US Stem Cell Inc (USRM)

[Dragon Lady]

Reading clinicaltrials.GOV site- seems to me, you'd want to be registered if your trial is to be taken seriously?

http://clinicaltrials.gov/ct2/manage-recs/faq#charge

Note this line specifically under FAQ (cut n pasted):
Can I register a study after it has started, has closed to recruitment, or has completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
See FDAAA 801 Requirements for more information.

That sounds kinda important to me- as in, if you want publication later in major medical journals, sounds like they want your trial to be "registered" and issued the .gov tracking number and all? That's the way I read that verbiage above?

Again, strictly my opinion. But being published is huge, big in anything medical- it's what makes your work "peer reviewed" and more or less "legit" when the day comes.

Also, on the clinicaltrials.gov web site- read this section called, "WHY should I Register and Submit Results"- sounds pretty convincing and important to me:

http://clinicaltrials.gov/ct2/manage-recs/background

"What Is the Purpose of Trial Registration and Results Submission?
Registering clinical trials when they begin, providing timely updates, submitting summary results, and making this information publicly available fulfills a number of purposes and benefits a variety of people."

Read the table of info that follows that- pretty important stuff to me, especially for something like a "Phase II/III" and it doesn't mention A THING about "cause it helps recruit" and "we have enough people so we don't need it" or similar? It lists a whole bunch of, what sound like real, real important reasons to me, why a company with a major, serious FDA type trial would most certainly want it registered/approved on the .gov site. NOTE: Under FAQ link above- it notes that if human subjects are involved- the trial must be submitted AND "approved" by a review committee to be assigned a trial tracking number and appear on the .gov web site. Kinda important I'd think?

Quote cut n paste from same page .gov web site:

Why Do I Need To Register My Trial and Submit Results to ClinicalTrials.gov?
Required by Law

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices. For more information:

See FDAAA 801 Requirements to learn about Responsible Party, Applicable Clinical Trials, and deadlines for registration and results submission
See the Protocol Data Element Definitions and Basic Results Data Element Definitions to learn about the specific data elements
See History, Policies, and Laws to learn about other relevant laws, including the Food and Drug Administration Modernization Act
View the online presentation

Key FDAAA Issues (9:23)
Deborah A. Zarin, M.D., Director, ClinicalTrials.gov, NLM
Discusses key issues in the Food and Drug Administration Amendments Act related to registering trials and submitting results.

Required for Journal Publication

The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for the publication of research results generated by a clinical trial. ClinicalTrials.gov is a registry where organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE.

See ICMJE section of Support Materials or visit http://www.icmje.org.

Selected Trial Registration Laws and Policies

A summary of key laws and policies requiring clinical trial registration are shown in the table below: