State of the Research Enterprise in IR and Recommendations for the Future: Proceedings from the Society of Interventional Radiology Foundation Investigator Development Task Force

Abstract

Interventional radiology (IR) is a dynamic specialty that thrives on innovation, and central to the mission of the field is the pursuit of technologically innovative, clinically relevant, and collaborative multidisciplinary research. The Society of Interventional Radiology Foundation (SIRF) has played a key role in IR research programmatic development, and a decade ago a major SIRF effort began to expand the scope of the IR research enterprise. Some notable successes have been achieved along the way (eg, the ATTRACT, CORAL, BEAT, and PRESERVE trials), but critical evaluation reveals significant room for improvement. The current funding environment for high-impact extramural research programs is the most challenging in the history of IR, and this situation is unlikely to improve significantly over the next decade. Because IR relies heavily on innovation for growth, a strong research enterprise is essential to the viability of the specialty. A review of IR research over the past decade raises 2 vital questions: first, does the current enterprise optimally serve the specialty and improve outcomes? and second, if not, how can its overall impact on sustaining and growing IR be improved? Awarding grants without further supporting and cultivating those who have the initiative to apply their innovations has proven to be insufficient in meaningfully advancing the IR research enterprise. This is evidenced by the high proportion of Society of Interventional Radiology (SIR) Pilot and Academic Development (Ernest J. Ring) grants that have not been developed beyond initial testing (so-called “one and done” projects), and the extremely small number of projects subsequently funded by major agencies. To address these observed deficiencies in the current IR research support structure in the context of an ever more challenging funding environment, the SIRF assembled a task force to critically evaluate the current state of IR research and explore how the SIRF can facilitate meeting future needs and goals. Although similar in many respects to a research consensus panel (RCP), the project differed in that action items were determined over ∼1 year and initiated over the course of the following year. The group was also expected to begin a long-term process based on these goals and to report on efforts to date aimed at advancing the research capability, accomplishment, and repute of the specialty. The present document serves both to lay out the results of the meeting and as a progress report through the end of 2017. On October 15–16, 2015, the SIRF convened an Investigator Development Task Force (IDTF). Panel membership included a group of expert scientists and physician scientists with a wide array of research experience (range, 1–34 years of faculty-level experience) and at all career stages (spanning Assistant Professor, Associate Professor, and Professor ranks). The IDTF included 13 total participants, 11 (85%) residing in the United States and 2 (15%) international. Of the participants, 8 (62%) were present at the initial meeting and the remaining 5 (38%) participated over the next 24 months as the work unfolded via teleconferences as well as in-person and e-mail discussions. The IDTF goals were to assess the current state of affairs in IR research, identify problems and underlying causes, propose adaptive solutions to address principal issues, and begin the process of implementing solutions. The focus was primarily on improving the SIRF grant program for coming generations of IR researchers. In addition, participants were charged with providing recommendations that would initiate dialogue in the IR community at large regarding how to respond to the challenges identified and the proposed solutions. For the initial discussion, panelists were asked both to identify issues in IR research and to prioritize them. The highest-priority topics were then assigned to teams for further discussion within breakout groups. Each team then provided a 30-minute presentation. After each presentation, an open discussion was held to enable a comprehensive assessment. For each of the topics, action items were identified and assigned. With continuing efforts through December 2017—primarily via teleconferences—action items were moved forward, proposals clarified, timelines estimated for implementation, and early-stage implementation in several areas begun. An assessment of the perceived obstacles and challenges facing the field of IR research resulted in several frequently cited concerns. These included an underdeveloped culture of research compared with other medical specialties, insufficient institutional and mentorship support, inadequate dedicated IR funding, and limited training in research and basic science. At their core, interventional radiologists (IRs) are innovators; however, to be credible this must be accompanied by due diligence to test these innovations in a hypothesis-driven manner. The IDTF prioritized 6 core areas to help accomplish this: sustainability, incrementalism, mentorship, accountability, leverage, and visibility. The panel produced 6 presentations in these areas, the results of which are summarized below and in the Table.TableSIRF IDTF-Developed Initiatives to Address