IN THIS ISSUE:
- Basic science students introduced to their role in clinical and translational research
- NIH opens pathways for collaborations between intramural and extramural investigators
- Study subjects in non-ideal circumstances deserve ethical treatment
- NIH welcomes new clinical fellows
- New Telework Feature in ITAS
- B2 level pedestrian walkway increases safety and efficiency
- Clinical Center staff honored with NIH Directors Awards
- Project SEARCH interns get first taste of NIH
- NIH dedicates special day to siblings of CC pediatric patients
- Public Health Corps officers rise to new rank and responsibilities
- Registration for pharmacology course open
- Department of Transfusion Medicine symposiums address latest in the field
- Try a little PLC (Plain Language Care)
- Upcoming Lectures
- New Clinical Research Protocols
ABOUT CC NEWS:
Published monthly for CC employees by the Office of Communications, Patient Recruitment, and Public Liaison. News, article ideas, calendar events, letters, and photographs are welcome. Submissions may be edited.
Clinical Center News
National Institutes of Health
Building 10, 10 Center Drive
Bethesda, MD 20892-1504
Lipsett Amphitheater, 12 noon
Lectures will be videocast.
Research, Evidence-Based Medicine and the Art of Healing
Richard Colgan, MD
Associate Professor, University of Maryland School of Medicine
Director, Undergraduate Education, Department of Family and Community Medicine
Research in Emergency Settings
Dave Wendler, MA, PhD
Head, Unit on Vulnerable Populations
Department of Bioethics, NIH Clinical Center
Raising the Bar for Publishing the Results of Clinical and Translational Research
Joseph E. Parrillo, MD
Professor and Chairman, Department of Medicine, Cooper Medical School of Rowan University
Director, Cooper Heart Institute, Cooper University Hospital
Diversity as a Vital Component of Health Systems Innovation
Marc Nivet, EdD
Chief Diversity Officer, Association of American Medical Colleges
Randomized Controlled Trials for Efficacy and Effectiveness Research
Denise Simons-Morton, MD, PhD
Director, Division for the Application of Research Discoveries
National Heart, Lung, and Blood Institute
The following new protocols were approved in June:
- Estimation of Brain Biomechanics using MRI; 12-CC-0139; Dr. John Butman; CC
- Clofarabine Followed by Lenalidomide for Treatment of High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia; 12-H-0146; Dr. Jeffrey K. Klotz; NHLBI
- Genetic Studies of Non-Alcoholic Fatty Liver Disease; 12-HG-0147; Dr. Maximilian Muenke; NHGRI
- SARC016: Phase 2 Study of the mTOR Inhibitor Everolimus in Combination with Bevacizumab in Patients with Sporadic and Neurofibromatosis Type 1 (NF1) Related Refractory Malignant Peripheral Nerve Sheath Tumors; 12-C-0148; Dr. Brigitte C. Widemann; NCI
- Eltrombopag Added to Standard Immunosuppression in Treatment-Naive Severe Aplastic Anemia; 12-H-0150; Dr. Danielle M. Townsley; NHLBI
- Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients with Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum; 12-C-0151; Dr. David S. Schrump; NCI
- Normative Values in Audiovestibular Testing; 12-DC-0152; Dr. Carmen C. Brewer; NIDCD
- Evaluation of Patients with Gastrointestinal Disease; 12-DK-0154; Dr. Stephen A. Wank; NIDDK
- Acceptance and Commitment Therapy for Adolescents and Adults with Neurofibromatosis Type 1 and Chronic Pain: A Pilot Study; 12-C-0155; Dr. Staci M. Peron; NCI
- A Randomized, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in PreviouslyTreated Patients with Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC); 12-C-0156; Dr. Tim F. Greten; NCI
- Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults with Congenital Heart Disease; 12-H-0158; Dr. Andrew E. Arai; NHLBI
- Effects of Antimicrobial Treatments on the Microbiome in Healthy Volunteers and Patients with Atopic Dermatitis; 12-C-0159; Dr. Heidi H. Kong; NCI
- Validation of the English Version of the Pain Interference Index and the Pain Rating Scale in Children, Adolescents, and Young Adults with Chronic Illness and their Parents; 12-C-0160; Dr. Staci M. Peron; NCI
- Therapeutic Trial of EPI - 74 3 In Patients with Disorders of Energy Utilization or Oxidation-Reduction; 12-HG-0161; Dr. William A. Gahl; NHGRI
NIH piloted training program to encourage careers and partnerships
|Dr. Juan Lertora, faculty lead of the Course in Clinical and Translational Research for Ph.D. Students, was one of many presenters during the course's two-week pilot in mid-July.|
Doctoral students in the basic biomedical sciences have a new resource for an introduction to clinical and translational research. A Clinical Center pilot program aims to increase the pool of potential researchers and collaborators by showing them opportunities in a broader field.
The Course in Clinical and Translational Research for Ph.D. Students welcomed its first class of 16 students on July 9. This pilot program invited participants for a two-week curriculum, taught on the NIH campus, to build a foundation in clinical and translational research in an effort to encourage young scientists to consider a future in the field. Students met with role models in the basic sciences from across the NIH intramural program who play key roles in clinical research studies.
"Sometimes, students working on very focused projects may not have a vision as to how their work will be integrated into a clinical application," said Dr. Juan Lertora, director of clinical pharmacology and faculty lead for the new program. "This program broadens their perspective and thereby increases the potential for translation of basic laboratory observations to clinical medicine."
Through lecture and interactive sessions, participants learned principles of clinical and translational research design, implementation, and analysis, and the process of scientific and ethical review.
Students participated in a mock institutional review board and learned the process of filing an investigational new drug application with the U.S. Food and Drug Administration. The course also included tutorials on training and funding opportunities, such as the NIH Bedside-to-Bench Awards Program.
"I am hoping that this program will be a bridge or a link to a professional clinical or translational career for me," said student Marangelie Criado-Marrero of the Ponce School of Medicine in Puerto Rico. "In a small school, you don't always have the opportunity to be in the lab with patients. There's so much to learn at the NIH and having the ability to work in the lab and also with patients is a great opportunity."
The genesis for such a curriculum came as a recommendation from the CC's Advisory Board for Clinical Research. Organizers hope the exposure to NIH research resources will increase the pool of potential candidates for partnerships and careers in translational and clinical research
"This course is another way to enhance the pipeline of translational researchers and is a wonderful way for basic scientists to learn the valuable roles they have as part of the research team, working closely with clinicians to move concepts from the bedside to the bench and back," said CC Director Dr. John I. Gallin.
The NIH is taking steps to expand engagement with extramural investigators interested in collaborating with intramural researchers to use the unique resources of the Clinical Center.
"The NIH Clinical Center is truly a national treasure and opening its doors to a greater pool of researchers will welcome fresh perspectives and cultivate new opportunities for discovery that will translate to greater human health," said NIH Director Dr. Francis S. Collins.
A new grant program, Opportunities for Collaborative Research at the NIH Clinical Center, will support these partnerships.
Until now, the CC has served exclusively the NIH Intramural Research Program. The CC launched a new website illustrating the hospital's research resources, such as its metabolic unit, pharmaceutical development capabilities, and advanced research-related radiology imaging services. The website offers a toolkit that outlines next steps for extramural researchers interested in working with NIH intramural investigators to use the CC and its research infrastructure.
"The Clinical Center should be available for collaborations that will further enhance the translation of scientific observations and laboratory discoveries into new approaches for diagnosing, treating, and preventing disease," said CC Director and NIH Associate Director for Clinical Research Dr. John I. Gallin.
In addition to the new grant program, extramural investigators may access CC resources through previously existing formal funding relationships, such as contracts, grants, and cooperative agreements. Administrative supplements to grants are also available for short-term Bedside-to-Bench Awards Program projects that involve partnerships between intramural and extramural investigators pursuing translational research projects.
The 2011 recipient of the Lasker~Bloomberg Public Service Award from the Albert and Mary Lasker Foundation, the CC is a 240-bed hospital and research facility with more than 1,500 clinical research protocols underway.
The recommendation that the NIH allow external investigators to use the unique resources of the CC to stimulate a broader range of research came from the Congressionally mandated Scientific Management Review Board (SMRB). The SMRB was authorized by the NIH Reform Act of 2006 and charged with examining the NIH's organizational structure and providing recommendations for enhancing the agency's mission. Read more in the SMRB's Report on the NIH Clinical Center (3.69 MB).
By Sarah Krosnick
While the results of a research study may be of great benefit to the greater public, the risk of the study to the individual participants must take precedence and researchers should act accordingly during planning and conduct. So concluded Dr. David Wendler, head of the Clinical Center Department of Bioethics Unit on Vulnerable Populations, in an evaluation of a study of children exposed to secondhand smoke.
In his editorial "The ethics of studying subjects in non-ideal circumstances" [disclaimer], published in the July issue of Tobacco Control, Wendler examined the methods of a study conducted by researchers in Naples, Italy to investigate a relationship between exposure to secondhand smoke and sleep bruxism, a teeth grinding or clenching disorder, among children.
The incidence of sleep bruxism was compared between two subject groups: children exposed to secondhand smoke and children not exposed. Researchers found that children exposed to secondhand smoke were more likely to experience sleep bruxism than those children not exposed. Although this study exposes yet another risk of inhaling secondhand smoke and its detrimental effects, Wendler found issues in the ethics of how the research was conducted.
Wendler's concern, and the topic of his editorial, was whether children were needlessly exposed to secondhand smoke. Since "we know a good deal about the negative effects of exposure to SHS," Wendler argued that it was important to ensure the study had sufficient social value or "rather than study the effects of SHS, researchers should protect individuals from SHS."
To analyze the study, Wendler presented four categories of research of ethical interest:
- active exposure (e.g., purposefully exposing the child to secondhand smoke, possibly in a laboratory setting),
- encouraged exposure (parents are encouraged to expose the child to secondhand smoke),
- observation (observe the effect of whatever level of secondhand smoke the parents expose the child to without intervening),
- and discouraged observation (parents are discouraged from exposing the child to secondhand smoke and investigators observe the effects of secondhand smoke from parents who are unable or unwilling to comply).
The researchers may have assumed that the children exposed to secondhand smoke in their study were in the observation category because parents exposed their children to secondhand smoke at routine levels. However, the study may have fallen into the category of encouraged observation since the parents in one arm of the study were instructed not to change their smoking habits, Wendler said. Parents may have wanted to quit smoking or exposing their child to secondhand smoke, he said, but felt unable to stop because they were enrolled in the study and had agreed to continue smoking at their baseline rate.
While this study has been completed, Wendler hopes his editorial will steer researchers in the right direction for future studies.
New clinical fellows from across the country mingled at a welcome reception held on July 9 and hosted by the Clinical Center and its Office of Clinical Research Training and Medical Education. The fellows networked with graduate medical education training program directors, institute and center directors, scientific and clinical directors, and other NIH medical and administrative staff. National Institute of Child Health and Human Development medical endocrinology fellow Mihail Zilbermint (center) connected with CC Director Dr. John I. Gallin at the reception.
NIH clinical fellows develop competence as specialist physicians and collaborate with world-renowned physicians to conduct cutting-edge patient-oriented research as they actively participate in a variety of investigational protocols at the CC. The CC sponsors eighteen medical specialty or subspecialty training programs accredited by the Accreditation Council for Graduate Medical Education, and the NIH supports numerous one-of-a-kind translational medicine fellowship training programs within the 27 NIH institutes and centers.
For more information on graduate medical education at NIH, visit clincialcenter.nih.gov/training.
The Integrated Time and Attendance System (ITAS) has a new feature to manage telework, which will be integrated during the month of August and fully operational by September 1.
Telework eligibility, ad hoc telework requests, and regular telework tour change requests will now be managed through ITAS. Managers and administrative officers will also be able to run reports to track telework activity and eligibility.
Clinical Center employees will be identified as "eligible" or "ineligible" for telework based on their position and qualifying factors such as satisfactory work performance. "Eligible" CC employees will be able to submit requests in ITAS for ad hoc telework or regular telework tour changes. Leave-approving officials will approve or deny telework requests, similar to approving or denying leave requests.
