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Aiming Higher in Dermatology Clinical Trials

March 20th, 2015 | Dermatology | Article

Let’s start with the basics. Dermatology is the branch of medicine dealing with hair, skin, nails and all its diseases. At a very simplified level, Dermatology treats visible ailments. Patients and doctors can typically see and/or feel when they have a dermatological concern. As a result, the dermatological patient database is quite large compared to other more difficult to diagnose therapeutic areas. However, a large patient pool does not independently guarantee an easy to enroll study. There is a lot a conscientious CRO can do to maximize enrollment timelines, guaranteeing sponsors the opportunity to benefit from shorter timelines and cost savings.

CRO experience comes into play early in the process. We have learned the importance of getting principal investigators involved at the very beginning, starting with the protocol writing. By adding PI feedback to our own extensive research, Biorasi optimizes the study inclusion/exclusion criteria to allow for optimal study results and rapid enrollment. For example, a sponsor may list a concomitant medication as part of their standard prohibited list. But a PI can identify the same medication as something that this particular population will be less than likely to give up and won’t actually interfere with the treatment. Seemingly small changes can make a big difference to enrollment numbers. We are focused on providing our sites the right framework and resources for success.

When we contract with a site to run a study, it is only the very beginning of our relationship. Just as Biorasi offers our sponsors preferred provider partnerships, we build strong partnerships with our sites as well. We take the time to select strong and responsive sites, which we can in turn provide with the means to enroll quickly and effectively. Sites benefit from working with a CRO that is truly invested in their own success. Biorasi benefits from working with sites that are driven to perform well. This emphasis on strong business relationships leads to high enrolling sites, which can shorten study timelines and cause significant cost savings.

Recently Biorasi has seen the direct effects of site optimization in our current Rosacea study. We exceeded projected goals and met 25% enrolled 4 weeks early. That kind of enrollment success could only be accomplished by our project team making the effort to tap into sites untapped potential. There is no denying that the leadership on the study is what made the difference in the study results.

Is it clear that we identify site relationships as a key part of our success?

As part of our effort to continue to grow our network of top tier sites Biorasi is attending the American Academy of Dermatology conference in San Francisco this weekend. We hope to see you there.