Keeping Up with Personalized Medicine: Adapting to Meet Patients ’ Needs
Medical technology is revolutionizing healthcare for patients worldwide and is now more than ever becoming crucial in the prevention, diagnosis, treatment, and management of numerous diseases. We are increasingly seeing the ability of medical technology to personalize treatments and target patientsâ individual needs. However, to ensure we are enabling access to these treatments, regulatory agencies need to consider new approaches to the approval process.
Historically, product approvals have focused on the standardization of a drug or a therapy to treat a large population of people with the same disease, safely and effectively. But in this new age of personalized care, these standards are insufficient for products coming to market that are designed to meet unique patient needs.
Currently, regulatory agencies including FDA seek large clinical data sets to demonstrate that drug products are safe and effective for patients. While safety and efficacy need to be held to the highest standards for certain areas of healthcare, such as regenerative medicine, these data sets are both difficult and unnecessary to achieve. In cases where the patient population is small and varied, requiring large clinical trials creates needless challenges.
Large clinical trials are very costly to run, difficult to recruit patients for, and often do not align with clinical endpoints for products that are intended to work individually for patients as opposed to a large population pool. Co...
Source: MDDI - Category: Medical Devices Authors: Mike Izon Tags: Regulatory and Compliance Source Type: news
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