Perceived IR Research ObstaclesCore AreaGaps and Principal ChallengesQuality Improvement ObjectivesProposed Actionable SolutionsSustainabilityDeficiency of durable, long-term, and/or longitudinal research projects undertaken across broad range of investigators and institutionsImprovement of IR research project depth and durability as well as scope of participating researchers and centersRenovation of SIRF grant development process aimed at enhanced investigator development and long-term thematic growthIncrementalismHistorical focus on small-scale research projects, resulting in relatively limited advances in knowledgeEncouragement of more innovative, paradigm-shifting, and foundational researchAdaptation of SIRF grant structure to support research innovation with broad impactMentorshipLack of formal research mentorship programs to support and guide nascent investigatorsEstablishment of structured mentorship program of guidance and supervision to foster and advance budding IR researchersCreation of SIRF-supported SIR RMB as well as establishment and growth of SIRF Research Mentorship NetworkAccountabilityIndistinct link between SIRF grant initiatives and research program developmentDelineation of metrics of success for allotted SIRF funding and efficacy of programmatic changes relative to current agendaRevise SIRF grant evaluation and tracking programs to assess efficacy of implemented programmatic improvementsLeverageLimited success at parlaying SIRF grants into extramural research fundingExpansion of research infrastructure at institutional levels to improve foundation on which to broadly advance IR research missionEncouragement and recognition of physical, administrative, financial, service, and personnel aspects of institutional research program investmentVisibilityRelative anonymity of IR investigators and research programsEnhancement of IR research conspicuity to improve breadth of recognition and depth of reputationLaunch of awareness campaign dedicated to increase visibility of IR researchIDTF = Investigator Development Task Force; RMB = Research Mentorship Board. Open table in a new tab IDTF = Investigator Development Task Force; RMB = Research Mentorship Board. A key goal of the SIRF grant program is to improve patient care by providing investigators with resources for generating preliminary data for extramural funding. Although SIRF funding is modest, the National Institutes of Health (NIH) and similar funding sources provide a level of support that allows a research enterprise to be sustainable. The IDTF examined the NIH funding success of SIRF Pilot and Ring grant awardees over an extended period. The SIRF has seen robust growth in the number of investigators applying for support, with 2- and 5-fold increases in applications for the Pilot and Ring mechanisms over 9 years, respectively (Fig 1). However, although a total of 53 SIRF grants (46 Pilot and 7 Ring) were awarded in the 2008–2017 funding cycles, only 2 (4%) of those SIRF awardees subsequently secured NIH funding. The IDTF then examined how many Pilot grant recipients later applied for a Ring award. Only 4 pilot grant recipients (9%) applied for a Ring award and only 1 of those (25%) was actually awarded the grant. In comparison, 88 applications from 67 investigators did not receive SIRF funding during the same time period, of which 3 investigators (3%) later received NIH funding. In summary, a SIRF award was neither as effective as desired nor sufficient to guarantee sustained research activity. Notably, the Pilot and/or Ring conversion to larger funding may be underrepresented by not including those funded by nontraditional mechanisms (non-NIH grant programs) and by the medical industry. The pay line varies from year to year, but the average pay line for SIRF Pilot grants (40%) is much higher than any equivalent federal grant (eg, the 2016 National Cancer Institute pay line was 9%). Despite this, very few investigators who were not awarded at their first submission exhibited tenacity in reapplying until successful. Among applicants, only 20% (9/48) resubmitted applications. Furthermore, review of the literature suggests little overlap between investigator-published topics and grant-related topics, suggesting a lack of focus and commitment of IR researchers to a specific topic, which is crucial to ensure long-term sustainability. Only a handful of institutions generate more than half of the applications for SIRF Pilot and Ring grants (Fig 2). Similarly, just 7 institutions received more than half of all the awards. More than 80 IR programs exist, suggesting that fewer than 10% of these academic programs carry out the bulk of SIRF-funded research. This underscores the effect that the institution, institutional mentorship, resources, infrastructure, and leadership have on supporting the research activities of individual investigators. These institutions have also received most of the IR-related NIH funding support, suggesting that a key to sustainability is the understanding and modeling of such environments that foster investigators who consistently produce excellent research. In the short term (1–2 years), the IDTF proposes modest changes to the current SIRF grant structure, including:1.Introduce a preproposal submission detailing specific aims, mentors, and resources to allow constructive dialogue with a SIRF mentoring committee. New investigators would thereby be given feedback