Accession Number:

ADA574733

Title:

Developing Treatment, Treatment Validation, and Treatment Scope in the Setting of an Autism Clinical Trial

Descriptive Note:

Annual rept. 16 Sep 2011-15 Sep 2012

Corporate Author:

ROBERT WOOD JOHNSON MEDICAL SCHOOL PISCATAWAY NJ

Personal Author(s):

Report Date:

2012-10-01

Pagination or Media Count:

8.0

Abstract:

We submitted and received approval for our latest Continuing Review CR. In addition a restructuring of this project was done along with related changes to the protocol to help increase the rate of subject recruitment including an amendment to our protocol to allow recruitment from AutismMatch. A second, 6-month no cost extension was applied for and approved to maximize subject recruitment. We attended the annual conference of Autism NJ. This conference is the largest of it s kind in the state. We had a booth to distribute our recruitment materials and Dr s. Ming and Wasiulla and Mr. Stenroos attended the conference with the goal of informing autism families, doctors, representatives of autism schools and autism centersdepartments of hospitals as well as researchers of our study and making contact with potential recruitment sources. We addressed an unforeseen problem with scheduling sample collections and baseline testing with our internal lab. We continue to treat and evaluate enrolled subjects tasks 3-7. We convened our DSMB board in November of 2011 and received approval to continue. We are preparing for our next DSMB meeting. We continue to search for additional funding and to continue to refine and increase our recruitment tools and sources to achieve our goal. We continue to look for additional funding to extend this project and to maximize enrollment. Please see initiating project W81XWH-08-1-0728 and partnering project W81XWH-08-1-0729.

Subject Categories:

  • Anatomy and Physiology
  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE