Forum for Clinical Mentored K Awardees 2013

Forum for Clinical Mentored K Awardees

December 12-13, 2013

Co-Chairs
Stephen I. Katz, M.D., Ph.D.
Susana A. Serrate-Sztein, M.D.
Marie Mancini, Ph.D.
Amanda Boyce, Ph.D.

Introduction

The NIH K08 and K23 Career Development Awards provide support for a sustained period of "protected time" (3-5 years) for intensive research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral or clinical sciences leading to research independence. Previous discussions have identified the K-to-R01 transition as a critical point in the development of junior investigators’ independent research careers.

Purpose

This forum was first held in 2012. Based on the feedback received from participants, NIAMS held another forum in 2013. The purpose of this forum was to bring together current NIAMS K08 and K23 awardees who are in their third year of award, as well as physician-scientists who have recently received R01 awards, and established researchers for a shared, open discourse on the challenges junior investigators face in pursuing research independence. The forum also provided an opportunity for the awardees to network with one another, as well as to interact with NIAMS leadership and extramural staff. The long-term goal of this forum is to enhance the Institute’s support of early-stage physician-scientists by encouraging and enabling K08 and K23 awardees to continue performing basic, translational, and/or patient-oriented research in their chosen fields.

Overview

In preparation for the meeting, participants were asked about obstacles facing clinician-scientists and about what NIAMS, as well as the broader medical/scientific community, might do to help support clinician-scientists to achieve research independence. Current K awardees were also specifically asked about the challenges they may have faced when accessing NIH or university research resources (e.g., core facilities, biological materials, data, biostatistical support, collaborations). Common themes from participants’ responses included challenges in balancing patient care and research, obtaining biostatistical and clinical coordinator support, and establishing research independence. These themes guided much of the discussion at the forum.

The forum started in the afternoon of December 12, with an overview of the current K awardees’ research. Awardees briefly outlined their research projects and progress. Each presentation was followed by a short period for questions and discussion. This session provided attendees with the opportunity to hear about each others’ research projects and to exchange information about strategies for overcoming challenges inherent in research. The discussions, combined with the material collected in advance, set the stage for the rest of the meeting.

The second day of the forum began with two parallel sessions. For the round-robin session, the 15 K awardees separated into four smaller groups and rotated among NIAMS extramural staff stations (i.e., grants management, review, program, and clinical research). This session provided the awardees with an overview of the organization and functions of the staff and components of the NIAMS extramural program, as well as an opportunity for discussion in a small group. All other forum participants met with NIAMS Director Dr. Steve Katz and NIAMS Deputy Director Dr. Bob Carter to provide input on the Institute’s Long-Range Plan. This discussion contributed to the cross-cutting section of the Long-Range Plan, particularly needs in training.

The rest of the forum consisted of a presentation on historical outcomes of the NIAMS Clinical Mentored Career Development Awards and two broad discussion topics: 1) ways in which current awardees can make the most out of their clinical mentored career development awards; and 2) strategies for a successful transition to research independence (i.e., R01 grant or equivalent).

Historical Outcomes: NIAMS Clinical Mentored Career Development Awards

Dr. Marie Mancini, NIAMS Program Director for systemic autoimmune disease biology, set the stage for the discussion by summarizing the findings from recent NIAMS and NIH evaluations, including

Focusing on the Present: How to Make the Most Out of Your K Career Development Award (Discussion Moderator: Dr. Kevin Cooper)

Mentors

Mentors are critical participants in the career development process. In addition to providing K awardees with space and resources to conduct their research, mentors have committed to helping the mentee navigate his/her research and ultimately his/her independent career course.

Participants talked about the advantages of having a mentoring team, rather than a single mentor, with each member providing guidance on a different area (e.g., career development, research techniques, work-life balance, grant-writing). In addition to their own formal mentoring team, early-stage investigators may take advantage of national mentoring programs provided by professional societies and other groups (e.g., American College of Rheumatology, U.S. Bone and Joint Initiative, American Society for Bone and Mineral Research). Some participants noted that identifying mentors external to their own department and even outside their own institution is important. K awardees may need to change mentors during the course of the award, particularly if they move to a different institution. NIH Program Directors can assist K awardees who find themselves in this situation. Peer-to-peer learning from other awardees, either within or outside an awardee’s own institution, also can be valuable.

