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          NIAMS Forum for Clinical Mentored K Awardees - December 2021


Roundtable


NIAMS Forum for Clinical Mentored K Awardees - December 2021 *April 29, 2022*
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    December 6-7, 2021Co-ChairsLindsey Criswell, M.D., M.P.H., D.Sc.Gayle Lester, Ph.D.Amanda Boyce, Ph.D.Ricardo Cibotti, Ph.D.Kristy Nicks, Ph.D.IntroductionThe 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.PurposeNIAMS 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, December 2018, 2019, and 2020. The K Forum brings together clinician-scientists with a NIAMS K08 or K23 award. In 2021, the meeting included the 3rd year NIAMS K awardees as well as one NIAMS intramural research program scholar. The Forum also included established clinician-scientists as mentors, some of whom had NIH K awards in the past, and representatives of professional and voluntary organizations with an interest in research within the NIAMS mission.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. NIAMS long-term goal in holding this Forum 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.Welcome and Research PresentationsThe Forum started on December 6 with a welcome by the NIAMS Director, Dr. Lindsey Criswell. Her remarks were followed by research presentations from K award investigators and the NIAMS intramural scholar.  The presentation session was moderated by Dr. Ricardo Cibotti. Each scientist briefly outlined their research project and progress and answered questions from the other participants. Dr. Gayle Lester closed the session with reflections on the presentations. She expressed the Institute’s appreciation to the speakers and commended them on their progress, especially in light of the challenges that clinical researchers have faced during the COVID-19 pandemic.NIAMS Extramural Program Structure and Functions and K Awardee Meetings with NIAMS Leadership and StaffAfter the research presentations, Dr. Kristy Nicks provided an overview of the NIH and NIAMS with a focus on the activities of the NIAMS Division of Extramural Research and how the Division administers extramural grants. Following a brief introduction to the organizational structure of NIH and NIAMS, Dr. Nicks provided more information about the NIAMS extramural program. She discussed the Office of Extramural Operations (OEO), which manages the NIAMS grants policies and procedures, the receipt and review of grant applications, and the oversight and management of clinical studies. She also described the Program Division, which supports and oversees the scientific and technical aspects of awards and includes program officials who are the primary points of contact for investigators.After the presentation by Dr. Nicks, the K awardees were divided into four groups that rotated through discussions with NIAMS leadership, NIAMS program and clinical management staff, NIAMS grants management staff, and NIAMS review staff. The discussions provided the K awardees with an opportunity to ask questions and interact with the NIAMS representatives.Tuesday Morning WelcomeOn December 7, Dr. Criswell welcomed the group back and reiterated NIAMS’ commitment to developing clinician-scientists. Dr. Criswell noted that the unpredictability of the NIH budget, the current funding climate, and the continuing COVID-19 pandemic are challenges for researchers. She expressed the Institute’s concerns about how the pandemic is affecting early-stage researchers, such as our K awardees. She reaffirmed NIAMS’ support for these early-stage investigators and encouraged them to contact their program officers for assistance if needed.Presentation and Discussion of K Award Past Outcomes, Future Directions, NIH Policy Updates, and Challenges Related to COVID-19After Dr. Criswell’s remarks, Dr. Amanda Boyce presented an overview of the K awards program. The presentation focused on outcomes of the program as well as information about related policies. Dr. Boyce highlighted analyses that were conducted to assess the success of the K awards and discussed some of the steps NIH and NIAMS are taking to address and overcome common challenges faced by early-stage clinician-scientists. Dr. Boyce then reported on policy updates that are relevant to clinician-scientists with career development awards and closed by briefly reiterating 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; andare more likely to apply for and receive at least one competitive renewal of an R01 grant.A small analysis was conducted by NIAMS in 2012 in collaboration with two rheumatology-related foundations. The results of the analysis 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. Additionally, the analysis identified the transition period between the K and the R01 awards as a vulnerable point in an investigator’s 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, clinical