Preclinical research indicates what a new compound should do. Ideally, clinical studies confirm it. But internal researchers and clinicians aren’t the only source of information that could be critical to a product’s success. On the front lines of clinical research, study subjects may offer sponsors insights into new indications or label extensions that clinical research alone hasn’t identified.
Cast a wider net
Generally speaking, clinical research looks to answer a lot of yes/no questions: Is it safe? Is it efficacious? Is it more effective than the existing treatment? All those questions are good and necessary, but they leave out a lot of potentially valuable information. They don’t capture a 360-degree view of the patient’s experience with the condition or the product’s impact on the patient’s quality of life — nor are they meant to. But those kinds of insights can often open the door to new lines of inquiry by identifying benefits that might have been overlooked or by bringing them to light much earlier in the product lifecycle than they would have been otherwise — so a different kind of research can be valuable.
Make new discoveries
How helpful would it have been to know, early on, that a drug designed to treat one aspect of depression also helped another component of the condition? Or that although a new oncology drug only offered a moderate benefit in regard to its primary endpoint, it ultimately made an enormous difference in the patients’ quality of life? Or that patients taking an investigational respiratory drug experienced vastly different benefits than what the planned statistical analysis was able to specify?
How we do it
Clinical SCORE tracks the patients’ journey, soliciting their hopes, fears and experiences before, during and after the trial. We have developed processes for obtaining qualitative and quantitative insights from study subjects and study coordinators, including a proprietary, two-step process for soliciting the insights sponsors need without the possibility of generating new adverse events (AEs). If you’d like to cast a wider net for information from your studies, email Blaine Cloud or call (877) 343—0100, ext. 1005.