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

How To Improve ClinicalTrials.gov Reporting? Have Centralized Unit Oversee Tasks

 
• By Brenda Sandburg

Report by Clinical Trials Transformation Initiative identifies barriers to registration and reporting of clinical trial results to ClinicalTrials.gov and the need for centralized approach to monitor process and educate those responsible for submitting information to the site.

clinicaltrials.gov
Clinical Trials Transformation Initiative recommends ways to boost reporting of clinical trials results to ClinicalTrials.gov • Source: Shutterstock

There has long been concern about the failure of some clinical trial sponsors to register and report study results to ClinicalTrials.gov. The Clinical Trials Transformation Initiative investigated the challenges sponsors face and concluded that organizations should have a centralized system to monitor and support submissions.

CTTI conducted its investigation as part of its public-private partnership with the US Food and Drug Administration. It reviewed the...

Welcome to Pink Sheet

Create an account to read this article

Already a subscriber?

More from Clinical Trials

US FDA Plan To Limit Studies Eligible For Pediatric Exclusivity Criticized By Industry, NORD

 
• By Sue Sutter

The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.

In Partnership with FDA

CDER Center for Clinical Trial Innovation (C3TI)

Discover how FDA’s C3TI is advancing clinical trials and creating new opportunities to shape the future of drug development.

Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations

 
• By Neena Brizmohun

Newly enacted standard contractual clauses for negotiating clinical trial agreements in Germany appear positive for sponsors compared to the clauses that trial sites were typically requesting in the past, eg, those relating to compensation for the transfer of inventions, according to lawyers.

Better, Faster, Quicker: EUCOPE’s Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

 
• By Eliza Slawther

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

More from R&D

Better, Faster, Quicker: EUCOPE’s Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

 
• By Eliza Slawther

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

Rese-Cel CAR T Therapy Secures EMA PRIME Designation

 
• By Neena Brizmohun

Cabaletta’s rese-cel is among the latest investigational drugs that have won a place on the European Medicines Agency priority medicines scheme. Meanwhile, 11 products were denied PRIME designations.

OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
• By Kate Rawson

The Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.