demands, and work-life balance. In recent years, NIAMS and/or NIH have made efforts to address these challenges 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, andsupporting 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,an update of the NIH extension policy for early-stage investigators who take time off for various reasons (e.g., childbirth),an update on NIH’s interest in diversity,guidance and information for NIH applicants and recipients of NIH funding in response to the COVID-19 pandemic and NIAMS guidance for new COVID-19 research and supplemental funding,a K Award policy update on concurrent support from a mentored K Award and research grant,an updated NIH extension policy for early-stage investigator status (ESI), andan update on the NIH policy for review and resubmission of new investigator R01 applications.Concurrent Sessions*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 the K awardees getting their first R01/U01 in the next 2-3 years. After the small group discussions, the meeting participants reassembled, and each of the three small groups shared insights from their discussions.The first group discussed how best to distinguish their work from that of their mentor as well as how to manage interactions with other senior co-investigators. They also talked about the potential benefits and drawbacks of staying at the same institution after the K award. The group talked about the new Steven Katz R01 award, as well as several other funding mechanisms such as the NIAMS R03 and R34. They also noted the availability of bridge funding from professional and voluntary organizations. Finally, they focused on the grant review process, including common errors of early-stage investigators, such as including too much data in an application. They talked about the difficulty of getting innovative projects funded and wondered whether videos might be allowed in grant applications in the future. Mentors highlighted the importance of having someone in another field read your grant application before submitting it.The second group talked about job searches and grant proposals and review. Topics related to grant applications included internal and external review by colleagues prior to submission, how to find previous grants to look at as examples, and how to proceed after receiving comments from reviewers. The group also noted that it would have been nice to have the information shared at the K Forum earlier on during the K award. They also noted that this information is important for all early-stage investigators pursuing research independence, but that some, particularly those from more disadvantaged backgrounds, may not receive it.The third group discussed balancing industry, foundation, and government funding, and agreed that it is important to look at all possible funding sources. The group also focused on the challenges of balancing commitments and knowing when and how to say no. Finally, they focused on the first R01 submission, including setting aside extra time in the months leading up to submission to focus on preparing the application. Mentors noted that K researchers do not need to apply to the same Institute for an R01 that funded their K award. They noted the importance of writing multiple possible aims and then seeking feedback from colleagues about which are strongest.After the reports from the breakout groups, all participants had the opportunity to comment or ask questions in response to the reports that were shared. Some were interested in understanding how applicants might identify examples of successful grants. The NIAMS staff shared that, in general, grant applications are not posted publicly. Some institutions do provide their funded grants as a resource. One option for finding funded proposals is to ask mentors and colleagues if they would be willing to share their applications.Others asked about the idea of including links and videos in grant applications. At the moment, these should be avoided as including them risks having the application administratively withdrawn. When in doubt, applicants should contact the appropriate scientific review officer to understand what information can be included in an application.One participant suggested that the K08 and K23 should be transitional awards so that more support would be provided towards the end of the grant period when investigators are preparing for the transition to independent research. Another noted that grant writing workshops are limited to Ph.D. scientists, with those with clinical degrees excluded, at many institutions. The NIAMS staff noted that many professional and voluntary organizations offer grant writing workshops open to those with clinical degrees. Some resources are also available on the National Institute of Allergy and Infectious Diseases and Center for Scientific Review websites.