From a technical perspective, the beginning of the clinical research process often brings to mind images of scientists in the lab. But long before a drug or device company begins the arduous and uncertain journey to develop a new therapy, it is the patients and their stories that inspire these efforts.
Patients not only influence development of new and better therapies, they participate in the late phase clinical trials that examine drug and device safety and efficacy. So, with so much at stake, it is no surprise that patient involvement is growing throughout all aspects of the clinical development process.
In June 2015, an FDA Draft Guidance was published which, in fact, is the first ever to be initiated by a patient group. Patient advocates for those suffering with Duchenne Muscular Dystrophy (DMD), a rare but progressive, fatal disease, have been pushing for better access to experimental drugs and FDA guidance on development, including clinical trial design.
Additionally, public-private partnerships like the Clinical Trials Transformation Initiative (CTTI) are actively exploring how to better collaborate with patient groups as part of their mission to improve the quality and efficiency of clinical trials.
As a provider of clinical trial expert committees and clinical safety and consulting services, ACI Clinical is available to support and assist the development of clinical trial solutions which support these growing patient engagement needs.