Objective of the Novel Outcome Measures for ASD Clinical Trials Award
Grants awarded through this request for applications (RFA) are intended to develop and validate objective outcome measures for use in clinical trials targeting core symptoms (social communication impairments and restricted, repetitive behaviors) of autism spectrum disorder, and disruptive behavioral symptoms commonly reported in individuals with autism (e.g., anxiety, tantrums).
There is a lack of quantitative, objective, reliable and sensitive tools to measure treatment response in behavioral and pharmacological clinical trials in autism. We seek innovative applications that will develop and validate clinically relevant outcome measures that will objectively and sensitively distinguish treatment effects from placebo response and reduce reliance on retrospective parent-reported behavior rating scales and assessments.
We especially encourage applications for outcome measures that:
- measure behaviors, skills or biomarkers that have relevance to one or more core autism domains of socialization, language and repetitive behavior, and that co-vary with autism severity.
- are objective and yield quantitative, continuous data of sufficient range.
- are feasible in terms of burden on participants and families.
- when possible, capture data from the participant in their natural environment rather than exclusively in the laboratory setting.
- are scalable and affordable for large clinical trials (e.g., 300-1,000 participants).
- are maximally sensitive to detect behavioral changes.
- can be used in a wide age range of individuals with autism.
- can be used in individuals with autism within a wide range of functioning levels or else carefully define the functional level to which the measure applies.
- have high test-retest reliability.
Examples of possible approaches include but are not limited to clinician-rated measures, language sampling tasks, combined measures of physiological data and observational behavioral data, eye-tracking and electroencephalography paradigms.
The application should include a validation study design including comparisons of the novel outcome measure or measures to known established outcome measures. The application should also include considerations for establishing normative data, justification of inclusion/exclusion criteria, the proposed range of age and ability level in the participants, and sample size based upon power calculations.
Eligibility and collaboration
All applicants and key collaborators must hold a Ph.D., M.D. or equivalent degree and have a faculty position or the equivalent at a college, university, medical school or other research facility. Applications may be submitted by domestic and foreign nonprofit organizations; public and private institutions, such as colleges, universities, hospitals, laboratories, units of state and local government; and eligible agencies of the federal government. There are no citizenship or national residence requirements.
If the proposal includes investigators at more than one site, all investigators should have demonstrated prior success in similar collaborations.
Funding period and budget
The grant period is two years. The maximum budget is $250,000, including indirect costs, per year for up to two (2) years. Exceptions with good justification will be considered but are not encouraged.
- Narrative, not exceeding six (6) pages (excluding references and figures). Proposals should include specific aims, background relevant to the application, significance of the proposed studies, preliminary results, experimental design, pitfalls and alternative strategies, and a timeline with milestones.
- Biosketches for Principal Investigator(s) and Key Collaborators.
- Current and pending support for Principal Investigator(s) and Key Collaborators.
- While there are no budget caps on the individual applications, budgets will strongly factor into the competitiveness of an application. Budgets of more than $250,000 annually will need convincing justification. It is unlikely that we will make an award larger than this amount. Proposals should include a realistic budget sufficiently detailed for evaluation of needed resources. We will work closely with investigative teams with competitive applications to arrive at a suitable budget. Indirect costs are limited to 20 percent of the modified total direct costs (see Clinical Research Associates policies). Applications with multiple Principal Investigators from different institutions that would like to be paid separately must include a signed signature page, budget template and budget justification for each Principal Investigator. Applications with subcontracts must include a budget and budget justification. The budget template and budget justification are available for download in the proposal attachments section of proposalCENTRAL’s full application.
- Research environment and resources. Investigators should demonstrate access to appropriate resources for high-capacity data collection and analysis, although we will work with awarded investigators to provide additional informatics support as needed.
- Data-sharing plan. The plan should include sharing of raw and analyzed data. We will work closely with awarded investigative teams to ensure that the plan includes timely dissemination of data with reasonable embargo provisions.
Application deadline and instructions for submission
We request that investigators who intend to submit a proposal send an email by 5 February 2015 with the intended investigators’ names and affiliations and their intended proposal’s title to grants(replace this with the @ sign)clinicalresearchassociates.net with the subject line: CRA RFA Notice of Intent.
Applications must be completed electronically and submitted using forms provided at proposalCENTRAL, which will be open for applications beginning on 6 January 2015.
The deadline for applications is 23 February 2015, 5:00 p.m. Eastern. No extensions will be given. If you have any difficulties, please contact grants(replace this with the @ sign)clinicalresearchassociates.net.
Competitive applications will receive external peer review. Funding for these awards will be made by Clinical Research Associates, an L.L.C. affiliated with the Simons Foundation; notification of award is expected by 1 June 2015, with funding expected to begin on 1 July 2015.
Scientific inquiries: sciencerfa(replace this with the @ sign)simonsfoundation.org 646-654-0066
Administrative inquiries: grants(replace this with the @ sign)simonsfoundation.org 646-654-0066
proposalCENTRAL: pcsupport(replace this with the @ sign)altum.com 800-875-2562