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

摘要

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. This includes changing of responsibilities and effort for some of the project member. These changes were in conjunctiwith the no-cost extension and were also approved by our IRB. Several amendments to our protocol were made increase recruitment and reduce burden on subjects including changes to recruitment tools, addition of new recruitment tools and addition of recruitment sources. We removed two blood tests that were no longer useful to the project and were therefore an excess burden to the subjects. Our new recruitment model contains the addition of other autism sites such as Children's Specialized Hospital and others. We have now begun tasks 3-7 and we continue to refine and increase our recruitment tools and sources to achieve our goal. Please see initiating project W81XWH-08-1-0728 and partnering project W81XWH-08-1-0729.