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Interagency Autism Coordinating Committee (IACC)
Autism Research Database
Office of Autism Research Coordination (OARC)
 
Project Element Element Description

Project Title

Project Title

Outcome Measures for Clinical Trials with Individuals with ASD: Challenges and Opportunities

Principal Investigator

Principal Investigator

No PI Listed

Description

Description

The meeting hosted clinicians, academic experts in the field of outcome measurement, representatives from eight pharmaceutical companies, funding agencies, and community stakeholders. The meeting’s goals were:  1) to discuss strategies for promoting more effective clinical trials of medications to address autism core and associated symptoms and  2) to develop consensus regarding  the best clinical assessments to determine whether a treatment has been effective in clinical trials. The group discussed the following key points to be addressed in future initiatives: (A) Since there are currently a number of very good outcome measures that are appropriate for clinical trials, developing consensus on a group of standard measures is a key next step. FDA approval of a medication requires consensus outcome measures. Among the questions that were discussed in regards to standard measures were: 1) what are the most sensitive outcome measures, 2) what is the best setting to measure outcome, and 3) from whom should the outcome data be collected (parents, teachers, clinicians)? (B) There are opportunities to develop new outcome measures based on promising technologies that provide measures of biological change. Experts in new technologies that can make use of devices such as the iPhone to collect outcome data in real time and in real world settings also offered several promising ideas. (C) Long-term success of those conducting clinical trials with people with ASD requires closer collaboration between parents, clinicians, and the basic scientists who are developing treatment targets.

Funder

Funder

Autism Speaks

Fiscal Year Funding

Fiscal Year Funding

26000

Current Award Period

Current Award Period

2011.0

Strategic Plan Question

Strategic Plan Question

Question 4: Which Treatments And Interventions Will Help?

Strategic Plan Objective

Strategic Plan Objective

Red dot: Objective has no funding. 4SE. Convene a workshop to advance the understanding of clinical subtypes and treatment personalization (i.e., what are the core symptoms to target for treatment studies) by 2011. IACC Recommended Budget: $50,000.

Project Link

Project Link

Outcome Measures for Clinical Trials with Individuals with ASD: Challenges and Opportunities (External web link)

Institution

Institution

N/A

State/Country

State/Country

New York

Project Number

Project Number

N/A

Federal or Private?

Federal or Private?

Private

Received ARRA Funding?

Received ARRA Funding?

No

History/Related Projects

History/Related Projects

N/A

 
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