Site Selection Success
When it comes to your site’s qualifications, you must be forthcoming with study sponsors.
By Aron Shapiro
Site selection for a clinical trial is a comprehensive process. It is akin to a site’s formal interview for study participation. If high-quality sites are selected, the trial will likely finish on time, on budget, and with clinically sound findings. In this issue’s column, we outline the specifics of site selection for clinical trials in retinal diseases.
WHAT THEY LOOK FOR
Contract research organizations (CROs) and pharmaceutical sponsors look for sites with a proven track record in retina trials and, as a bonus, experience with similar studies. The track record starts with a comprehensive understanding of, and a careful adherence to, good clinical practice (GCP) trial guidelines. A well-trained, experienced clinic staff is also essential, as is a patient population that is capable of meeting study enrollment goals.
To better understand your site’s capabilities and research experience, many sponsors start the site selection process by asking you to complete a feasibility survey or site qualification questionnaire with questions tailored specifically to their study. This is an important tool that contract research organizations and sponsors use to determine how quickly you might enroll patients in their study. CROs will also use your questionnaire responses to gauge your equipment and staff resources. CROs and sponsors have moved from paper-based to web-based questionnaires, which allow them to tabulate responses and acquire data more quickly.
HOW TO POSITION YOUR SITE
Although the questionnaires may seem tedious (especially when you need to repeat them for each sponsor and each study), they are often the only tools the sponsors have to assess your site. Therefore, be responsive and thorough. The sponsor will frequently need full cooperation and timely responses during the trial. The initial feasibility or site qualification questionnaire is the first demonstration of how your site will work moving forward.
Be detailed and accurate when completing questionnaires. Typical feasibility questionnaires include questions regarding satellite offices, doctors and investigators, common practice patterns, and current or previous clinical trials in which the investigators have participated. See the sidebar Questionnaire Queries for more details.
Make sure that your practice resources are presented adequately. If you have a dedicated research coordinator for clinical trials at your site, be sure to articulate that. If your site runs a tight ship and has a great track record hitting milestones on time, be sure that gets noted. Access to local referral networks or patient communities is also of value. If you have developed radio, social media, or newspaper advertisements that have attracted new patients, include this in the questionnaire as well. This type of information helps the managing parties understand your capabilities and gives them the full scope of what your site is capable of.
Sites that propose recruitment plans also stand out to sponsors. This may be going above and beyond the questionnaire, but if your practice is able to provide assurance as to how recruitment goals will be met—for example, providing results of a database search or patient metrics from the past few months to document the number of patients at the practice meeting the inclusion criteria—this will build confidence in the sponsor that your site not only has an adequate population for the study, but also is motivated to participate. The size of the database used to identify patients for any particular study will affect patient enrollment; sites with larger numbers of patients available and qualified for a study will speed up timelines.
The decision to select an investigational site is not easy for study sponsors and CROs, and, in some cases, critical factors may be out of the control of the candidate site. For example, statistical or demographic considerations will influence the number of sites participating in a study and which sites are chosen. Beyond these factors, managing parties will select sites based on a combination of infrastructure capabilities, experience, recruitment prowess, and overall clinical study track record. The CRO or sponsor will also need to know that your commitments to other studies will not compromise your ability to complete its trial. This key issue becomes more critical as your reputation as a superior clinical study site grows. Ultimately, the sponsor will determine whether your site has matched a passion for excellence in clinical research with the commitment of time and diligence necessary to successfully execute a clinical protocol.
• CROs and investigation sponsors rely on basic questions during initial evaluations of possible clinical sites. Here are a few areas you can expect them to cover:
• Whether you have experience with specific equipment or imaging tools such as spectraldomain optical coherence tomography (OCT) devices and high-resolution digital fundus photography systems
• Whether your site uses a central or local institutional review board and what approval timelines are associated with that agency, and whether the US Food and Drug Administration or other regulatory agency has recently audited your site
Keep in mind that, when reviewing the completed questionnaires for a trial, CROs and sponsors are filtering through a lot of data. It is important to clearly respond to the questions at hand and provide details that reflect what you have to offer. For example, do not leave them guessing whether your OCT machine is a Spectralis or Cirrus; list exact models and quantities for study equipment.
Also pay attention to whether the study has any unique requirements, and exemplify your experience. Do you have adequate resources to have masked and unmasked investigators? If so, say so!
The phase of the study often dictates some aspects of the decision-making. A sponsor conducting a phase 1 study may, given the time-intensive nature of these types of trials, focus more on the resources at hand at a site. A sponsors conducting a phase 3 study may want to review a site’s previous enrollment history for similar indications, or it may want to know the number of patients at a practice to plan for quick enrollment timelines. If a sponsor is adding more sites while a trial is under way, then it may look to see if your practice uses a central or local institutional review board or how quickly you move through the contract and study startup process. Because site selection criteria vary by sponsor, your best bet is to provide as much detail as possible.
Some newer research sites do not have a long record of experience. If your site is on the greener end of the spectrum, then you should take the opportunity to reach out to the CRO or sponsor and help it better understand how you plan to ensure that quality research is conducted at your site, from the training and standard operating procedures you have in place, to guidelines on how patients will be recruited, to the oversight and team meetings that are already parts of your research infrastructure. CROs and sponsors are not necessarily looking for a single criterion when vetting sites; rather, they are looking for a complete package.
Finally, the site selection process is a good time for you to ask questions and demonstrate your desire for engagement. Ask the CRO or sponsor any questions you may have about the study, the delivery of the investigational product, the inclusion and exclusion criteria, the timelines, etc. Your thorough review can not only show your potential for dedication to the study but also set the tone for the dedication that you will bring to the trial. As your experience in trial execution and management grows, you will find that your practice is considered a qualified potential site for a growing number of studies, as long as you maintain a commitment to clinical excellence and can effectively communicate your assets to new potential sponsors. n
Section Editor Diana Do, MD
• professor of ophthalmology, director of retina fellowship training
program, University of Nebraska Medical Center, Omaha
Section Editor Chirag Shah, MD, MPH
• retina specialist, Ophthalmic Consultants of Boston
• vice president of retina, Ora, Andover, Mass.