on their research ideas and specific aims by successful researchers before developing an entire grant proposal. This would allow refinement of concept, resulting in a more robust and sound grant proposal. A working document (proposal development form) is currently in the pilot stage with very positive feedback, and the website has been updated for the 2018 application/funding cycle.2.Require a short section in new grant proposals specifically addressing the “long-term strategic vision” to encourage new investigators to set long-term goals. This will be implemented in the 2019 application/funding cycle.3.Introduce a formal “specific aims” page for the next tier of funding development as part of the 6-month progress report of the Pilot grant process. This will be implemented in the 2019 application/funding cycle.4.Identify the factors contributing to the success of individuals from the handful of institutions with a demonstrated track record of sustained research activity and success with grants. Such institutions will be crucial to seeding and fostering success elsewhere. The IDTF proposes to interview the leadership and investigators at successful institutions to determine key elements that can help other institutions to develop and foster fledgling research programs. This will be accomplished from 2018 to 2020. In the long term (5–15 years), the IDTF proposes that the SIRF take a larger supervisory role in ensuring the sustainability of investigator research programs through active participation via SIRF mentorship. Drawing analogy from the commercial domain, this would be equivalent to the role played by a member of a management board who not only invests in a company, but also brings resources and sustained attention to ensure that an endeavor succeeds. This might take the form of assisting the grant recipient to draft specific aims, or developing a longer-term research plan for NIH Career Development or Research Grant applications. This may also involve helping the investigator to develop the mentorship, roadmap, and timeline to sustainable funding. The IDTF thinks that these changes will help future generations of researchers to take the long-term view required to develop the higher-impact research IR needs. It would also allow the reviewers to advise new investigators on specific funding opportunities. IR was born out of innovation. The fast-paced nature of invention was spurred on by a culture of “tinkering” to solve intractable problems in an era of high morbidity. The barriers to clinical translation were arguably lower than today, owing to the earlier developmental stage of the field, lower regulatory hurdles, and fewer players in the game. As such, there was a higher potential for clinical impact with minor stepwise innovations. Small investments in isolated research projects therefore had the potential to affect treatment paradigms. As the field has matured and the research landscape has evolved, there is a need to invest in IR projects that tend toward paradigm-shifting research rather than toward incremental improvements. The IR research community is charged with 2 tasks: first, to provide evidence validating current clinical practice, and second, to establish the foundation for the future. In both spheres, current research efforts have been deficient. In the clinical arena, a focus on retrospective reviews of isolated institutional experiences has limited the quality of IR evidence. Reasons for the scarcity of randomized controlled trials (RCTs) in IR are likely related to limited IR expertise in RCTs, complex logistics with a multidisciplinary approach, a paucity of partner sites, and inadequate access to funding. Patients and providers are often desperate for procedures that have not been validated. Providers feel pressured into offering therapies that have not been substantiated by rigorous evaluation (such as venous angioplasty for chronic cerebrospinal venous insufficiency) or are still in the early stages of evaluation (such as bariatric embolization). IRs must refrain from relying on anecdote and providing services with unknown outcomes or lacking scientific basis. This culture change requires an investment in the training on prospective clinical trial development, statistics needed for proper planning and conduct of RCTs, and analysis of larger datasets. The IDTF further endorses participation in clinical trials and the movement toward national registries championed by the SIR. Advances in molecular imaging, theranostics, nanotechnology, pharmacogenomics, and “big data” analytics are needed to realize the potential of the “age of precision medicine.” By engaging in basic and translational scientific research, IRs can help in guiding these breakthroughs. The field of IR is uniquely qualified owing to our inherent skillset. These research domains, however, require a level of team science and sustained research effort not historically required in the nascent, developmental stage of IR. This requires fostering long-term vision and strong research collaborations outside of the field. Engagement and cooperation with other multidisciplinary sciences, as well as private industrial partners, is critical to advancing research capabilities, activities, and accomplishments within the field of IR. In the short term (1–2 years), the IDTF proposes a set of changes to the current SIRF grant structure to emphasize vision and