Johns Hopkins Institute for Clinical and Translational Research Applies Human, Technology Solutions to Research Challenges

The Institute for Clinical and Translational Research (ICTR) at Johns Hopkins University, now in its second year, has established a variety of innovative initiatives dedicated to addressing known barriers to research. By continually seeking feedback from the research community, the ICTR has revealed some previously unrecognized (or under-recognized) institutional challenges to clinical and translational science that it now plans to address.

The addition of two research navigators, Linda E. Post, R.N., B.S.N., and Vincent Williams, B.S., C.C.R.P., has exponentially increased the ICTR’s ability to provide personalized service to investigators. Their combined three decades of experience in research nursing and coordination at Hopkins make them ideal first points of contact, and they have already guided hundreds of investigators to important services and information.

The navigators also serve as important resources to our Accelerated Translational Incubator Program (ATIP) funding recipients. Upon receiving these pilot awards, which range from $25,000 to $100,000, each ATIP investigator is assigned a navigator to assist in developing milestones and identifying potential impediments. To date, ICTR has received 192 ATIP applications and funded 15 proposals in the first two cycles. A third cycle of submissions is under review.

ATIP applications are processed through Connection Request, the ICTR’s custom software system designed to unify existing service request forms and quickly create new ones. In addition, both the navigators and the ATIP award evaluators use the software to manage workflow. The name “Connection Request” reflects the ICTR’s slogan: “Where science and people connect.” Currently integrated services include biostatistics; communications, data management, and computing; study participant recruitment and retention; translational technology core services; and research ethics.

Another technological solution is the Clinical Research Management System (CRMS), a secure, Web-based application that organizes and streamlines clinical research management by storing subject enrollment information in a secure location, maintaining a library of research forms, creating real-time case report forms and automatically generating protocol schema. CRMS also tracks potential research participants who decline to join a study or do not complete a research study, which means that the efficiency of research participant recruitment efforts can be systematically monitored and assessed.

An overarching ICTR goal is to enhance the image of study participation by emphasizing the social contribution made by study participants. This year, for example, the ICTR sponsored an Alzheimer’s Research Participation Appreciation Forum where study participants were directly thanked and celebrated. The ICTR’s research subject advocate, Liz Martinez, R.N., B.S.N., C.C.R.C., has singlehandedly established a “stickers-and-pins” program that provides on-the-spot recognition in our clinical research units. The ICTR has designated May “Research Participant Appreciation Month” at Hopkins, with a campus-wide publicity campaign based on the message that: “Behind every treatment and every cure is a group of extraordinary volunteers.” ICTR is also joining with the nonprofit Center for Information and Study on Clinical Research Participation and other regional organizations for a Baltimore Clinical Research Education Day on May 9.

By supporting these and many other micro- and macro-scaled, human- and technologically-based solutions, the ICTR has made significant strides in identifying and addressing areas of need and establishing its services and resources within the research community at Johns Hopkins.

Clinical Research Management KFC Hosts 2nd Annual Workshop

The Clinical Research Management Key Function Committee (CRM KFC) seeks to improve efficiency and streamline processes related to clinical research management. At its second annual workshop on June 22–23, 2009, representatives from all the CTSA institutions will discuss metrics and data collection to support performance improvement in clinical research management. Participants will share lessons learned, network with their counterparts at other CTSA institutions, and gain the perspective of experts from NIH, industry, the NIH Office for Human Research Protection, consulting groups, and FDA. Each of the 39 CTSA sites has been asked to send four participants who represent clinical trials, related contracts, clinical investigators, and “champions of change”— institutional leaders with responsibility and authority over protocol processing.

The workshop will be held at Natcher Conference Center on NIH’s Bethesda campus and is supported by a conference grant awarded by NCRR to Yale University. More Information.

The CRM KFC is spearheading the CTSA consortium’s effort to collect baseline data about the time it takes to process protocols (specifically, institutional review board approval) and negotiate contracts—areas thought to be barriers to getting research trials underway. As two pilot studies begin, all the CTSA sites have been asked to provide data on processing of protocols and contracts for one month in 2009. Each site will track processing from initiation to completion, noting key intermediate points, and record the information in a central registry (Vanderbilt University’s Research Electronic Data Capture, or REDCap). The sources of data will be kept anonymous to others viewing the registry so that users can analyze data as a learning exercise and because anonymity obviates the need for exact comparability among data. These initial forays into collecting consortium-wide data on process measures are intended to encourage those involved in clinical research management to begin using process data for performance improvement. Eventually, it is hoped that data coordinators and others will work together to develop standard definitions for process flow and process metrics across the consortium and design and conduct studies of comparable data. Data reporting should be complete in 2009. The CRM KFC will evaluate the data and propose the next steps.

The CRM KFC is working closely with the CTSA Strategic Goal Committee on National Clinical and Translational Research Capability. During the past four months, the CRM KFC has increased collaborative efforts with other KFCs to share resources and develop projects using complementary strengths. For example, the June workshop will feature an FDA speaker and breakout sessions on investigational drug and device applications to address issues raised by the Regulatory Knowledge KFC. The workshop presentation from the Office of Human Research Protection will speak to issues of concern noted by the Clinical Research Ethics KFC. A representative of the Biostatistics, Epidemiology, and Research Design KFC is assisting with the development of the pilot studies and will advise the CRM KFC on how to use the resulting data.