*Professional and Voluntary Organizations Meeting with NIAMS Staff*During the breakout sessions, 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 missions and resources available to early-stage investigators, some of which are specifically designed to supplement and support researchers with existing NIH career development awards. The resources discussed ranged from new investigator, bridge, and supplement awards to assistance in establishing mentor and peer networks and awards to help address COVID-19-related research delays. The organizations also highlighted their efforts to improve diversity and inclusion of women and underrepresented groups working in their mission areas. These efforts focus both on diversifying the scientific workforce, including awards to improve networking and mentorship opportunities, and on encouraging research that addresses health disparities through targeted funding opportunities. The groups also discussed awards to help retain researchers and support investigators whose grant applications fell just short of NIH paylines.Grantsmanship PanelAfter the breakout session and discussion, the meeting continued with a panel 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 you would like to see on the aims page and the research strategy section of a competitive R01 application from a new principal investigator?*The mentors emphasized the importance of making the application clear and concise so that is it easy for reviewers to read and understand. For example, including subheadings in the aims page can sometimes make is easier for reviewers to find what they are looking for (e.g., context, research strategy, relationship between aims, rigor, and reproducibility). It is important to start with a broad long-term goal, including context for why the goal matters and the knowledge gap that the proposal addresses. After defining the problem, it is important to present the research strategy that will be used. One mentor also recommended highlighting innovation and public health relevance to make it easy for reviewers to understand why the research is important. Successful applications should also be interesting, and one way to stimulate interest is to present the work as a “story” with a beginning, a middle, and an end, leaving out any extraneous information. The aims page should also include one or two sentences summarizing what the applicant expects to achieve. If the application is a competing renewal, it’s also important to give a sense right at the beginning of the application of what was accomplished with the prior grant.*What are the most common grantsmanship errors that you see in R01 applications from new principal investigators?*The mentors mentioned several common errors in first-time R01 applications. A very common error is submitting an application that is overly ambitious. In many cases, it is better to have a little data that is of high-quality than to include data where rigor is lacking. Applicants should refrain from making figures very small in order to include more information, as such figures can be difficult to read. In addition, the mentors noted that three aims are not required and applicants should consider whether two aims are enough.Another mistake is neglecting to include information for all required sections. Address sex as a biological variable even if the information seems obvious. Address pitfalls and alternative approaches. If applying for funding under a specific funding opportunity announcement, read the announcement carefully and include all required elements.It is important to demonstrate rigor, including statistical rigor throughout the application Many new applicants forget to put statistics in figures, include “n=1” data, or forget to show replicates and significance. Applicants also sometimes make the mistake of including incomplete figures.*When you were a new PI, what common errors did you need to correct to get your first R01 award?*The mentors shared the challenges they faced when applying for funding as new investigators. One issue was demonstrating that specific aims are independent such that if one aim fails the other(s) could continue. Applicants should also be able to articulate a plan for how they will move forward to potentially learn from or alter an aim if it is not successful. Others noted the opposite problem, where reviewers indicate that the aims are too disconnected. They mentioned that it is also important to convey how aims are related. Another issue was representing power calculations. If possible, it may be helpful to study funded grants to understand how to successfully write about power calculations. It also may be necessary to work with a statistician. One mentor emphasized that the rationale for the project should be very clear. In this regard, it can be helpful to think carefully about the rationale for each specific aim and what accomplishing each aim would mean in terms of moving science forward.