DoD Autism Research Program Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD Autism Research Program (ARP) Clinical Trial Award (CTA) is a U.S. Department of the Army funding opportunity administered through the Congressionally Directed Medical Research Programs (CDMRP) to support well-designed clinical trials that could make a meaningful, near-term difference in how autism spectrum disorder (ASD) is treated or managed. The central purpose of this mechanism is practical clinical impact: it is meant to move beyond exploratory work and directly test interventions in people, with the goal of improving outcomes for individuals with ASD and addressing urgent needs identified by the autism community. A key restriction is that funds cannot be used for preclinical studies, such as animal or laboratory experiments intended to justify moving into humans. Applicants are expected to propose an actual clinical trial, and the program directs investigators to CDMRP guidance (notably Appendix 6 in the Application Instructions and General Information) to help distinguish a true clinical trial from other forms of clinical research.

A defining feature of this award is its emphasis on speed to implementation. The proposed clinical trial is expected to begin no later than 12 months after the award date, which signals that the program is looking for teams that are ready to launch: protocols should be mature, operational plans should be realistic, and sites, recruitment strategies, and regulatory pathways should be sufficiently developed to avoid long delays. This also implies that the trial concept should be feasible within the award period and budget, with clear milestones that reflect real-world trial start-up requirements such as IRB review, contracting, staff training, and data management setup.

For fiscal year 2009, the ARP highlighted two priority research areas. The first is comorbidity, meaning the many co-occurring medical and functional issues that frequently accompany ASD and can substantially affect quality of life and day-to-day functioning. The announcement lists examples including gastrointestinal problems, sleep disorders, behavioral challenges, speech and language issues, psychiatric conditions, seizures, immune dysfunction, motor and sensory deficits, metabolic dysfunction, and the ways ASD can affect intellectual ability. Clinical trials responsive to this area would typically test interventions that prevent, reduce, or better manage these co-occurring conditions, or that tailor ASD management strategies to account for them.

The second priority area is predictors for treatment outcome, focusing on identifying biomarkers, clinical characteristics, or other phenotypic markers that can forecast whether a person is likely to benefit from a particular treatment. This includes predictors relevant to traditional interventions as well as complementary and alternative approaches. In practice, this could mean clinical trials that incorporate stratification factors, collect biological samples or behavioral measures to identify response signatures, or test whether specific subgroups respond differently. The goal is to move the field toward more personalized and efficient care by learning not only whether an intervention works on average, but also for whom it works, under what conditions, and who is unlikely to respond.

From an administrative standpoint, this opportunity was posted February 1, 2009 (Funding Opportunity Number W81XWH-09-ARP-CTA) and offered support through either grants or cooperative agreements, under the science and technology/research and development category. The estimated total funding was $2.2 million, with an expectation of making about two awards. There was no cost-sharing or matching requirement, and eligibility was described as unrestricted, meaning a wide range of applicant organization types could apply as long as they met any clarifications in the full announcement. The CFDA number associated with the program is 12.420 (Military Medical Research and Development). The original application closing date was July 22, 2009, later extended to August 19, 2009, and the opportunity was archived on August 21, 2009.

For applicants needing help accessing the full announcement or navigating submission systems, the notice provided support contacts including PA HELP (301-619-7079; cdmrp.pa@amedd.army.mil), eReceipt HELP (301-682-5507; help@cdmrp.org), and the CDMRP Help Desk.

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