innovation, including:1.Defining a proportion of grants reserved for high-risk, high-innovation projects.2.Providing greater weighting to innovation when assessing such grants.3.Fostering collaborative relationships with industry for projects that align with existing needs and priorities of industry.4.Establishing a grant category that has patent submission as its ultimate goal to accommodate device-related projects.5.Soliciting a list of collaborators able to provide expertise on complex research methods.6.Providing increased visibility to truly innovative grant proposals and their results (publicity efforts to begin in 2018). In the long term (5–15 years), the IDTF proposes that SIRF facilitate research partnerships with funding from industry partners by establishing and developing a database of ongoing proposal requests (similar to the NIH Request for Applications) from industry partners. The lack of formal research mentorship impairs IR investigators from fully developing. However, the burgeoning research interest in IR provides the opportunity to develop an IR-specific mentor network. This could provide a structured program of guidance, supervision, and direction, and serve as the glue for a tight-knit and supportive research community. Providing additional mentorship for developing research ideas, skills, and grant writing will improve the potential for IR researchers to establish independent programs. Mentorship availability is likely a strong factor in the concentration of grants at a small number of institutions. In the short term (1–2 years), the IDTF proposes creation of a SIRF-supported SIR Research Mentorship Board (RMB) composed of experienced researchers with a broad panel of expertise. This board would be oriented specifically toward research and would be much more targeted than the recently launched Mentor Match program. With the long-term trajectory and depth required, the time frame would be much longer. Members would be selected based on their interest in IR and their willingness to mentor aspiring IR researchers with developing research ideas, learning new experimental protocols, and writing papers and grant proposals. Such depth does not exist in programs through other radiology societies and is an ambitious undertaking (1Freel S.A. Smith P.C. Burns E.N. Downer J.B. Brown A.J. Dewhirst M.W. Multidisciplinary mentoring programs to enhance junior faculty research grant success.Acad Med. 2017; 92: 1410-1415Google Scholar). RMB members will work with SIRF grant applicants’ institutional mentors to develop effective mentorship strategies for SIR members interested in developing research programs. It is estimated that recruiting an experienced RMB will require a minimum of 5 years. It is envisioned that the SIRF would assemble a task force for building the RMB, assemble a comprehensive list of current funded researchers and laboratories in IR (early targets for recruitment to the RMB), develop guidelines for mentorship, standardize metrics for assessing success, and publish these resources on the SIRF website. Initial contact efforts in 2017–2018 have been warmly received in all instances. In the long term (5–15 years), the IDTF proposes that the RMB will establish and grow a Mentorship Network. This Network would include laboratories willing to train researchers outside of their own institutions in specific research protocols and techniques. Travel and housing for these teaching laboratories will be supported by a new category of research travel awards from the SIRF. Applications for these travel awards will be reviewed by the SIR Grant Review Committee with RMB input and would be approved on a competitive basis. The research travel award will be developed in 2018 in time for the 2019 application/funding cycle. The RMB and Mentorship Network will also organize, oversee, and participate in mock study sections that will periodically review grant applications “in progress” to help aspiring SIR researchers prepare and refine these applications. This will help to make them more competitive for SIRF grants and extramural funding agencies. The mock study sections will provide input from multiple mentors outside of the SIR researchers’ institutions that will complement the work with the researchers’ institutional mentors. Furthermore, the IDTF will evaluate ways to include applicants in the actual review process early in their training, such as observing at the grant review study section. This will enable them to gain experience with the process and eventually become reviewers. There are sufficient active and experienced SIR researchers to establish the RMB; as the mentorship program produces more IR researchers, the pool for future members will grow. The IDTF proposes that the RMB will also recruit non-SIR member researchers who are currently performing or have performed IR-aligned research to participate in the SIR Mentorship Network. Recruits can also be semiretired or retired researchers who wish to remain active and assist aspiring SIR researchers. The IDTF believes that providing an incentive will facilitate participation for those in the Mentorship Network. This could, for example, include complimentary membership or reduced rates for meeting attendance. In cases where Network members provide exceptional service, it could also include some other form of recognition. Grantees currently submit a progress report and a final report marking