Establishing and maintaining a productive mentoring relationship is one of the many challenges faced by K awardees. Participants noted that meeting potential collaborators and establishing fruitful collaborations, and successfully hiring, training, and managing clinical and research staff require skills that are not always inherent or taught. Some K awardees had taken advantage of leadership courses offered by their institutions.

Mentoring relationships can also be challenging given the current fiscal climate. Mentors may not be amenable to the K awardee taking their research with them, if the mentor is also struggling to get funding for their related projects. Concerns about establishing an independent research career led some participants to choose research projects that differed from their mentor’s interests in order to ease the transition to independence. Participants noted that it is important to have the conversation early on with the mentor about what research specifically belongs to the K awardee, and how they can take that project with them as they move to establish an independent research career.

Obtaining additional research support

The NIH mentored K award provides salary and benefits, plus some money for research support (supplies, technician, etc.). K awardee participants emphasized the importance of obtaining financial and intellectual support in addition to what is provided through the NIH K award. There is considerable institutional variability in access to additional resources, with some providing additional financial support to K awardees, access to a clinical coordinator, or biostatistical support. K awardees at institutions with a Clinical and Translational Science Award (CTSA) noted that they receive a variety of benefits from this resource, including research tools, access to collaborative academic partnerships, and other staff support. Some K awardees have received additional funding from foundations or other organizations. However, due to the policy constraints on K awards, outside supplemental funding is often not a viable option to provide additional salary support.

Balancing patient care and research

The K08 and K23 awards support clinically-trained professionals, most of whom see patients in addition to conducting research, teaching and fulfilling administrative responsibilities. Patient care activities include dealing with clinical questions, prescription refills, consultations with colleagues, as well as a myriad of administrative duties. K awardees mentioned that the nature of clinical practice is to be available to answer patients’ questions and follow up with them, beyond the time specifically reserved for clinic, which leaves less time to conduct research. The lines demarcating a K awardee’s clinical practice time versus clinical research time can be unclear, particularly to K23 awardees, who are conducting patient-oriented research.

Conducting clinical research

A common issue brought up by K awardees who are conducting clinical studies was challenges associated with patient recruitment and regulatory requirements. The level of involvement and the availability of clinical coordinators to assist K awardees in patient recruitment for their projects seems to vary among institutions. Several awardees mentioned that it is difficult to fund a clinical coordinator position within the framework of the K award, and others mentioned frequent turnover of clinical coordinators as a major issue. Meeting the requirements of the institutional review board (IRB) that reviews and approves patient-oriented research before studies can begin is also time consuming. Participants with access to an institutional CTSA noted that they were able to get assistance navigating the requirements of the IRB through resources provided by the CTSA. Some institutions do not see the need to provide laboratory space or technician support to individuals conducting clinical research. However, these resources may be vital to ensuring the success of the research. In addition, clinician scientists must maintain their education and training to retain their clinical licensure, which often takes time away from research.

Looking to the Future: Planning a Successful Transition to Your R01 (Discussion Moderator: Dr. Betty Diamond)

A widely accepted measure of research independence and a primary goal for most K awardees is to successfully compete for an NIH R01 grant as the principal investigator (PI). Forum participants who had recently received their first R01 shared their experiences with establishing independent projects. K awardees should remain alert for the right moment — when their science is at its most promising and they have sufficient preliminary data — to write their applications. However, it is difficult to know when you do indeed have "enough" preliminary data, and several people mentioned the challenge of generating sufficient preliminary data necessary for an R01 application while on a mentored K award. Investigators may experience a lapse of research funding in the interval between the end of a K award and the obtaining of an R award. Some organizations, such as the American Society for Bone and Mineral Research and the American College of Rheumatology/Rheumatology Research Foundation, in an effort to mitigate the risks and effects of research funding lapses for junior investigators, are offering bridge funding to support K awardees for 1-2 years until they are awarded their first R01.

Like most researchers, K awardees also need to balance the time they spend writing grant applications with the continued need to publish papers. A number of the K participants mentioned difficulty in determining authorship (and authorship order) on publications; holding the senior author position denotes project leadership and a level of research independence; this can be particularly meaningful when being considered for an independent research grant or for a promotion. There is also a need to weigh the benefits of publishing a number of smaller papers, or continuing to collect data with the hope of publishing a paper in one of the major journals.

