Yiu-fai Cheung, MD Department of Paediatrics and Adolescent Medicine LKS Faculty of Medicine The University of Hong Kong Hong Kong, China Sharing in GRF Application

Is this an appropriate time to apply? experience, credentials track record Should I publish more on focused clinical topics first? Discussion with mentor(s) Pre-Incubation

What reviewers are looking for scientific merit potential impact novelty solid hypothesis and logical objectives appropriateness and feasibility of proposed methodology credentials of investigators (PI and CoIs) existing facilities Pre-Incubation

Why am I selecting this clinical problem? experience and competence aware of the fields research directions (Blue Ocean strategy) and knowledge gaps competitive edge Incubation

Is this an important clinical problem to study? What is the clinical impact? paradigm shift in the understanding of clinical phenomenon and disease mechanism with long- term implications changes in clinical practice (diagnosis, management) and outcomes changes in health care policies correlative or descriptive versus mechanistic Incubation

Be careful if the proposal is based solely on the following premises this clinical problem has not been studied previously (so-what and why not?) limited data are available (how does your proposal add to the existing literature?) existing data are extremely controversial (how does your study help to resolve the controversy?) recent availability of new technologies (method in search of problem versus hypothesis-driven) personal interest Incubation

Effect of iron overloading on arterial distensibility and endothelial function in patients with beta-thalassaemia major

Developing and Writing Your Research Plan

Hypothesis-driven clinical studies define hypothesis before designing the study Hypothesis (one simple sentence): testable, focused, clearly conceptualized and articulated Primary and secondary objectives: actionable terms (to determine, compare, correlate …..) internal peer review Hypothesis and Objectives

Beware of an unfocused hypothesis and hence unclear objectives just a fishing expedition being overly ambitious Hypothesis and Objectives

With testable hypotheses with achievable objectives, what then is the long-term impact? possible outcome in terms of local relevance and clinical significance and implications Hypothesis and Objectives

Work done by others a concise updated literature review (what is known) identify gaps in knowledge (what is unknown) discuss existing controversies (what is uncertain) justify the need for this study and describe how the study is innovative establish links between the background and the proposed hypothesis and objectives brief recapitulation of the clinical significance (do not overstate the significance) Background

Work done by your group show the expertise (line up collaborators) demonstrate your track record (PI and CoIs) summary of promising preliminary data support your hypothesis show the link to the proposed study demonstrate feasibility help to build the confidence of reviewers Background

Study design case-control study, randomized control trial, epidemiologic survey, other designs how to recruit representative subjects from the target population randomization and blinding procedures use of flow charts / diagrams may be helpful Research Plan and Methodology

Subjects reassure the reviewer of availability of participants (provide supportive data) inclusion/exclusion criteria (justify the criteria and address potential biases) controls (what is meant by normal controls?) Research Plan and Methodology

Intervention and outcome measures comprehensive description of intervention strategy and its implementation potential risks, protective measures, benefits outcomes definition of primary and secondary outcome measures validity and reliability Research Plan and Methodology

Instruments and data collection and procedures description of the instruments (validity, reliability) data to be collected (ensure their inclusion in statistical analysis) Research Plan and Methodology

Sample size calculation and statistical analysis discuss with biostatistician power calculation for primary outcome measure estimate realistic attrition rate framework of statistical analysis address missing data Research Plan and Methodology

Other aspects timetable awareness of and ways to address potential limitations contingency plans in case of roadblocks Research Plan and Methodology

the last to complete the first to be read by reviewers how to engage and sustain their interest simple and concise nature of clinical problem need for this research innovation hypothesis, objectives, methodology clinical significance Abstract

Finally Putting yourself in the shoes of the reviewers conciseness, clarity layout and formatting avoiding jargons and too many abbreviations self-contained proposal need to be taught at times abstract and hypothesis and objectives