Reporting Failed Trial Data: New Rules for ClinicalTrials.gov
FDA’s new proposed rules will make you revamp the way you register data on ClinicalTrials.gov.
Take 90 minutes and hear from one of the industry’s ClinicalTrials.gov experts on what you’ll need to do to update your trial data registration procedures.
Under sweeping new changes drug and biologic makers would have to submit all clinical trial data to the federal government — including data for products not approved by the FDA — under a massive proposed expansion of data collection.
Once this proposed rule is final, it will replace all previous guidance to date.
The proposed rule outlines numerous additional requirements:
Under the proposed rule, companies would have to submit trial data no later than one year after the date of the final data collection on the trial’s primary outcome, even if the trial fails.
The rule specifies when a drugmaker needs to register a trial, which should be no later than 21 days after enrolling the first participant. Data elements that should be submitted at that time include the descriptive information, recruitment information, location and contact information for the trial site.
There should only be one responsible party that submits the information on any clinical trial. The sponsor would be considered the responsible party until a clinical trial investigator can be designated.
The rule also puts in place new requirements on adverse event data. The sponsor must submit two tables: one summarizing all serious adverse events, and another listing each adverse event that occurred to five percent or more of subjects in any arm of the trial.
The proposed rule would require that all studies of off-label uses of approved drugs also be publicly reported.
Sponsors must include information on how to obtain expanded access to investigational drugs used in applicable clinical trials, but only if those products are available through an expanded access (e.g. "compassionate use") program.
This webinar will prepare both your regulatory affairs and clinical trial management teams to assure that changes are properly made to your program.
Join FDAnews and clinical-trials expert Scott Cunningham Esq. for a 90-minute orientation session that helps you get ready for a new era in clinical-trial submissions.
You can’t afford to wait until a final rule is promulgated.
Here’s just a sampling of what you’ll discover:
How to modify your processes and compliance status to conform to HHS’s sweeping new proposed changes
Making certain your entries in ClinicalTrials.gov are consistent with internal records
Closing address gaps in reporting
Determining when the 21-day rule begins and what constitutes the “first” participant
Ramifications of submitting trials on off-label drug uses
Data on adverse events — the perils of providing too little or too much information
And much more!
Don’t get caught short. Learn what you need to know now. Order your webinar CD and transcript TODAY.
Clinical Trial Regulatory Management
Clinical Trial Information Disclosure
Global Clinical Safety and Pharmacovigilance
Scott Cunningham Esq. is a member of Covington & Burling’s Food and Drug practice group, representing clients in matters before the FDA and other agencies, Congress, state and federal courts. Specialty areas include: new-product development and clinical trials; IRBs; new-product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; and SEC disclosure.