Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ClinicalTrials.gov Compliance: Absent Regs, Enforcement Of Reporting Still Lags

Executive Summary

The National Institutes of Health is still drafting regulations, but Rep. Markey’s TEST Act, which would impose more extensive reporting requirements, has won praise from stakeholders for some of its definitional details. In an election season, its prospects for passing are slim, but aspects of the legislation could serve as a model for pending regulations.

You may also be interested in...



JAMA Studies Provide More Ammunition For Trial Disclosure Reformers

JAMA studies focus on the high number of terminated and unreported trials, plus discrepancies in publicly reported trial results. Publication comes as the Institute of Medicine consults stakeholders about trial data sharing and ahead of new reporting laws in Europe.

“Hidden Trials” In The Age Of Transparency: ClinicalTrials.gov Director Sees Room For Improvement

The global push towards clinical trial registration and transparency hasn’t ended the problem of “hidden trials,” the head of NIH’s ClinicalTrials.gov cautions. But the existence of registries helps better analyze the problem and offers some fairly simple steps to get closer to the goal of assuring that all clinical trials are available to the public.

Clinical Trial Data Release: Be Careful What You Wish For, Industry Exec Says

Some advocates and researchers say that data availability could inform repurposing opportunities for products, but a GSK exec cautions that it could just as easily bring a flood of confusing information.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS054739

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel