Forum for Clinical Mentored K Awardees 2012

Forum for Clinical Mentored K Awardees

December 13-14, 2012

Co-Chairs

Stephen I. Katz, M.D., Ph.D.
Susana A. Serrate-Sztein, M.D.
Marie Mancini, 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

The purpose of this forum was to bring together currently funded 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 interact with NIAMS extramural staff and leadership. 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 clinician-scientists. Current K awardees were also specifically asked about challenges they may have encountered when accessing NIH or university research resources (e.g., core facilities, biological materials, data, biostatistical support, collaborations). Deidentified responses were shared with all participants before they arrived. Common themes from participants’ responses—including balancing patient care and research, obtaining mentoring, and establishing independence—guided much of the discussion.

On December 13, participants gathered for an overview of the current K awardees’ research. Awardees outlined their projects and progress. Each presentation was followed by a short period for questions. This session provided attendees with the opportunity to learn about others’ research projects and to exchange information about strategies for overcoming challenges inherent in establishing a research career. The discussions, combined with the material collected in advance, set the stage for the rest of the meeting.

The next day of the forum began with the participants splitting into two groups. One consisted of the 13 K awardees, who participated in a round-robin session where they separated into smaller groups and rotated among NIAMS extramural staff (i.e., grants management staff, scientific review officers, program directors, and clinical coordinators). The session provided the awardees with an overview of the organization and functions of the staff of the NIAMS extramural program, as well as an opportunity for discussion in a small group.

All others met with NIAMS Director Dr. Steve Katz and NIAMS Deputy Director Dr. Bob Carter to discuss the role of the NIAMS Centers programs in clinical career development activities. This discussion will contribute to an ongoing NIAMS evaluation of its Centers programs. Participants discussed how NIAMS Centers can better train, mentor, and otherwise support people who are interested in establishing independent research careers. All agreed that formal career-development components of NIAMS centers should complement institutions’ existing programs, rather than to duplicate them.

The remainder of the day was spent discussing the historical outcomes of the NIAMS Clinical Mentored Career Development Awards; ways in which current awardees can make the most out of their Career Development Awards; and strategies for planning successful transitions to R01 grants and independent research careers.

Historical Outcomes: NIAMS Clinical Mentored Career Development Awards

NIAMS Program Director Dr. Marie Mancini 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

Obtaining additional research support

The NIH mentored K award provides salary and benefits, plus some money for research. 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 statistical and database support. Thus, some K awardees are able to take advantage of institutional K awardee supplements or access to other resources (e.g., core resources or databases). Some have received additional funding from foundations and other organizations. The extra financial support can be used for diverse needs ranging from supplies to personnel (e.g., a clinical coordinator).

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. Some participants experience pressure to spend more time seeing patients to generate revenue for the institution. One person noted that patient care is largely what provides physicians with income. Another mentioned that the nature of clinical practice is to want to answer patients’ questions and follow-up with patients. The requirement that K awardees spend a finite percentage of their time (75 or 50 percent, depending on their clinical specialty) on research can be useful when setting boundaries. K awardees shared strategies for managing time (1 week of clinic, 3 weeks of research vs. seeing patients at a set time each week). Regardless of the approach, patient care activities including clinical questions, prescription refills, and consultations with colleagues are time consuming; this is not unique to clinical researchers. The line between a K awardee’s clinical practice time and clinical research time can be unclear, particularly for K23 recipients.

Conducting clinical research

Several K awardees who were conducting clinical studies mentioned challenges associated with patient recruitment and regulatory requirements. The availability and involvement of clinical coordinators to assist K awardees in patient recruitment for their projects varies among institutions. Participants shared strategies for engaging colleagues in the recruitment process. One strategy is to first present a study concept to the department or division that will be involved in the patient recruitment. This allows the researcher to get feedback about what would facilitate recruitment, and a general approval of the concept before approaching the institutional review board (IRB) that reviews and approves patient-oriented research before studies can begin. Experiences with IRBs, material transfer agreements, and other requirements vary with institutions. Some institutions that have NIH Clinical and Translational Science Awards (CTSAs) are participating in consortia that have centralized IRBs.

Mentoring

Mentors are critical participants in the career development awards. In addition to providing K mentees 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. A former K award recipient mentioned that having a research mentor who is not vested in the awardee’s patient-care responsibilities can help with the aforementioned need to balance clinical practice and research.

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 that are provided by some 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 institution is important. 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 occurs in many ways. People have different needs at different times. Mentorship is the responsibility of both the mentor and the mentored. People may need to change mentors, particularly if they move to a different institution. NIH Program Directors can assist K awardees who find themselves in this situation.

K awardee participants also were interested in how they could become good mentors. Advice included learning from your own experience as a mentee, and reviewing the guidance that is given to people who are searching for a mentor and developing the specified traits. Because mentorship takes time and resources, the decision to become a mentor should be well thought out.

Looking to the Future: Planning a Successful Transition to Your R01

Becoming a principal investigator (PI) on an NIH R01 grant is a widely accepted measure of independence and a primary goal for most K awardees. Researchers who had recently received their first R01s shared their experiences with establishing independent projects. For some, their R01 applications directly related to the scientists’ K award projects. K awardees who wish to continue their project with R01 support 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, several people mentioned the challenge of getting sufficient preliminary data necessary for an R01 application while working under a K award. This means investigators may need to plan for funding for additional research time in the interval between the end of a K award and the obtaining of an R award. Applicants also need to balance the time they spend writing grant applications with the continued need to publish papers. An additional challenge is that some K awardees will need to have obtained a different position (e.g., an assistant professorship instead of an instructorship) before their institutions will permit them to apply for R01 grants.