the end of research project periods. However, there may be alternate methods to encourage investigators to commit to continuing research in the post-award period. It is of prime importance that the SIRF evaluates the effectiveness of the changes proposed herein and to track metrics of success (eg, publications, additional grants) for allotted SIRF funding. With this in mind, specific benchmarks for accountability will be established to determine efficacy of the “new” program relative to the current grants program. This additional oversight will enable increased consistency in the grant review process and provide high-quality instructive critiques to the grant applicants, ultimately strengthening future applications. To evaluate the efficacy of the mentorship and grant programs, the IDTF proposes that a new set of evaluations be performed. In addition to the progress and final reports, grantees will be asked to submit a curriculum vitae (with grant-related publications highlighted) and a list of grants applied for and/or obtained at 3 and 6 years after the term of an SIRF-funded grant. Data will be abstracted to determine the effectiveness of the program in spurring grantees toward a sustainable line of investigation. The program will commence in 2018, and the SIRF will review the data annually. As noted earlier, SIRF grantees have had limited success at parlaying grants into extramural research funding. The onerous funding environment of the NIH, Department of Defense, and other agencies presently makes this very difficult. In addition, fewer premiere SIRF Ring Grants have been awarded over the past few years, because the proposals have been judged to be of insufficient quality or preparation. It is critical that the SIR and SIRF continue to foster support from the IR community at large. The vital tools needed to establish a successful research program include training, mentorship, money, protected time, institutional research infrastructure, and multidisciplinary collaborations. Within busy IR practices at the majority of institutions, these tools and resources are often unavailable. Therefore, for the SIRF to improve this environment, participation of dedicated and experienced institutions is essential. To effectively leverage SIRF grant support, the IDTF proposes to highlight institutions that support highly successful IR research programs. The components and details of these successful research programs will be analyzed, publicized, and potentially recognized (eg, by institutional designation). By doing so, we hope to set standards to which other institutions aspire. The IDTF proposes to publish an informational document on the SIRF website with annual updates. Such best practices could include:1.Participating in the SIR RMB.2.Providing protected research time to faculty.3.Providing financial access to training resources.4.Providing internal pilot fund opportunities.5.Providing access to research personnel.6.Providing meaningful start-up packages for new faculty.7.Supporting extramural applications.8.Promoting formal mentoring.9.Agreeing to serve as training site for extramural trainees. SIRF could consider concentrating resources to participating institutions or those working closely with the participating institutions (via the RMB and/or extramural training). Publicizing member institutions will serve as a reference for up-and-coming IR researchers as well as collaborators from outside of IR, and could also guide the development of multicenter clinical trials. Publicity should serve as additional leverage to encourage institutions to invest in the IR research community and encourage further support of the local IR physicians performing research at individual institutions. Proposed timelines are to design such programs in 2018 and begin implementation in 2019. To leverage support from industry and nonprofit partners, the IDTF proposes that SIR members and leaders engage industry partners through the Corporate Ambassador Program and similar mechanisms. Resurrecting IR participation in groups such as ECOG-ACRIN (Eastern Cooperative Oncology Group–American College of Radiology Imaging Network) could leverage established clinical trial development and administration skills toward building the sorely needed evidence base for IR interventions. IR is a natural fit for this, but participation is only sustainable with a strong cadre of research-oriented physicians. Representing <0.5% of the estimated 1 million practicing physicians in the United States, IR suffers from anonymity. Not only is the field almost invisible to the public (2Baerlocher M.O. Asch M.R. Puri G. Vellahottam A. Myers A. Andrews K. Awareness of interventional radiology among patients referred to the interventional radiology department: a survey of patients in a large Canadian community hospital.J Vasc Interv Radiol. 2007; 18: 633-637Google Scholar), but many of our medical colleagues—including referring physicians—have a poor understanding of what IR has to offer (3Mok P.S. Tan E.Y. Baerlocher M.O. Athreya S. What do family physicians know about interventional radiology? A survey of family physicians at a large Canadian annual scientific assembly.J Vasc Interv Radiol. 2010; 21: 1250-1254.e1Google Scholar, 4O'Malley L. Athreya S. Awareness and level of knowledge of interventional radiology among medical students at a Canadian institution.Acad Radiol. 