*How can you assess if your application is overly ambitious?*It can be difficult to determine whether a grant proposal is overly ambitious. For new applicants, getting feedback from colleagues, mentors, and others can be helpful in determining whether the applicant’s aims are reasonable. Applicants also can ask themselves a few key questions that may shed light on whether proposal is feasible. For example, for clinical trials, if an applicant proposes to recruit a certain number of participants, can the applicant demonstrate that they have been able to do this previously? Is it a struggle to get the budget to cover all of the work? Another sign that a grant is overambitious is that the section on pitfalls and alternative approaches is underdeveloped.*How much preliminary data should be included in an application? How much do you really need and why are these data important?*Applicants need to provide enough data to support each aim. The goal is to show that the research proposed is feasible and the “signal” is worth pursuing. It is not important how many figures are included, only that each aim has support. Don’t forget any aims, i.e., an application with three aims, should provide data for all three. Only data that is rigorously generated and of high quality should be included. Researchers should include enough data to convince a reviewer that the applicant is qualified to do the research they are suggesting. So, where possible, show data that indicate that the applicant or others on the application have experience conducting the types of studies proposed in the application.*How should the alternative approaches/competitive concepts pages be addressed?*This section in particular is one where the information provided by new applicants is often weaker than that provided by more experienced grant writers. Many new investigators are so focused on the research problem that they forget to look at the question from the point of view of a reviewer. It is important to question one’s own approach. It can be helpful for reviewers if applicants summarize, at the end of each aim, what the alternative approach will be if the proposed research strategy does not work. This can help applicants to identify the weakest links in their proposed strategy and consider what could be done to bolster them. It is important to focus on the major limitations and not spend time on minor ones, i.e., the scenarios and alternative approaches need to be relevant and realistic. The mentors noted that seeing a well-considered discussion of the limitations of a proposal can bolster a reviewers’ confidence in an applicant. The ability to critique the approach demonstrates that the researcher has thought carefully about the work. Where possible, applicants should convey what might be learned if an aim fails and how that outcome might inform the next step in the research.*What do you need to show on rigor/reproducibility section that most early-stage investigators ignore?*In this section, it is important for applicants to demonstrate that they know their data and the data of others in the field. For clinical and epidemiological projects, it is important to lay out the processes for data extraction, validation, code review, and data cleaning and analysis. Applicants need to show how their data are organized and modeled. Applicants should address missing data and how they will deal with it. All of these specifics are critical for reproducibility, and they convey to reviewers that the applicant understands the data and what information would be needed for someone else to reproduce their results. This also holds true for basic studies. Researchers need to think about what information would be needed to reproduce the findings. Investigators may benefit from collaborating with a statistician who can help with data analysis and statistics.*How do you write the intro section to a revised application to respond to reviewer concerns?*The mentors underscored the need for humility and recognizing that reviews can help to make the work better. If the initial score and percentile were relatively high, it can be helpful to include them. If most of the scores were good, but one was problematic, it can be helpful to focus on how that score could be brought up. If there are only a few comments, it may be best to address each comment individually. If there are many comments, it can be helpful to group them into themes and respond once to each theme. Another strategy is to grade the comments as major, intermediate, or minor and address them from most to least important.*How do you address premise or gaps in prior research and how it relates to significance?