Robert Carter, M.D.
Gayle Lester, Ph.D.
Ricardo Cibotti, Ph.D.
Kristy Nicks, Ph.D.
Amanda Boyce, Ph.D.
The NIH K08 and K23 Mentored Research 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 clinician scientists’ independent research careers.
NIAMS held its first K Forum in 2012. Based on the positive feedback received from participants, NIAMS convened subsequent meetings in 2013, 2014, 2015, 2016, March 2018 and December 2018 and 2019. The NIAMS K Forum brings together clinician scientists with a NIAMS K08 or K23 award. While the meeting has traditionally included only 3rd year K awardees, in 2020, some 4th year K awardees who had not attended the meeting previously also participated. The Forum also includes established clinician scientist as mentors, some of whom have had NIH K awards in the past, and representatives of professional and voluntary organizations. The purpose of the meeting is to foster a shared, open discussion of challenges K investigators face in pursuing research independence. The Forum also provides an opportunity for the K awardees to network with other participants and interact with NIAMS leadership and staff. The long-term goal of the meeting is to enhance the Institute’s support of early-stage clinician scientists by encouraging and enabling them to continue performing basic, translational, or patient-oriented research in their chosen fields.
Overview of NIAMS Extramural Structure and Functions
The Forum started on December 7 with a welcome by the NIAMS Acting Director, Dr. Robert Carter, followed by an overview of the NIAMS extramural program by Dr. Kristy Nicks. Dr. Nicks also introduced some of the extramural staff in the areas of grants management, scientific review, and management of clinical awards, as well as program officers who serve as the principal liaisons between extramural investigators and the NIH. The focus of the presentation was on helping attendees understand how NIAMS administers extramural grants. After providing a brief introduction to the structure of NIH and NIAMS, Dr. Nicks provided more information about the NIAMS extramural programs. The NIAMS Division of Extramural Research consists of the Office of Extramural Operations, which manages the NIAMS grants policies and procedures, and the Program Division, which supports scientific research in the NIAMS mission areas. Grants Management specialists are responsible for the business management aspects of grants. The Scientific Review Branch oversees the receipt and review of grant applications. The Clinical Management Team is involved in the oversight and management of clinical research studies. The extramural Program Division supports and oversees the scientific and technical aspects of awards.
The introduction to the extramural program was followed by research presentations by the investigators in the 3rd or 4th year of their K award, which were moderated by Dr. Ricardo Cibotti. The scientists briefly outlined their research projects and progress. Their presentations were followed by a short question and answer period.
Tuesday Morning Welcome
On December 8, Dr. Robert Carter, NIAMS Acting Director, welcomed the group and reiterated NIAMS’ commitment to developing clinician-scientists. He recognized how the unpredictability of the NIH budget, the current funding climate, and, this year, the emergence of the COVID 19 pandemic, is a strain on all researchers. He expressed the Institute’s concerns about how the pandemic is affecting early-stage researchers, such as our K awardees, and the disproportionate toll it has on women as well as all researchers with childcare or other family caretaking responsibilities. He reaffirmed NIAMS’ support for these early-stage investigators and encouraged K awardees to contact their program officers for assistance as necessary.
Presentation on K Award Outcomes, Policies, and Funding Opportunities
After Dr. Carter’s remarks, Dr. Amanda Boyce presented information about the clinical K awards program and its outcomes along with highlights about related polices. She covered some analyses of the success of the K awards as well as some of the steps the NIH and NIAMS are taking to overcome common challenges faced by early-stage clinician-scientists. She then reported on policy updates over the past year that are relevant to clinician-scientists with career development awards. Finally, she briefly reiterated the goals and purpose of the K Forum.
A 2011 NIH-wide evaluation of K01, K08, and K23 awards explored who applies for and receives mentored career development awards and the effects of the K award on research productivity and independent careers. The analysis compared outcomes of individuals who received a K award to those of similar individuals who applied for but did not receive a K award. The evaluation showed that K awardees:
- are more likely to have subsequent research publications;
- are more likely to apply for subsequent NIH research awards;
- have a higher R01 award success rate;
- have a higher percentage of years with subsequent NIH support; and
- are more likely to apply for and receive at least one competitive renewal of an R01 grant.
A small analysis was conducted by NIAMS in 2010 in collaboration with two rheumatology-related Foundations. It suggested that individuals who received both foundation support and an NIH K award were more likely to apply for and receive R01 funding than K awardees that did not have such additional support. Furthermore, the analysis identified the transition between the K and the R01 awards as a vulnerable point in progression to independence.