Informatics Networking Meeting Sparks Sharing and Collaboration

The General Clinical Research Centers (GCRCs) Informatics Working Group sponsored a Clinical and Translational Informatics Networking Meeting at the Mayo Clinic at Scottsdale, AZ, on February 4–5 that brought together individuals who enable clinical and translational researchers using informatics. The meeting sought to promote networking and collaboration to solve shared challenges in clinical and translational research informatics, share best practices and contribute to shaping the future of this area. The meeting focused on smaller research institutions and those in less resource-rich regions, and the attendees represented a diverse range of institutions, programs and perspectives.

“The enthusiasm and energy generated by the interaction of the participants has sparked collaborations among individuals who did not know each other before this meeting,” says Michael Lin from Mayo Clinic, who chaired the meeting planning committee.

Over 50 attendees—all of whom are used to solving problems confronting clinical and translational scientists at their respective institutions—left with an appreciation for their new colleagues from across the country who work in a variety of NCRR-sponsored programs (GCRCs, Research Centers in Minority Institutions, IDeA Networks of Biomedical Research Excellence, Centers of Biomedical Research Excellence and CTSA sites).

Presentations during the two-day program focused on the informatics tools and resources in place at different institutions, best practices, successful collaborations and ideas for future collaborations. Although most of the attendees worked in similar roles in different program areas, in almost all cases they did not know each other or have any experience with the research resources used by their peers. They quickly grasped the challenges described by presenters and just as quickly gained an understanding of informatics tools and technical solutions being used to support research(ers).

The event generated the following key ideas:

• Develop additional in-person informatics networking opportunities
• Create a central inventory of tools and resources available at various institutions
• Maintain communication among attendees and their respective program areas
• Explore cross-program informatics collaborations to foster mutually beneficial relationships

The GCRC Informatics Working Group organized the meeting, with travel support through the GCRC award at Wake Forest University. Meeting Agenda Presentations.

Highlights from the 2009 National Clinical & Translational Research Education Annual Meeting

The National Clinical & Translational Research Education Annual Meeting, Empowering Individual and Team Success in Clinical and Translational Research, brought together more than 400 scholars and educators. Held at the Marriott Wardman Park Hotel in Washington, D.C, on April 14–15, the meeting provided clinical research scholars with training and career development opportunities while giving educators an opportunity to share best practices for education, mentoring and career development.

Steven DeKosky, M.D., vice president and dean of the University of Virginia School of Medicine, kicked off the meeting by discussing the importance of integrating the strengths of the individual with those of the team, thus improving the chances of success in discovery and translation. In a subsequent panel discussion, representatives from academia, government, foundations and industry offered diverse perspectives and advice on balancing career development while pursuing independent and collaborative funding opportunities.

In plenary sessions, Kurt Stange, M.D., Ph.D., professor of family medicine, epidemiology & biostatistics, oncology and sociology at Case Western Reserve University, spoke about translating research into practice and practice into research. Susan Johnson, M.D., associate provost for faculty and professor of obstetrics and gynecology at the University of Iowa, discussed how to get things done in the midst of chaos. Groups of presenters from multiple institutions collaborated to present workshops for meeting participants, reflecting the multidisciplinary and collaborative thrust of the CTSA program.

Key activities for scholars included a mock study section in which participants reviewed grant proposals to learn more about the review process, a tour of the NIH Clinical Center and a poster session. More than 125 scholars met one-on-one with 28 NIH program officers representing 14 NIH institutes. Throughout the two-day meeting, participants had opportunities for “speed mentoring” with faculty and NIH staff. More than 210 scholars attended 12 workshops on topics that included:

• Getting the most out of your mentor,
• Writing papers without (too much) pain,
• Negotiating a faculty position,
• Dealing with rejection and responding to reviewer comments,
• Understanding conflicts of interest,
• Working with the media and delivering memorable messages, and
• Collaborating with industry.

Educators attended eight workshops throughout the conference, including:

• NIH update for educators,
• The role of competencies in defining a profession,
• Training mentors,
• Strategies for meeting clinical and translational science education needs across health professions,
• Innovations in curriculum,
• Designing and launching doctoral programs, and
• Using the National CTSA Education Resource Program.

The 2010 meeting is scheduled for April 6–7 at the same location.

An Eye to the Future: Training the Next Generation of Researchers (NCRR Reporter, Winter/Spring 2009)

Future translational researchers are now benefiting from the training and education provided through innovative programs at medical institutions across the nation with support the CTSA program. Although these training programs have diverse strengths and goals, they share the common mission of providing junior investigators with the knowledge, skills and resources they need to conduct science that will improve human health. Read more.

The Business End of Translational Research (NCRR Reporter, Winter/Spring 2009)

With its focus on multidisciplinary collaboration, the CTSA program creates an environment in which business principles can inform scientific development, speeding up the translational process. A number of CTSA grantees have forged relationships with business schools that take advantage of a natural synergy of resources. Read more.