The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
MedTech IoT start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position themselves for success with investors. Here is how to get there.
Before product developers can more confidently design RWE studies and venture away from the traditional path of lengthy prospective studies, industry must overcome several challenges. This article provides insight on these barriers and perspective on how industry might fully realize the promise of RWE in the near-term to advance health care.
Randomized clinical trials are the gold standard for conducting clinical research. They are, however, fraught with issues and come with burdens to the patient, site and sponsor. Decentralized trials (DCTs) allow for a novel, agile and more cost-effective approach to an industry standard and traditional methodology. Here’s how to determine if a full or hybrid DCT is a good option for your clinical trial.
“Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.
Clinical Trials Labeling and Regulated Content Management Added to Cloud-Based Platform
We have the opportunity to refine processes that were implemented in a hurry during the pandemic, along with the insight to improve the entire healthcare system.
A review of new, successful treatment options for the novel coronavirus.
An upcoming webinar will discuss the new methods and protocols that have emerged as a result of conducting trials and HF studies during the pandemic.