Benefits of the Trial Results Summaries Portal

Posted by Francine Lane on Feb 28, 2017 8:01:42 AM


INTRODUCTION:

If you saw our press release, you know we just released the Trial Results Summaries Portal. This solution represents a major shift in clinical trial transparency where we are connecting patients to trial results summaries in a more efficient and reliable manner.

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Topics: Clinical Trial Disclosure, Trial Results Summaries, Patient Engagement, Plain Language Summaries

The Final Rule Goes Into Effect

Posted by Francine Lane on Jan 19, 2017 9:40:55 AM


On Wednesday, January 18, 2017, the Final Rule for Clinical Trial Disclosure in the US went into effect.  But what is the Final Rule and what does it mean for study sponsors?

In September 2016, the United States Department of Health and Human Services (HHS) issued 42 CFR Part 11 for Clinical Trials Registration and Results Information Submission, commonly referred to as the “Final Rule”.  This Final Rule was a required update to Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007.  The Final Rule clarifies and completes requirements for registering clinical trials and disclosing clinical trial results.

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Topics: Clinical Trial Disclosure

7 Ways To Clean Up Your Data On TrialsTracker

Posted by Francine Lane on Nov 28, 2016 8:01:00 AM


Clinical Trial Results Reporting

In early November 2016, Ben Goldacre and Anna Powell-Smith launched the TrialsTracker website.  This website analyzes data from  ClinicalTrials.gov to determine which studies appear to be missing clinical trial results.

TrialsTracker is currently focused on sponsors with more than 30 trials, assessing the results disclosure status for interventional phase 2, 3, or 4 trials registered on ClinicalTrials.gov that were completed between 2006 and 2014 (24 months prior to the current date).  The expectation on the TrialsTracker site is that study results are available within two years of study completion on ClincialTrials.gov or that a published article can be found on PubMed referencing the ClinicalTrials.gov issued identification called an NCT ID, unless a formal request to delay results has been submitted to ClinicalTrials.gov.

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Topics: Clinical Trial Disclosure

Where should I register my clinical trial?

Posted by Francine Lane on May 25, 2016 2:46:26 PM


There are 15 clinical trial registries that conform to the WHO Primary Registries, including  ClinicalTrials.gov, and over 50 specialty registries in the United States (US) alone.  That is more than 65 possible places to disclose your clinical trial.  How can you narrow the list of possibilities to determine where you should disclose your trial?  Here are a few helpful considerations when determining your approach to clinical trial disclosure.

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Topics: Clinical Trial Disclosure

Clinical Trial Transparency Hits the C-Suite

Posted by Thomas Wicks on Jul 29, 2015 4:25:40 PM


You may have seen clinical trial transparency in the news last week as international publications like the Wall Street Journal and Financial Times covered the topic. A collection of 85 different asset managers and pension funds from the US, EU and Australia aligned with the AllTrials initiative to urge clinical trial sponsors to be more transparent with clinical trial data.

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Topics: Clinical Trial Disclosure

Introduction to Clinical Trial Disclosure

Posted by Francine Lane on Jun 5, 2015 12:13:50 PM


Are you new to disclosure and don’t know where to start?  This is the first in a series of “Back to Basics” on clinical trial disclosure and is intended to help navigate the challenging world of disclosure.

Disclosure in clinical trials is becoming relevant to more and varied organizations.  Once the domain of large pharmaceutical and biotech companies, smaller biopharma, academic, and research organizations are paying close attention to disclosure.  Read on to find out why.

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Topics: Clinical Trial Disclosure