Prospective applicants were urged to get colleagues and mentors to review their proposals before submitting them to the NIH. Some institutions and professional societies (e.g., the U.S. Bone and Joint Initiative) mentor K awardees and other junior investigators by providing forums through which senior investigators provide feedback on draft research proposals and grant applications. These resources can be useful once potential applicants have formulated ideas for their next project.

Establishing independence

Participants discussed different strategies for distinguishing their research from their mentors’. Some participants have developed distinct patient cohorts, established collaborations that do not involve their mentor, or have drawn distinctions between different types of studies (e.g., in vitro vs. in vivo).

R01 applications should be predicated on a team of scientists that is capable of answering the proposed research questions. While reviewers may question the independence of people who include their K award mentors as personnel in their R01 applications, clearly articulating the mentor’s role may alleviate this concern. New projects should move the field forward in a direction that is distinct from the mentors’ work.

Submitting a multi-PI application

Increasingly, health-related research involves teams that vary in terms of size, hierarchy, location of participants, goals, disciplines, and structure. NIAMS supports NIH policies that formally allow more than one PI on individual research awards. The presence of more than one PI on an application or award diminishes neither the responsibility nor the accountability that any individual PI has for the project and its results.

The decision to submit a multi-PI application should be driven by the scientific questions being asked. For example, a clinical researcher may wish to partner with someone who has expertise in genomics to design a study to ask questions that neither investigator could answer independently.¹

Participants

BONEWALD, Lynda, Ph.D., University of Missouri-Kansas City School of Dentistry
*BROWN, Daniel R., M.D., Ph.D., Massachusetts General Hospital/Harvard Medical School
CHOATE, Keith A., M.D., Ph.D., Yale University School of Medicine
*CHOWDHARY, Vaidehi R., M.D., Mayo Clinic
CROFFORD, Leslie J., M.D., University of Kentucky
DAIKH, David, M.D., Ph.D., University of California, San Francisco
*DRAKE, Matthew T., M.D., Ph.D., Mayo Clinic
*FERGUSON, Cristin M., M.D., Wake Forest School of Medicine
GILKESON, Gary S., M.D., Medical University of South Carolina
*JAIN, Nitin B., M.D., M.S.P.H., Brigham and Women's Hospital/ Harvard Medical School
*KIM, Seoyoung C., M.D., M.S.C.E., Brigham and Women's Hospital/ Harvard Medical School
KONG, Heidi, M.D., M.H.Sc., National Cancer Institute
KYTTARIS, Vasileios, M.D., Beth Israel Deaconess Medical Center/Harvard Medical School
*LAWLOR, Michael, M.D., Ph.D., Medical College of Wisconsin
LEE, Francis Y., M.D., Columbia University, College of Physicians and Surgeons
*LIAO, Wilson, M.D., University of California, San Francisco
MUHLRAD, Paul, Ph.D., Muscular Dystrophy Association
MICLAU, Theodore, M.D., University of California, San Francisco
*POLGREEN, Lynda E., M.D., M.S., University of Minnesota Twin Cities
PRAHALAD, Sampath M.D., M.Sc., Emory University School of Medicine
*RANGANATH, Veena K., M.D., M.S., University of California, Los Angeles
SAH, Robert, M.D., Sc.D., University of California, San Diego
*SIMPSON, Eric L., M.D., M.C.R., Oregon Health and Science University
SHANE, Elizabeth, M.D., Columbia University, College of Physicians and Surgeons
*SU, Laura, M.D., Ph.D., Stanford University School of Medicine
*TOROK, Kathryn S., M.D., University of Pittsburgh Medical Center

*Current K08 and K23 awardees

NIAMS

BAKER, Carl C., M.D., Ph.D.
BOYCE, Amanda, Ph.D.
BUSCHMAN, Justine
CARTER, Robert, M.D.
CHEN, Faye H., Ph.D.
CIBOTTI, Ricardo, Ph.D.
DRUGAN, Jonelle K., Ph.D., M.P.H.
KATZ, Stephen I., M.D., Ph.D.
KESTER, Mary Beth, M.S.
KHAN, Shahnaz
LANGER, Mark
LIN, Helen, Ph.D.
LINDE, Anita M., M.P.P.
MANCINI, Marie, Ph.D.
MAO, Su-Yau, Ph.D.
MARRON, Kathryn, Ph.D.
McGOWAN, Joan A., Ph.D.
MOEN, Laura K., Ph.D.
NELSON, Melinda
NICHOLSON, Anna
NUCKOLLS, Glen, Ph.D.
PANAGIS, James S., M.D., M.P.H.
RAFFERTY, Charles, Ph.D.
SERRATE-SZTEIN, Susana A., M.D.
TONKINS, William Phil Jr., Ph.D.
THACH, Yen
TYREE, Bernadette, Ph.D.
WANG, Fei, Ph.D.
WASHABAUGH, Charles, Ph.D.
WITTER, James, M.D., Ph.D.
ZHENG, Xincheng (Ted), M.D., Ph.D.

¹Bridging the translational research gap: a successful partnership involving a physician and a basic scientist. Kong HH, Segre JA. J Invest Dermatol. 2010 Jun;130(6):1478-80. doi: 10.1038/jid.2010.65. PMID: 20463666 [PubMed - indexed for MEDLINE] PMCID: PMC3519100

Roundtable