Dr. Boyce discussed challenges facing early-career clinician-scientists, such as salary coverage, educational debt, transition to independence, time in training, mentoring support, protected time, and clinical demands. She also presented efforts in recent years by the NIAMS and/or NIH to address these challenges, including by:
- increasing salary and research costs for K08 and K23 awards in 2016,
- clarifying supplemental salary and compensation policies for research career development awards,
- supporting an educational loan repayment program,
- offering a limited competition small grant program (R03) for NIAMS K08 and K23 recipients,
- supporting the Stephen I. Katz Early Stage Investigator Research Project Grant, named after NIAMS’ former director, for an innovative project in an area of science that represents a change in research direction for an early stage investigator and for which no preliminary data exist,
- setting a higher payline for early-stage investigators,
- supporting the NIAMS Supplements to Advance Research (STAR) from Projects to Programs for early-stage investigators,
- supporting the NIH K24 program to provide support for mid-career researchers who would like to serve as mentors in patient-oriented research with or without a clinical trial.
Dr. Boyce also mentioned several policy updates from the NIH related to K career development awards and early-stage researchers, including,
- policy update on concurrent support from a mentored K award and a research grant,
- an update of the NIH extension policy for early-stage investigators who take time off for various reasons (e.g., childbirth,
- discontinuation of the NIH policy for review and resubmission of new investigator R01 applications, which had been underutilized since its inception,
- an update on NIH’s interest in diversity, and
- guidance and information for NIH applicants and recipients of NIH funding in response to the COVID-19 pandemic.
Breakout Sessions and Group Discussion: How to Maximize Chances to Get the First R01/U01 in the Next 2-3 Years
In the afternoon, the K investigators met in small breakout groups with the mentors to discuss strategies to maximize the chances of getting the first R01/U01 in the next 2-3 years. After the small group discussions, the meeting participants reassembled and the small groups shared insights from their discussions. Some major themes were grantsmanship and how to sustain one’s career during challenging times, which included working with mentors, obtaining research support, and forging productive collaborations.
The group discussed various tips and lessons learned for writing and submitting a grant, noting that time management is critical. Another important aspect was the emotional reaction to receiving critiques and how to manage that response in order to improve the grant. The group also discussed different NIH funding mechanisms and research support from professional and voluntary organizations.
Career sustainability during challenging times
In light of the ongoing pandemic and the pressure it places on research, the group discussed the importance of creative ideas and inventive ways of conducting science. These might include interacting productively with mentors, seeking research support from a variety of sources, developing effective collaborations, and maintaining a healthy work-life balance.
Professional and Voluntary Organizations Meeting with NIAMS Staff
While the K awardees met in breakout discussions with the mentors, NIAMS staff met with representatives from the professional and voluntary organizations to discuss how NIH and the organizations can work together to support K scientists. The organizations’ representatives briefly described their organizations resources for early-stage investigators, some of which are specifically focused on researchers with NIH career development awards. Resources mentioned ranged from new investigator awards and bridge and supplement awards to grant writing courses and help in finding mentors. The organizations also discussed their work related to improving diversity and inclusion of women and underrepresented groups in the fields that they serve, with a focus both on diversifying the workforce and on encouraging research that addresses health disparities. The groups also noted some of the challenges they are hearing about from investigators, particularly early-stage scientists, related to the COVID 19 pandemic such as lab shutdowns, slowed trial enrollment, and lack of “elective” surgeries that may limit opportunities to collect data or samples. Both NIH and the professional and voluntary organizations are working to provide flexibility to researchers as they navigate these challenges.
After the breakout session and discussion, participants heard a panel discussion on grantsmanship moderated by Dr. Cibotti. Panelists included the meeting mentors and Dr. Alexey Belkin, a NIAMS program Director who previously worked at the NIH Center for Scientific Review. Questions and a brief summary of panelists’ responses are provided below.
As a reviewer, what do you want to see on the aims page/research strategy page of the application from an early stage investigator?
Panelists recommended that applicants make sure that their aims page could be read in 10-15 minutes because reviewers typically make up their minds about the merit of a grant quickly. Applicants need to educate reviewers about the field and help them understand the hypothesis, background data, and aims. It is important that reviewers, who may be in other fields, understand the questions that are being asked and why the research is useful. To determine whether the aims page will be clear to reviewers in other fields, it may be helpful to share the aims page with colleagues who are outside the field to make sure they understand why the research is being conducted and its significance. A goal should be to ensure that the reviewer will know after reading the aims what the investigator wants to do keeping in mind that it is not as important to stress how the research will be accomplished as it is to convey why it is of interest. It can be helpful to clearly state the significance in the first paragraph. A small figure to show the overall model is extremely helpful.
