Sarah B. White, MD, MS, is an associate professor of radiology in the division of vascular and interventional radiology at the Medical College of Wisconsin. Dr. White is also chair of the SIR Foundation Clinical Research and Registries Division and will serve as the new contributor of this regular IRQ column.
In addition to being the recipient of the 2016 SIR Foundation Dr. Gary J. Becker Young Investigator Award, she has received awards for her research from several national and international organizations, including the Association of University Radiologists, the Radiological Society of North America (RSNA), and, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). She was also the Constantin Cope Cook Interventional Radiology endowed fellow at the University of Pennsylvania.
We sat down with Dr. White to get her perspective on the importance of conducting clinical research and how best to collaborate with the IR team around important initiatives like registries.
How does collaboration impact your experience in conducting clinical research?
WHITE: Since the discovery of penicillin, the amount of medical knowledge continues to expand exponentially. Even after 4 years of medical school and 3–5 years of residency, physicians cannot be knowledgeable in everything. Collaborations therefore have become the key to good patient care, allowing physicians to share their expertise. Research requires the same multidisciplinary, collaborative spirit. As IRs, we are uniquely qualified to help with research efforts, as we are not only experts in imaging but also in the clinical care of patients and image-guided interventions, but we need our colleagues in other disciplines to add their input to strengthen our clinical research.
How have you promoted teamwork and collaboration within the research community?
WHITE: Teamwork hinges on engagement from all members of the team, which can easily be obtained when all the investigators share a common interest. When clinical trials are developed to answer questions spanning multiple disciplines, collaboration is easier to obtain.
What kind of clinical research training is available for your team?
WHITE: Clinical research training is not yet a formal process in radiology. Because of my love of research, I chose to pursue a master’s degree in clinical investigation at Northwestern University. This degree incorporated classes related to basic clinical trial design, including biostatistics and epidemiology, but also focused on ethical issues related to human research and team building.
If someone would like to pursue more informal training, there are many foundation-run courses. For example, the SIR Annual Scientific Meeting offers many sessions about how to get started in research, and RSNA runs a course where physicians learn how to develop a clinical trial protocol.
What is the importance of peer-reviewed studies?
WHITE: The peer review process allows for an unbiased review of research in order to ensure the highest level of scientific quality, integrity and merit.
How does clinical research promote advancement in scientific knowledge among the IR community?
WHITE: As innovators, IRs find creative solutions for difficult problems on a daily basis. However, as we develop new technologies and new minimally invasive alternatives to surgical procedures, our colleagues and payers are demanding data. By engaging in clinical trials in IR, we are proving the safety and efficacy of our procedures and are thereby able to shift treatment algorithms.
What is the role of registries in promoting collaboration within the IR community?
WHITE: Every day, IRs across the country face similar challenges—proving the safety and efficacy of our procedures and defending our procedures to payers to ensure payment. Pooling data allows for more robust, statistically significant outputs, which can better demonstrate the role of IR procedures in clinical medicine. In addition, registries have the potential for us to prove that procedures, when performed by IRs, can be done with higher quality outcomes at a lower cost to the health care system.
How are registries used to evaluate patient outcomes across different medical centers?
WHITE: Because variability exists between medical centers, aggregate data allows for more generalizable outcomes data for IR procedures. For example, outcomes at big cancer cancers may not be representative of overall outcomes. Registries allow an overview of outcomes for the broader population.
How did SIR get actively involved in registries?
WHITE: SIR initially became interested in registries due to the need for radiologists to report quality measures. Jeremy C. Durack, MD, MS, FSIR, has teamed up with the American College of Radiology (ACR) to develop the IR Quality Registry. Because registries require manpower for data input, Dr. Durack has also build an IT infrastructure that uses standardized, structured reports that allows the seamless reporting of data into the database, with very little user oversight (see more details on p. 24).
How can SIR members get a new registry started?
WHITE: Because of the interest and need for registries, SIR Foundation has incorporated clinical registries into its Clinical Trials Division. There is now a new vetting process for investigators with an idea for a registry:
- Submit an initial letter of interest (LOI) to SIR Foundation including a concise explanation of the idea, a proposed outcome for the data (e.g., procedural reimbursement, proving safety and/or efficacy, validating new technology, etc.) and the foundation’s role in the process (funding, helping find industry partners, creating standardized reports, etc).
- The LOI will initially undergo review by SIR Foundation staff and me. If the “ask” of the foundation is significant, the LOI will be reviewed by the review committee, which is made up of registry experts, clinical trial experts, me, the foundation chair and vice-chair, and a content expert from the Service Line Advisory Board (SLAB).
- Comments will be returned to the investigator within 30 days of submission and, if appropriate, a request will be made for a full proposal.
- Full proposals will be reviewed by the review committee quarterly in a fashion similar to a grant study section. The Payment Research and Policy (PReP) Task Force will provide input to ensure that the proposal is aligns with SIR priorities.
Does SIR have funding mechanisms to help with clinical research?
WHITE: SIR Foundation holds biannual research consensus panels (RCPs), which are multidisciplinary meetings discussing current research topics critical to our specialty. The meeting, which is sponsored by the foundation, has covered a range of topics such as “IR performance measures,” “Image-guided biopsy in the era of personalized cancer care,” and “Submassive pulmonary embolism short- and long term outcomes: Where are we and where do we need to be?”
Additionally, SIR Foundation offers a Funding Source Development Grant that allows support for investigators to develop a protocol for a clinical trial or federal grant application. For more details, visit bit.ly/2bD4hEj.