*Addressing premise and gaps can be challenging for early-stage investigators. Newer applicants may focus too much on their own project and not enough on the broader context. It is critical to convey why the project is important. In completing this section, it can be helpful to use bullet points to present the premise and research gaps.Mentor PerspectiveDr. Clifford Rosen, an established clinician-scientist, provided his perspectives on building a career in clinical research. Dr. Rosen has mentored many new investigators in his laboratory and at other sites through collaborations. His work focuses on clinical trials, basic bone cell laboratory studies, and clinical medicine. As part of his presentation, he wanted to inspire M.D.s who are trying to maintain a balance between clinical and basic research.Mentorship is a lifetime process. It is a commitment that occurs over many years, even if you spend only one year in a person’s lab. It also is a bidirectional relationship; mentors get something out of the relationships too.Dr. Rosen focused on three of his mentors, noting their energy and enthusiasm for the science they were doing. His mentor during his first grant submission and rejection guided him through the resubmission process and helped him rebuild his confidence. A long-distance mentor guided him despite the fact that Dr. Rosen was not at a large academic medical center at the time. He collaborated on grants and projects with his third mentor. Other pivotal events in his career include participating in study sections as a reviewer and chairing study sections and mentoring his own students who have since influenced his career.Dr. Rosen listed five traits of a good mentor. Mentors need enthusiasm. They should not be threatened by their mentees. Mentors have flaws but should support you. Mentors need time to listen to you. They should have the ability to see something in you that you do not see in yourself.ClosingDr. Criswell noted that she enjoyed the K Forum and was impressed with the high quality and sophistication of the research being conducted by NIAMS K awardees. She thanked the mentors for sharing their insights and advice with the K researchers. She also thanked the NIAMS staff who have been working with the K awardees and on the K Forum.Participants*BERNSTEIN, Elana J., M.D., M.Sc., Columbia University College of Physicians and Surgeons*CAPPELLI, Laura C., M.D., Johns Hopkins University School of Medicine*CHENG, Abby L., M.D., M.P.H.S., Washington University in St. Louis School of MedicineCUMMINS, Deborah, Ph.D., Orthopaedic Research and Education FoundationDOMIRE, Jacqueline, National Psoriasis Foundation*ESLAM POUR, Aidin, M.D., M.S.C.I., Yale University*FASSETT, Marlys, M.D., Ph.D., University of California, San FranciscoFEGHALI-BOSTWICK, Carol, Ph.D., Medical University of South Carolina*FINDLAY, Andrew R., M.D., Washington University in St. Louis School of Medicine*FISHBEIN, Anna B., M.D., Northwestern University Feinberg School of MedicineJAN DE BEUR, Suzanne, M.D., Representing the American Society for Bone and Mineral ResearchJONES, Lynne C., Ph.D., Representing the Orthopaedic Research Society*KIURU, Maija, M.D., Ph.D., University of California, Davis*LEE, Pui Y., M.D., Ph.D., Boston Children's HospitalMARCHIOLO, Eryn, M.P.H., Rheumatology Research Foundation*MECOLI, Christopher A., M.D., M.H.S., Johns Hopkins University School of MedicineMINNILLO, Rebecca, D.M., M.P.A., Society for Investigative Dermatology*NAIK, Haley, M.D., University of California, San Francisco*RICARDO-GONZALEZ, Roberto R., M.D., Ph.D., University of California, San FranciscoRIEKE, Kate, American Academy of DermatologyROSEN, Clifford J., M.D., Tufts University School of MedicineSCHER, Jose U., M.D., New York University Grossman School of Medicine*SHAH, Viral, M.D., University of Colorado Anschutz Medical Campus*SIMMONS, Daimon P., M.D., Ph.D., Brigham and Women's Hospital*SIMPSON, Cory L., M.D., Ph.D., University of Washington School of MedicineSIMPSON, Eric, M.D., M.C.R., Oregon Health and Science University*TEDESCHI, Sara K., M.D., M.P.H., Brigham and Women's Hospital*TILSTRA, Jeremy, M.D., Ph.D., University of Pittsburgh School of MedicineVASSILEVA, Maria T., Ph.D., Arthritis FoundationWEIN, Marc N., M.D., Ph.D., Massachusetts General HospitalWHEATLEY, Mary J., I.O.M., C.A.E., Scleroderma FoundationYAZDANY, Jinoos, M.D., M.P.H., University of California, San Francisco**Indicates current NIAMS K08 and K23 awardees.*NIAMSBELKIN, Alexey, Ph.D.BOYCE, Amanda, Ph.D.BROWN, MarkBURROWS, Stephanie Y., Ph.D.CARTER, Robert, M.D.CAUGHMAN, Cindy, M.P.H.CIBOTTI, Ricardo, Ph.D.CRISWELL, Lindsey A., M.D., M.P.H., D.Sc.DRUGAN, Jonelle K., Ph.D., M.P.H.DUNDAS, Colleen, M.P.H.FERRADA, Marcela, M.D.FURUMOTO, YasukoGARRICK, Nancy, Ph.D.JOFFEE, KathieKHAN, Shahnaz, M.P.H.LABBE, Colleen, M.S.LESTER, Gayle, Ph.D.LIN, Helen, Ph.D.MANCINI, Marie, Ph.D.MARQUITZ, Aron, Ph.D.NELSON, MelindaNGUYEN, Van, Ph.D.NICKS, Kristy, Ph.D.NYACK, Nicole, M.P.H.TAYLOR, James M., Ph.D.THACH, Yen 
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