What common errors do you see in new PI applications?
One mentor noted that new investigators could benefit from a “less is more” approach. Putting forward an overly ambitious application, with too much information, is a common mistake for early-stage investigators. Early stage investigators particularly should keep their applications clear and simple. Another common mistake is including interdependent aims (where if aim 1 does not work out, aim 2 becomes useless). Interdependent aims can be perceived by reviewers as too risky. Investigators writing their first R grant also should be aware that the standard for a K award application is very different than for an R award. For example, if data are not publication quality, they should not be included in the preliminary data section for an R award.
When you were a new PI, what common errors did you need to correct to get your first R01 award?
Many of the mentors mentioned how challenging it can be read study section critiques. However, they stressed that the comments can help make the research better and should be viewed in that light. So, one thing that many indicated that they had to learn was to see the comments as helpful. Some mentioned that they had made the mistake of not placing enough emphasis on writing the rigor section. In this regard, they noted that investigators need to clearly spell out things like statistical analysis and power. Others felt that they needed to work on fully developing the pitfalls/limitations section. Some of the mentors noted that there had been lots of emphasis by reviewers on the ability to do the research independently without the K award mentor. However, other mentors noted that early stage researchers need to be discrete in demonstrating independence. Clear statements about your own independent lab spaces/assets are important. One mentor mentioned the need to perfect the timing of submitting a particular application. If it is submitted too late (at the last minute) there may be problems getting it through the application submission system in time, but if it is submitted too early, the ideas may not be “mature” enough and the application may be triaged. One mentor cautioned that an R01 application should focus on one pathway, not all of them, within a disease. Clear statements about model systems and what they are replicating from the disease and why that model was chosen are important. Many of the mentors said they needed to learn that applications are received differently by different individual reviewers or review panels. They noted that there can be great variability in how applications are received, but often it will work out. Applicants can resubmit, so it is important to be persistent, but also necessary to gauge the overall enthusiasm of the study section for the application. For an A1, application, you will not know if you will get 1, 2, 3 or none of the prior reviewers, so it is important to address all concerns and to understand that the next reviewer may be an entirely new person.
How can you assess if your application is overly ambitious?
One mentor commented that “If you think your proposal will take 4 years, and you are asking for 4 years, it is probably overly ambitious and isn’t taking into account all the pitfalls that may come along (especially patient recruitment).” It can be helpful to think whether or not the aims and sub-aims, will lead to publications. If you expect only the aims to be papers, then the application is probably okay. If all sub-aims are papers, then it is probably overly ambitious. One mentor advised to only submit 2 aims. Another suggested starting with plenty of lead time so that the applicant can let the application sit for a few weeks after writing it and then revisit it with a fresh perspective to determine if it is too ambitious.
How much preliminary data should be included in an application?
A mentor noted the need to demonstrate that proposed tools and technologies are feasible, effects are real, and the applicant knows the logical next steps based on the data. Training data and publications are preliminary data. So, researchers can work with those until they are funded, rather than writing de novo. It is important to present your preliminary data rather than to assume reviewers will read your papers. It is a good idea to work on your figures and share them with others to make sure that the images are clear and to the point. Also, it is important to make preliminary data legible and to avoid micro-fonts.
How should the alternative approaches/competitive concepts pages be addressed?
This section likely reflects the discussions researchers already are having in the lab. It is a good idea to acknowledge the shortcomings and limitations of your system upfront, rather than burying them. For research with patients, state if you have ongoing access to the cohort and potential ways to gain knowledge from unexpected results so that those findings are useful. One mentor thought that reviewers pay more attention to this section for new investigators than for established investigators, noting that reviewers want to see something more than the best-case scenario.
What do you need to show on rigor/reproducibility section that most ESIs ignore?
Rigor should show throughout the entire application, not just in this section. In the section, reviewers want to see that the applicant has replicated the data set forth, so state explicitly that the data have been reproduced. Do not assume that the reviewers know what statistical shorthand means. Be explicit and “show your work.” State what the planned analysis is to make sure it is clear to reviewers.
How do you write the intro section to respond to reviewer concerns?
