Grant assessment (Asia ARVO 2011) 5 areas Significance how impt is disease or tx to human health? Feasibility likely to be impediments?

s? Why is it impt? Specific aims, Background and significance How innovative

What are you going to do? Research methods How you will likely overcome impediments

CV, collaborators, envt, resources Translation more fields Importance Hypothesis or need for data Potential research is creative and novel Relevant to funding agency Broad impluications Topical subject Neglected areas High health benefit

Order: 1. Overview (aims/deigns/significantsce) a. Currently unavailable data b. Test x major hbypotheses c. Could lead to advances that could stimulate techniques for other imaging 2. Specific aims: likely papers a. page b. Broadly define long term objective c. Specific and achievable d. Significance and implications e. Hypothesis important to current field with biological rationale. f. Will improve understanding of either aetiology, r/f or patho of dz g. Opening statement then specific aims. Specifically, we aim to evaluate the following Aim & Hypothesis for each

3. Background what is known, supportive pilotdata, what is missing a. Known vs unknown b. Preliminary vs current c. Directions of field and gaps in knowledge. d. Highlight conflicting results from diff studies e. Positive findings support, negative makes less clear f. Structure: i. Introduction: describe disease and statement g. Make clear links between existing data and proposed study 4. Research plan and methods overview, specific methods, stats methods and study a. Overview b. Population c. Measurement of outcome d. Measurement of variables of interest e. Study operations f. Sample size and power determinations Points 40% preliminary background, 40% methods 20% translation of information Describe selection of source material 5. power, timeline 6. Summary

Clinical trials: endpoint determination based on dz progression? Vision? How defined? Eg. logMAR instead of Snellen Use state of the art methods Measurements of other variables dont overload, include confounders and effect modifiers, consider measurement issues Sample size considerations Tolerable type 1 = 5% Tolerable type 2 = 20 Power of study to detect differences Calculate when sample size fixed ask stats person!

Role of pilot studies What you have done to support the grant Demonstrate collaborators abilities to complete proposal

Budget considerations

Justify every person listed as to what they will do and for how long Tie budget to study schedule and time line

Hypothesis: does your proposed study translate? Research does it read well? Sentence structures. Sequency easy to follow? Conclude well? Young investigators: get onto other peoples grants. How to respond to difficult review/rejection (Salmna Quereshi) Criteria Content is new Improves on an earlier work Interesting or topical Covers a neglected or emerging topic Contradicts earlier work Provides perspective on or reviews a topic

Rejection - Repearts - Topic already well known - Not interested - Fatally flawed - Methods and results dont support the conclusion - Inadequately powered to meet the objective - Authors answer question different to one they posed - Poorly written Responses 1. Provisional acceptance a. Prepare vision later with each of the reviewes and section editors and EIC criticisms addressed sequentially and clearly b. Have criticisms in bold and responses underneath c. Improve other aspects of paper esp language to improve clarity highlight changes in pink, never delete without acknowledging deletion d. Respond quickly e. Revision letter to EIC and section editor 2. Non revisable a. State in revision letter explaining why not b. Clearly highlighted in discussion the weaknesses in manuscript 3. Reject without resubmission a. Root cause analysis prior to submission elsewhere b. Dont i. Ignore legitimate criticisms and resubmit elsewhere without modeification 4. 6 causes

a. Failure of reconnaissance (lit r/v) b. Failure of situational awareness i. Readership and EIC preferences, focus ii. Lack of awareness of previously published papers in journal iii. References to commonly cited articles iv. Manuscripts are perishable c. Design failure i. Under powered ii. Outcome measures changed during course iii. Outcome measure is invalid surrogate for clinical outcome d. Failure to execute i. Methods and introduction are more impt than discussion ii. Title and abstract are v. impt: simple clear and brief. Cinclusion relevant to hypothesis, avoid detailed stats, title should engage readers iii. Simple active language iv. Avoid abbreviation always e.