1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

AI And The ‘Diffusion’ Of Responsibilities In Decentralized Trials

 
• By Vibha Sharma

Experts argue that current guidelines on attributing responsibilities in clinical trials point in the right direction but lack the specificity to address the diffusion of responsibilities caused by the use of AI systems in decentralized studies.

Communication of people in the business of the company. Delegation of work and responsibilities. Functioning of departments and divisions of the company. Decentralized networking. Teamwork cooperation
Responsibility diffusion makes it harder to trace outcomes back to individual actions (Shutterstock)
Key Takeaways
  • The use of AI-driven systems in decentralized clinical trials can lead to the diffusion of responsibilities across multiple actors and technologies, complicating oversight and accountability.
  • Three experts, in partnership with the EU initiatives Trials@Home and Hypermarker, have published a paper recommending that trial sponsors follow a three-step approach to manage diffused responsibilities in a more effectively.
  • They suggest that sponsors should map tasks and duties into distinct clusters, identify risks and challenges for knowledge and control, and organize communication.

The use of artificial intelligence (AI)-driven systems in decentralized clinical trials (DCTs) can result in the “diffusion” of responsibilities across multiple actors and technologies, and requires study sponsors to look...

Instead of simply focusing on establishing effective communication lines between the various actors involved in a trial, sponsors should follow a three-step approach that entails mapping tasks and duties, identifying...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

More from Geography

UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.