For more information on telework and workforce management and development initiatives at the CC, visit the Office of Workforce Management and Development Intranet site (NIH Only).
|Marty Haghjou (left) and Charles Owens, project officers with the NIH Office of Research Facilities, supervised completion of the
new B2 level pedestrian walkway.
A new walkway designed exclusively for Clinical Center B2 level pedestrian traffic was completed in early July. The eight-foot-wide pedestrian walkway, which runs parallel to the B2 level "super corridor" for vehicle traffic, offers a safe and upgraded alternative to the previous space that forced pedestrian, freight, and trolley traffic into the same eight-foot hallway.
Much of the B2 level corridor, most built more than 50 years ago, also received a face lift with new ceiling, flooring, and paint. The pedestrian walkway also received sprinkler and lighting upgrades, as well as new signage and mirrors at high-traffic intersections. Vertical posts were placed in the hallway to divert vehicle traffic to the super corridor. "Before the corridor was completed, safety was a concern. The new pedestrian hallway addresses safety and improves aesthetics," said project officer Marty Haghjou of the
NIH Office of Research Facilities.
NIH Director Dr. Francis S. Collins honored staff members for superior performance and special efforts significantly beyond their regular duty requirements with 2012 NIH Director's Awards at the annual ceremony on July 18.
Twenty-three Clinical Center staff members were among the more than 300 recognized.
In the scientific and medical category, Dr. Ronald Summers, CC Radiology and Imaging Sciences senior investigator, was recognized for skill and leadership in his field.
In the same category, the KPC Outbreak Investigation and Response Team received an award for unprecedented real-time investigation and coordinated response by the Microbiology Service, Hospital Epidemiology, and NHGRI investigators to a multidrug-resistant KPC Klebsiella outbreak. The team included Dr. Stella Antonara, Dr. David K. Henderson, Dr. Anna Lau, Angela Michelin, Robin Odom, Dr. Tara Palmore, Dr. Julie Segre, Dr. Evan Snitkin, Frida Stock, Dr. Pamela Thomas, and Dr. Adrian Zelazny.
Maggie McGuire, media relations specialist, received an award as part of the Trans-NIH Collaborative on HBO Documentary Obesity Awareness Campaign group for dedication and teamwork to increase awareness of NIH and evidence-based information on obesity.
The PLAID Study Group, honored for deciphering the genetic and pathophysiologic cause of PLAID, a novel disorder of immune dysregulation, included Dr. Parizad Torabi-Parizi, a Critical Care Medicine Department clinical fellow.
Patient Representative Laura Cearnal received an award in the administrative category for her outstanding dedication and for listening to the needs of patients and responding with respect and compassion.
In the same category, Nutrition Department Chief David Folio was honored in recognition of exemplary leadership of the CC Nutrition Department.
Two CC staff were included in the NIAMS National Multicultural Outreach Initiative. Dr. Gwenyth Wallen, chief of the Nursing and Patient Care Services Nursing Research and Translational Science Section, and Kaitaia Fu, special events coordinator, were among those cited for outstanding efforts in establishing the initiative, which is dedicated to reaching underserved racial and ethnic populations.
Chief Financial Officer Maria D. Joyce was recognized for demonstrating exceptional leadership in the implementation of key strategic management and financial initiatives at the CC.
Housekeeping Supervisor Joseph Cowling was honored for consistently placing the CC's needs ahead of his own in directing Building 10 trash operations and in housekeeping services at the Family Lodge.
Also in the technical and clerical support category, bone marrow technologist Jamie Hahn was honored in recognition for her outstanding dedication and service in support of the mission of the Department of Laboratory Medicine and NIH.
Oretha Potts, Kristin Stafford, and Sujatha Yelamanchili of the Nutrition Clinical Health Technicians Team were also recognized in this category for outstanding dedication and extraordinary commitment to providing exceptional customer service and nutrition care to CC patients.
Dr. Frederick Ognibene, CC deputy director for educational affairs and strategic partnerships and director of the Office of Clinical Research Training and Medical Education, received a Common Fund Leadership Award in recognition of the development of the Medical Research Scholars Program and continued commitment to provide high quality training opportunities for future clinician-scientists.
