1. Medtech Insight
  2. >>Business
  3. >>R&D
  4. >>Clinical Trials

MDIC Project Looks To New P-Value Possibilities

The Medical Device Innovation Consortium is launching a new pilot project with FDA and the Michael J. Fox Foundation to incorporate patient preference into device trials in a ‘scientifically valid way’, according to MDIC CEO Bill Murray, who spoke to MedTech Insight from the AdvaMed 2016 conference in Minneapolis. In our video interview, Murray discusses the project's aim to adjust the statistical design of a study for Parkinson's disease based on patients' willingness to accept risks.

The Medical Device Innovation Consortium, FDA and the Michael J. Fox Foundation for Parkinson's Research are working on a project to design trials that look beyond requiring the standard cutoff p-value of 0.05 or less to judge statistical significance. Instead, they aim to establish statistical standards based on information about what risks versus benefits patients are willing to accept.

According to MDIC, the pilot project will develop and test a method to incorporate preferences of Parkinson's patients into the...

Welcome to Medtech Insight

Create an account to read this article

Already a subscriber?

More from Clinical Trials

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

More from R&D

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.