The decision to shift focus in your clinical research site to a different medical indication can be influenced by myriad factors. Perhaps you are no longer seeing the volume of studies you previously saw in your area of expertise. Maybe your patient population has changed and you must adapt to meet their needs. It could just be that it’s time to apply your skills and resources to something new.
“Clinical operations work is multi-faceted, required individuals to have knowledge and experience in both research and business.” 1
Whatever the reason, here are some guidelines for attaining a study in a new indication
Leverage your relationships.
Review your local professional and personal contacts. Do any of these contacts have a practice in a different therapeutic area than you? If so, connecting with these contacts could be a great strategic approach to branch out into a new indication, simply by association. Initiate contact and start having conversations. Ask questions about the studies they have conducted, equipment needs, patient populations, etc. Capitalizing on these established relationships can help you create a referral network for future protocols. Think about these relationships when you are completing a feasibility questionnaire for a study outside of your usual therapeutic area and be sure to showcase all potential patient access. Additionally, contacts who are referring physicians can act as sub-Is for your site, and, as a result, grant you access to studies you may not have been qualified for before.
Conduct observational studies.
While observational studies are not necessarily revenue-drivers, they are great “filler” studies to work on during slower times. These studies provide you with an opportunity to introduce and establish yourself with large sponsors and CROs, and to break into a new therapeutic area. If you have access to the appropriate patient population for an observational study, and if it will not cost you anything to conduct and manage, it is worth considering. An observational study can be added to your CV to showcase your experience, and demonstrate to sponsors and CROs that your site has the capacity to run trials in a variety of indications.
Keep an open mind.
Think outside of the box when considering whether or not to take on a new study. A study you may have declined at first glance may be perfectly accessible if you are able to negotiate a better advertising budget or are able to utilize recruitment support. Think of the reasons why you wanted to decline the study in the first place, then determine possible solutions for those problems. Are the solutions feasible? Do you need to do something as simple as hiring a recruitment coordinator for the study? Do you need to utilize a call center to assist with patient pre-screening and retention? Maybe you already have a recruitment coordinator and need to allocate money within the budget for more traditional advertising, instead. If the solutions seem within reach, taking on the study might be worth serious consideration.
During this process, leverage not only your previous clinical research experience, but also the patient populations you may have access to that are not in your typical line of focus. For example, if you have historically been exclusively dedicated to endocrinology studies, but are located in a climate that gives you easy access to patients with sun damage, you should consider expanding your therapeutic areas to include dermatology. Additionally, many therapeutic areas have overlapping indications. Think about the symptoms your patients are experiencing, not just the specific illness itself (i.e. diabetes and foot ulcers; women’s health and urology; psychiatry and pain; women’s health and migraines) and aim for studies that address those symptoms.
Over the years of working with a multitude of research sites in various therapeutic areas, we have noticed that many sponsors and CROs will automatically remove a site from consideration based solely on their name. Your site’s name may be pigeon-holing you in ways that you are unaware of, holding you back from new opportunities before you even get a chance to present your experience and patient access. For example, if you have mainly focused on neurology studies but want to break into new therapeutic areas, you may want to consider condensing your site name from “Brain Behavior of Houston” to “BB of Houston” to reduce sponsor bias.
Develop a roadmap.
No matter the reason why you want to expand the indications your site works with, you need a plan for how you are going to do it. Mallory Thomas, our Director of Site Relations, is an expert in breaking sites into new therapeutic areas. She has specific advice for her sites: “Develop and implement a plan for what is needed for each new indication you want to branch into. Do you need raters? Any specific equipment? Injectors? Once you lay out what is needed and have checked off all boxes, it is easier to approach new protocols. Use other sites who are already skilled at these types of studies for support.” Thinking critically about each and every detail of what is needed for a study in a new indication will set you up for success. Knowing ahead of time what will be required of you, and planning so that you will be able to implement and follow through on what is needed, will show sponsors that you are prepared and increase the likelihood that you will be selected for a study.
There are many ways to leverage your site’s experiences and capabilities that will assist with breaking into a new indication.