PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):

LETTER OF INTENT (LOI) TEMPLATE: Pharmacological Treatment of Anxiety Disorders in Children, Adolescents, and/or Young Adults

Instructions:

An LOI is required for new and resubmitted applications. Provide the information requested on the attached template. You must answer all questions listed in the template. Highlight or boldface the changes if this is a resubmission.Aside from removal of the questions under each section header, no other modifications may be made to this template;any modifications will result in administrative withdrawal of the LOI.Applicants are required to follow the rules and guidelines listed below:

  1. Replace the questions on the next page with your response, but retain the question numbers.
  2. Do not include figures or general tables.Tables maybe included only for power calculations.
  3. References will not be includedwithin the three-page limit.
  4. Do not upload this cover page.
  5. Do not include supplemental materials (e.g., supporting journal articles and Letters of Support) or additional information not requested on the template (e.g., responses to reviewer comments or Resubmission Letters). Their inclusion will result in LOI rejection without review.

Any additional template modifications will result in disqualification of your LOI. The LOI must be submitted as a PDF in PCORI Online.

Formatting Guidelines:

  • Header: Include the Principal Investigator’s (PI’s) full name on every page in the top-left corner.
  • Font:Calibri size 11
  • Spacing: Single
  • Margins: Half-inch (The header may fall within the top margin, but the body text may not begin closer than a half-inch from the edge of the page.)
  • Page numbers: Consecutive
  • Page limit:Three pages (excluding references)
  • File name format:PI Last Name_(four digits of LOI number)_LOI.pdf. An LOI number will be generated automatically and visible at the top of the web page in PCORI Online once the LOI has been saved.
  • References:PCORI suggests including all references as in-text citations using American Medical Association citation style, but other citation styles are accepted.

LOIs are competitive and will be screened by PCORI staff. The information included in this template will be used as the primary source of information for the screening process. Focus on including critical information because space is limited. Provide a description that allows the scientific community to understand the project—including the aims and study design—without reviewing the full application.If you have any additional questions, contact PCORI at or 202-627-1885 for administrative inquiries and or 202-627-1884 for programmatic inquiries.

LETTER OF INTENT (LOI) TEMPLATE: Pharmacological Treatment of Anxiety Disorders in Children, Adolescents, and/or Young Adults

TITLE OF PROPOSED STUDY:

Specific Aims:

  1. State the goals of the proposed research, the comparators, and the expected outcomes.

Background:

  1. Describe how your comparative clinical effectiveness research (CER) question aims to addressdocumented or known evidence gaps. Provide references for these known gaps from systematic reviews/clinical practice guidelines. Describe how the proposed study will help address decisional uncertainty currently facing patients and clinicians or other decision makers.

Significance:

  1. Describe and cite supporting references for the way in which each option being compared has previously been shown to be efficacious or effective, or how the option is commonly used in clinical practice.

Approach: Describe the overall strategy, comparators, methodology, and analyses to be used to accomplish the specific aims.

  1. Study Design:Briefly describe the study design (e.g., individual or cluster randomized trial, nonrandomized [prospective or retrospective] study, or other design [please specify]).
  1. Engagement Approach:Identify the patients and other relevant stakeholders you consulted in determining that the proposed study addresses their needs for evidence to help in decision making. Recommend the potential national organizations that needto be involved in collaborating with you on all aspects of the study, including study planning, execution, and dissemination of study findings. Describe your commitment to engaging them actively in the conduct of the study.
  2. Study Population and Setting:Specify the study population (e.g., age range, level of anxiety severity) and the settings.
  1. Comparators:List the options or clinical strategies being compared, and provide evidence of efficacy or wide use for these interventions. Note that all options must be in current clinical use.
  1. Outcomes:Describe the outcomes that people representing the population of interest notice and care about, including your use of patient-reported outcomes when patients or people at risk of a condition are the best source of information.
  1. Analytic Plan:Describe a priori specific plans for data analysis that correspond to major aims.What are the prespecified subgroup analyses? Briefly discuss the (hypothesized) Heterogeneity of Treatment Effect and its clinical/decisional implications, based on prior evidence.
  2. Sample Size and Power:Provide the total sample size for the main CER analysis and the number per arm (N1, 2, 3, 4 . . .), as applicable.

Prior Relevant Experience

  1. What is your previous experience with recruiting and retaining study participants in trials of similar size, study design, and,in particular, the proposed target population(s)?

Anticipated Impact

  1. If the proposed intervention study aims are met, what factors (e.g., characteristics of the intervention, target environment) will facilitate or impede thesustainability and scalability of the intervention in real-world settings?

Duration and Total Direct Costs

  1. What are the estimated total direct costs and project duration of the proposed study?

a)Provide a brief justification indicatinghow the funds will be used and why the level of funding and duration requested are appropriate. Answers such as “will not exceed $15 million” are not adequate and will be deemed nonresponsive.

  1. Are you requesting a budget with total direct costsgreater than $15 million? (Note that these costs will be taken into account when evaluating your LOI in terms of the value of the research.)

Answer: Yes/No_____

a)If your proposed budget exceeds a total direct cost of $15 million, provide a brief description of how any additional funds will be used, documenting the budget requirements with respect to the scope of the proposed research and the data collection and analysis efforts.

b)If the proposed level of funding cannot be provided, explain the feasibility of conducting the research with no more than $15 million in direct costs.

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PCORI Cycle 1 2018Pharmacological Treatment of Anxiety Disorders in Children, Adolescents, and/or Young Adults PFA: Letter of Intent Template