Image reading centers are a critical component of a clinical trial in ophthalmology, and trial investigators should know how to effectively work with them to ensure efficient trial activity. Retinal Physician sought out tips for retina specialists working with reading centers for clinical research purposes. Several experts share their thoughts below.
JENNIFER TOURTELLOT, CRA, OCT-C
Program manager, Boston Image Reading Center, Boston, Massachusetts
Reading centers have several important roles in the support of clinical trials, including providing key input during the study design, generating image acquisition manuals, and certifying participating clinical sites. Interpretation of images is performed by trained graders using a standardized and objective approach, resulting in reliable and reproducible unbiased results.
During your site activation, the reading center will provide your site with an image acquisition manual. This manual includes detailed, study-specific image acquisition procedures ensuring all sites implement the same methods. It also includes instructions for certifying your photographers and devices, indicates which devices are acceptable for use considering the endpoints being analyzed, labeling for proper deidentification, and instructions for exporting and transmitting the files.
Steps we have identified at the Boston Image Reading Center that your site can take to ensure success begin with identifying the appropriate personnel at your site to manage image-related activities. Whether it be a study coordinator or photographer, it is important to assign an organized individual with facility in using digital imaging software as a point person for the sponsor and reading center to ensure timelines are met and there is a contact for query resolution. This is especially important both during site activation, because this often requires day-to-day oversight, and during subject enrollment, if time-sensitive eligibility reports are being provided and evaluated.
Work closely with your team to identify ideal candidates to image for certification and subjects to enroll in the study. For certification, there are often specific criteria that must be met with regard to pathology, and it can be immensely helpful for investigators to suggest patients who might meet these criteria and would also result in high-quality images. When considering subjects to enroll in the study, keep in mind the ability to collect clear, quality images is often part of the inclusion and exclusion criteria.
You can help to avoid queries by ensuring all personnel involved with the acquisition or submission of images read and frequently refer to the study manuals. Common queries include not using the correct naming convention, exporting the incorrect file types, and not adhering to the acquisition protocol. It is understood this is not always possible due to unforeseen circumstance with the subject or equipment, so please reach out to your reading centers if there is any deviation from the instructions outlined in the manual or protocol. Reading centers are there to support your site and help ensure an efficient and successful trial.
Managing Your Study Subjects During the COVID-19 Pandemic
CINDY NOVALIS
Globally, almost all clinical research sites conducting imaging for ophthalmic or safety research have been affected by the daily operational challenges that have arisen due to the COVID-19 global epidemic. Most sites are experiencing short-term site closures or site staff shortages. The US Food and Drug Administration has released clear guidelines on when to conduct visits and how to document missed visits, in its recent guidance document, “FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency” (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic ). Additionally, most sponsors have already released amendments, clarifications, or note to file guidelines on their expectations for current study conduct.
Your site should review and adhere to these guidelines as your current circumstances allow. If you have any doubts about study subject visits, always include both your sponsor and monitoring team in your request for more information. Key components of good study subject management are frequent and clear phone or email communication with your study subjects and your study teams, and adequate documentation of missed visits related to COVID-19 circumstances.
If you are working from home for the first time, we suggest doing a few minutes of online research to select among the best strategies for keeping yourself healthy and effective during this unique time. Implementing things like regular timed breaks and creating a secluded work-space which is sequestered from sleeping areas, if possible, can make a big daily difference in your energy reserves and tolerance. Family members may also constantly be at home, increasing the stress of the work-home environment. Be up front with your study team if you are having an issue keeping up with certain work or holding effective live meetings during this time, and you should expect to receive an empathetic and supportive response.
MARGARET GRAHAM
Research photographer, Retinal Consultants of Boston, Boston, Massachusetts
When presented with a study protocol, read through and make sure you understand what images are to be taken. As a research photographer for Jeffrey Heier, MD, at Retinal Consultants of Boston, I create a “cheat sheet” of what is actually needed for imaging and go over it with the other photographers. I keep a folder for each study with the protocol, certifications, the “cheat sheet” and instructions for how to send the images (what type of file is needed, where to send it and how to set up the folder). I do this for every study.
Each day, I print out the study schedule for the following day. I then pull all the “cheat sheet” protocols that we will need so we are ready when the subject comes in.
We have requisitions that the coordinators fill out with all subject information. It helps to keep that in front of you when sending the images. It is a good source document.
Try to send images to the reading centers within a day or two. I try my best to send out all images the same day they are taken. If you have a clinic that is study heavy and you don’t stay on top of submissions, it can be difficult to keep up. Also, when a query is sent, try to take care of it right away. There is a lot of paperwork involved in a study and the less pile-ups you have, the better.
It is also imperative that you maintain all equipment that will be used for the study. At Retinal Consultants of Boston, we clean our camera lens every day.
CINDY NOVALIS
Director of clinical operations, Digital Angiography Reading Center, Great Neck, New York
The first important consideration for ensuring a successful clinical trial is the source documents. These procedural documents should be used by your site to capture all the activities that are supposed to take place at a given study subject visit. Read through your source documents carefully to confirm that they cover each aspect of the subject’s visit compared to what the study protocol requires, from intake items such as blood pressure and ETDRS BCVA to the required image testing, including the imaging protocol specifics and, if applicable, the indicated study eye. Composing and regularly using a robust source document based on protocol visit requirements improves your internal communication, guides staff on specific protocol visit requirements, and will help to minimize your site’s protocol deviation rate over time.
Your site should have written standard operating procedures (SOPs) explaining how key aspects of study subject visits are being managed, and by whom. The more you stress the use of and familiarity with SOPs, the more staff members will understand their specific roles and responsibilities, and the less deviations from protocol requirements will tend to occur. Your site SOPs should be updated regularly enough so that all currently running protocol activities are covered. Staff members performing specific tasks should supplement them with work instructions that all site staff responsible for that task agree are correct and up to date. RP