Dr. Gwenyth Wallen was also honored with a Ruth L. Kirschstein Mentoring Award for exemplary performance while demonstrating significant leadership, skill, and ability in serving as a mentor.
The 12 interns in the NIH-Project SEARCH 2012-2013 class visited the NIH on July 17 for an introduction to the program that provides employment opportunities and experience to young adults with disabilities through a 30-week unpaid internship. This class will begin the week of August 27 with placement in eight NIH institutes and centers, with locations both on and off campus.
This is the third year of the program, which the Clinical Center piloted, and organizers report success both in permanent placement of many interns following graduation and in the positive effect the program has had on promoting diversity and inspiring staff.
|Liam Axelrod (left) and Arthur Knopfmacher look through a microscope as bone marrow technologist Jamie Hahn explains
more about platelets at the DLM
exhibit "Fantastic Voyage."
The National Cancer Institute Pediatric Oncology Branch, The Children's Inn at NIH [disclaimer], and the Clinical Center Rehabilitation Medicine Department Recreation Therapy Section hosted the fifth annual Sibling Day on July 17, recognizing siblings of CC pediatric patients.
Brothers and sisters participated in therapeutic games, educational opportunities, and demonstrations designed to help the kids share their expertise as super siblings and recognize them for their important role in the health care team. Event director Dr. Lori Wiener, head of the NCI's Pediatric Psychosocial Support and Research Program, said that the needs of siblings are often met less sufficiently than for other members of the family. Her goals for the day were to help bring light to the unique experiences that a brother or sister might endure and unite the groups that support siblings of pediatric patients year-round for one special day focused on siblings.
|Super sibling Gabriela Axelrod learns
use a pipette.
Jamie Hahn, a bone marrow technologist in the Department of Laboratory Medicine Hematology Section, has helped host the department's "Fantastic Voyage" exhibit for the past five years. Her presentation taught siblings how an illness can affect the production of blood and its components.
"Now they can see what the doctors were talking about, and it helps them be less afraid and less apprehensive when they go to a doctor's office," she said. "We don't want them scared; we want them to be excited about science and medicine, and maybe even inspire them a little bit."
|Super siblings Bobby and Maria Nguyen learn about cell cultures at the NIH's
fifth annual Sibling Day.
Siblings also got to examine a fake brain in the operating room, learn about medical photography and illustrations, and try out the mock MRI scanner to feel what it is like for their sibling.
Super sibling Gabriela Axelrod was excited for the day's events and enjoyed the opportunity to learn more about the CC. "I think it is really cool here. I like walking around and looking at the new things I haven't seen before," she said. "The day is just about us. I'm a super sib!"
Kids also made dream catchers to whisk away bad dreams and concluded the day with an awards ceremony at The Children's Inn where each sibling was presented with a certificate commemorating their participation and role as a "Super Sib, Super Star." Parents, patients, and staff gathered to applaud this vital role in the family system.
By: Sarah Krosnick
The 10th annual U.S. Public Health Service Commissioned Corps Promotion Ceremony, held on July 26 in Masur Auditorium, recognized 34 NIH employees promoted this year in the Commissioned Corps. Corps officers work for federal agencies on the forefront of public health treating individuals who need it most. Officers are dedicated to public health promotion, disease prevention, and the advancement of public health science.
The ceremony also honored officers who were recently called to active duty, retired, or graduated from the Commissioned Officer Student Training and Extern Program. Family, friends, and colleagues acknowledged the dedication and accomplishments of these NIH employees, many of whom work in the Clinical Center.
Dr. Lawrence Tabak, NIH principal deputy director, in his opening remarks cited appreciation of the efforts of the Commissioned Corps officers, specifically commending their readiness and preparation to serve the nation and the world. He also noted that these promoted employees are tangible evidence of the progress being made in the medical world made possible by the Commissioned Corps. RADM Boris Lushniak, U.S. deputy surgeon general, spoke of the new responsibilities of those recently promoted
As providers of care for the underserved and the vulnerable, the officers must protect the health of these underprivileged groups. Lushniak stressed that with the achievement of a higher rank comes more responsibilities. At the same time, he said, the promoted employees must reflect upon their beginnings and thank their mentors for giving them the opportunity to fulfill their duties to nation and the world.
