roadway congestion."
According to Haden, 4,000 NIH employees currently commute by public transportation and
receive Transhare, an incentive to encourage employees to commute by public transportation
or vanpool. Employees can receive up to $100 a month in Transhare subsidies, but must be
willing to surrender any NIH parking permits and off-campus parking access cards.
In an effort to encourage carpooling, NIH has made 536 carpool parking spaces available
on campus. Currently, there are only 316 carpools and 10 vanpools registered with the
NIH Parking Office.
"When employees commute together or use other forms of transportation, it cuts back on
the greenhouse emissions and also reduces the number of cars on the campus parking lots,"
said Haden. "However, with varying work schedules, some employees find it difficult to
carpool or even be locked into timed schedules that are used by buses or vanpools."
Instead, most employees rely on the 848 off-campus parking spaces and take one of four
off-campus shuttles to the main campus.
According to the 2000 Census, nearly seven out of 10 Washington area residents are choosing
to drive alone to work. The average one-way commute has increased to 32 minutes, up three
minutes from a decade ago.
But those statistics don't matter to Wise, who will continue to commute via the Beat the
Beltway Blues bus. "Before I started riding this bus, if I woke up with a headache, I
would just call in sick, because I knew it wasn't going to get any better by the time
I fought traffic and got to work," she said. "Now I just take some aspirin, get on the
bus, and when I get to work I feel much better."
For more information about the Beat the Beltway Blues bus or to find a route in your
area, visit http://www.mtamaryland.com/index.cfm.
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Here's the scoop on Pharmacy's ice cream social
This is a tale about appreciation, remembrance, and ice cream—a tale that occurred in
May but seems a more fitting summer story.
When the Pharmacy staff held an ice cream social on May 13 they probably weren't thinking
about President Ronald Reagan's 1984 designation of July as National Ice Cream Month, or
how 90 percent of Americans enjoy ice cream. But they may have been wondering why the
Pharmacy Department was hosting it at all.
It all began with the Pharmacy Residency Class of 2001. The class wanted to give
something back to the Pharmacy team for the training, mentoring, and support they had
given the residents. To show their gratitude, residents sponsored the department's
inaugural Pharmacy Ice Cream Social last year.
Pharmacy staff decided to keep up the tradition in 2002. "We wanted to continue it
in the spirit of the 2001 Class and in memory of Kelli Jordan," said Chuck Daniels, chief,
Pharmacy Department. Jordan, a resident in that Class, passed away in the fall of 2001.
Whether the focus of a social gathering or just eating pleasure, ice cream has been
historically popular, as evidenced by the amount Americans consume each year—about 23
quarts per person.
In terms of the Pharmacy staff's ice cream social though, just how much of the sweet stuff,
aside from the cones, sprinkles and sundae fixings, was there?
"Last year it was like a Baskin-Robbins ice cream shop in here," said Patricia Smith, program
support specialist. This past May, according to Smith, management made sure to "gear up with
at least eight and a half gallons."
Vanilla, chocolate, Neapolitan, and butter pecan were America's top five favorite individual
flavors in 2001. Pharmacy's leading flavor this year (by definition, the "one that ran out
first"), was Edy's 'Almond Joy' said Smith.
The Pharmacy Residency is a one-year postgraduate program with four different areas of
concentration-Pharmacy Practice; Drug Information and Pharmacotherapy; Oncology; and
Primary Care.
Please don't call Ben & Jerry's.
—by Dianne Needham
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Primary care updates
Join the Clinical Center Nursing Department for its fifth primary care update
seminar on August 21, 3-4 p.m. in Lipsett Amphitheater. Mary Schroeder, M.S., C.R.N.P., and
Jennifer McKeon, M.S.N., C.R.N.P., will present the topic, "Management of Common Dyslipidemias."
Lipsett renovations
Lipsett Amphitheater will be closed for renovations beginning November 4 through
January 31, 2003. The ORS Management staff will contact all clients with events scheduled
in Lipsett during this closure period to arrange for an alternate location. Contact
Marianne Bachman at 301-435-1677 for more information.
ClinPrat training program
The NIH Clinical Pharmacology Research Associate Training Program is a three-year
postdoctoral research fellowship sponsored by the Clinical Center and the National
Institute of General Medical Sciences. Postdoctoral training positions are available
starting July 1, 2003 and in subsequent years. Candidates must have an M.D., have
completed three years of residency training and be board eligible in a primary medical
specialty. Candidates must be U.S. citizens or permanent residents of the United States.
For more information call Donna Shields at 301-435-6618.
Science in the Cinema
The Office of Science Education announces the return of its popular film and
discussion series "Science in the Cinema." Every Thursday evening beginning July 11 at 7 p.m.
in Natcher Auditorium, a film with a medical, science-related theme will be shown. The event
is open to the public. For more information, visit http://science.education.nih.gov/cinema.
CRIS educational session
A video rerun of a popular CRIS education session is set for August 14 at 1:30 p.m.
in the CC Medical Board Room (2C116). "Implementing Electronic Patient Record Systems,"
was first presented in August 2000. The speaker is Stephanie Reel, chief information
officer and vice provost for information technology, Johns Hopkins University, and
vice president for information services, Johns Hopkins Medicine. CME credit is offered.
For more information visit http://cris.cc.nih.gov/summer.
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Editor:
Tanya C. Brown
Contributing
writers: Colleen Henrichsen, Dianne Needham, John Iler
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Clinical
Center News, 6100 Executive Blvd., Suite 3C01, MSC 7511, National Institutes
of Health, Bethesda, MD 20892-7511. Tel: 301-496-2563. Fax: 301-402-2984.
Published monthly for CC employees by the Office of Clinical Center
Communications, Colleen Henrichsen, chief. News, article ideas, calendar
events, letters, and photographs are welcome. Deadline for submissions
is the second Monday of each month.
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