2012; 19: 894-901Google Scholar, 5Leong S. Keeling A.N. Lee M.J. A survey of interventional radiology awareness among final-year medical students in a European country.Cardiovasc Intervent Radiol. 2009; 32: 623-629Google Scholar). This issue especially plagues IR researchers, who, as a result, may rarely be sought for collaboration. Preclinical IR research is the least visible component of the specialty, despite the fact that its future depends on it. The recognized standing of IRs as a purveyors of state-of-the-art imaging technology, innovators in clinical approaches and procedure methodologies, challengers of medical status quo, and experts across organ systems and medical conditions offers unprecedented opportunity for IRs to be leaders in research. The potential of IR to push the frontiers of medicine hinges on its capacity to make new discoveries through basic and translational research. Our strong roots in innovation defines us, yet our early advances predate the competitive funding and strict regulatory environment that we currently inhabit. We need representation on NIH and similar study sections; because there is a recognized shortage of reviewers with imaging expertise, there is ample opportunity for IR physicians to become involved in NIH and similar study sections, which will potentially help to advance the IR mission of high-quality research by increasing awareness of the value of IR within NIH institutes and other agencies. The scientific advances of the future will require an even deeper understanding of fundamental disease processes. Fortunately, a growing number of physician-scientists among the IR ranks are trained to drive innovation through preclinical research. Basic, translational, and clinical research are costly, challenging, and time consuming; even so, we can model ourselves to some extent after our colleagues in other research-rich specialties and create a nurturing environment. Tenacious individuals willing to take on this challenge can face funding and logistical obstacles, pay cuts, tensions created by clinical demands, and misconceptions about the demands of research. The first step is to raise awareness of the value and centrality of preclinical and clinical IR research. Shining a light on IR research benefits everyone. Policy makers, hospital administrators, and the public will recognize the exciting cutting-edge research. IR research questions will garner more public attention and interest, which could translate into greater funding. Demonstrating the value of IR research contributions will lead to more opportunities through interdisciplinary collaborations. Within our field, highlighting research will help to foster a supportive culture, as well as facilitate connection of scientists with similar interests across institutions. The IDTF proposes the funding of a position dedicated to increasing the visibility of IR research in various media: articles and editorials (eg, IR Quarterly, the Journal of Vascular and Interventional Radiology, non-IR medical journals, and popular periodicals), online (eg, www.sirweb.org and www.theii.org), and in social media (eg, Twitter and Facebook). The SIRF should also provide incentives to encourage researchers to present at scientific meetings outside of IR. In the long term, the development of a robust research and mentoring network will also help to increase the visibility of the research enterprise. Although our present low profile presents a challenge, it can be mitigated through a conscious and concerted awareness campaign designed to highlight the potential of IR to define the cutting edge of medicine—without the cutting. The core tenet of the IDTF is that the field of IR must shift the emphasis from supporting individual projects to the nurturing of investigators who demonstrate promise and commitment to IR research. This must be accomplished within a SIRF-supported longitudinal framework of support and feedback. We must cultivate a culture whereby developing the research skill set is valued. By ensuring prospective investment in a research culture, starting at the beginning of IR training, to support future success, IR will do more than survive: it will thrive and branch out into new areas of patient care. The end result will be increased awareness of our value among other specialties and hospital administrators, lower costs, expanded roles of IR in medicine, and, ultimately, improved outcomes for patients. Although many details need refinement, change is coming. The IDTF invites and encourages input from the membership of SIR on the issues and recommended adaptations articulated herein. The IDRF calls on the IR community to once again draw on the spirit of exploration that has led the youngest primary medical specialty to have twice as many procedural codes as any other. We need to innovate within ourselves, creating a robust research infrastructure that will allow us to continue to blossom in our clinical work and change the way the world thinks about science and medicine, even if the majority of patients do not know what an interventional radiologist does. The IDTF-offered recommendations are difficult, forward thinking, and labor intensive, but they would represent a large step forward and position IR as not just a specialty, but the specialty most on the cutting edge of precision medicine. The authors recognize funding by the SIRF and administrative assistance by Audrey Ford and Sara Myers.