Collaborators can be an important asset when applying for an R award. Although they need not commit effort or be listed as key personnel, they can write letters of support for the grant application, indicating their role in the project and detailing how they will support you. The benefit of collaboration may be an increase in resources — both intellectual and material. However, increased collaboration may require more efficient time and people management.

Prospective applicants were urged to get colleagues and mentors to review their grant proposals before submitting them for review. Some institutions and professional societies mentor K awardees and other junior investigators by providing forums through which senior investigators provide feedback on draft research proposals and grant applications. Established investigators encouraged the K awardee participants to volunteer to review papers and grant proposals for their colleagues as a way to gain experience. Some institutions and foundations offer grant writing classes, and participants were encouraged to take advantage of these opportunities. Participation in study sections can also provide invaluable insights as to what review committees consider when evaluating grant proposals.

Participants

*ASSASSI, Shervin, M.D., M.S., University of Texas Health Science Center at Houston
*CHANG, Gregory, M.D., NYU Langone Medical Center
*CHIEN, Peter C., M.D., Beth Israel Deaconess Medical Center/Harvard Medical School
CIVITELLI, Roberto, M.D., Representing the American Society for Bone and Mineral Research, Washington University
COOPER, Kevin D., M.D., University Hospitals Case Medical Center and Case Western Reserve University
DAVIDSON, Anne, M.B.B.S., Representing the Rheumatology Research Foundation, The Feinstein Institute for Medical Research/Hofstra North Shore-LIJ School of Medicine
DIAMOND, Betty, M.D., The Feinstein Institute for Medical Research/Hofstra North Shore-LIJ School of Medicine
*ENIS, David R., M.D., Ph.D., University of Pennsylvania School of Medicine
*GUDJONSSON, Johann E., M.D., Ph.D., University of Michigan Medical School
*HARRIS, John E., M.D., PhD, University of Massachusetts Medical School
JONES, Lynne C., Ph.D., Representing the Orthopaedic Research Society, Johns Hopkins
*KAUFMAN, Charles K., M.D., Ph.D., Brigham and Women’s Hospital/Harvard Medical School
LEE, Yvonne C., M.D., Harvard Medical School/Brigham and Women’s Hospital
*LIANG, Kimberly P., M.D., University of Pittsburgh
*LIAO, Katherine P., M.D., M.P.H., Harvard Medical School/Brigham and Women’s Hospital
*LITTLE, Dianne, B.V.Sc., Ph.D., Duke University Medical Center
*NELSON, Amanda E., M.D., M.S.C.R., University of North Carolina at Chapel Hill
PAYNE, Aimee S., M.D., Ph.D., University of Pennsylvania
*PHILLIPS, Kristine, M.D., Ph.D., University of Michigan Health System
*TOM, Wynnis L., M.D., University of California, San Diego
*WEISS, Pamela F., M.D., M.S.C.E., Children’s Hospital of Philadelphia
WHEATLEY, Mary V., American College of Rheumatology
*YAZDANY, Jinoos, M.D., M.P.H., University of California, San Francisco

*Current K08 and K23 awardees

NIAMS

BAKER, Carl C., M.D., Ph.D.
BOYCE, Amanda, Ph.D.
BURROWS, Stephanie, Ph.D.
BUSCHMAN, Justine, M.S.
CARTER, Robert, M.D.
DRUGAN, Jonelle K., Ph.D., M.P.H.
KATZ, Stephen I., M.D., Ph.D.
KESTER, Mary Beth, M.S.
KHAN, Shahnaz, M.S.
LANGER, Mark
LESTER, Gayle, Ph.D.
LIN, Helen, Ph.D.
LINDE, Anita M., M.P.P.
MANCINI, Marie, Ph.D.
MAO, Su-Yau, Ph.D.
McGOWAN, Joan A., Ph.D.
MOEN, Laura K., Ph.D.
NELSON, Melinda
NICHOLSON, Anna
OMBRELLO, Michael J., M.D.
PANAGIS, James S., M.D., M.P.H.
REUSS, Reaya, M.S.
SALAITA, Kathy, Sc.D.
SERRATE-SZTEIN, Susana A., M.D.
THACH, Yen
WANG, Fei, Ph.D.
WASHABAUGH, Charles H., Ph.D.
ZIELINSKI, David, Ph.D.

Roundtable