As a show of support, friends and family helped change the boards on the uniforms of the officers to signify official promotion. Newly promoted social worker CAPT Jeasmine Aizvera said she is proud to serve the NIH and help families through their greatest difficulties.
The Principles of Clinical Pharmacology course, sponsored by the Clinical Center, will begin in Lipsett Amphitheater on September 6. The course will be held Thursdays from 6:30 pm to approximately 7:45 pm and will run through April 25, 2013. The registration deadline is August 30.
"Many medical schools don’t offer formal courses in clinical pharmacology," said Dr. John I. Gallin, CC director. "This course covers what researchers need to know concerning the clinical pharmacologic aspects of drug development and use."
Topics such as pharmacokinetics, drug metabolism and transport, assessment of drug effects, drug therapy in special populations, and drug discovery and development are taught.
"We have assembled an outstanding faculty for this course, drawing from the scientific staff at the NIH, the FDA, the pharmaceutical industry, and many prestigious academic institutions in the United States," said course director Dr. Juan Lertora, director of CC clinical pharmacology and a member of the Office of Clinical Research Training and Medical Education.
Since the course was first offered 15 years ago, it has expanded beyond the CC to include a number of off-site partners. Last year 486 students from 26 long-distance sites registered for the course, in addition to the 393 enrollees at the NIH.
"We have been very pleased with the great interest generated by this course," added Dr. Frederick P. Ognibene, deputy director for educational affairs and strategic partnerships at the CC and director of the OCRTME.
Registration is open to all interested individuals without charge, unless the course is being taken for graduate credit. This course may be taken for graduate credit through the Foundation for Advanced Education in the Sciences (FAES) [disclaimer] as PHAR 500 I and PHAR 500 II. Contact the FAES directly at 301-496-7976 before August 17. Certificates of participation will be awarded at the end of the course to all students who attend at least 75 percent of the lectures
The recommended textbook is Principles of Clinical Pharmacology, Third Edition (2012), edited by Arthur J. Atkinson, Jr. and other course faculty. This textbook is available in the FAES Bookstore on the CC B1 level and at the NIH Library (online version).
Additional information regarding the Principles of Clinical Pharmacology course, including online registration, is available online or at 301-496-9425.
Immumohematology and blood transfusion
The Clinical Center Department of Transfusion Medicine and the American Red Cross will host the 31st Annual Immunohematology & Blood Transfusion Symposium on September 13 in Masur Auditorium.
Developed to inform about recent developments, current practices, controversies, and laboratory management issues relative to transfusion medicine, the event will be of interest to health-care providers who work with blood products.
Advanced registration is required and there is no fee for attending the symposium. Please register before September 1. For more information, visit clinicalcenter.nih.gov/dtm/research/symposium.html.
Red cell genotyping
The full-day event is intended for medical and laboratory professionals interested in clinical red cell genotyping applications for immunohematology and transfusion medicine, and will review the laboratory aspects and clinical benefits of red cell genotyping in patients and donors.
Web writing: Part 2—Repurposing print text for the web
If you need a cost-effective way to inform your audience, turning printed matter into web pages may serve you well. But to repurpose print for the web, don’t simply "cut-and-paste" text into a web page. What works in print may not work on the web.
Words are words, right?
The medium makes the message. Print material reads differently from web content. Print has space for narrative. Paragraphs can be longer, and explanations can be detailed. Web content is different.
Web page readers scroll and scan
Web page readers have a mission. They visit your page for a purpose, and your information should help them fulfill it. If it doesn’t, they leave quickly.
So before you craft a web page from printed material, think about why readers need your content.
- What do readers want to do?
- Will your content help them do it successfully?
- What words really need to stay?
Turning print documents into effective web content
Though your web document will look different from its print form, the content can still serve your audience’s information needs. Put important, clear messages at the top of the web page.
- Group content into logical chunks.
- Use headings.
- Highlight key facts in bulleted lists.
- Explain complex instructions with visual tools, such as tables, but keep them simple.
- You can also include a link to a "printer-friendly" version.
Select the best from your print document for the web, and it will have PLC.