One approach might be to separate out responses by reviewer and then address and organize by topic and response. It is important to detail how the grant was changed to address critiques. Remember to respond to each reviewer comment (e.g., it may help to copy/paste). Another suggestion was to put scores from each reviewer in the upper corner so others can see the scores. The mentors noted that it can be challenging to read critiques of work that you care about and have worked hard to produce. This is a challenge for established investigators as well as early-stage researchers. Nevertheless, it is very important to try not to be too emotional or defensive when formulating responses. If this is challenging, it may help to put the reviews away and come back to them later. It can also be helpful to be systematic in how a rebuttal will be formulated (e.g., will it consist of literature or more data).
How do you address premise or gaps in prior research and how it relates to significance?
It can be helpful to use bullet points to present premise and research gaps.
Presentation: Reflections on An Undulating Career Path
Dr. Nunzio Bottini, an established clinician-scientist, provided his perspectives on building a career in clinical research. He presented some of the critical elements researchers need for a fulfilling and successful career, including perseverance, discipline, organization, effective communication, and a collaborative network of peers. Dr. Bottini noted that it is important for researchers to choose a field, course of study, or scientific question they find most interesting, rather than what is most popular, and cautioned that individual success in science is often only determined by the work and discoveries that build on each researcher’s findings. Dr. Bottini encouraged the K awardees to harness their passion to drive creativity and to keep in mind that even those who love their work face difficulties from time to time. He also highlighted the importance of mentorship, offering that throughout your career in academia you should always be mentoring others and working with individuals who can serve as mentors to you.
*ABUABARA, Katrina, M.D., MSCE, University of California, San Francisco
*ASHOURI SINHA, Judith, M.D., University of California, San Francisco
ASSASSI, Shervin, M.D., M.S., University of Texas Health Science Center at Houston
*BARNADO, April, M.D., M.S.C.I., Vanderbilt University School of Medicine
BOTTINI, Nunzio, M.D., Ph.D., University of California, San Diego
CUMMINS, Deborah, Ph.D., Orthopaedic Research and Education Foundation
*DIETZ, Matthew, M.D., West Virginia University School of Medicine
DOMIRE, Jacqueline, National Psoriasis Foundation
*DY, Christopher, M.D., M.P.H., Washington University School of Medicine
*FELDMAN, Candace, M.D., M.P.H., Sc.D., Brigham and Women’s Hospital
*GEORGE, Michael, M.D., MSCE, University of Pennsylvania
GRECO, Valentina, Ph.D., Yale University
GUDJONSSON, Johann, M.D., Ph.D., University of Michigan
*HENDERSON, Lauren, M.D., M.M.Sc., Harvard Medical School
*HSIEH, Elena, M.D., University of Colorado Anschutz School of Medicine
*JEFFRIES, Matlock, M.D., University of Oklahoma Health Sciences Center
JONES, Lynne C., Ph.D., Representing the Orthopaedic Research Society
*KING, Jennifer, M.D., Ph.D., University of California, Los Angeles
MARCHIOLO, Eryn, M.P.H., Rheumatology Research Foundation
*MCMAHAN, Zsuzsanna, M.D., M.H.S., Johns Hopkins University School of Medicine
MINNILLO, Rebecca, D.M., M.P.A., Society for Investigative Dermatology
MODLIN, Robert, M.D., University of California, Los Angeles
NAIK, Shruti, Ph.D., NYU Langone Health
*NAYAK, Renuka, M.D., Ph.D., University of California, San Francisco
*NOE, Megan, M.D., M.P.H., M.S., Brigham and Women’s Hospital
*RAO, Deepak, M.D., Ph.D., Brigham and Women’s Hospital
*SCHOENFELD, Andrew, M.D., Brigham and Women’s Hospital
*WALLACE, Zachary, M.D., M.Sc., Massachusetts General Hospital
*Indicates current NIAMS K08 or K23 awardees.
BELKIN, Alexey, Ph.D.
BOYCE, Amanda, Ph.D.
BURROWS, Stephanie Y., Ph.D.
CARTER, Robert, M.D.
CAUGHMAN, Cindy, M.P.H.
CIBOTTI, Ricardo, Ph.D.
DUNDAS, Colleen, M.P.H.
GARRICK, Nancy, Ph.D.
KHAN, Shahnaz, M.P.H.
LESTER, Gayle, Ph.D.
LIN, Helen, Ph.D.
MANCINI, Marie, Ph.D.
MAO, Su-Yau, Ph.D.
NGUYEN, Van, Ph.D.
NICKS, Kristy, Ph.D.
REUSS, Reaya, M.S.
SALAITA, Kathy, Sc.D.
SERRATE-SZTEIN, Susana A., M.D.
TAYLOR, James M., Ph.D.
TORGAN, Carol, Ph.D.